Friday, October 24, 2014

New FDA and BARDA Keynotes Provide Regulatory and Global Perspectives at Vaccines Development & Production Summit

We are excited to announce the addition of two keynote speakers to IBC's Vaccine Development Production Summit taking place December 8-9, 2014 in Boston, Massachusetts.
  1. - Tina Roecklin, Consumer Safety Officer of FDA offers regulatory perspective on the goals for characterization of glycoconjugate vaccines, which have proved to be very effective at preventing diseases caused by encapsulated bacteria. Examples of the methodology used to address these goals for characterization will be presented.
  2. - Arlene Joyner, Senior Project Officer/Program Manager of BARDA provides an overview of the key BARDA Core Service programs that are designed to assist pharmaceutical companies developing novel vaccines and therapeutics to protect against Chemical, Biological, Radiological and Nuclear (CBRN) threats as well as emerging infectious diseases such as Ebola and pandemic influenza. 
In addition to these two great keynote additions, this year's program brings together a global panel of vaccine experts to help you:
  • - Benchmark your vaccine development progress against today's national headlining cancer vaccine developments 
  • - Create a more efficient vaccine manufacturing process - Improve the efficacy of your vaccine therapeutic
  • - Utilize new technologies to enhance your research and delivery efforts 
 For full program details download the brochure today.


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BioProcess International Announces Winners of the 2014 BioProcess International Awards

Eight award winner recipients and twenty-four finalists recognized for bioprocessing achievements during industry gala.

BioProcess International (BPI), a business-to-business publication, today announced the winners for the 2014 BioProcess International Awards. The awards celebrate the outstanding achievements, collaborations, business strategies, social corporate responsibility and technology applications that will allow the industry to deliver better, more effective treatments to a global patient base.

Winners and finalists were honored and recognized by their peers during a very entertaining and exciting awards dinner and ceremony yesterday evening, 22 October at the Hynes Convention Center in Boston.

Winners and Finalists for the 2014 BioProcess International Awards are:

Excellence in Leadership
  • - (Winner) Dr. Robert Preti, Founder, President, and Chief Scientific Officer, Progenitor Cell Therapy (PCT)
  • - (Finalist) Lynn Bottone, Site Leader, Sanford Site, Pfizer
  • - (Finalist) Olivier Loeillot, General Manager, Enterprise Solutions, GE Healthcare Life Sciences
Emerging Company
  • - (Winner) ToleRaM Nanotech, LLC.
  • - (Finalist) BioCision
  • - (Finalist) Horizon Discovery
Corporate Citizenship
  • - (Winner) Bayer HealthCare
  • - (Finalist) Biogen Idec
  • - (Finalist) Sigma-Aldrich
Excellence in Facility Design or Retrofit
  • - (Winner) Gallus BioPharmaceuticals/GE Healthcare Life Sciences
  • - (Finalist) Vetter
  • - (Finalist) FUJIFILM Diosynth Biotechnologies
Best Collaboration
  • - (Winner) TAP Biosystems/Merck & Co., Inc.
  • - (Finalist) Invetech Inc./Janssen Research & Development, LLC
  • - (Finalist) Promosome/GE Healthcare Life Sciences
Upstream: Best Technology Applications
  • - (Winner) ambr250 — TAP Biosystems/Merck & Co., Inc.
  • - (Finalist) XDR-50 MO Fermentor System — GE Healthcare Life Sciences
  • - (Finalist) STX® Scalable Transfection System — MaxCyte
Downstream: Best Technology Applications
  • - (Winner) Natrix HD Membranes — Natrix Separations, Inc. /Gallus BioPharmaceuticals
  • - (Finalist) BioT Temperature Stability Systems — BioCision
  • - (Finalist) Allegro Single-Use Filling Needles — Pall Life Sciences/Disposable-Lab SAS
Analytical: Best Technology Applications
  • - (Winner) MicroScale Thermophoresis (MST) — NanoTemper Technologies GmbH
  • - (Finalist) ImageStreamX®(ISX) — Enzo Life Sciences/Amnis (part of EMD Millipore)
  • - (Finalist) SGS M-Scan Services — SGS Life Sciences

From Some of the Award Winners:
“It is a fantastic honor to be nominated for the BioProcess International 2014 Award, along with TAP Biosystems, for both Best Collaboration and Best Technology Application-Upstream for the development of the Ambr250 automated bioreactor system. The collaboration and resulting Ambr250 technology was intended to have true value to end users through the improvement of productivity, accuracy, consistency, and the work life balance of the scientist. Being nominated as a finalist in these categories shows the value the technology brings to these areas,” said David Pollard, Executive Director, Merck & Co., Inc.

“We spend a lot of time trying to understand the requirements of the end-users and the context into which our systems are placed. Being a BioProcess International 2014 Awards finalist with the excellent team from Merck is an acknowledgement that such time and effort is really worthwhile,” said Richard Wales, Director Business Development, TAP Biosystems, Part of the Sartorius Stedim Biotech Group.

