Friday, May 22, 2015

Social Flash Sale! 25% off the Standard Rates to BPI China and Antibody Engineering China!

Register with code SAVE25 to activate your 25% discount off the standard rates to IBC’s BioProcess International Conference and co-located Antibody Engineering China Conference taking place August 12-13, 2015 in Shanghai, China.

Visit the BPI China Website Here: http://bit.ly/1FsH7tP
Visit the Antibody Engineering China Website Here: http://bit.ly/1F1xYVQ

This 25% discount limited-time offer expires on Tuesday, May 26th. Register using the below links and use the code: SAVE25

Click Here to Register for BPI China: http://bit.ly/1FsH7tP
Click Here to Register for Antibody Engineering China: http://bit.ly/1F1xYVQ

Don’t miss out on the most comprehensive biologics event in Asia covering the entire spectrum of antibody, protein and biotherapeutic development from discovery and preclinical/clinical to process development and manufacturing.

Hear from the below dynamic keynotes on:
  • Multi-specific Biologics
    Robert Friesen, Ph.D., Janssen R&D, LLC (Johnson & Johnson), USA
  • Antibody Lead Discovery & Optimization
    Rene Hoet, Ph.D. Bayer Healthcare, Germany
  • Analytical Control from Phase I to Post Approval
    Sherry Guo, Ph.D. F. Hoffmann-La Roche Ltd., USA
  • And more!
Download the BPI China Brochure Here: http://bit.ly/1PATAUp
Download the Antibody Engineering China Brochure Here: http://bit.ly/1Hzqj8b

Activate your 25% savings now with code SAVE25! Offer expires 5/26

Click Here to Register for BPI China: http://bit.ly/1F1xYVQ
Click Here to Register for Antibody Engineering China: http://bit.ly/1F1xYVQ

Qualifications, rules and regulations:
Offer cannot be applied retroactively to confirmed or pending registrations from today's date and prior. 25% discount cannot be combined with any team discounts or other promotions and/or discount offers. Discount is only valid from May 22– May 26, 2015. All registrations are subject to IBC approval.

Best,
The BPI China and AntiBody Engineering China Teams
@ibcusa
#BPIChina
#AntibodyEngChina


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Friday, May 15, 2015

Last Chance to Save Up To $550 off Immuno-Oncology

As research in cancer immunotherapies continues to rapidly evolve, it is critical to separate the real opportunities from the hype. There has been great progress with checkpoint inhibitors, CAR-T and T-Cell therapies, cancer vaccines, agnostic antibodies, and combination therapies.

IBC's Immuno-Oncology provides the critical insights and strategies you need to improve response rates, efficacy, and get closer to a cure!

Download the full agenda for complete session and speaker information here:

Immuno-Oncology
Advancing the Next Generation of Cancer Immunotherapies
September 30 – October 1, 2015
Hilton Alexandria Mark Center, Alexandria, VA

Visit the website for more details: http://bit.ly/1A4NPY2

Don't miss out on maximum savings for IBC's Immuno-Oncology!

Register by May 15 to Save up to $550 off the standard rates: http://bit.ly/1A4NPY2

Register today and explore the latest advances in Immuno-Oncology to:
-          Design next generation immunotherapies by understanding recent advances made with CAR-T and T-Cell therapies, checkpoint inhibitors, cancer vaccines, and agnostic antibodies
-          Develop a successful combination therapy strategy by gaining insights from global leaders on effective combinations
-          Improve the discovery and development of your promising immunotherapies by hearing best practices and lessons learned from the first wave of cancer immunotherapies

Best,
The Immuno-Oncology Team 2015
@ibcusa
facebook.com/ibclifesciences

www.ibclifesciences.com/ImmunoOncology


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Wednesday, April 29, 2015

Earn a FREE Pass to the Bioprocess International in Boston, MA – Become a Guest Blogger!

Earn a complimentary all-access pass to Bioprocess International Conference & Exhibition by serving as a Guest Blogger at the event. As a Guest Blogger, you’ll have access to the Bioprocess International event’s comprehensive agenda attracting the best insights from around the world, right in Boston, Massachusetts in October.





