Tuesday, February 9, 2016

Peptide Vaccine Manufacturing | Interview with Dr. Mimoun Ayoub of CordenPharma


"The concept of designing immunomodulating peptide cocktails and trigger the immune response has been mainly initiated by biotech companies who owns more than 80% of the current cancer vaccine pipeline."

In a recent interview with TIDES, Mimoun Ayoub, Ph.D., Director, Global Peptides & Injectables Platform, CordenPharma, Switzerland, shifts the focus towards the topics that will be addressed in his talk at the upcoming TIDES event. In his talk he will be examining the peptide vaccines that are designed to activate B-cells and killer T-cells to recognize cancer cells as foreign agents. Cancer cells have surface protein modifications such as phosphorylations and glycosylations that differentiate them from healthy cells. The peptide epitopes used are usually fragments from these modified proteins. These "cocktails" of peptide fragments can be further engineered to increase their immune activity and plasma half-life by constraining the peptide backbone through introduction of cyclization or non-natural amino acids in the sequence. The production and analytical challenges related to cocktail peptide vaccines will be discussed.

In the interview, Dr. Ayoub also addresses:
  • The role peptide vaccines play in the in the development of novel cancer therapies
  • Regulatory challenges during the development and manufacturing of peptide vaccine "cocktails"
  • Future delivery methods for administering peptide vaccines

To learn more from Dr. Ayoub, join him at IBC's 18th Annual TIDES event this May in Long Beach, CA where he will be chairing the Peptide Chemistry Manufacturing and Controls track as well as speaking in a session titled "Peptide Vaccine Manufacturing : Drug Substance and Drug Product CMC Challenges" Download the brochure to access the complete agenda and speaking faculty. 


Register for TIDES now and save $500 - To activate your savings, use the code B16180BLOG100  



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Monday, February 8, 2016

The General Evolution of the Vaccine Industry

For a sneak peek at the high caliber of content presented at BPI West, we had industry expert Rahul Singhvi, COO of Takeda Vaccines join us for an exclusive interview.

In this interview, Rahul Singhvi, MBA, the Chief Operating Officer at Takeda Vaccines starts by discussing the general evolution of vaccine industry over the years and what the industry looks like today. He mentions that companies in the vaccine space today tend to be very insular - controlling all aspects of the process - but continues on to say that Takeda is proudly taking a partnering approach and goes on to explain what that means and why it is important. On top of that, Rahul continues to discuss what he feels the greatest needs and opportunities are in terms of technological innovation, development and manufacturing solutions. And finally makes some bold predictions on the vaccine industries future, and the key trend and opportunities that you should watch for.


Interested in learning more? Join us at BPI West - March 14-17 in Oakland, CA. Register before 2/19 with the code BPIWEST16BL and save $300 | To activate your savings, click here.



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Friday, February 5, 2016

Advances in Continuous BioProcessing | Experts from Pall Life Sciences Provide Insights

Pall Biopharmaceuticals' Leader Provides an Update on Significant Technology Advances Enabling Integrated Continuous BioProcessing 

video

There is a lot of talk about Continuous Bioprocessing, but how does the desire for a continuous bioprocess get turned into reality? On October 29th, 2015 at BPI in Boston Michael Egholm provided Pall Life Sciences' view on building a working GMP end-to-end continuous bioprocess. The activity on the project is fast paced and this will be an update on the latest in continuous processing.

Join the Pall Life Sciences team at BPI West for their session on March 14th as they provide a much needed update on technological advances that are enabling integrated continuous bioprocessing.

Interested in learning more? Register for BPI West now and save $300 - To activate your savings, use the code BPIWEST16BL

Pall Life Sciences provides process, pilot and laboratory filtration, separation, purification and fluid handling devices, systems and services, with single-use systems available for all unit operations from cell culture through final formulation and filling.


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Wednesday, February 3, 2016

[Survey] Bioprocessing Efficiency | Enter for a Chance to Win









Maximize Efficiency; Streamline Biopharmaceutical Process Development & Production 

One of the major goals of BPI West it to provide information that you can use to streamline and accelerate process development and production to maximize efficiency from basic research to commercial manufacturing. With that in mind, we would greatly appreciate a few moments of your time to answer the following questions to help us better understand your needs and approaches to accomplishing these goals.


Upon completing the survey, you will be entered into a drawing to win an all-access pass* to BPI West, taking place in Oakland, CA March 14-17, 2016. Learn more about BPI West.

The compiled results of this survey will be distributed as a detailed infographic reportt, depicting the current state and future directions of the biopharmaceutical industry.

We truly value the information you have provided and thank you in advance for taking the time out of your busy day to participate in our survey.

*Offer is not valid for existing or pending registrations, and cannot be retroactively applied. IBC USA & BPI West are not responsible for any hotel or travel costs.


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Tuesday, February 2, 2016

Impurity Guidelines to Oligonucleotides | An Interview with Andrew Teasdale of AstraZeneca


In a recent interview with TIDES, Andrew Teasdale, AZ Impurities Advisory Group Chair, AstraZeneca, United Kingdom examines the scope and applicability of both new guidance (ICH Q3D and ICH M7) and existing guidance (ICH Q3A / Q3B) to Oligonucleotides, looking into practical challenges and how they might be addressed and the potential application of generic, platform risk assessment approaches.


When discussing the impurities that face oligonucleotide developers, Andrew said, "The most common impurities in oligonucleotides are still related substances (oligomeric impurities)". However, this still begs to question what does one need to consider when mitigating risk for these impurities? Access the complete interview now.