“ToleRaM Nanotech is delighted with being recognized as a finalist for the BioProcess International 2014 "Emerging Company" award. We are dedicated to the efficient delivery of targeted nanotherapeutics by merging bioengineering with medicine, and are truly honored by this recognition,” said Satish N. Nadig, M.D., Ph.D. Title: Chief Medical Officer (CMO) ToleRaM Nanotech; Assistant Professor of Surgery, Microbiology & Immunology - Medical University of South Carolina.

See more quotes from our finalists and winners.



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Thursday, October 23, 2014

#BPIConf 2014: Collective Intelligence Is Vital for Disruptive Innovation In Biologics Manufacturing

Rizwan Manzer, Scientist with Experience in Pharmaceutical Drug Development, is on site at BioProcess International to capture the insights of our keynote presentations.

On the 3rd day of BioProcess International Conference Exhibition at Boston, morning plenary session was chaired by Peter Abair, Director of Economic Development and Global Affairs,
MassBio. In his opening remarks he emphatically mentioned the role of Massachusetts’s leadership position in the life science industry and how to prepare for the future to maintain same standing. He also shared the finding of Impact 20/20 report, that how Mass Bio is helping organizations to achieve success and creating economic activities in Massachusetts. Since there is drop in NIH funding and reimbursement is becoming uncertain, preparing industry for the future is becoming challenging. He strongly recommended companies to become patient centric and demonstrate the value to maximize the access to capital. He also recommended to leverage information technology to advance the life science industry.

In the following presentation, Ganesh V. Kaundinya, Co-Founder and Chief Scientific Officer, Momenta Pharmaceuticals, presented Understanding complexity in Biological System through Big Data Analytics – Application to Biosimilars and Novel Biologics and discussed how information technology and big data approach can be used in the life science industry to understand the complexity of biological system. In general big data approach allow better understanding, more amenable to statistical analysis and easy to create algorithms for normal and abnormal trends. However, in life science there are different types of data that generate heterogeneity and it’s difficult to come up with one algorithm. He talked about the core aspects of biosimilar platform which is define the target and understand what you are copying and generate depth of information about it. Once, cell lines with finger print for biosimilar is ready then go for the process optimization. Only finite number of genes, proteins, metabolites drives protein production, so use rational approach to manage key nodes that impact most of the protein production. When there is enough data, put them together to understand the relationship between different attributes and integrate different data. Momenta Pharmaceutical is also applying similar approach for their novel biologics program to design multi-target therapeutics for oncology and orphan autoimmune indications.

Next presentation was Delivering Innovation in Biotherapeutics Manufacturing: From Continuous Improvement to Disruptive Innovation, What Can Current Industry Trend Tell Us About the Next 10 Years, by Ralph Lambalot, Vice President Biologics Development AbbVie. He advocated to challenge the barriers of innovation and encouraged to question the established paradigm. In his presentation Dr. Lambalot talked about repetitive cycle of innovation and string of innovation curves in different fields and how non-conformity and collective intelligence are vital to stay innovative. He also highlighted the importance of innovation in the early stage of product design because as we progress in the development cycle, the window of opportunity for the innovation goes down.


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Wednesday, October 22, 2014

Introducing the FDA/CMS Summit for Biopharmaceutical Executives

Join us for the 10th Annual FDA-CMS Summit, for biopharmaceutical executives, December 11-12, 2014 in Washington, DC. Our keynote speakers and panels will take a deep dive into each of these topics, and more. You'll leave better able to make strategic decisions on issues such as:

• The commercial outlook for biopharma under the new health care exchanges

• Updates on the latest drug review statistics from the Office of New Drugs and industry's experience under the new review "Program"

• The future of drug safety at FDA - both for the increasingly popular rare disease drugs as well as new treatments for large primary care markets like obesity and diabetes

• What's in store for the reauthorization of PDUVA VI, and a preview of what's to come as industry and FDA take a second look at BsUFA and GDUFA.

• Coming changes to Medicare Part D and what CMS has in store for the prescription drug benefit

• What the mid-term Congressional elections will mean for the biopharma industry.