Conference & Exhibition
October 26-29, 2015
Hynes Convention Center, Boston, MA


We are looking for an industry expert to be the face of our Bioprocess International social media campaign. The premise is to provide Bioprocess and Life & Science related articles, whitepapers, and overall original content with a strong focus on a whole bioprocessing industry from product development to biomanufacturing.
The Bioprocess International conference guest blogger’s responsibilities will include but not limited to submitting one post per week to the Future of Biopharma blog between now and the conference and attending specifically assigned sessions at the event and blogging live or same day.

This is a great opportunity for you! You'll get a FREE pass to Bioprocess International plus exclusive access to a networking community of world's largest gathering of bioprocessing and biomanufacturing scientists and professionals in the industry of your interest!

You also have a chance to GAIN exposure through our five health related-blogs and more than 20 healthcare LinkedIn groups.

Learn more about the Bioprocess International Conference & Exhibition event by visiting our website: http://bit.ly/1HQXRgr

To APPLY please contact Krista Lentini at klentini@iirusa.com or call 646 895 7316. Feel free to share your short biography, links to your blog or writing samples, along with a few sentences about why we should choose you to become the Guest Blogger for Bioprocess International Conference & Exhibition 2015!

*Guest Bloggers are responsible for their own travel and lodging.
*All content is subject to IBC approval.
 
We hope to have you join us in Boston!


Cheers,
The Bioprocess International Team

#BPIconf
Future of Biopharma Blog http://futurebiopharma.blogspot.com/


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Thursday, April 23, 2015

Exciting Trends in Bioprocessing

A White Paper Exclusive
By Alfred Doig and Susan Dana Jones, Ph.D., BioProcess Technology Consultants, Inc.

Getting products onto the market as quickly as possible still remains a key driver in the development of recombinant therapeutic proteins. Any advance in bioprocessing is of particular interest to the industry if it significantly shortens the development timeline or improves the end product. Even better are advances that do both. In the monoclonal antibody (MAb) area, platform processes have enabled companies to standardize on specific mammalian cell lines, transfection approaches, process conditions and downstream processing to shorten the development timeframe.

Access an exclusive white paper to read about several interesting trends in two development areas, which have the potential to shorten the development timeline still further.

Does this topic interest you? If so, we invite you to attend the BioProcess International (BPI) Conference & Exhibition, scheduled for October 26-29, 2015, is the world's largest gathering of bioprocessing and biomanufacturing scientists, executives and technology providers, bringing over 1,600 attendees, 150 exhibitors, 160 speakers and 100 posters to Boston—providing the most effective platform to launch or learn about new products, showcase and evaluate new bioprocess technologies, share and receive input on scientific research and meet the industry's leading innovators in bioprocess development.

BPI covers all phases of bioprocess development including upstream, downstream, analytical, formulation, manufacturing, quality/regulatory and drug product/fill-finish.

» Learn more about the topics that will be presented at BPI



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Tuesday, April 21, 2015

Are You Keeping Up with Your Competition at TIDES?

Over 70 leading and emerging oligonucleotide and peptide companies will be Exhibiting, providing cutting-edge Spotlight Presentations and/or Sponsoring networking sessions at TIDES 2015, coming to San Diego this May. What do they know?

They know:

·         TIDES is the largest gathering of the oligonucleotide and peptide community where networking and business gets done. Over 50% of the attendees are President’s, VPs, C-Level, Directors and Managers that hold the true buying decision power in their hands. Meeting face-to-face with these decision makers will accelerate business, partnerships and sales.
·         Whether in the Exhibit Hall, between sessions or during the scheduled Networking Receptions, you have direct access to hundreds of leading minds and businesses.
TIDES is the leading source of advances in technology, strategies and case studies that span from R&D through Commercialization. Your company needs to be an important part of this community and conversation.

Why let your competition have all the glory?

·         Secure one of the remaining 10 exhibit spaces left >> Request an updated floor plan
·         Sponsor a Spotlight Presentation and prove that your company is a thought-leader in the industry. We have a few select spots remaining in the agenda. Contact me for subject and topic areas.
·         Brand your company through sponsorship of the TIDES Lounge or other branding opportunities.
·         Capitalize on this unique opportunity to highlight your company's expertise to 800+ qualified attendees from 25+ countries.   As our valued event sponsor/exhibitor, your company's brand awareness extends beyond our attendees to our thousands of targeted email subscribers, website visitors and event prospects.   Give me a call or shoot me an email today to discuss how your participation at this year's TIDES meeting will help you achieve your company's targeted growth goals.

