Wednesday, October 1, 2014

BioProcess International Poster Preview: The Renaissance of Expanded Bed Adsorption?

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place October 20-23, 2015 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: The Renaissance of Expanded Bed Adsorption?

Presenter: Martin Hoffman, Biotechflow

About: 20 years after development, Expanded Bed Adsorption chromatography fell out of favour in Bioprocessing. Proposed improvements in process efficiency- obtaining high yields from unclarified feed stocks- were compromised by column design and process run failures; in part caused by blocked meshes, lipid breakthrough and demand for high buffer volumes producing high eluting volume. Current media optimize Dynamic Binding Capacity within the expanded bed. Coupled with improved inlet design, increased bed densities are achieved, which permit high flow rates (450 cm/hr) and throughputs. Direct product capture reduces unit costs by 66%, and labour cost and process time. Comparisons with packed bed chromatography result in higher product yield and 43% reduction in buffer volume. Fully-scalable, cGMP EBA column design improvements prevent vortex formation, whilst ultrasound technology enables contactless monitoring of process dynamics and flow rate via feedback to the skid; both factors maximize expanded bed stability. Reduced column footprint and height requirements increase versatility. In recent years, step changes in incubation techniques, media design, column technology and sensor applications have enabled proven improvements in EBA process efficiency and operations. The initial promise may now be considered as surpassed, and a renaissance of Expanded Bed Adsorption Chromatography should be proposed.

Can't make it to  Boston for the whole event but still want to browse the Exhibit Hall and check out the BPI Innovation Theater?  You can join us with an Exhibit Hall and Keynote Pass!  Find out more and register here.


Share this article with your social network, just click below to share now!


Tuesday, September 30, 2014

Choosing a Technology for Immune Response Detection

This post was contributed by Russ Peloquin, SQI Diagnostics, Inc. 

Isotyping the ADA response to therapeutic proteins has become a significant aid for pharmaceutical and biotechnology companies who intend to bring their compounds to the FDA for approval. It’s also a key component for drug efficacy and ensuring the safety of patients worldwide.

The traditional method to obtain a full immune response to a given therapeutic would be to develop individual assays as standard ELISAs or individual ECL tests for each isotype and immunoglobulin subclass. The time and expense to do this can be extreme as well as too costly to outsource to a CRO.

Immune Response Detection Technology ChoiceHowever, the ability to multiplex these various isotypes and in following recent FDA recommendations, performing epitope mapping of the protein of interest, yields the highest quality results from a single sample in one or a few wells provides many advantages. The advantages include reduction in human error, variability from one assay to the next, significant reduction in labor and method development cost, as well as getting the most detailed information in a single reaction. Choosing a technology that has also shown to have superior drug tolerance with minimal matrix interference also deserves attention.

Automation is also a key driver for many laboratories’ decisions on which technology to choose. Although each project may require various throughput efficiencies at various stages in the development process, finding a technology that is automated provides a “grow into” model that can well suit a lab’s need for both high throughput needs, as well as lower throughput testing. A software that runs this automation and assay development that is 21 CFR part 11 should also be a strong consideration.

Automation also lends itself to the importance of judicious use of both therapeutic compound and study sample. That’s why the technologies being evaluated should only need a minimum amount of patient sample and drug of interest in order to yield the kind of information that a multiplex technology can produce from a single well. This is especially true for those drugs that treat rare diseases and those study samples that are in low volume, quantity, and availability.

Although certainly not required by regulators, a manufacturer that is a provider of clinical diagnostic IVD (in-vitro diagnostic) FDA-cleared kits and is cGMP and ISO-certified, gives researchers confidence in the technology’s robust QA and QC practices.

These ideas are not new to the bioanalytics arena, but are becoming increasingly more important in the evaluation of existing and new technologies to assess immunogenicity.  


You can hear more on the latest in the field at the Immunogenicity for Biotherapeutics conference. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100. Register here and use code XP1938BLOG.



Share this article with your social network, just click below to share now!