 
Speakers Include:

o Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA)
o John Jenkins, MD, Director, Office of New Drugs, Food and Drug Administration (FDA)
o Leah Christl, Associate Director, Biosimilars Program, Office of New Drugs Food and Drug Administration (FDA)    
o Gerald Dal Pan, MD, Director, Office of Surveillance & Epidemiology, Food and Drug Administration (FDA)
o Jim Robinson, President, Astellas Pharma US    
o Sumant Ramachandra, MD, PhD, MBA, SVP & Chief Scientific Officer, Hospira
o Robert Clark, VP, US Regulatory Affairs, Novo Nordisk    
o Francois Nader, MD, CEO, NPS Pharmaceuticals
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Beier, Partner, Bay City Capital    
o John McHutchison, MD, Executive Vice President, Clinical Research, Gilead
o Mark McClellan, MD, PhD, Senior Fellow and Director, Health Care Innovation and Value Initiative, Brookings Institution    
o Niall Brennan , Acting Director, Office of Enterprise Management, Centers for Medicare & Medicaid Services (CMS)
o Tamara Syrek Jensen, JD , Deputy Director, Coverage and Analysis Group, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)    
o Mark McCamish, MD, PhD, Global Head Biopharm.& Oncology Injectables Development, Sandoz International GmbH
o Karen Jones, VP, Global Head of Oncology Regulatory, Genentech    
o Chris Garabedian, CEO, Sarepta
o David Mott, General Partner, Biopharmaceutical Investments, New Enterprise Associates (NEA), Former CEO, MedImmune    
o Steven Nissen, MD, MACC, Chairman, Department of Cardiovascular Medicine, The Cleveland Clinic Foundation

Register now for this can't-miss event! 


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#BPIConf 2014: Continuous and Optimized Manufacturing is the future of Biopharmceutical Manufacturing

Rizwan Manzer, Scientist with Experience in Pharmaceutical Drug Development, is on site at BioProcess International to capture the insights of our keynote presentations.

On the second day of the ongoing BioProcess International Conference and Exhibition at Boston, the keynote presentation Chair Guenter Jagschies, Senior Director, Strategic Customer Relations, Biotechnologies R& D, GE Healthcare life Sciences kicked off the afternoon keynote presentation with industry reality check. He emphasized the need to bring down the cost of research and development to keep the Biopharmaceutical industry competitive and meet the need of patients.

In the next presentation, John G. Cox, Executive Vice President Pharmaceutical Operation & Technology, Biogen Idec presented Delivering on a Global Biopharmaceutical Portfolio.  Biogen Idec’s strategy for success through innovations in R&D. Protein Development, and manufacturing. He stressed on the need of innovation at each stage of drug development process to meet the need of future demands, especially when different kinds of drugs i.e oligonucleotides, cell therapy, gene therapy are coming to the market. Though, currently industry has surplus manufacturing capacity, but that may change in the next couple of years by 2020 and suggested to adopt flexible and optimized manufacturing model. He also highlighted the importance of continuous manufacturing to bring down the cost of goods sold to make it affordable.

The third keynote speaker of the day, Robert Mattaliano, Group Vice President and Head of Biologics Sanofi- Genzyme R & D center presented Keeping the patients and caregiver’s experience in mind and highlighted the importance of patients and caregivers perspectives for good product development. It is the patient and the caregiver whose opinion matters most in the product design to deliver the best product. He also suggested that with the changing landscape of emerging new combination and format of medicine, biologics should be treated as integrated system with delivery device. At the end of his talk he suggested to spend more time and resources to understand the biology of disease state, since only the better understanding of pathogenesis of disease guarantees and assure the success of new molecule.

Last speaker of the session, Geoffrey Ling, Director, Biological Technologies Office, DARPA enthusiastically talked about Biologically-derived medicines on demand for Battlefield Medicine. He encouraged the bioprocess scientists and engineers to collaborate with DARPA to accelerate the cycle of innovation and manufacturing. He also shared his experience about how his organization expedited the development of FDA approved artificial arms.

Stay tuned to twitter with #BPIConf for updates throughout the day!


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Tuesday, October 21, 2014

#BPIConf: Six Insights on BioProcess Manufacturing Innovation

On the first day of BioProcess International, we were able to sit in on 3M™'s full day symposium Innovation through Integrated Process Development.

Here were our six of our take aways:
  • 1. Rob Piper, Principal Scientist, Amgen on the strengths of using disposables: low investment, small footprint, single/quick expression, short implementation time, reduced qualification/maintenance and fast passed product of change
  • 2. According to Abhinav Shukla, Ph.D., of KBI Biopharma, mixed mode chormotography: examine and incorporate modulators into process that can help increase selectivity and purity of a product.
  • 3. Kumar Dhanasekharan, Director of Process Development of Cook Pharmica emphasized that continuity in process development as should be developed and scaled as production occurs through the different phases.
  • 4. 3M recently conducted the web seminar 3M™ Innovation: Transforming and Redefining Biopharmaceutical Purification with 3M™ Emphaze™ AEX Hybrid Purifier – which was discussed throughout the day in the track. See the web seminar here.
  • 5. Rahul Singhvi, Ph.D, MSc., COO, Global Vaccines Business Unite, Takeda Pharmaceuticals brought a different perspective to the table. He challenged production innovators to take a new approach to manufacturing tried and true vaccines the access to childhood vaccines is not reliable, accessible or affordable enough.
  • 6. Holistic approach to biopharmaceutical development – this should lead to a higher performances with lower cost of manufacturing processes.
Stay tuned to #BPIConf to follow along with today's events and check back for more highlight posts throughout the event!