To learn more from Andrew about oligonucleotide impurities, join him at IBC's 18th Annual TIDES event this May in Long Beach, CA where he will be speaking in his session titled "Assessment of the Relationship of Impurity Guidelines to Oligonucleotides - Opportunities for Rationale Approaches to Management of Risk". Download the brochure to access the complete agenda and speaking faculty.



Register for TIDES now and save $500 - To activate your savings, use the code B16180BLOG100


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Monday, February 1, 2016

[Interview] K.V. Subramaniam, Chief Executive Officer of Reliance Life Sciences

In this interview, K.V. Subramaniam, MBA, Chief Executive Officer of Reliance Life Sciences, discusses the history of Reliance Life Sciences and their companies evolution over their 13 year history. With K.V.'s extensive knowledge in emerging markets, he discusses what it takes to gain traction in India and other emerging markets... more specifically, he discusses the innovation imperatives for India and other emerging markets; in regards to where he sees needs, and the opportunities for technology and product solutions. On top of that, K.V. discusses how the market itself has changed over the years and what it will look like moving into 2016 and beyond.


Interested in learning more? Join us at BPI West - March 14-17 in Oakland, CA. Register before 2/19 with the code BPIWEST16BL and save $300!


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Thursday, January 28, 2016

Industry Expert Paul Parren, Ph.D. Provides Exclusive Insights on ThinkTank


ThinkTank, is a free knowledge community focused on the antibody engineering field. Ask questions. Share answers. And boost your reputation. IBC Life Sciences, producer of the Antibody Engineering & Therapeutics conference, hosts these conversations to enable efficient knowledge exchange amongst practitioners. Insight is within sight.

ThinkTank has been built for professionals in a mobile world, who need high-quality answers to difficult questions from people with experience and expertise.

One of the many industry experts who actively participate on ThinkTank is Paul Parren, Ph.D., Senior Vice President and Scientific Director, Genmab, The Netherlands – Below you will find snippets of his responses to a variety of questions that have been posed on the platform. To continue your learnings with the Antibody Engineering community, be sure to login to ThinkTank now.


Excerpts from Dr. Parren's insights via ThinkTank;

With all the different antibody modalities to choose from (bispecifics, antibody fragments, antibody mixtures, ADCs and other conjugations, fusions, antibody combinations), how does one decide which approach to use in a specific project? And what are some advantages and disadvantages of these various modalities?

Dr. Parren: Your approach would be guided by the target product profile, i.e. does your application require long/short half-life, antibody effector function yes/no etc. This should eliminate a number of the possibilities. Then the approach becomes empirical in which I would recommend to produce a model antibody in a number of the remaining formats and assess for maximal activity/safety in comparison to competitor drugs.

Which immunotherapeutic antibody mechanisms have shown the most promise in the clinic? And where is this field headed next?

Dr. Parren: Hard to say in general. Preferably a therapeutic antibody engages multiple mechanisms as a single specific mechanism may, for example, not work against all diseased cells or in all anatomical niches. The required mechanisms will in addition be strongly dependent on your intended application.

The development future of non-canonical therapeutic antibodies (such as nanobodies, antibody scaffolds)? 

Dr. Parren: This is a very broad question and therefore not easy to answer in general terms. In my opinion, antibody fragments such as nanobodies, will have their strongest appeal in areas not served by classical, full length, antibodies. That is in areas for which topical or local administration is most appropriate. One could think of ocular injection or inhalation. In addition, applications which require a short in vivo half-life are attractive, e.g. imaging or in which short, temporary, target inhibition is important.

Should patients be pre-screened (genetically or epigentically) in order to achieve the maximum efficiency/efficacy of antibody therapy?

Dr. Parren: Prescreening of patients to be treated with targeted therapies is important to achieve maximal effects and proper patient selection is the future. Choosing the right biomarker or companion diagnostic will be critical however. Genetic prescreening may only be suitable for some applications, i.e. when screening for target expression, an antibody-based diagnostics may be more appropriate. The impact of the microbiome on antibody therapy is a relatively new field, which needs substantial further investigation, but definitely an area to watch.

The current therapeutic antibodies are targeting membrane-bound or circulating proteins. Any efforts or prospects on targeting intracelluar proteins using antibody/derivatives?

Dr. Parren: The best progress on targeting intracellular proteins is in the targeting of MHC-peptide (e.g. WT1 and NY-ESO-1) complexes presented on the surface of tumor cells with antibodies or affinity-matured TCR antibody-like constructs. Several groups are trying to target antibodies to intracellular compartments, but none of these efforts is ready for prime time yet.



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Wednesday, January 27, 2016

Novel Delivery Strategies for Oligos and Peptides - $600 Savings End Friday, 1/29



Register by this Friday, January 29th and receive up to a $600 savings – Use the code B16180BLOG100 to save. Click here to register.

Recent advances in delivery strategies have paved the way for improved targeting, efficacy and patient usability for the oligonucleotide and peptide therapeutic industry. Ensure that your team is up-to-date on the latest drug delivery strategies for accelerated product development by attending IBC's 18th Annual TIDES meeting, held May 9-12, 2016 in Long Beach, California.

Register today to attend the industry's #1 forum for oligonucleotide and peptide leaders to build successful partnerships and accelerate products from early discovery through late-stage development and commercialization.