Continued Process Monitoring to Predict Product Variation

Today, we feature another one of our exclusive interviews from a BioProcess International Speaker.  Today we look to Pawel Drapala, Ph.D., Senior Process Engineer, Technical Manufacturing Services, Alexion Pharmaceuticals, Inc. who goes in depth on how process monitoring can be used not only to pass inspections but also ensure the identity, purity and strength of products but also to predict and avoid deviation in products.


Dr. Drapala will present Strategies for Continued Process Monitoring of Commercial Cell Culture and Purification at Large Scale on Thursday, October 23 at BioProcess International Conference and Exhibition.  Don't forget that as a reader of this blog, when you register to join us and mention priority code BPI14BLOG, you can save 20% off the standard rate.


Share this article with your social network, just click below to share now!


Monday, September 29, 2014

Inside look at single use bioreactors at Genentech

Edward Chan, Technical Specialist 2, Cell Culture Pilot Plant, Genentech, recently had the chance to sit down with the BioProcess International team and preview his presentation about single use bioreactors at BioProcess International.  He shares what specific runs the operate on,   He goes in to further discuss how UNICAN addresses how single vendors and creates felxibility in the single use manufacturing process.


Chan will be presenting UNICAN: Dual Capability in Single Use Bioreactor on Tuesday, October 23. For more information on this session and the rest of the program, download the agenda. Would you like to join us in Boston at BioProcess International Conference and Exhibition? Save 20% off the standard rate when you register with code BPI14BLOG.


Share this article with your social network, just click below to share now!


2 Days Only: BioProcess International Registration Savings Extended!

2 Days Only: Register for BPI by Tuesday 9/30 with priority code BP14FS2 and you will save $200 off the standard rate conference or training course rates.

Register now.  Mention priority code BP14FS2.

BioProcess International 2014 – October 20-23, 2014 – Boston, MA 
1500+ Attendees | 150+ Exhibitors | 80+ Scientific Posters | 25+ Industry Leading Partners 

As the #1 event in the bioprocessing industry, we are continually working to evolve BPI with the needs of the industry and make sure that you have a highly enjoyable, productive and rewarding experience.

Complete programming coverage of the full bioprocessing continuum - featuring 65 innovative case studies and 70 new data presentations intended for companies of all sizes and at every stage of development.

The world's largest bioprocess exhibition - featuring over 150 exhibitors, lounges, and the BPI Theater with live product launches to help you plan future purchasing decisions.

Face-to-Face Networking opportunities that no other bioprocessing event can offer, plus access to BPI's event specific partnering tool to schedule meetings.


*This promotion is only valid September 29-30 only. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IBC approval.


Share this article with your social network, just click below to share now!


Friday, September 26, 2014

Perspectives on Assessment, Assurance and Drug Quality: Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about Abbreviated License Pathway for biological products- which rely on “highly similar” FDA product on existing knowledge about the safety, purity, and potency of the reference product. He mentions that as of February 28, 2014, CDER had 62 requests for an initial meeting and how FDASIA makes it criminal to stay silent about counterfeiting or safety related issues.Baker states that the FDA has a focus on quality expectation for clinical performance.

Want to know more? Watch the interview here:


Watch Part 1.

Biopharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California.  To get the latest updates on the 2015 program, sign up for email updates.


Share this article with your social network, just click below to share now!


Thursday, September 25, 2014

Paired ADCC Reporter Bioassays Enable Differentiation of Antibody Fc Effector Activities via V158 and F158 Variant FcyRIIIa Receptors

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Paired ADCC Reporter Bioassays Enable Differentiation of Antibody Fc Effector Activities via V158 and F158 Variant FcyRIIIa Receptors.