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Monday, October 20, 2014

BioProcess International (BPI) 2014 Opens its Doors to More than 1500 Industry Leaders Seeking New Technologies, Partnerships, and Critical insights

Today IBC Life Sciences, is pleased to kick off the 2014 edition of BioProcess International Conference & Exhibition, the world’s largest event dedicated to biological development and manufacturing. Being held at the Hynes Convention Center in Boston from October 20-23, this year’s event will see more than 1500 industry professionals from across the biological development value chain to engage in intensive learning, networking and partnering.

“We are pleased to see that some of the industry’s leading companies have chosen to showcase their new products in the highly anticipated BPI Theater this year. The continued success of the BioProcess International Conference & Exhibition is due to the unwavering commitment of the sponsors, exhibitors, speakers and the attendees who ultimately help to cure disease and improve lives,” said Elizabeth Cutler, Managing Director, IBC Life Sciences.

The event opens with five visionary keynote presentations by John G. Cox, Executive Vice President, Pharmaceutical Operations & Technology, Biogen Idec; Robert Mattaliano, Ph.D., Group Vice President and Head of Biologics, Sanofi-Genzyme R&D Center; and, Geoffrey Ling, M.D., Ph.D., Director, Biological Technologies Office, DARPA.

The four main conference tracks are: cell culture & upstream processing, recovery & purification, manufacturing strategy, formulation & delivery and analytical & quality. These take place on October 21-23.

Plus, IBC will hold pre-conference symposiums on October 20, four bioprocessing professional development training courses on October 20-21 and the new success factors for early stage bilogics and early stage companies session on October 22.

The exhibit hall is open October 21-23 and features 150 exhibitors, the BPI Theater, lounges sponsors by SAFC, Pall Life Sciences and HETIRISK and the emerging marketplace pavilion.
New the year, the BPI Theater located in the exhibit hall (October 22-23) opens with an impressive lineup of new product launches from leading companies including, Meissner Filtration Products, Pall Life Sciences, EMD Millipore, Asahi Kasei Bioprocess, Sartorious Stedim and Purolite.

A high level of productive networking is anticipated by the strong adoption by this year’s attendees of partnering360 event specific networking tool. This new networking tool will make identifying and engaging with best-fit partners at the event easier than ever before.

Plus, the event will be the ideal backdrop to host the BioProcess International 2014 Industry Awards which celebrate and recognize the outstanding people, organizations and technologies that have significantly changed, impacted, and advanced the efficiency of biotherapeutic development and manufacturing process.

We're also onsite covering the event through our social media channels.  Follow #BPIConf on twitter for session updates and visit this blog each morning for a recap of each day's top sessions.


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Friday, October 17, 2014

BioProcess International Conference and Exhibition Starts Next Week!

Next week, over 1,500 bioprocess professionals are gathering in Boston for the industry's #1 bioprocessing event at BioProcess International Conference and Exhibition. Four days of content will will focus on cell culture & upstream processing, recovery & purification, biologics manufacturing strategies, analytical and quality, and formulation and drug delivery. Who else has registered to join us?

Here's some of the companies:
3M Purification, Abbvie. Alexion Pharmaceuticals Inc, Baxter Healthcare Corporation, BD Biosciences, Bio Rad Laboratories, BioProcess Technology Consultants, Bristol Myers Squibb, Chromatan Corporation, Corning Inc, EMD Millipore, Entegris, Eppendorf, Fujifilm Diosynth Biotechnologies, Genentech Incorporated, Hydranautics, Integra Companies Inc, JNC Corporation, Lonza, Merck & Co Inc, Momenta Pharmaceuticals, North Carolina State University, Parker Domnick Hunter, Progentics, Regeneron Pharmaceuticals, SAFC Biosciences, Shire, Takeda Pharmaceutical, United Therapeutics Corporation, VWR International LLC, WuXi AppTec


Want to join us?  As a reader of this blog, you can still save 20% off standard rates!  Register with priority code BPI14BLOG.  Have any questions?  Email me at jpereira@iirusa.com


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Thursday, October 16, 2014

Design of Experiments for Fed-Batch Process Development in Shaken Cultures

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Design of Experiments for Fed-Batch Process Development in Shaken Cultures.



When designing a recombinant protein production process, a high number of parallel cultivations must be carried out. That task is typically performed using batch cultures in shake flasks or microwell plates, in which fermentation conditions are not monitored. To overcome that limitation, we combined the SensorDish Reader and Shake Flask Reader systems (from PreSens) with an enzymatic glucose delivery system (EnBase technology from BioSilta Oy) for Escherichia coli cultivations. Our objective was to determine whether SensorDish reader cultures would yield reproducible process data that were directly comparable to those at shake flask scale (left).