Industry Experts Present Novel Delivery Strategies for Oligonucleotides and Peptides:


Centyrins as Targeting Agents for Next-Generation Modular Therapeutics
Vadim Dudkin, Ph.D., Scientific Director, Centyrex, Johnson & Johnson

The biophysical properties of Centyrins make them ideal as targeting agents for a variety of novel delivery technologies. Centyrex is exploiting this platform via novel therapeutic applications aimed at addressing outstanding challenges in...(continue reading)
________________________________________

Treatment Opportunities for Cystic Fibrosis Using Aerosolized Antisense Oligonucleotides
Shuling Guo, Ph.D., Director, Antisense Drug Discovery, Isis Pharmaceuticals

Cystic fibrosis (CF) is one of the most common life-threatening genetic diseases affecting ~30,000 people within US and ~70,000 worldwide. Lung disease is the major cause of morbidity and mortality in CF. Antisense oligonucleotides (ASOs) administered by aerosol delivery distribute broadly into...(continue reading)
________________________________________

ITCA 650 (Exenatide Delivered Continuously via a Matchstick-Size Subcutaneous Osmotic Mini-Pump) an Investigational Therapy for Type-II Diabetes
Scott Peterson, Ph.D., Executive Director, Corporate Development, Intarcia Therapeutics, Inc.

ITCA 650, an investigational therapy for T2DM currently in Phase 3 clinical trials, is an osmotic mini-pump that can subcutaneously deliver exenatide (a GLP-1 receptor agonist) for extended periods of time. This presentation will cover the technology behind...(continue reading)


For more session information, download the complete agenda.



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Thursday, January 21, 2016

Evaluating the Oligo and Peptide Market and Investment Landscape

The global oligonucleotide and peptide therapeutic market is experiencing rapid growth due to the constant development of new technologies, emerging markets and novel drug classes. Stay at the forefront of global investments, deals and developments in the oligonucleotide and peptide market by attending IBC's 18th Annual TIDES meeting, held May 9-12, 2016 in Long Beach, California.

Industry Experts Provide Updates on the Oligonucleotide and Peptide Market and Investment Landscape: 


1. The Oligo Therapeutics Market Landscape – A 15 Year Retrospective on Market Trends, Deals, Investments, and Key Clinical Developments with a Look to the Future Gary Carter, Director of Strategy and Marketing, Nucleic Acid Solutions Division, Agilent Technologies, Inc. Over the last 15 years the number of oligo therapeutic programs has grown from roughly 100 programs in 2002 to almost 300 in 2015, driven by the emergence of new classes such as siRNA, miRNA, and exon-skipping therapeutics, coupled with corresponding increases in direct investment and deal values. Read full abstract here.

2. Redefining the Therapeutic Peptide Business in the 21st Century Rodney Lax, Ph.D., Business Consultant, PolyPeptide Group The last 30 years has seen significant changes in our expectations for peptide therapeutics. While the peptide manufacturing industry has consolidated during that period, the complexity of the products themselves, the scale of manufacture, and number of potential delivery platforms have continually increased...(read full abstract here )

3. Personalized Medicine Patent Law Update Laura A. Labeots, Ph.D., J.D., Partner, Husch Blackwell Brief summary of Subject Matter Eligibility of patents based on natural products (35 USC 101) will be presented, along with discussion of practical implications of developing case law surrounding personalized medicine and nucleic acid diagnostics and therapeutics...(read full abstract here)

The #1 Meeting for Oligos and Peptides!

• 800+ attendees representing 25 countries help you forge new business and scientific collaborations;
• 100+ speaker presentations across 5 tracks provide a customized agenda of solutions for your company’s current challenges;
• 70+ exhibitors demonstrate the latest products and technologies to accelerate your therapeutic to market;
• 40+ poster presentations keep you abreast of cutting-edge industry and academic research

For full program details, download the TIDES 2016 brochure today!

Register by January 29 and Receive a $600 Savings! Use unique code B16180LINK100.

Best,
The TIDES 2016 Team

Visit the website.
Follow us on Twitter: @ibcusa #ibcTIDES
Read our blog: www.futurebiopharma.blogspot.com


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Wednesday, January 20, 2016

8 Reasons Why You Can't Miss BPI West | Plus! Register by Friday, 1/22 and Save $400


8 Reasons Why You Can't Afford to Miss BPI West:
1. First and only phase-based format event that fosters the collective sharing ideas, strategies and solutions across departments to improve speed, cost and quality at every stage of development
2. Breakdown the barriers and collaborate across stages of development to achieve end-to-end integration
3. Discover the latest breakthroughs on successfully implementing continuous processes and linking them together to achieve fully continuous processing from cell culture through to drug substance
4. Accelerate the design and development of novel drug substances for next generation therapeutics by integrating candidate selection and early development
5. Develop strategies for fast tracking early stage biologics and managing the life cycle of a break through therapy designated product
6. Speed up and streamline the transition into development by utilizing manufacturability assessments, automation, and QbD in late stage discovery and R&D
7. Implement disruptive technologies and achieve operational excellence to drive manufacturing efficiencies and minimize costs
8. Uncover the future of single-use systems and next generation facility design, modelling and management in current and emerging markets

Want to learn more about the event? Download the brochure.

Register by this Friday, January 22nd and receive up to $400 in savings - Use the code BPIWEST16BL to save.




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Tuesday, January 19, 2016

[Podcast] Biodevelopment Centers; Flexibility, Modular Facilities & the Benefits




Many people think about flexibility in many different ways. One of which, ensure the ability to change very quickly the set-up of pants to adapt the various parts of the manufacturing suites. Flexibility is not only about pushing in or pulling out some new equipment, it’s also about changing completely the way you work in the plant.