PowerPoint PresentationAntibody-dependent cell-mediated cytotoxicity (ADCC) contributes to clinical efficacy of a broad range of therapeutic antibodies. FcγRIIIa polymorphism of individual cancer patients are correlated with clinical efficacy of some of these antibody drugs. Classic ADCC cytotoxicity assays rely on primary effector cells, which are highly heterogeneous and variable. To quantitatively measure antibody activity and evaluate the impact of FcγRIIIa polymorphism, we developed a pair of reporter-based ADCC assays using two engineered effector cell lines in Jurkat that stably express an NFAT-RE driven luciferase reporter and either FcγRIIIa /V158 or FcγRIIIa /F158 polymorphism variant.

Read the full article here.


You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.


Share this article with your social network, just click below to share now!


Wednesday, September 24, 2014

BioProcess International Poster Preview:Large-scale Production of Human Mesenchymal Stem Cells in BioBLU® 5c Single-use Vessels

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place October 20-23, 2015 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: Large-scale Production of Human Mesenchymal Stem Cells in BioBLU® 5c Single-use Vessels

Presenter: Khandaker Siddiquee, Eppendorf, Inc.

About: Stem cell-based regenerative medicine has great potential to revolutionize human disease treatments. Among the various stem cell platforms, mesenchymal stem cells (MSCs) represent one of the highest potentials as evidenced by clinical trial activities. Currently, there are over 400 clinical trials based on MSCs registered at clinicaltrials.gov. Although successful expansion of MSCs in vitro has been well established, the large clinical-scale production of MSCs remains a bottleneck, potentially limiting the immediate clinical applications should some of the ongoing trials receive FDA approval. In this study, we demonstrate the success of large clinical-scale culture of human adipose-derived mesenchymal stem cells (AdMSCs) in an industrial single-use vessel at 3.75 liter (L) scale (working volume). The vessel offers a precision controlled environment for the ideal growth of stem cells under simulated physiological conditions. Stem cells and culture media were monitored, analyzed, and controlled, thus allowing us to produce AdMSCs in large clinical-scale quantities while maintaining healthy stem cell properties as evidenced by stem cell marker assays and differentiation assays performed at the end of the culture. Furthermore, with clinical relevance in mind, every cell culture step from T-flask to shake flask to bioreactor vessel was conducted strictly using single-use consumables.

Can't make it to  Boston for the whole event but still want to browse the Exhibit Hall and check out the BPI Innovation Theater?  You can join us with an Exhibit Hall and Keynote Pass!  Find out more and register here.


Share this article with your social network, just click below to share now!


Tuesday, September 23, 2014

Roche Plans on Being in the Thick of Heating Immunotherapy Market

During a recent interview, Roche Chief Executive Severin Schwan indicated that the company would likely continue its focus on smaller-scale deal making.  The company will continue to focus on smaller acquisitions of “innovative companies” such as its recent purchase of Intermune.  “We have to be very consistent in our approach to M&A,” Schwan noted in an interview with the Wall Street Journal.

What the executive also addressed in that interview was the emerging area of immunotherapy—a space which Roche reportedly plans on moving five experimental drugs into clinical trial this year.  With companies such as Bristol-Myers Squibb, Merck and AstraZeneca all developing new therapies in this space, the competition has become intense.  Some analysts project that the industry as a whole could be worth as much as $35 billion annually in the future. 


Schwan believes this race will be decided by those with an edge in R&D.  “The winners and losers in the long term, I am absolutely sure, will be [decided by] those who do the clever combinations,” he told the newspaper. 

We’ll have more on the latest in immunogenicity at the 15th Annual Immunogenicity for Biotherapeutics event. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.

SAVE $100. Register here and use code XP1938BLOG

Don’t miss a thing. Sign up for our email updates
Follow us on Twitter
Join us on LinkedIn




Share this article with your social network, just click below to share now!


BioProcess International (BPI) 2014 Announces Program Schedule for the New BPI Theater

The BPI Theater is specifically designed to give leading companies and scientific pioneers in biologics a platform to showcase their newest products, services and innovations that are driving the development of next-generation biologics.