 Especially in the biopharmaceutical industry, a consistent process development from microliter to industrial scale requires consideration of many different perspectives to completely understand a transition process. We created a design of experiments (DoE) to determine optimal parameters at two different cultivation scales. Such batch-type cultivation principles in orbitally shaken systems (mostly shake flasks, but also microwell plates and bench-scale fermentors) are used to obtain acceptable results with as little effort as possible. Unfortunately, they are mostly carried out without considering the important influence of conditions in large-scale production on product quality and process yield. To learn more, read the 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.


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Wednesday, October 15, 2014

BioProcess International Poster Preview: Seg-Flow® Automated Nutrient Monitoring and Continuous Feed Platform for Precise Nutrient Feed Control

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: Seg-Flow® Automated Nutrient Monitoring and Continuous Feed Platform for Precise Nutrient Feed Control

Presenter: Ashley Fisher, Flownamics, Inc.

About: Fed-batch culture processes are commonly used for the production of various biotherapeutic and other industrial commodities. A widely employed nutrient feed control strategy for both cell culture and microbial fermentation processes is direct feedback control, in which the nutrient feed is directly controlled by the nutrient, i.e., glucose, concentration. However, various iterations of this feeding approach exist which may not be conducive to culture growth and productivity. In order to optimize culture performance, the means by which the substrate is fed to the culture is just as, if not more, important as maintaining the desired media substrate levels. An automated feedback control platform, which employs a continuous feed strategy based on the culture’s real-time nutrient consumption rate, has been developed by Flownamics®. This integrated platform consists of the Seg-Flow® automated on-line sampling system, a nutrient analyzer and a feed pump. The Seg-Flow system was evaluated for its ability to precisely control media glucose concentrations in both low and high consumption rate culture simulation models. The results showed that the integrated Seg-Flow system was able to precisely control media glucose concentrations at the prescribed levels through real-time glucose consumption rate calculation and continuous feeding.

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.


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Friday, October 10, 2014

Approaching Quality of Biopharmaceutical Manufacturing at the Highest Level

In today's featured interview 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 the challenges in the bio processing industry, the systems based thinking facing the industry and knowledge management, He also looks at the challenges facing the industry, the future of regulation of continuous process validation, He also addresses how global supply chains can help the needs of the patients. Want to learn more?

Watch the interview here:


To hear more exclusive insights from biopharmaceutical production regulators, join us at the 2015 Biopharmaceutical Development and Production Week. It will take place March 30-April 2 in Huntington Beach, California. To receive updates on the program as they occur, sign up for email updates.



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White Paper: T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation

At our upcoming Immunogenicity for Biotherapeutics Event, Anne S. De Groot will be joining us to present New Approaches & Emerging Technologies To Overcome The Effects Of Immunogenicity.

Ahead of that presentation, she shared a few of her recent research papers, including one titled T-cell dependent immunogenicity of protein therapeutics: Preclinical assessment and mitigation.   In this paper, they look at the strategies to assess immune responses to protein therapeutics during the preclinical and clinical phase of development.  In this particular white paper, they focus on Td contributions to immunogenicity.

Here is an excerpt:
1.1. The immunogenicity of protein therapeutics
Since the approval of the first recombinant biological therapeutic, insulin, in October 1982, more than 165 biotherapeutic agents have entered the marketplace and have generated an estimated $99 billion in sales worldwide [1], [2], [3] and [4]. Therapeutic biologics offer the advantages of increased specificity and reduced toxicity compared to small molecules. However, when administered to patients, these protein-based drugs have the potential to elicit immune responses that may directly impact drug safety, efficacy, and potency. For example, anti-drug antibodies (ADA) that develop in response to a therapeutic protein may alter the drug's pharmacokinetic profile and abrogate its pharmacodynamic effect (neutralizing activity) [5], [6], [7] and [8].

Immune responses to proteins are characterized by the generation of antibodies (humoral immune response) that could be T cell dependent or independent. T-independent antibody responses may be generated when B cells recognize a repeated pattern (motif) in the therapeutic protein and respond by transiently producing low-affinity, predominately IgM antibodies [9]. Antibodies that are generated in conjunction with T cell help are referred to as T cell-dependent or thymus-dependent (Td) antibodies. This process, described in the next section, involves a complex interplay among antigen presenting cells, T cells, secreted cytokines, and B cells, emphasizing the importance of genetic factors such as HLA haplotype expression and T cell/B cell repertoire in immune responses to administered proteins. Thus, measurement of ADA IgG responses usually indicates that T cells are involved in the immune response to the protein. Moreover, a number of clinical studies now suggest that high levels of T cell-driven IgG ADA have the potential to cross-react with the endogenous counterpart, an adverse effect that can have serious consequences [10], [11] and [12].