In regards to modular facilities, S├ębastien Ribault, Ph.D., Director Biotechnology/Life Science, Head of BioDevelopment Center, EMD Millipore mentioned that they have had a number of different experiences, the first of which was modifying an existing Biodevelopment Center. He said, “We divided the building into two parts. We’ve kept 50% stainless steel and we’ve modified the remaining 50% by making fully single-use” and it turns out that during the modification process, “we kept running the plants”. Dr. Ribault continued “We noticed then, that you can run the plants while making modifications in you are using flexible concepts.”

In this podcast interview, Dr. Ribault discusses:
  • What it means for your Biodevelopment Center to be flexible
  • More experiences relating to modular facilities
  • The benefits he has experienced (at the expected level)
  • The benefits he has experienced (that were not anticipated)
  • The next steps

Listen to the podcast or download the transcript here.

Want to learn more? Then join us for BPI West, March 14-17th in Oakland, CA. Rates increase Friday, 1/22 – register now with the code BPIWEST16BL and save $400!
 


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Monday, January 11, 2016

[Podcast] Disposable Membrane Chromatography Systems for mAb Purification




While around 75% of therapies in the market are based on antibodies and the classical way of purifying them in the bed chromatography approach. This method of purification is only good for a product with a long shelf-life or is in high demand. What about the products with low demand or are only for therapeutic and clinical use?

Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon says “if the product has got a long shelf-life, a long demand, that makes sense for us to invest in it and create a good infrastructure, a good footprint and bear the high operational and capital expenditure. But, if the product is in the development phase and you need to have some quick lots of drugs so that we can try clinically, that does not make sense. And, by moving to the disposable technology we are also reducing the chances of cross contamination.”

In this podcast interview, Dr. Siddhartha Shrivastava explains:
• The importance of disposable membrane chromatography systems for mAb purification
• Why disposable technology is more appealing compared to conventional technology
• The cost effectiveness of disposable technology
• Large scale testing of disposable membrane chromatography systems

Listen to the podcast or download a transcript here!

Editor’s note: Interested in learning more about the importance of disposable membrane chromatography systems for mAb purification? Then join us for BPI West, March 14-17th in Oakland, CA.

Download the event agenda or visit the event website.

Save $400 - Register with the code BPIWEST16BL




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Friday, January 8, 2016

Leaders from Amgen and Celltheon Set to Keynote BPI West

Specialists from every discipline and stage of development aim to achieve the common goals of optimizing speed, reducing cost, and improving quality from basic research to commercialization. What helps the learning curve is to benchmark best practices from the exclusive experience of the top minds in the biopharmaceutical industry.

The leading experts from Amgen and CellTheon will get together at BPI West in Oakland, CA (March 14-17, 2016) to share their exclusive case studies and new data and evaluate the different approaches that are being utilized to streamline and accelerate development and production across:

- Basic Research & Discovery
- Early Stage Process Development & Pre-Clinical Manufacturing
- Late Stage Process Development & Clinical Manufacturing
- Commercial Manufacturing & Beyond

The following keynotes have been announced:



Amita Goel, MSc. Founder, and CEO, Celltheon will be presenting on Innovative Technologies for the Expression of Next Generation Bio Therapeutics;


Rohini Deshpande, Ph.D. Executive Director, Process and Product Development, Amgen will give a talk on End-to-End Integration;



Ran Zheng, Ph.D., Executive Director, Plant Manager, Amgen is joining BPI West with a presentation called “Unleashing the Power of Innovation to Tackle Biomanufacturing's Greatest Challenges, Fuel Growth and Drive Value Creation.”


To see more speakers and to get the most up-to-date brochure, click here
Don’t miss the chance to learn the innovative strategies and technologies and help move the pipeline of next generation drug candidates closer to approval!

Register before Friday, January 22nd and save $400 – Simply use the code BPIWEST16BL, to save. 



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Monday, January 4, 2016

Cell therapy blockbuster or safe and cost effective supply chain?

By Mystery Blogger

The golden opportunity of a blockbuster (drug selling more than $1bn per year) might have to be revisited for many Big Pharma and SMEs which invested in cell and gene therapy development. Given the pressure due to patents expiring and biosimilar competition, this should sound as a massive relief. This is probably due to the fact that these products, arguably more than other drugs, were born in University Research centres and therefore the focus has been on development. Bio-preservation has been regarded as a trivial afterthought. Not many developers seem to pay much attention to stability studies which are paramount in order to design and develop the best supply chain option for the product. As the industry moves from scientific curiosity to sustainable commercialization, we know that preserving viability and potency of cell based products is anything but simple. If for vaccines and monoclonal antibodies, store and transport at 2-8 ⁰C is enough to preserve the product for 18 months or even more, it is not that simple for cell based products. Bio-preservation strategies will depend on cell type, temperature, excipients, primary container (materials and shape). There are mainly 3 bio-preservation methods for cell therapy medicinal products:
-          Controlled ambient temperature:  15-25 ⁰C, limited shelf life
-          Hypothermic storage : 2-8 ⁰C, prolonged shelf life but normally requires addition of protective agents ( like HypoThermosol, BioLife Solutions)
-          Cryopreservation: - 80 ⁰C or below. It requires addition of toxic cryoprotectants (like DMSO) which protects cells from ice crystals forming during cooling.

Because it normally enables the longest shelf life for the cell-therapy products, cryopreservation is often regarded as the gold standard or rather the “hoped” standard. Although it potentially equates to a more stable product, the costs associated with dry nitrogen shipping and storage may encourage developers to look at -80°C or even -20°C (should stability data allow these temperatures). Cheaper storage and shipping fees will lower cost of goods. 