Join us in San Diego next month. Register for TIDES today: http://bit.ly/1OBPwgA
Best,
The TIDES Team



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Wednesday, April 8, 2015

BDP Week 2015: Conventional vs Single-Use Facilities Panel Discussion

By: Maribel Rios, Managing Editor of BioProcess International

On Wednesday, 1 April 2015, the Biopharmaceutical Development and Production Week meeting held a Q&A session between attendees and a selected panel, moderated by Adam Goldstein (Genentech, a member of the Roche group). Panelists included Nuno Fontes (Boehringer Ingelheim), David Fritsch (Fritsh Consulting), Francis Kobina Insaidoo, PhD (Merck Research Laboratories), Chris Antoniou (Biogen Idec), and James D. Vogel (The BioProcess Institute). The panel first discussed the merits of moving to an all-single-use facility, such as Amgen’s facility in Singapore as opposed to continuing to use a stainless-steel-based facility and making modifications with single-use systems. Questions and discussion focused on the following:

·         Does building a complete single-use facility make sense? The panel agreed that there are some processes (e.g., early stage, smaller volume, pilot studies) in which the complete or near-complete use of single-use systems make sense. Larger-volumen(>2,000 L), commercial-scale, and dedicated processes would be more susceptible for stainless-steel systems.
·         How does cost of goods and other economic factors play a role? The panel agreed that manufacturers must examine all factors carefully, including timelines for building a facility. Other concepts, such as ballroom-style or modular facilities also can reduce timelines.
·         Are there single-use solutions for high cell density and high-titer processes? And are there ideas for addressing the limitations of single-use mixing of such processes? The panel responded that work on “loop” systems is ongoing through companies such as HyClone/Thermo/GE.




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Thursday, April 2, 2015

BDP Week 2015: Extractables and Leachables

By: Maribel Rios, Managing Editor of BioProcess International

On Tuesday afternoon, 31 March 2015, the single-use track of the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California, focused on the challenges associated with particles and extractables and leachables (E&L). Bobbijo V. Redler, PhD (Merck & Co., Inc)  began by defining the terms and the different types of E&L studies, including controlled extraction studies (screening), simulation studies, leachables testing (using methods validated for registration), and routine monitoring (also using validated methods). She reviewed simulated study designs, the use of various analytical techniques for E&L studies, and efforts of the E&L team of the BioPhorum Operations Group (BPOG).

James Vogel (The BioProcess Institute) presented on the work of the Bio-Process Systems Alliance (BPSA) on its 2014 particulates technical guide, “Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Processing Equipment.” The 12-chapter compendium is targeted for both end users and supplies of single-use components and systems. The session ended with a roundtable moderated by Redler. Panelists included Weibing Ding (Biogen Idec), James Vogel, and Michael Rupperto, PhD (Material Needs Consulting). The session consisted of a Q&A with attendees. Various issues were discussed, including the following:

·         Whether the BPOG extractables protocol published last year (Ding W, et al. Standardized Extractables Testing Protocol for Single-Use Systems in Biomanufacturing. Pharm. Eng. Nov-Dec. 2014) actually is a “best practices” document and if it truly can be used for “comparability.” Panelists said that the protocol does provide some flexibility, the document is a “step forward,” and that ASTM (Association for Standards Testing and Materials) and USP (US Pharmacopeia) Chapter <661.3> work is ongoing.

·         Whether it is better to discontinue use of a component is easier than to conduct continuous monitoring for extractables. The panel answered that the decision is often a matter of time and cost and that the material may have unique properties that are needed.

·         How to determine a threshold for extractables information and the definition of BPA-free. The panel emphasized the importance of smart material selection, paying close attention to materials, including secondary packaging, and continually assessing risk.


·         Whether the BPOG protocol (above) should actually be more rigorous. The panel mentioned that not many company are conducting in-process leachables testing for process equipment, reminding attendees that suppliers are responsible for extractables tests and end users are responsible for leachables testing. The general intention is to get single-use implemented quickly. 