T cell responses contribute to the generation of ADA. Proteins with therapeutic potential are produced in cell lines that are derived from a variety of sources, including mammals (both human and non-human), insects, bacteria, plants, yeast, and viruses. Small differences in the protein sequence and/or post-translational modifications (e.g., glycosylation, oxidation, deamidation, acylation, and alkylation) can contribute to the immunogenic potential of the therapeutic protein. Furthermore, the manufacturing process may involve multiple steps (e.g., regulation of gene expression, purification, concentration, formulation, and long-term stabilization) to produce recombinant proteins of sufficient quantity and quality to meet clinical release criteria. At each of these steps, there is potential for the introduction of biochemical or biophysical modifications into the molecules that may influence the immunogenicity profile of the biologic product. While these aspects of protein production may not impact function of the therapeutic protein, modifications inherent in the manufacturing process can have a major impact on host immune responses. For example, consider the case of Erbitux, a protein with non-human type glycosylations that caused anaphylaxis in selected patients who had pre-existing antibodies targeting these carbohydrate structures [13] and [14]. Host cell proteins derived from recombinant protein-producing cell lines may co-purify with a therapeutic product to become part of the final formulation [15] and [16]. These impurities, even in small quantities, have the potential to stimulate an unwanted immune response. In at least one recent case, they induced anti-host cell protein antibodies and contributed to the suspension of a clinical trial [15] and [16].

Read the full paper here. 

If you'd like to join Annie at Immunogenicity for Biotheraputics this coming October 20-22 in Boston, as a reader of this blog, when you register to join us and mention code XP1938BLOG to save $100 off the current rate.

Follow the jump for the references.



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Celebrate Columbus Day! Register for Pharma and Healthcare Events Thru Monday and Save $300!

Register for any of the following IIR events and receive a $300 discount*


Mention code COLUMBUSLI when registering for each/any of the following:

-  Register here for IIR’s 15th Annual Business of Biosimilars event taking place October 20-22, 2014 in Boston, MA, visit the website for full details.

-  Register here for IIR’s 15th Annual Immunogenicity and Biotherapeutics event taking place October 20-22, 2014 in Boston, MA, visitthe website for full details.

-  Register here for IIR’s 10th Annual Bioassays and Bioanalytical Method Development event taking place October 20-22, 2014 in Boston, MA, visit the websitefor full details.
Have any questions? E-mail Jennifer Pereira.

*This promotion is only valid October 10th-13th 2014. 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 IIR approval.




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Thursday, October 9, 2014

Science Meets Culture: BioProcess International the Industry’s #1 Event for Learning, Networking & Engagement

In less than two week, BioProcess International will take place in Boston, MA. One of the most popular features at BPI is the scientific poster displays. Great news! This year, we have a record number of your peers sharing their current research. To check it out you can swing by the exhibit hall to view more than 100 posters on display which will showcase today’s hottest research. See a preview of some of this year’s posters,

With 4 full days of learning and hearing insights from some of the top minds in the bioprocessing industry, BPI will also give you we give you a chance to kick back, relax, and meet your fellow colleagues at our evening receptions.

On Tuesday, October 21, join us for the International Food Festival sponsored by Roche. We’ll transform our exhibit hall into a global experience where you can watch cooking demonstrations and sample Asian, Middle Eastern and European food.

On Wednesday, October 22, we’re letting our team spirit shine. We’re transforming the exhibit hall into a game day experience with sports themed food and interactive Wii games. This event is co-sponsored by Bio-Rad Laboratories and IBC Life Sciences.

You can also take advantage of our new networking tool partnering360® - where you can connect and meet with your peers throughout the day and at our evening networking receptions.

What other events can you look forward too? Check them out.

Don’t forget, as a reader of this blog, you register to join us in Boston this coming October 20-23, you can save 20% off the standard BioProcess International rates. Register here and mention code BPI14BLOG.  One-Day Exhibit Hall and Keynote Passes are also available.

Have any questions? Feel free to reach out to Jennifer Pereira.


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Accounting for the Donnan Effect in Diafiltration Optimization for High-Concentration UFDF Applications

Today, we feature an article from our partners at BioProcess International Magazine. This is an excerpt from the article Higher-Order Structure Comparability: Case Studies of Biosimilar Monoclonal Antibodies.


The biopharmaceutical industry is targeting high-concentration protein formulations to enable subcutaneous administrations. Such administration can provide better patient convenience than intravenous administration. One challenge associated with high-concentration formulations is increased electrostatic interaction between proteins and excipients. That is a result of increased protein-charge density at high protein concentrations. Such interactions can create an offset between excipient levels in final products and diafiltration buffers in ultrafiltration processes. The effect of such electrostatic interactions in a membrane process is known as the
Donnan effect.

