BPI Contributor

February 1, 2009

6 Min Read



Biological assays continue to be considered the “quality” assay for biopharmaceuticals. Companies often ignore their importance and find themselves on clinical hold in phase 2 — or worse, in phase 3 — because their biological assays do not meet current expectations. (Usually there are performance, robustness, and/or specificity problems.) This is the conference to find out the newest technical, regulatory, and practical trends for the all-important biological assays.

IBC’s 18th International Bioassay meeting has it all. Get the tools you need to quickly and efficiently develop critical biological assays needed for successful product development. This is the only conference with no hidden agenda, and no single point of view being pushed. It is a technical conference that allows you to discuss and share information in a collegial environment. Here you will discover many practical approaches that can be applied to your assays. Plate layouts, new cell cultivation techniques, statistical tools for validation and assay development, and platform approaches are just some of the new topics you will hear at this year’s conference.

Stay up-to-date with the most recent trends. Find out about bioassays and how they are used to determine product potency, characterize clinical products, monitor clinical samples for unwanted neutralizing antibodies, and even provide clinical efficacy endpoints. This conference is perfect whether you are experienced or new to the bioassay field.

Top scientists from companies with approved products will be sharing their experiences and tricks of the trade in developing, validating, and maintaining biological assays. New statistical approaches will be explored which are helping developers meet aggressive development time lines.


Assay Development

Assays for Eventual Product Approval

USP Bioassay Update and Discussion

Regulatory Aspects of Bioassays

Bioassays to Measure Neutralizing Antibodies

Transferring Bioassays

Program highlights include a regulator’s perspective on technical requirements for biological assays, strategies for establishing platforms for bioassays, case studies for bioassay development and optimization, bioassays for product characterizations, neutralizing antibody assays, and bioassays for biosimilars.

USP Update

The US Pharmacopeia (www.usp.org) is writing four new bioassay chapters: <1032> for development, <1033> for validation, <1034> for data analysis, and an unnumbered “road-map” chapter that will include a glossary. Walter Hauck (senior scientific fellow at USP) will update the status of these four chapters and plans for the existing chapter <111>.

Preconference Workshop

On Tuesday 14 April 2009, Laureen Little, principal consultant at Quality Services and editor/publisher of BioQuality, chairs a preconference workshop on Biological Assay Validation. Part 1 (“Statistical Design and Analysis of Biological Assay Validation”) describes designs that demonstrate bioassay linearity across a representative range of potencies as well as long-term variability — instructed by Tim Schofield, consultant to the biopharmaceutical industry. Part 2 (“Practical Approaches to Validating Potency Assays”) shares helpful concepts and approaches to potency assay validation — instructed by Sally Seaver, president of Seaver Associates, LLC.

Keynote Address

Bioassay (R)Evolution, by Meena Subramanyam (senior director at Biogen Idec): This talk will provide a general overview of the evolution of bioassays and progress made in the use of bioassays in drug development to ensure product quality and to confirm product comparability after manufacturing changes. More specifically, selection and implementation of appropriate assays to support product release and characterization as well as to assess presence of neutralizing anti-drug antibodies will be addressed.



BioProcess International European Conference and Exhibition

21–24 April 2009

Düsseldorf Congress Center (Düsseldorf, Germany)

BioProcess International invites you to take a look at the conference themes to be covered in its fifth annual European event.

Scale-Up, Economics, and Manufacturing Strategy

Gain a comprehensive update on operational strategies, technologies, manufacturing production and process development for the biopharmaceutical industry. Strategy for capacity planning for all stages of development will be reviewed by Abbott Bioresearch Center. Technology transfer of an in-licensed late-stage development biotech product to a new site (challenges and lessons learned) will be reviewed by Eli Lilly and Company. Centocor Inc. will take a holistic view to demonstrate the role of pilot plants in product development. And Cobra Biomanufacturing Plc will look at cost reductions and improved development times through the use of disposable systems.

Formulation Strategies for Biologics

Benefit from two days dedicated to tackling the challenges faced during formulation development, including the use of analytical methods in formulation development and applying quality by design to your formulation strategies. Attend a full-day workshop on “Developing Formulations for Prefilled Syringes,” 21 April 2009. Hear critical insights from in-depth case studies delivered by leading industry and academic experts.

Benefit from a case sturdy on biophysical characterization of protein formulations delivered by ImClone Systems Inc. and Genzyme. Examine the importance of forced degradation and stability studies in formulation devolvement with Genmab, Boehringer Ingelheim, and academic experts. Hear how Amgen applies quality-by-design to its formulation strategies. Gain invaluable insight into the multiple effects of Tweens on stability and aggregation and learn about the most appropriate analytical techniques to detect aggregation. Explore the difficulties of analyzing and characterizing drugs in formulation with high-protein concentrations through case studies from Abbott and Genentech.

Recovery and Purification

Are downstream bottlenecks a myth or reality? Are you looking at improving your downstream processing to fit the increasing upstream product titers? Here you can discover what is being done and who is looking at trends and new methods to solve these issues. What are the latest chromatography methods and column material being used? What options are available for the design of different materials? Are you replacing Protein A or abandoning it all together?

Continuous chromatography for efficient purification of therapeutic proteins will be discussed by Professor Massimo Morbidelli from the Swiss Federal Institute of Technology. Medarex will review process analyses to identify and alleviate CMO facility constraints to scale-up the Humab manufacturing process. How can protein crystallization help to improve the selectivity, efficiency, and economy of biotech processes? Bayer HealthCare AG will address this question. Separation challenges of ultralarge biomolecules and bimolecular assemblies will be discussed by Professor Alois Jungbauer from Austria’s University of Natural Resources.

Cell Culture and Upstream Processing

Hear case studies on your peers’ experiences in the improvement of cell culture processes to help increase yields and optimize production processes. Learn how to increase cell culture productivity to reduce bottom-line costs. Review the current and future trends in protein expression. Assess the use of transient technology for early stage development.

Analytical Methods for Biologics

This conference discusses the latest analytical techniques, methods, and tools being adopted by the biopharmaceutical industry to ensure that you are ahead of the competition and in line with your company’s objectives. Hear how leading companies develop new analytical methods, set critical quality attributes, overcome aggregation, and find solutions to problems with impurities, posttranslational modifications, and glycan analysis.

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