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Tuesday, March 31, 2015

BDP Week 2015: BPSA Roundtable

By: Maribel Rios, Managing Editor of BioProcess International

The Bio-Process Systems Alliance (BPSA) presented a single-use applications roundtable on Monday, 30 March 2015, at the BioPharmaceutical Development and Production (BDP) Week meeting in Huntington Beach, California. Mark Petrich, PhD (Merck & Co., Inc.) moderated the panel consisting of Jerry Martin (Pall Corporation), Jeffrey Carter, PhD (GE Healthcare), James Vogel (The BioProcess Institute), and Todd A. Kapp (Parker-Hannifin Corporation). Martin started with a historical review of the BPSA, a trade organization formed in 2005 and now consisting of 46 member companies (suppliers and end users) whose goal is to “advance single-use worldwide and facilitate implementation of single-use technologies.” 

Carter and Vogel then reviewed BPSA’s active and recent projects, consisting of the following:
·         Single-Use Manufacturing Component Quality Test Matrices (currently under final review and should be available for the BPSA Annual Summit, 13-15 July 2015, in Washington DC)
·         Change Notification Practices (currently in the initial stages of documenting)
·         Extractables (currently continuing collaboration with other organizations such as ASTM, ASME-BPE, and USP)

·         Quality Agreement Template for Single-Use Biopharmaceutial Manufacturing Products (published July 2014, currently soliciting feedback from users of the template, with possible future revisions)
·         Particulates Guide, a 12-chapter compendium addressing why particulates are an issue, how to identify them, and so on (currently soliciting further input)

The roundtable concluded with Knapp presenting the future focus of BPSA, including the annual summit and its new scholarship fund.


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Thursday, March 26, 2015

Visionary Keynote Interviews + New Poster Award at TIDES

TIDES is coming to San Diego in 6 weeks!  Get a sneak peek of this year's meeting by listening to exclusive interviews with a few of this year's visionary keynote speakers, who provide their perspectives on the current state of the oligonucleotide and peptide industry.

Start planning your team's trip to attend this year's meeting and access 800+ like-minded attendees, 100+ speaker presentations, 70+ exhibitors and 40+ scientific poster presentations.  The $200 registration savings deadline expires on April 10, so secure your seat today: http://bit.ly/1bxzMyX
Plus, all registered attendees gain immediate access to Attendee Connect, the partnering tool that allows you to communicate with fellow attendees before, during and after the meeting.

Stanley T. Crooke, M.D., Ph.D. CEO, Isis Pharmaceuticals, Inc.
The progress of technology has yielded new chemistries like Generation 2.5.  How will that improve the potential of antisense technology?

SC:  Second generation drugs today that we make are significantly better than second generation [drugs] of just a few years ago in that we get about twice as much potency and we have much better tolerated drugs and that's a product of advances in technology.  Generation 2.5, we would expect would give us an increase in potency of about ten-fold...(Listen to the full interview)

You say that you are focused on creating the maximum value for your drugs and technology.  Tactically, how are you going that?

SC:  I think focusing on maximum value is the only hope for the industry in general.  With the technology we have at Isis, we have the benefit of very rapidly being able to take genetic information and convert it to drug.  So step one is to...(Listen to the full interview)

Kunwar Shailubhai, Ph.D., Co-Founder and CSO, Synergy Pharmaceuticals, Inc.
Can you discuss the scientific rationale for developing a uroguanylin peptide analog to treat functional GI disorders?

KS: Two known agonists of GCC that are in clinical development are Linactotide, which is an FDA approved drug and our molecule, plecanatide for functional disorders/chronic constipation and IBS-C. Now, our molecule – plecanatide – is an analogue of uroguanylin whereas Linactotide is an analogue of e-coli enterotoxin. So, I would like to emphasize...(Listen to the full interview)

What challenges do you see the peptide industry facing in the next 5 years?