The Donnan effect on excipient levels has received significant attention in recent years. Theoretical modeling has been developed to predict excipient and pH changes as a result of the Donnan effect in monoclonal antibody (MAb) processes. One model based on the Poisson–Boltzmann equation provided good prediction of excipient levels in the final retentate pool. A second model developed by Bolton et al. demonstrated to be predictive for basic MAb and acidic Fc-fusion proteins. The latter study also included several mitigation strategies to achieve target levels of excipients at the end of an ultrafiltration–diafiltration (UFDF) process. Both publications provide tools for understanding the influence of the Donnan effect on target formulation excipients. By contrast, our study focuses on the influence of the Donnan effect on removal of starting buffer excipients during diafiltration.

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.


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Wednesday, October 8, 2014

BioProcess International Poster Preview: Direct Quantification of Residual Host Cell DNA

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: Direct Quantification of Residual Host Cell DNA

Presenter: Nancy Ngo, Bio-Rad Laboratories

About: Many therapeutic proteins and vaccines are manufactured using bacterial and mammalian host cells. Manufacturing processes are prone to leaving biological impurities from these cells, such as host cell DNA (HCD). The presence of HCD in drug substances poses safety concerns and must be removed to ensure product quality and safety. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO), have provided guidelines defining acceptable levels of HCD allowed in final drug products; the upper limit is 100 pg/dose and 10 ng/dose as stated by the FDA and WHO, respectively. Therefore, the method to quantify residual HCD and monitor DNA clearance should be highly sensitive to meet these regulatory requirements. Here, we introduce a highly precise and sensitive method for residual HCD quantification, without the need for DNA extraction, using droplet digital PCR (ddPCR). We created a panel of test matrices to simulate various process intermediates and analyzed these samples using ddPCR. Spiked-in DNA can be fully recovered even in complex matrices with high precision and femtogram-level sensitivity. The results from our study clearly show the effectiveness of ddPCR in detecting residual HCD by a direct method and without the need for DNA extraction.

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.


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BioProcess International BOGO - 3 Days Only Buy One Exhibit Hall & Keynote Pass – Get One 50% for a Friend


Hynes Convention Center – Boston, MA

Conference: October 20-23 | Exhibition: October 21-23

3 Days Only: Qualified professionals register from October 8-10 with priority code BP14FSEHBOGO will receive 50% off a second one-day exhibit hall & keynote pass for a friend.

Register now.


View Complete Exhibit Hall & Keynote Pass Details.

As the industry’s #1 event – BPI brings you a one-of-a kind-bioprocessing marketplace that has an unrivalled reputation for size & quality, including:
  • - 1500+ Attendees
  • - 150+ Exhibitors
  • - 5 Compelling Keynotes
    • o Enabling Delivery of Novel Pipelines, John G. Cox , Biogen Idec
    • o Delivering Innovation in Biotherapeutic Manufacturing, Ralph Lambalot, Ph.D., Abbive
    • o Keeping the Patient’s and Caregiver’s Experience in Mind, Robert Mattaliano, Ph.D., Sanofi R&D
    • o Biologically-Derived Medicines on Demand for Battlefield Medicine, Geoffrey Ling, M.D., Ph.D., DARPA
    • o Complexity in Biological Systems & Big Data Analytics, Ganesh V. Kaundinya. PH.D., Momenta Pharmaceuticals
  • - 25+ New Product Launches
  • - 80+ Scientific Posters
  • - Technology Workshops
  • - The BioProcess International Theater -- NEW THIS YEAR
  • - Causal Networking Lounges – Sponsored by Pall Life Sciences, SAFC and HETRISK
  • - BPI Passport Prize Program
  • - Fun, Themed Networking Receptions with Cooking Demos and Games!
    • o Tuesday, October 21, International Food Festival – Sponsored by Roche
    • o Wednesday, October 22, Sports Night Spectacular – Co-Sponsored by Bio-Rad Laboratories & IBC Life Sciences
Questions? Email Jennifer Pereira.

*This promotion is only valid until October 10 2014 only. This offer is for new, qualified professionals only. Qualification criteria is located on the event website. Sponsoring and exhibiting companies at the event are not eligible for this offer. All registrations are subject to final approval by IBC Life Sciences.


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Monday, October 6, 2014

Biogen Idec focuses on the patient and sustainability in manufacturing

At one point in time, it was thought that drug substance was one of the most important parts of drug manufacturing. But BioProcess International keynote speaker John G. Cox, Executive Vice President, Pharmaceutical Operations & Technology at Biogen Idec believes that one of the most important parts of bioprocessing is looking at the patient and providing the drug in a way that is easy for the patient to use.

John also provides insights on how  Biogen Idec isn't only looking at the way they develop drugs for patients - they're also looking at how they develop drugs and finding sustainable ways to manufacture drugs.  As they expand and build, buildings are outfitted drive sustainability.