Another influencing factor for the storage conditions of the product could also be the nature of the illness being treated. Acute illnesses being treated by autologous therapies may not require long term storage of product if the therapy is genuinely curative in nature. Furthermore, not every cell therapy product can be effectively cryopreserved (with currently available technology and methods). 

World leading research groups have proved and disproved the potential negative effect of cryopreservation on the therapeutic effect of cell-based medicinal products. Many readers will agree there are so many variables to take into consideration that perhaps nobody will ever be able to confidently state that cryopreservation is safe and effective to use for cell-based products. It might affect a particular mechanism of action while being completely innocuous for others. Therefore, the key concern for developers should be to validate a relevant potency assay and get the stability data necessary to design the best bio-preservation option on a case by case basis.

Here is a list of marked cell-based products, how many of them are cryopreserved?



































However, preserving viability and potency is only the first step. For both autologous and allogeneic products, there are three key points to consider: 

§  Safety: Full traceability of the entire supply chain, from donor to patient.

§  Scalability: Operations should be designed in a way to manage an increasing number of patients, from 1 per week in phase I to 10 or more in Phase III and commercial stage. If Novartis hopes to launch its CTL019 in 2017, this might translate in as many as 200 patients per week.

§  Flexibility: This is important for both the company and the patient. The former needs to coordinate with the hospital when to ship the product and the latter, who might often been seriously ill, has too travel to the hospital on a set day.


It is the first time in history that big pharma company or SMEs have to design a more service-based model than a product-based.  For a physician and for the patient, what will ultimately matter is that the drug does the trick, especially for life threatening diseases.  As we move towards a more individualized medicine, one might envision that pharmaceutical companies will make more profit from the service they provide than from their products. Many industries have already witnessed such paradigm shift. Companies like TrakCel are leading the way in proving cell and gene therapy manufacturers with the tools to deliver the right product to the right patient at the right time. 

According to TrakCel, costs can also be reduced by maximizing the available assets and optimizing headcounts necessary in the supply chain. For autologous products, where two procedures are necessary, it will be possible to collect the sample from the patient in a hospital nearby and limit the travel to a specialized hospital for the treatment with the finished product. More flexibility will also come from a longer shelf life. Shelf life as short as 18 hours are not commercially viable for large patient populations. Even by using specialized express couriers, the risk of failure linked to scheduling can be very high. More innovative ways to increase the length of the shelf life are under development. Research groups are even going as far as lyophilize the product. 

So far it has been mainly applied to red blood cells preservation. If this will ever be possible with other cell types, it can be a game changer in the industry. Nurses and doctors could easily re-suspend the product as they are used to doing with more conventional drugs, but perhaps this is a topic for another blog post. 


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Thursday, December 17, 2015

Announcing: TIDES 2016 Keynote Lineup | Brochure is Now Available



IBC’s 18th Annual TIDES meeting is coming to Long Beach, CA May 9-12, 2016. TIDES is the industry's #1 forum for oligonucleotide and peptide leaders to build successful partnerships and accelerate products from early discovery through late-stage development and commercialization.

RVSP by January 29th, 2016 with code B16180LINK100 and receive $600 savings off the standard rate. Secure your best rate now.

Keynote and Featured Speakers Provide Novel Strategies to Accelerate Product Approval:

  • Mixed-Incretin Receptor Biochemical Signaling at Multiple Receptors
    • • Richard DiMarchi, Ph.D. Professor of Chemistry | Indiana University
  • Drisapersen: Case Study
    • • Robert Baffi, Ph.D., Executive VP, Technical Operations | BioMarin Pharmaceutical
  • Quark's Long History of Oligonucleotide Development
    • • Danny Zurr, Ph.D., Chairman and CEO | Quark Pharmaceuticals Inc.
  • Technologies for Targeting Molecules to Sites of Disease
    • • John Reed, M.D., Ph.D. Global Head | Roche Pharma, Switzerland


TIDES by the numbers:
  • 800+ attendees representing global innovators, suppliers and thought-leaders who can expand your pipeline and grow your business
  • 100+ case studies and new data presentations providing novel strategies to accelerate your product to market
  • 70+ exhibitors showcasing new technologies to improve your process development, analytical and manufacturing/scale-up efforts


Sponsorship and Exhibition Opportunities
Showcase your expertise to 800+ global buyers by becoming an event sponsor or exhibitor at TIDES. A wide variety of options are available to meet your company's goals and budget. Contact Patrick Gallagher pgallagher@ibcusa.com for pricing and package details.





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Tuesday, December 15, 2015

BPI West Brochure is Now Available for Download | Save $500 Now, Rates Increase Friday

Break down the barriers between departments and stages of development at BPI West - the industry's first and only phase-based format event! 



BPI West is one-of-a-kind phase-based format is designed to capitalize on the latest approaches and technologies to help move the pipeline of next generation drug candidates closer to approval. Collectively share ideas, strategies and solutions to improve speed, cost and quality from basic research to commercial manufacturing.

Top 3 Reason Why You Can’t Miss BPI West:
  1. Learn how to streamline and accelerate the development to approval process by collaborating at the interfaces of discovery, R&D, process development, and manufacturing
  2. Discover the latest tools, technologies, and strategic approaches to increase efficiency, productivity, and cost savings at every stage of development
  3. Foster the cross-fertilization of new ideas and perspectives to reach new levels of clinical and commercial success

This new format will bring together experts from every discipline and stage of development to achieve the common goals of optimizing speed, reducing cost, and improving quality from basic research to commercialization. Benchmark best practices, hear exclusive case studies and new data presentations at BPI West in Oakland, CA.