KS: The biggest challenge when we started working on this compound was to develop large-scale manufacturing.  The next thing that I believe is quite challenging for peptide drugs is formulation. Formulation should be done in a way that.....(Listen to the full interview)

The TIDES 2015 Poster Award
The TIDES 2015 Poster Award, sponsored by AUM LifeTech, Inc. will recognize TIDES 2015 poster presenters whose poster submission and research efforts demonstrate exceptional advances and breakthroughs in the following areas: discovery, pre-clinical and clinical aspects of oligonucleotide based therapeutic research including but not limited to mRNA silencing and manipulation, miRNAs, short and long non coding RNAs, exon skipping, delivery, genome edting, etc.

Three poster award recipients will receive $12,500, $7,500 and $5,000 respectively, in in-kind support/technology/products from AUM LifeTech, Inc. Through this support, awardees will have access to AUM’s next generation oligonucleotide technology that can be used to further awardee’s research. Please refer to www.aumlifetech.com for details on AUM’s RNA silencing and manipulation technology. Submissions from academic and research institutes are especially encouraged, as are submissions from industry. 

To apply for the poster award, you must be a registered TIDES attendee and submit your poster abstract by April 10, 2015 >> Submit your poster abstract today: http://bit.ly/1Iz2PND
Register by Friday, April 10 and receive a $200 Savings. Your $200 Savings Priority Code = 00DCL3R2B. Register here: http://bit.ly/1bxzMyX

Group rates are available for companies registering 4+ attendees.  Call 646-895-7445 to secure your team's seat today.

Sponsorship/Exhibition Opportunities: More than 70 leading and emerging oligonucleotide and peptide companies will be exhibiting or sponsoring this year's TIDES meeting.  Contact Sales Manager Steve Rooney at srooney@ibcusa.com to secure one of our few remaining exhibit spaces and/or spotlight speaking opportunities.

Cheers,

The TIDES Team


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Wednesday, March 18, 2015

Antigen Express on Cancer Immunotherapy and Peptides

In today's featured interview from TIDES 2014, Eric von Hofe, Ph.D., President, Antigen Express, Inc. discusses peptides, cancer immunotherapy, peptide vaccines, and his experience at the TIDES 2014 event. He states that peptides constitute the minimum unit required to generate in response to solid advantages when developing therapeutic materials and that peptides “rev-up” the immune system to go out to be specific canto cells. Do you want to learn more? Watch this interview:


TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  At this year's event, we're offering two days of content focusing on Peptide Chemistry Manufacturing and Controls and Peptide Discovery, Preclinical and Clinical featuring insights from companies such as PolyPeptide Group, Amgen, NOXXON Pharma, Zealand Pharma and more. For more this year's program by downloading the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.


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Wednesday, March 11, 2015

Advances in siRNA Developing Delivery Solutions

In today's featured interview from TIDES 2014, Jared A. Gollob, M.D., Vice President, Clinical Research, Alnylam Pharmaceuticals, Inc. discusses exciting advances in siRNA.  He says there are several different delivery formulations and the company goes after targets they have confidence in.  He also talks about focusing on moving siRNA therapies into Phase III trials.  To learn more, watch the interview:


TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  This year,John Maraganore, Ph.D.; Chief Executive Officer, Alnylam Pharmaceuticals, will be giving the keynote presentation Strategies and Challenges in the Development of Oligonucleotide and Peptide Drugs: Perspectives on DrugDevice Combinations and Drug Product.  For more information about this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.


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Wednesday, March 4, 2015

New Tools for Genome-Wide Functional Screens Needed to Develop New Drugs

Guest Post: Paul Diehl, PhD, Director of Business Development at Cellecta - Paul will be speaking at IBC's Genome Editing Applications conference March 18-19 in Boston.


Despite the need for new innovative therapies, the rate of novel drug development has remained level with about 35-40 new approvals each year (see figure below). One crucial factor restricting the rate of new drug discovery is the limited set of therapeutic gene targets. There are approximately 1,500 approved therapeutic compounds, but they target only about 300 gene products. Most new compounds in testing are directed toward these same known targets.

However, the potential number of drug targets is at least an order of magnitude greater. DrugBank associates over 4,000 targets with the 7,500 compounds in its database, and GeneCards catalogues over 10,000 genes that have data indicating they “cause, predispose, or protect from diseases.” Why does the current pharmacopeia only exploit less than 10 percent of the potentially targetable gene products then?