John will be joining us on Tuesday, October 21 to present the keynote session Delivering on a Global Biopharmaceutical Portfolio: Biogen Idec’s Strategy for Success through Innovations in R&D, Protein Development and Manufacturing.  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 BPI14BLOG, Looking for options with your registration?  Not only do we have the full pass - but we also have a keynote and exhibit hall pass.  Find out more here.


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Friday, October 3, 2014

Announcing the Finalists for the 2014 BioProcess International Awards

BioProcess International (BPI), a business-to-business publication, today announced the finalists for the 2014 BioProcess International Awards. The awards celebrate the outstanding achievements, collaborations, business strategies, social corporate responsibility and technology applications that will allow the industry to deliver better, more effective treatments to a global patient base. Award winners and finalists from around the world, will be recognized at a special dinner and ceremony during the 2014 BioProcess International Conference on Wednesday, 22 October 2014, at the Hynes Convention Center in Boston, MA.

“These prestigious award finalists represent the people, organizations and technology applications that define excellence, best practices, and promising collaborations that allow our industry remain innovative and on the cutting-edge," said Brian Caine, Publisher of BioProcess International. “Congratulations to each finalist on this incredible achievement.”

Categories and finalists appear below:

BioProcess International 2014 Award Finalists

Excellence in Leadership — honors the strong leaders and mentors who have successfully driven biopharmaceutical commercial success through motivating their teams for growth and innovation.
  • • Lynn Bottone, Site Leader, Sanford Site, Pfizer
  • • Olivier Loeillot, General Manager, Enterprise Solutions, GE Healthcare Life Sciences
  • • Dr. Robert Preti, Founder, President, and Chief Scientific Officer, Progenitor Cell Therapy (PCT)
Emerging Company — honors the biopharmaceutical companies to watch and those that have successfully raised awareness within the scientific community.
  • • BioCision
  • • Horizon
  • • ToleRaM Nanotech, LLC.
Corporate Citizenship — honors the companies that have made significant contributions through activities within a broader urban or regional community.
  • • Bayer HealthCare
  • • Biogen Idec
  • • Sigma-Aldrich
Excellence in Facility Design or Retrofit — honors a biotech facility that exemplifies innovation through the use of key technologies and/or designs.
  • • Gallus BioPharmaceuticals/GE Healthcare Life Sciences
  • • Vetter
  • • FUJIFILM Diosynth Biotechnologies
Best Collaboration — honors promising collaborations that have proven to result in significant benefits toward accelerating drug development or mitigating risks.
  • • Invetech Inc./Janssen Research & Development, LLC
  • • Promosome/GE Healthcare Life Sciences
  • • TAP Biosystems/Merck & Co., Inc.
Upstream: Best Technology Applications — honors a user or supplier that through the adoption and application of a technology is paving the way toward a new approach to biopharmaceutical process design.
  • • XDR-50 MO Fermentor System — GE Healthcare Life Sciences
  • • STX® Scalable Transfection System — MaxCyte
  • • ambr250 — TAP Biosystems/Merck & Co., Inc.
Downstream: Best Technology Applications — honors a user or supplier whose new technologies show, though well-documented applications for bioprocessing, that they are indeed game-changers.
  • • BioT Temperature Stability Systems — BioCision
  • • Allegro Single-Use Filling Needles — Pall Life Sciences/Disposable-Lab SAS
  • • Natrix HD Membranes — Natrix Separations, Inc. /Gallus BioPharmaceuticals
Analytical: Best Technology Applications — honors a user or supplier that has demonstrated increased functionality in novel combinations with other analytical technologies, whether old or new; or the technologies may reveal significant benefit in new bioprocessing applications — including emerging product sectors.
  • • MicroScale Thermophoresis (MST) — NanoTemper Technologies GmbH
  • • ImageStreamX®(ISX) — Enzo Life Sciences/Amnis (part of EMD Millipore)
  • • SGS M-Scan Services — SGS Life Sciences


The 2014 BioProcess International Awards Ceremony
The 2014 BioProcess International Awards program culminates with a special dinner and ceremony taking place on October 22, 2014, at the BioProcess International Conference and Exhibition, in Boston, MA. To purchase tickets to the awards dinner and ceremony ($125.00) and receive a complimentary exhibit-hall-only pass, please click here, enter code BP14BPANE, choose your registration preference and select the BioProcess Awards Ceremony & Dinner as your second option.

To view award program details and dinner sponsors, please visit our webpage.


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Sutro's Techniques for Protein Production

In today's featured interview from Biopharmaceutical Development and Production Week 2014, Trevor J. Hallam, Ph.D., Chief Scientific Officer, Sutro Biopharma, Inc. talks about optimizing protein production. He also looks at Sutro's unique approach to creating these molecules in a system manner that produces quality products that the patients can rely on. He also addresses how the antibody drug conjugates field is evolving. Want to know more? Watch the interview here:


Find out more about Sutro Biopharma.

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


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