Don't forget! This Friday, December 18th is your last chance to save up to $500! Use the code BPIWEST16BL to save - Register here.



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Monday, December 14, 2015

BioProcess International Conference 2015 - An Overview for Anyone Who Missed It!

by Brandy Sargent

Introduction
While attending this year’s BioProcess International Conference (BPI) in Boston last month, I was excited because it seemed to be a larger turnout then I’d remembered from previous years. BPI recently confirmed that it was in fact the largest attendance in BPI’s twelve-year history. In addition to the larger turnout, the content felt fresher and very relevant to the current challenges and potential solutions facing the industry. BPI provides talks focused on improving the manufacturing process for biopharmaceuticals, enables industry networking opportunities, and the chance to see the latest products and technologies.

Conference Highlights
For me one of the biggest highlights of the conference was the keynote, “Amgen’s Next-Generation Biomanufacturing Facility by Kimball Hall, Vice President Manufacturing, Amgen Singapore Manufacturing Pte. Ltd. In the talk Ms. Hall describes the 200 million dollar next generation manufacturing facility Amgen built in Singapore. The facility was built in less than two years, half the time of a more traditional facility, and is state of the art in terms of innovative technologies. One of the enabling technologies used in the facility is single-use technology. The facility is over 90% single-use, in fact they only need one autoclave. The facility also incorporates continuous processes and relies on the concept of closed system manufacturing.

Ms. Hall describes how they have implemented a closed system approach to allow for a central manufacturing suite where upstream and downstream can be conducted in the same room. They are using smaller, single-use bioreactors coupled with continuous processes in downstream and real time quality analysis to ensure both an efficient process and a closed system. Ms. Hall states that using this manufacturing approach, they have been able to achieve improvements in yield and reduction in cost per gram.

In addition this closed system approach also permits their solution prep area to operate for both media and buffer prep with closed raw material bags, anti-static powder transfer sleeves and connections to 5,000 L single-use mixing vessels ensuring material stays closed within its equipment. To move solutions from the prep room to manufacturing, they have built openings in the walls, which allow solutions to be pumped through this opening into the other room. Material can also be pumped from the central manufacturing suite through an opening in the wall into the final purification room.

Ms. Hall addresses possible environmental impact concerns about the amount of single-use materials by walking through the environmental impact. First, they use less water for heating, cooling and cleaning. The facility overall has a smaller footprint with lower air quality classifications, thus reducing energy consumption and lowering emissions. They have can achieve solid waste reduction due to the smaller reactor size and they are working on recycling the bags and are with a group developing a way to incinerate them for biofuel.

Responding to a question about perceived regulatory risk for this next generation facility, Ms. Hall said that they have met with regulatory bodies along the way, who have been positive but have always said “we’ll have to see on inspection”. They would like it to be licensed as is but have risk mitigation plans in place for how to accommodate any required changes.

One thing that Ms. Hall also makes clear is that the relationships with suppliers have been critical. The suppliers are deeply embedded in this process and she even remarked that there were employees from the supplier companies sitting in her cafeteria during performance lot runs, waiting to help solve any problems that might arise. With the increasing complexity of these technologies, it is key that the relationships with suppliers be strong and that there is trust. Specifications and product details must be shared back and forth so that the best process can be developed and if any problems arise they can be addressed quickly.

As the question and answer session began, one person stood up to ask a question, I’m sorry I didn’t catch her name, but she called the building of this facility “Brave.” Initially it struck me that she used that that term to describe the building of this facility, but upon further reflection I understand why. In building this facility, Amgen has really committed to changing the biomanufacturing paradigm. They have invested incredible amounts of time and resources into a project that has no absolute assurance of regulatory licensing and have shared these details publically as a guide for others. For the industry to evolve it takes a company to embrace new technology and to “go first” to prove that it is feasible and that it can receive approval from the regulatory bodies. The first or firsts must pave the way before others feel comfortable to do it as well. To some in the industry who have been considering this kind of manufacturing platform, but have been waiting to see what will happen, I can see how this move may be considered brave. For a person who has been covering these innovative technologies and was able through Ms. Hall’s talk to see it all put together into one facility, for me it was inspiring.

Another really interesting talk was the keynote on “What is the Future of Continuous Processing – What is the Time Frame for Implementing Fully Continuous Processing in Commercial Production?” by Konstantin Kostantinov, Ph.D., Vice President, Technology Development, Genzyme. Genzyme has long been a proponent and pioneer for continuous processes in biomanufacturing. At the BDP conference earlier this year, there was a wonderful talk given by Dr. Veena Warikoo, Director, Purification Development, Genzyme on their concept of the bioprocessing facility of the future. Please see, “Continuous Bioprocessing – The Biomanufacturing Model of the Future?” for more details.

Other conference highlights this year included:

  • Keynote presentations from Merck, Novartis, and the Duke Human Vaccine Institute
  • A pre-conference symposium that had an entire track dedicated to Cell Therapy
  • Ask the Regulators Open Forum
  • Bioprocessing Problem-Solving Moderated Discussions
  • Town Hall Forums
  • BPI Theater Panel discussions on “Accelerating Biopharmaceutical Development and Manufacturing” and “CMO Panel Discussion on Perspectives and Lessons Learned on Overcoming Challenges with Tech Transfers and Biomanufacturing,”


Different Discussions by Conference Track
There were some overall themes this year that I felt were a continuation of many great discussions that were presented at the BDP Conference earlier this year including continuous processing in both upstream and downstream and implementation of closed systems. This is by no means an exhaustive list, but some highlights of the talks I attended by track include:

Cell Culture
  • Perfusion and continuous processes continue to be a hot topic
  • Several talks on novel approaches to cell line development including talks on CRISPR/Cas9 technology and how this can be applied to cell line development and production.
  • Good discussion surrounding glycolsylation and how to achieve consistentcy. This included discussions around how media is involved in that process and predicting glycosylation profiles using metabolic data.
  • Media improvements and using high throughput approaches to process development and media screening.