The problem is that there is still too much unknown about how most gene products actually work. A tremendous amount of genetic information has been amassed and deposited into online databases. Data about how, under certain conditions in some systems, transcription of certain genes increase or decrease, proteins that interact, and genes that are mutated more frequently in certain systems. Almost all of this data, however, is simply correlative. These massive databases simply do not contain the key information required to really understand how genes produce biology. No amount of deep and thorough analysis of the massive amount of information currently stocked away can illuminate how most genes function because there is a critical dearth of information indicating which genes actually drive the biology.

This lack of information about which genes are responsible for biological responses and disease progression stems from the difficulty in obtaining this data experimentally. Data is needed that causally links gene products to phenotypic changes. This requires assays that assess how the perturbation of certain genes changes the responses or characteristics of cells in a model system, and there are few experimental approaches to generate this sort of data efficiently.

Some techniques, such as genomic recombination technologies like transcription activator-like effector nucleases (TALENs) and zinc-finger nucleases (ZFNs), can provide the needed data by disrupting or otherwise altering genetic targets in a precise manner. However, functional analysis tools must be able to assay the roles of large numbers of genes simultaneously. Collecting data on this scale requires parallel measurements in genome-wide functional assays, which is difficult with these gene manipulation techniques.

There are really only two technologies that currently form the basis of techniques for broad-based genetic screens that assess the functions of large numbers of genes in a single assay: RNA interference (RNAi) and CRISPR knockout screens.

Although RNAi and CRISPR loss-of-function screening approaches are effective, their potential to elucidate gene function remains somewhat limited. One limitation is that either approach only looks at the effects produced by the disruption of a single gene within the system. In reality, though, it is rare that one gene produces one trait. Most phenotypes are caused by multiple interacting genes. While loss-of-function screens can be designed to look for interacting genes, such as Bassik, et al. has shown, paired gene screens can only be run on a limited set of a few hundred genes, so efficient combinatorial assessments of interacting genes across the genome is really out of reach at the moment.

Also, disruption of gene function by knockdown or knockout provides only a limited range of functional assays. Genes may also be activated or otherwise functionally modulated to produce biological responses. Although RNAi can only be used for loss-of-function screens, CRISPR has shown some potential in screening for the activation or gain of genetic function. There is the potential, then, for the development of more sophisticated CRISPR-based screens that assay for genetic changes activating new pathways or bringing about novel biological transformations that may well elucidate disease development.

Thus, while RNAi and CRISPR loss-of-function screens provide one of the few effective approaches currently available for genome-wide functional screening, they are not sufficient to meet the daunting challenge of understanding how genes produce biology. Progress in identifying novel therapeutic targets will continue at a glacial pace until more advanced techniques are developed to address the challenge of teasing out the complex genetic networks that drive and control cellular responses and processes.

  
New Drug Approvals and R&D Expenditures on Annual Basis. The number of new drugs with novel mechanisms approved each year by the FDA (left axis) as compared with the annual expenditures reported by pharmaceutical companies in the 2014 Biopharmaceutical Research Industry Profile published by PhRMA (http://www.phrma.org/profiles-reports).



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Application Space for Peptides

In today's featured interview from TIDES 2014, Patrick C. Reid, Ph.D., Chief Scientific Officer, PeptiDream, Inc of Japan talks about how a lot of work involving peptides are not published yet. That kind if info is obtained in this type of conference. He also states that the therapeutic side has commercial potential, application space for peptides are limitless, and that he does not see any disease that can’t be therapeutically targeted with peptides. He expects peptides to represent against therapeutic modality. To learn more, watch the interview here:


TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  This year, Ravi S. Harapanhalli, Ph.D., Vice President, Technical, PAREXEL International and Former Branch Chief, Office of New Drug Quality Assessment, US FDA, will be on hand to present Strategies and Challenges in the Development of Oligonucleotide and Peptide Drugs: Perspectives on DrugDevice Combinations and Drug Product.  For more information about this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.


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Friday, February 27, 2015

Has disposable technology been tested on a large scale yet?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he shares  the importance of disposable membrane chromatography systems for mAb purification.