“The BPI Theater is a exceptional opportunity for companies to stand out for the crowd and demonstrate their leadership and innovation,” said Elizabeth Cutler, Managing Director at IBC Life Sciences. “As the most significant event in the bioprocessing and manufacturing industry, we are committed to providing our delegates with the conference features, content and tools to maximize their ROI.”

The BPI Theater hosts interactive activities including live product demonstrations, interactive panel discussion, oral poster presentations and even more information-packed content. A vanguard of leading companies enabling the development of new biological products have already committed to launching their new products at the BPI Theater, including Pall Life Sciences, Asahi Kasei Bioprocess, Sartorius Stedim Biotech, Purolite Corporation, Meissner Filtration Products.

Additional BPI Theater programming includes the re-broadcasting of the selected keynote presentations, oral poster presentations, BioProcess International Awards recap, Impact 20/20 report update from the MassBio Association, strategic discussion and expert Q&A panel, prize announcements and more. See the full schedule here.

Additionally, new to BPI this year is partnering360®, a powerful tool for networking with potential partners. At BPI 2014 delegates gain exclusive access to a BPI specific partnering360® site, enabling them to identify and schedule meetings with potential partners, and foster deeper engagement before, during and following the event.

BioProcess International conference programming is held on October 20-23, two-day training courses on October 21-22, BPI Theater is open on October 22-23 and the exhibition is October 21-23.  As a reader of this blog, when you register to join us an mention code BPI14BLOG, you can save 20% off standard rates.


About IBC Life Sciences
IBC Life Sciences, a division of Informa, is your connection to the life sciences industry. Through conferences, webinars, podcasts and its suite of integrated marketing solutions, IBC Life Sciences delivers expert knowledge, valuable connections and customized offerings so customers can meet their goals. www.IBCLifeSciences.com


Share this article with your social network, just click below to share now!


Monday, September 22, 2014

What can Massachusetts do to keep their edge in the biopharmaceutical industry?

Mass Bio and Health Advances released the Impact 20/20 report earlier this year detailing how they believe Massachusetts could best keep their edge in innovation and technology in the innovation sector.  The report concluded that Massachusetts should bring value to the industry by bringing value to the health care industry and having a meaningful impact on patients lives.

They outlined the following four things to ensure the success of their industry:
  1. 1. Demonstrating Value 
  2. 2. Supporting Company Formation and Sustainability
  3. 3. Opportunities in Life Sciences Information Technology
  4. 4. Articulating the Patient Focus
The report also addresses the question of value of the Massachussetts healthcare cluster now that health care has changed with the implementation of Obamacare. Value created should be measured according to patients and what they receive - be an amplifier for the needs of each patient and figure out how to benefit them. The state needs to continue to work on ensuring a vibrant start up environment - have funding for innovative companies and affordable work space for them to conduct their research.

Read the full report here.

Peter Abair, Director of Economic Development & Global Affairs, MassBio and Sheela Hegde, Partner, Health Advances will be joining us in the BioProcess International Theater this October to dive in-depth on their findings and suggestions for the Massachusetts biotech sector.  We invite you to join us in the Innovation Theater on Wednesday, October 22 and Thursday, October 23.  Special rates are available for the Exhibit Hall.  Visit the pricing webpage to find out more and register.


Share this article with your social network, just click below to share now!


Friday, September 19, 2014

Merck KGaA to Further Biosimilar Investment

Merck KGaA announced plans today keeping the group on track for its “Fit for 2018” plan for growth and transformation.  Part of those plans include an additional $165 - $190 million investment in biosimilars for 2015.  Ultimately, that exact number is dependent on the outcome of certain Phase I trials that are currently ongoing.  That, of course, is in addition the $128 million the German company has set aside for biosimilars this year.

In addition, the company plans to expand on existing partnerships with India’s Dr. Reddy’s and Brazil’s Bionovis with an in-licensing agreement for a late-stage biosimilar.  Initially, the drug will be intended for smaller, emerging markets.  Between 2015 and 2016, Merck plans to initiate anywhere from two to five Phase III clinical trials. 