Recovery and purification
  • In downstream, just as in upstream, implementation of continuous processes was a hot topic.
  • Several discussions around using new recovery and purification technologies to improve overall efficiency and purification
  • Looking at non-chromatographic purification of proteins
  • High throughput process development strategies.

Manufacturing strategy

  • Facility design incorporating the ballroom suite or central manufacturing suite approach.
  • Closed systems as a way to enable more flexible facilities, see “Closed Systems in Biomanufacturing Offer A Variety of Benefits,” for more information.
  • Continued process verification (CPV) strategies
  • How to utilize facility design, single-use technologies and bioprocess automation in BRIC countries.
  • Data collection, data management and bioprocess automation.

Drug Product Manufacturing and Fill-Finish Processing

  • Implementing PAT tools and applying QbD
  • Streamlining and integrating drug substance and final drug product manufacturing
  • New strategies for aseptic filling
  • Several talks on particulates and appropriate approaches

Analytical, Formulation and Quality
  • Talks on integrating critical quality attribute monitoring and multi-attribute monitoring and control.
  • High throughput analytical assays for process development support and quality control
  • Many talks on biosimilars and product quality, characterization and comparability.
  • Good discussion on supplier relationships and ensuring raw material tracking and control.

I will cover several of these areas in more detail in the coming weeks – stay tuned. In 2016 …

A new BPI West will make its debut March 14-17, 2016 in Oakland, CA and will be the West Coast compliment to BPI in Boston October 4-7, 2016. Register with the code BPIWEST16BL and save $100 off the current rate.


This overview of BPI was contributed by Brandy Sargent, Editor of Cell Culture Dish. View the original post in its entirety here. 



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Friday, December 4, 2015

Antibodies as Drugs: A Lesson from Before the Antibiotic Era

This post was contributed by Twist Bioscience


'His penicillin will save more lives than war can spend’ was the tagline accompanying a serious-looking Alexander Fleming on the cover of the May 15th, 1944 issue of TIME Magazine. With his discovery of penicillin came the antibiotic era of medicine. However, when one giant rises, another must fall. Serum therapy was, almost overnight, systematically dethroned as the accepted treatment for infectious diseases.

The cover of the May 15th 1944 issue of TIME magazine, which features Alexander Fleming shortly after his discovery of Penicillin. Source.

Serum therapy, the treatment of an infectious disease by injection of an immunized animal’s blood serum, was first used to cure disease in the 1890s. In the 40 years it took for penicillin to be discovered, serum therapy treated a swath of diseases including tetanus, diphtheria, measles and chicken pox.

By inoculating an animal with a dead pathogen, the animal’s antibody-rich immune sera could be extracted. Injecting the immunized animal sera into patients lead to prophylactic, bactericidal, antitoxic and protective benefits. However, it would take around six months to develop a serum, and even then only around 40% of patients would show improvement, making antibiotics were a better solution1.

Today, with the threat of antibiotic resistance looming, antibody treatment is reinstating itself into the next era of medicine. Significant developments that enable us to mass-engineer an antibody’s binding domains have occurred in recent years. Our ability to screen candidates for highly efficient binding, and grow them into concentrated sera of monoclonal antibodies has also drastically improved.

With this, antibody therapy has become accepted into routine clinical practice. Antibody research is now at fever pitch, with thousands of published clinical trials on PubMed today.

Monoclonal antibodies have incredible potential in disease and disorder treatment, due to their ability to explicitly bind specific molecules. The immunosuppressant Muromonab-CD3, given to organ transplant patients, was the very first to be approved by the FDA for human use in 1985. Since its approval, many monoclonal antibodies have now been cleared for use, or are advancing through clinical testing. Disease targets include Crohn’s disease, cancer, asthma, psoriasis, diabetes, HIV, influenza and Alzheimer’s disease.

Importantly, antibody-based therapies are moving toward completely humanized monoclonals (as opposed to those sourced from mice). Research focuses on engineering low toxicity, high target specificity and improved manufacturability – all characteristics bolstered by the advent of synthetic biology, especially massively multiplex DNA libraries.

These vast libraries contain around 1010 different antibody sequences, representing every possible combination of mutations at particular points within an antibody’s variable regions. The single set of mutations that confers perfect, high-specificity binding to an antigen of interest can then be fished out with a number of high throughput screening technologies. Such advancement has been pivotal to antibody therapy research, pushing engineering costs down, reinforcing efforts to treat complex diseases with global reach, such as cancer.

The many ways an antibody can be engineered to destroy a tumor cell. Source: (Chao et al., 2012)

In addition to DNA libraries, advances in next-generation sequencing-based diagnostics have opened new avenues for targeted, personalized, antibody-based therapies. By sequencing a tumor biopsy, it is possible to identify specific cancer-related surface antigens that are overexpressed – known as the ‘oncotype’ of the patient’s tumor. The corresponding antibody treatment can then be administered.