Has disposable technology been tested on a large scale yet at Patheon? 

As I said, there are two parts. One is the clarification and we are testing Clarasolve Filters and  he second part is we are replacing chromatographic columns with membranes. So, for our process --- in essence, we are not reinventing the wheel because Clarasolve Filters are from Millipore and the membranes that we are using are from Natrix, one of our collaborators. 
So, we have not reinvented the wheel. What we have done is we have merged both these technologies to come up with a hybrid process which is far more effective and far cheaper compared to the classical platform or traditional platform methods. 
Having said that, we have not yet tested the full process at scale. But, Clarasolve has been using multiple commercial products and they are being used multiple times successfully both by Patheon and by many other companies, as well. And Natrik members are also employed in many of the clinical trials. So, individual contributors are already being tested and are proven in the market that they are liable to be used for the production of human injectibles. We have mix them to produce the whole process and, of course, --- as you know, Patheon is a CDMO and we have got ample opportunities to test them and we are in the process of testing them. But, of course, they are not yet tested at scale.

In this interview Dr. Shrivastava also discusses disposable technology, why it's more appealing than traditional technology and it's cost effectiveness, .  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


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Wednesday, February 25, 2015

[Video] ALN-TTR Programs for Transthyretin Amyloidosis

In today's featured presentation from TIDES 2014, Jared A. Gollob, M.D., Vice President of Clinical Research at Alnylam Pharmaceuticals, Inc. presents how explains how Transthyretin Amyloidosis is formed and how it develops throughout the body.  Transthyretin (TTR) amyloidosis is caused by the deposition of liver-derived mutant and/or wild-type TTR in peripheral nerves, GI tract and the heart. Patisiran (ALN-TTR02), which is being developed for familial amyloidotic polyneuropathy (FAP), is a systemically administered lipid nanoparticle (LNP) formulation of a small interfering RNA (siRNA) targeting wild-type and all mutant forms of TTR that is currently in Phase 3. ALN-TTRsc, which is being developed to treat familial amyloidotic cardiomyopathy (FAC), is a subcutaneously administered N-acetylgalactosamine (GalNAc)-conjugated siRNA also targeting all forms of TTR that is currently in Phase 2. This presentation will review the clinical results to date with both patisiran and ALN-TTRsc. To learn more, watch the actual presentation:


TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  This year, Ravi S. Harapanhalli, Ph.D., Vice President, Technical, PAREXEL International and Former Branch Chief, Office of New Drug Quality Assessment, US FDA, will be on hand to present Strategies and Challenges in the Development of Oligonucleotide and Peptide Drugs: Perspectives on DrugDevice Combinations and Drug Product.  For more information about this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.


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Friday, February 20, 2015

How much more cost effective is a disposal technology approach?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he sheds light on the cost effectiveness of disposable technology.


How much more cost effective is this approach?
Sid: To answer this question I would like to explain the mAb or the industrial standard of gold standard of antibody purification. So, of course, as I said that requires a full battery of chromatographic columns that would be paired with the expensive resins. Among those expensive resins, the major resins which are used for antibody purification is Protein A, which is super expensive. So, that can be a significant. A 100 liter column would run upwards of around $1.6 to $2.5 million dollars. So, it is super expensive and the whole process costs millions of dollars. But, in the approach that we are going to present, you will see that we have replaced these expensive chromatographic columns with our collaborator company Natrix’s, hydrogel membranes, which has reduced the cost significantly. 
And we have also change the classical centrifugation approach to purify the harvest material or the depth filtration material with high capacity new material from Millipore called: “Clarasolve filters”. With the combination of these two systems, we have seen and we have estimated that there would be a significant savings in cost that would run upwards of millions of dollars in whole process. There is a significant chances that this process is very lucrative and very appealing and is also working very nicely.

In this interview Dr. Shrivastava also discusses the appeal of disposable technology and how it applies to the large scale.  Download the entire interview here.

Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


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Wednesday, February 18, 2015

[Video] TIDES: AZD9150 and its Effect on Tumors

In today's featured interview from TIDES 2014, David C. Blakey, Ph.D., the Chief Scientist of Oncology iMED at AstraZeneca discusses the next generation of antisense molecules, AZD9150 and its effect on tumors and why TIDES is a great place to be for the industry. He also talks about bigger traction, which tackle lower uptake tissues and a combination of both peptides and nucleotides. To learn more, watch this interview:



This year at TIDES 2015, AstraZeneca's Regina Fritsche-Danielson, Ph.D., Associate Professor and Senior Director and Head of Bioscience Heart Failure Department will present Modified mRNA as a Potential Therapeutic for Patients with Cardiovascular Disease.  For more information on this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off the standard rate.


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Friday, February 13, 2015

Why is disposable technology more appealing compared to conventional technology?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he looks at the appeal of disposable technology.

Why is disposable technology more appealing compared to conventional technology?
Continuing from where I left off in my last sentence, as I said 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.

As I said before, again, cleaning, and associated cleaning validation, basically reduced maintenance costs, reduced lead times, increased speed of implementation and time to market , that can be significantly be reduced because we have reduced significantly the time of the processing over the 30 some processes. And we have also reduced the labor costs because of the low cleaning requirement or cleaning validation requirement. And, of course, low space requirement and footprint requirement. That is a main reason why disposable technology is more appealing and more and more people want to go towards that.

In this interview Dr. Shrivastava also discusses disposable membrane chromatography systems, it's cost effectiveness, and how it applies to the large scale.  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


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Wednesday, February 11, 2015

[Video] Breakthrough Status: Are You Ready?

In today's featured presentation from TIDES 2014, Jeffrey Baker, Ph.D., Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration talks about FDA SIA (Safety and Innovation Act). He presents a rundown of this act and talks about NDAs (Non-disclosure agreement), and BLAs (Biologics License Applications). Baker states that FDA SIA has made available a pathway for rapid approval of drugs critical to public health, however companies need to be prepared to manufacture and meet patient needs. Are you ready? For details, watch the presentation:



TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  This year, Ravi S. Harapanhalli, Ph.D., Vice President, Technical, PAREXEL International and Former Branch Chief, Office of New Drug Quality Assessment, US FDA, will be on hand to present Progress in Advancement of RNAi Therapeutics.  For more information about this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.


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Friday, February 6, 2015

What is the importance of disposable membrane chromatography systems for mAb purification?

Biopharmaceutical Development and Production Week speaker Siddhartha Shrivastava, Ph.D., Senior Scientist, Downstream Process Development, Patheon recently took some time to sit down with us and discuss his upcoming presentation centered around downstream processing.  Today, he shares  the importance of disposable membrane chromatography systems for mAb purification.

What is the importance of this work?
Sid: Well, the topic as name suggest --- the non-chromatographic platform for mAb purification. As we can see, around 70-75% of those therapies in the market are based on antibodies and the classical way in which industry approaches (this is) to purify them is a bed chromatography approach. What that means is that you need to have a good platform of bed chromatography columns with some costly resins. Of course, we need to have a lot more space, a big footprint resulting in high capital expenditure, as well as operational expenditures for those platforms to purify the mAb.
It is good for a product which has got a long shelf-life or is high in demand, but for the products which have got a low demand or are only for therapeutic or clinical use or clinical trials, that kind of expenditure does not make sense. So, we are trying to focus that part, the drugs which have got a low demand and the product that needs fast turnover, we are trying to develop the technology which will be, in essence, a disposable or single-use so that we would have low validation cost, low cleaning cost and low installation cost and of course, what that would mean are low leading times on the material process that would, of course, mean the product cost would be reduced significantly. 
So, this is the essence and the target of the work that we did. Here at Patheon we are trying to generate a uniform platform matter for the mAB purification using this technique. This will be described in my presentation, as well.
In this interview Dr. Shrivastava also discusses disposable technology, it's cost effectiveness, and how it applies to the large scale.  Download the entire interview here.


Dr. Shrivastava will be presenting Disposable Membrane Chromatography Systems as a Platform for mAb Purification on Thursday, April 2 at Biopharmaceutical Development and Production Week.  As a reader of this blog,when you register to join us March 30-April 2, 2015, you can save 20% off standard rates when you mention code XB15155BLOGJP! Have any questions? Reach out to me at jpereira@iirusa.com.


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