The release also noted some internal shuffle within Merck.  Stefan Oschmann has been promoted to deputy CEO and Vice Chairman of the executive board while Belén Garijo will move up to the executive board and head the pharma business. 

The full press release can be found here.

We’ll have more on the latest developments in the biosimilars market at the 15thAnnual Business of Biosimilars meeting. Join us October 20-22 in Boston, MA. Download the agenda to see what’s on tap.
                                                                                                     
SAVE $100.  Register here and use code XP1986BLOG.

Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn





Share this article with your social network, just click below to share now!


Perspectives on Assessment, Assurance and Drug Quality

In today's featured presentation from Biopharmceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the FDA’s work environment is of assurance, assessment, and assertion, the space of assertion that a company has, process validation (making an assertion and being an advocate, in a data driven way),and the many ways to look at quality by using different tools to evaluate it. Baker stated that he believes that design is about providing an experience.

Want to learn more? Watch the first part of the presentation here:


Biopharmaceutical Development and Production Week is will take place March 30-April 2. The agenda will feature more unique insights into the regulations of biopharmaceutical production so be sure to sign up to receive program updates for the 2015 agenda.


Share this article with your social network, just click below to share now!


Thursday, September 18, 2014

Site-Specific Characterization of Glycosylation on Protein Drugs

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Site-Specific Characterization of Glycosylation on Protein Drugs.


BPI_A_141206AR05_O_F0001gA large proportion of biotherapeutic products are glycoproteins. These include erythropoietin and other cytokines, antibodies, glycosyltransferases, and glycosidases, which together generate billions of dollars in sales worldwide. Such drugs are inherently complex. As new treatments emerge and biosimilars are evaluated, the need to better understand their molecular structures is more acute than ever.

Therapeutic glycoproteins are typically produced as recombinant products in cell culture systems. Glycosylation is of major importance during development of these drugs because their glycan chains markedly affect product stability, activity, antigenicity, and pharmacodynamics. A detailed description of the structural features for such carbohydrate-containing molecules is increasingly expected as part of their new drug applications (NDAs) or comparability protocols.

Read the full article here.


You can find out more about topics like this and meet and network with other professionals in the bioprocessing field at this year's BioProcess International Conference and Exhibition.  As a reader of this blog, when you register to join us October 20-23 in Boston, you are eligible to receive 20% off the standard rate when you mention code BPI14BLOG.


Share this article with your social network, just click below to share now!


Tuesday, September 16, 2014

Alzheimer's Diagnosis and the Role of Biomarkers

Xuemei Zhao, Principal Scientist Merck Research Laboratories 

Alzheimers disease biomarkers marker identification diagnosisAlzheimer’s disease (AD) is the most common form of dementia and it is increasingly prevalent in people over 65 years old.  In developed countries, AD places a tremendous burden on individuals and society.  To date, the cause and progression of the disease are not fully understood.  Although symptomatic therapy has been approved, there is no agent available to stop or reverse the disease.  Many therapeutic candidates are in development with some showing promising results.  Clinical diagnosis of AD relies on characteristic neurological and neuropsychological features.  A definite diagnosis of AD, however, can only be made by examining the neuropathological hallmarks of the disease, amyloid plaques and neurofibrillary tangles, at autopsy.  Therefore, biomarkers that aid in the diagnosis of AD would have great value in the development of AD therapeutics and clinical practice. 

Protein markers in cerebrospinal fluid (CSF) and neuroimaging markers have been shown to contribute to the diagnosis of AD.  CSF protein biomarkers include total tau, phosphorylated tau, and the 42 amino acid form of amyloid-b (Ab42).  Some recently developed positron emission tomography (PET) agents for amyloid deposition imaging are the 11C Pittsburgh Compound B (11C-PIB) and newer, FDA-approved amyloid imaging agents such as Amyvid and Flutemetamol.  Other AD imaging modalities are atrophy on structural magnetic resonance imaging (MRI), and hypometabolism on [18F]fluorodeoxyglucose (FDG) PET.  The validity of these biomarkers of amyloid plaque deposition and neurodegeneration owing to AD is supported by autopsy correlation studies.  Implementation of these markers in the clinic, however, is not ideal in that CSF collection by lumbar puncture is a relatively invasive procedure and PET/MRI measurements are expensive, facility restricted, and may be further limited by personal conditions such as pacemakers.  Therefore, identification of robust biomarkers in an easily accessible body fluid would aid in the early detection of the disease and facilitate development of disease-modifying agents.  