One well-known example of a cancer-treating, FDA-approved monoclonal antibody is Herceptin – for treatment of HER2-positive (HER2+) breast cancer oncotypes. In a large fraction of aggressive breast cancers, HER2 is overexpressed causing accelerated cellular proliferation. Herceptin targets HER2 receptors, blocks their signaling pathway, and attenuates tumor growth and proliferation. In a 10-year study of 4,000 women with early-stage HER2+ breast cancer, treatment with Herceptin showed a 37% increase in overall survival and a 40% increase in disease-free survival compared to a cohort treated only with chemotherapy2.

A vial of the breast cancer fighting, monoclonal antibody - Herceptin. Source.

Herceptin binds specifically to its cancer-specific antigen, however, oftentimes antigens are shared between cancer and some of the body’s own cells, causing the destruction of healthy tissues.

Yvonne Chen of UCLA, who spoke at the recent 2015 Synthetic Biology Congress in London, discussed her research on integrating synthetic biology and antibody engineering to solve this problem. Her group engineered antibodies to contain additional binding domains – so one antibody will only have strong binding if two antigens are present. This ensures the antibodies exclusively bind to a specific cancer cell.

Synthetic biology tools are revolutionizing high-throughput antibody engineering. As the cost of writing DNA decreases with new methods of DNA synthesis, the speed of development will increase. Simply, pharmaceutical and biotechnology companies will be able to test more options to improve specificity and manufacturability. In turn, this will enable highly targeted and highly beneficial therapies for the hardest-to-treat diseases, which can be delivered to patients worldwide.



About Twist Bioscience
At Twist Bioscience, our expertise is synthetic DNA. We have developed a proprietary semiconductor-based synthetic DNA manufacturing process featuring a 10,000-well silicon platform capable of producing synthetic biology tools, such as oligonucleotides, genes, pathways, chassis and genomes. By synthesizing DNA on silicon instead of on traditional 96-well plastic plates, our platform overcomes the current inefficiencies of synthetic DNA production, and enables cost-effective, rapid, high-quality and high throughput synthetic gene production. The Twist Bioscience platform has the potential to greatly accelerate the development of personalized medicine, sustainable chemical production, improved agriculture production as well as new applications such as in vivo diagnostics, biodetection and data storage. For more information, please visit www.twistbioscience.com. Twist Bioscience is on Twitter. Sign up to follow our Twitter feed @TwistBioscience at https://twitter.com/TwistBioscience.






1. Glatman-Freedman, Casadeval. Serum Therapy for Tuburculosis Revisited: Reappraisal for the Role of Antibody-Mediated Immunity Against Mycobacterium Tuburculosis. Clin Microb Rev. 1998.

2. Perez et al. Trastuzumab Plus Adjuvant Chemotherapy for Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Planned Joint Analysis of Overall Survival From NSABP B-31 and NCCTG N9831. J. Clin. Oncol. 2014.


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Monday, November 30, 2015

Celebrate Cyber Monday with 25% Off IIR and IBC Pharma and Life Sciences Events

Use code CYBER25 for 25% off the current rate TODAY ONLY. For this exclusive savings use code CYBER25 to register today, November 30th for all the below IIR and IBC Life Sciences pharmaceutical and life sciences conferences:

Antibody Engineering & Therapeutics
December 7-10, 2015
San Diego Convention Center
San Diego, CA
Discount code: CYBER25
Download the brochure: http://bit.ly/1MZnpHL

RIM
Regulatory Information Management Summit
December 14-15, 2015
Ritz Cartlon
Washington DC
Discount code: CYBER25
Download the brochure: http://bit.ly/1lU3rYj

FDA/CMS Summit
December 14-15, 2015
Washington DC
Discount code: CYBER25
View the agenda: http://bit.ly/1lpMvs8

Drug Delivery Partnerships
January 20-22, 2015
PGA National Resort & Spa
Palm Beach Gardens, FL
Discount code: CYBER25
Download the brochure: http://bit.ly/1QPkxU0

Asia TIDES
February 24-26, 2016
Westin Miyako Kyoto
Kyoto, Japan
Discount code: CYBER25
Download the brochure: http://bit.ly/1lU53S2

ePharma
February 29-March 2, 2016
Sheraton Times Square
New York, NY
Discount code: CYBER25
Download the brochure: http://bit.ly/1YD9hLV

BioProcess International Conference & Exposition West
March 14-17, 2016
Oakland Marriott City Center
Oakland, CA
Discount code: CYBER25
View the preliminary agenda: http://bit.ly/1OzE7A6

TIDES
May 9-12, 2016
Long Beach Convention Center and Entertainment Center
Long Beach, CA
Discount code: CYBER25
Download the brochure: http://bit.ly/1OqjtEp

We hope to see you at our 2015-16 events!

*All registrations are subject to approval. Discounts cannot be retroactively applied*

Cheers,
The IIR and IBC Life Sciences Teams






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Friday, November 20, 2015

Join Think Tank, a knowledge community focused on the antibody engineering field

 

We are pleased to announce the launch of Think Tank, a free knowledge community focused on the antibody engineering field. Join us! IBC Life Sciences, producer of the annual Antibody Engineering & Therapeutics conference, hosts these conversations to enable efficient knowledge exchange amongst practitioners. Insight is within sight.

This easy-to-use Q&A platform will enable you to:
  • Ask experts for advice
  • Share your knowledge
  • Build your expertise
This community has been built for professionals in a mobile world, who need high-quality answers to difficult questions from people with experience and expertise. We invite you to join and start using it to get expert answers to your questions and to offer your own insights to others. Together we can transform the antibody-engineering field.

Please join Think Tank and start connecting with experts and exchanging knowledge.

We look forward to seeing you on Think Tank!



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