We performed two independent studies, discovery and validation, to identify AD markers by profiling proteins in human plasma using the aptamer-based SOMAscanTM technology.  Specifically, we aimed to identify markers with better performance than the best-performing CSF markers, tau and Ab42, to discriminate AD from non-demented controls.  We constructed a 5-protein classifier in the discovery study and demonstrated that the plasma protein classifier allowed the prediction of AD with 100.0% sensitivity, 80.0% specificity, and 90.0% accuracy in an independent validation study, matching or outperforming CSF tau and Ab42.  Individual-matched plasma and CSF samples were obtained at the same visit, allowing direct comparison of diagnostic performance between the plasma protein classifier and CSF protein biomarkers.  Moreover, the classifier also correctly predicted mild cognitive impairment (MCI), an early pre-dementia state of the disease, with 96.7% sensitivity, 80.0% specificity, and 92.5% accuracy.  These studies demonstrate that plasma proteins could be used effectively and accurately to contribute to the clinical diagnosis of AD.  Although additional and more diverse cohorts are needed for further validation of the robustness, including the support of post mortem diagnosis, the 5-protein classifier appears to be a promising blood test to contribute diagnosis of AD. 

Learn more about Xuemei's work in identifying Alzheimer's disease. 

You can hear more from Xuemei at this year's Bioassay and Bioanalytical Method Development event.  Join us October 20-22 in Boston, MA.  Download the agenda here to see what else is on tap.   

SAVE $100. Register here and use code XP1969BLOG

Sign up for our e-mail updates
Follow us on Twitter
Join us on LinkedIn




Share this article with your social network, just click below to share now!


What’s Next in Cell Culture & Upstream Processing?

This fall at BioProcess International, we have a track dedicated to Cell Culture & Upstream Processing.  When you join us to learn about this topic, find out more about proven approaches and technologies to reduce timelines and increase efficiency and productivity.

This October in Boston, we look at
  • ● Genomic Tool Implementation
  • ● Synthetic Biology Applications
  • ● Implementing Continuous Processing for Manufacturing
  • ● Commercial Single-Use Applications
  • ● Process Intensification
  • ● Raw Material Integrity Testing
  • ● Media Development and Optimization
  • ● Small Scale Models and Tech Transfers
Companies have experienced many recent achievements to improve quality, cost, efficiency and productivity in cell culture, but what impact will the next wave of disruptive technologies and innovations have on biologics production?

Check Out These Key Case Studies & New Data Presentations Featured in these Informative Cell Culture & Upstream Processing Focused Sessions to Find Out: 
  • • What's Next In Biologics Production New Data & Case Studies from: SAFC, Amgen and Lily Research Laboratories
  • • Improving Product Quality & Control Case Study from: Amgen
  • • Innovation at the Interface of Upstream & Downstream Production New Data & Case Studies from: FloDesign Sonic and Bioprocessing Technology Institute
  • • Improving Efficiency, Productivity and Timelines in Cell Culture New Data & Case Studies from: Genentech, BioGen Idec and Fujifilm Diosynth Biotechnologies
  • • Continuous Processing for Manufacturing (Sponsored by Novasep) New Data & Case Studies from: Sanofi Global Biotherapeutics, Merck & Co, The Pennsylvania State University and BioGen Idec
  • • The Next Wave of Single Use Manufacturing: Closed Systems, New Technology and Cost Comparisons (Sponsored by: Life Technologies and Thermo Scientific) New Data & Case Studies from: Biogen Idec and Bayer Healthcare
  • • Late Stage Cell Culture New Data & Case Studies from: Alexion Pharmaceuticals, AstraZeneca and Merck Research Labs
  • • High-Throughput, QbD and DOE Approaches to Process Development New Data & Case Studies from: Genentech, Biogen Idec and Gallus Biopharmaceuticals

Plus, this Interactive Panel Discussion: How Well do you Know the Raw Materials Used in Your Upstream Manufacturing - Sponsored by BD Bioscience in the Impact of Raw Materials on Product session.

As a reader of this blog, when you register to join us at BioProcess International Conference and Exhibition this October 20-23 in Boston and mention code BPI14BLOG, you can save 20% off the standard rate.  Have any questions or need further information?  Feel free to reach out to Jennifer Pereira.


Share this article with your social network, just click below to share now!


Monday, September 15, 2014

Challenges of analytics for complex molecules versus monoclonal antibodies

Dr. Johnson Varghese, the Senior Director and Head of Analytical Development Group at Shire
Pharmaceuticals, recently sat down with the BioProcess International team to discuss establishing criticality of product attributes, challenge are analytics for complex molecules than for monoclonal antibodies and more.

In the interview, he also looks at in-vitro assays that are being developed using biological materials of fibroblast cells with a physiological relevance. Advantages of this method, which is using cells from patients with the disease  and using relevant sub-sprays include assurance of accurate measuring and it allows you to be able to probe conformational aspects of the enzyme.


Dr. Varghese will be the chair of the Analytical and Quality track at the BioProcess International Conference and Exhibition on Wednesday, October 22.  He will be facilitating presentations around the topics of Elucidating the Structure/Function Relationships of Complex Glycoproteins, Elucidating the Structure/Function Relationships of Complex Glycoproteins and facilitating a panel with the speakers of the day's presentations.  For more information on these sessions and the rest of the program, download the agenda.  As a reader of this blog, when you register to join Dr. Varghese at BioProcess International with code BPI14BLOG, you can save 20% off the standard rate.


Share this article with your social network, just click below to share now!


Friday, September 12, 2014

Innovation in a Maturing Manufacturing Sector Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Tina M. Larson, Senior Director, Technical Development Operations & Engineering, Genentech, talks about four innovations in the mAb industry which include: manufacturing consistency, novel drug formats, manufacturing plant design, and drug delivery.  She states that there are two categories of improving manufacturing consistency which are process development approaches and manufacturing technology approaches. She also talks about how one of the most important technologies in the mAb field is data technology.  And one thing they use data technology for is to monitor the health processes.

Watch the Part 2 of her presentation for more information:


Watch Part 1 here.

Biopharmaceutical Development and Production Week will take place March 30-April 2 in Huntington Beach, California. Sign up to receive email updates as they become available.


Share this article with your social network, just click below to share now!


Thursday, September 11, 2014

Hospira Joins Business of Biosimilars, Last Chance to Save is This Friday

At this year's 15th Annual Business of Biosimilars Conference, partner with 100+ movers and shakers in the biosimilars space including pharma, biotech, and legal experts at the leading forum to drive commercialization and market access of biosimilar drugs. By attending, you will learn how to:
  • Identify business opportunities by analyzing the commercial realities of the market
  • Increase market access by expanding your global footprint in the US, EU, and emerging regions via a new "Around the World in One Day" workshop
  • Gain clarity from legal experts on state substitution laws, interchangeability, and takeways of high profile court cases
  • Navigate through regulatory complexities, maximize market uptake, and drive commercial success of a biosimilar drug
Plus! We're excited to announce that Mohamed H. Ladha, Global Biologics Marketing, Global Pharmaceutical Marketing, Hospira has joined the Biosimilars speaker faculty. Hear from him and other industry experts in the below panel:
Looking at the Commercial Realities of the Biosimilar Market
  • •  
    Moderator: John J. Lewis, Senior Vice President, Policy & Public Affairs,           Association of Clinical Research Organizations
  • •  
    Panelists:
    • - Giles Somers, Lead Analyst, Generics and Biosimilars, Datamonitor
    • - Carsten Brockmeyer, CEO, Formycon AG
    • - Mohamed H. Ladha, Global Biologics Marketing, Global Pharmaceutical Marketing, Hospira
Don't miss out on the opportunity to gain a 360 degree view on regulatory complexities, policy adoption, globalization and commercialization of the biosimilars industry. Download the brochure today to see how you can capitalize on the expected growth in the biologic medicines market.

Don't forget! This Friday, 9/12 is your last chance to SAVE $200! PLUS, you can save an extra $100 as a reader of this blog for a total of $300.  Register here and use code XP1986BLOG.


Follow us on Twitter: @FutureOfBiopharma & @Biosimilars
Join us on LinkedIn




Share this article with your social network, just click below to share now!


George Church and Feng Zhang to keynote inaugural Genome Editing Applications conference

IBC Life Sciences, the organizer of market leading events in drug discovery and biologics development, today announced that George Church and Feng Zhang, two world-renowned scientists, will provide the keynote presentations at the Genome Editing Applications conference to be held on March 18-19, 2015 at the Hilton Boston Back Bay, Boston, MA. The Genome Editing Applications conference is the first comprehensive event to focus on the applications of genome editing technologies and genome engineering in therapeutic development, drug discovery and screening and other research applications.

"The emerging applications of genome editing tools hold enormous potential for the development of powerful life saving therapies. Genome editing technologies also offer significant advantages in drug discovery, target validation, screening and other pharmaceutical research applications, including development of gene therapies, cell therapies and immunotherapy. In George Church and Feng Zhang, we are excited to have two of the most respected leaders in the field to share their insights on current and future technologies and applications in genome editing and genome engineering, “said Michael Keenan, Conference Director, IBC Life Sciences.

The event features a compelling program that enables delegates to:
  • • Learn about therapeutic applications of genome editing in cardiovascular disease, gene therapy, stem cell therapy, CART cell immunotherapy, hemophilia B and other advances in in vivo genome editing
  • • Gain an in-depth update on the latest technology advances and applications of CRISPR-Cas9 including a discussion of off-target issues, delivery to cells/tissues, improving specificity and multi-genic alterations
  • • Apply genome editing as a research and drug discovery tool in target identification and validation, genome-scale screening, gene targeting, cell line validation and transgenic animal models
  • • Compare the advantages and disadvantages of CRISPRs, ZFNs, and TALENs for various applications and discover ways to navigate the IP landscape of genome editing technologies for your own projects
For more information about the Genome Editing Applications conference and how to register, visit the webpage.

About the Genome Editing Applications conference
IBC’s Genome Editing Applications conference will showcase the most up-to-date therapeutic and biomedical applications emerging using CRISPRs, ZFNs, TALENs, AAVs and other genome engineering technologies. From validation of targeted cell lines and development of transgenic animal models to therapeutic uses in cell therapy, gene therapy and immunotherapy, this event will also highlight applications in drug target identification/validation and lead discovery and explore how these technologies are being used for whole-genome and functional screening as well as basic research applications. A special emphasis on CRISPR will highlight the design of novel CRISPR constructs and discuss practical aspects of CRISPR including off-target effects, how to improve specificity and delivery to specific cell types, including potential applications in multi-genic alterations. By attending this applications-focused conference you will learn about advances in all of the latest genome editing technologies, including comparisons, advantages and disadvantages of each. You will also learn how to position your company for success in genome editing in the face of the still-evolving IP landscape of CRISPR and other genome editing approaches.

About IBC Life Sciences
IBC Life Sciences, a division of Informa, is your connection to the life sciences industry. Through conferences, webinars, podcasts and its suite of integrated marketing solutions, IBC Life Sciences delivers expert knowledge, valuable connections and customized offerings so customers can meet their goals. www.IBCLifeSciences.com


Share this article with your social network, just click below to share now!