2013 Archived Content

August 22-23, 2013

Cambridge Healthtech Institute’s Inaugural
Early IND Strategies: Analytical Development

Optimizing the Selection and Performance of Preclinical Analytical Studies


Day 1 | Day 2 | Short Courses | Download Brochure 

Friday, August 23, 2013

8:00 am Continental Breakfast in the Exhibit Hall


Early Analytical Challenges For Emerging Therapeutics 

8:55 Chairperson’s Opening Remarks

Debra Meyer, BS, Senior Principal Scientist, Analytical Research and Development, Pfizer

9:00 IND Process for a Biosimilar Product

Judy Chou, Ph.D., Vice President, Research & Development, Tanvex Biologics

9:30 Strategies and Challenges in Bioassay Development for ADCs vs mAbs

Debra MeyerDebra Meyer, BS, Senior Principal Scientist, Analytical Research and Development, Pfizer

A number of therapeutic monoclonal antibodies (mAbs) have been approved over the past 25 years, mainly for oncology and inflammatory indications.  In oncology, mAbs are often used in combination with traditional cytotoxic drugs to enhance efficacy.   A relatively new class of therapeutic compounds for oncology is antibody drug conjugates (ADCs), in which a cytotoxic drug is covalently conjugated to a mAb.  ADCs are designed to facilitate the targeted delivery of cytotoxic drugs to tumors while minimizing systemic toxicity.  Each component of an ADC is important to achieve efficacy with minimal toxicity so the ability to evaluate the potency of this multi-component compound in bioassays is critical.  The complex structure and mechanism of ADCs requires a strategy that involves bioassay approaches for both the mAb (target binding) and the drug (cytotoxic activity).  Using case studies, this presentation will describe the strategies and challenges of bioassay development and characterization for early stage ADCs in comparison to those for mAbs.

10:00 Analytical Characterization of Antibody-Drug Conjugates

Gaya RatnaswamyGaya Ratnaswamy, Associate Director, Analytical & Formulation Development, Agensys

This presentation will focus on the challenges of analytical method development and characterization for ADCs in comparison with that of mAbs using case studies. Strategies for the analytical development for early stage versus late stage will be presented.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing


High-Throughput and Miniaturized Assays 

11:00 High Throughput Analytical and Miniaturized Assays Used for the Testing of Mannose, a Critical Quality Attribute 

Susan CallahanSusan Callahan, Senior Associate Scientist, Amgen

With the aims of process efficiency and cost saving in biopharmaceutical companies nowadays, companies are moving towards high throughput and miniaturized assays to meet analytical needs with accuracy, precision, and speed. Many technological improvements/breakthroughs in robotics and instrumentation have been made recently which have allowed for enhancements in the analysis of critical quality attributes. This presentation will focus on the evolution of glycan analysis from traditional methods to the most recent breakthroughs in high throughput and miniaturized assays.

11:30 Miniaturizing ELISA Assays for Process Development Support in 384 Well Format

Matthew Troutman, Research Biochemist, Vaccine Bioprocess R&D, Merck

Analytical methods serving early biological pharmaceutical candidates have historically served as bottlenecks in process and formulation development.  In addition, earlier development initiatives in the pharmaceutical industry have resulted in increased sample counts and reduced data turn-around time requirements.  In reaction to this common problem and increasing demand, ELISAs for process monitoring and development have been migrated to a 384-well from the traditional 96-well platform.  Platforms have been developed for routine testing, reagent screening and automated Design of Experiments.


Case Studies of Critical Assays in Preclinical Development 

12:00 pm Testing Strategy to Ensure the Removal of Raw Materials as Process-Related Impurities in Bioprocesses

Anil Raghani, Ph.D., Principal Scientist, Process and Product Development, Amgen

While most raw materials used for the manufacturing of biological products are considered safe, some of these components may result in undesirable process-related impurities in final drug products. In this presentation, the application of a risk-based approach to determine the clearance testing requirement of process reagents will be discussed. Case studies of the application of prior knowledge acquired at the process design phase to the testing strategy will be presented.

12:30 Sponsored Presentation (Opportunities Available)

1:00 Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own


Early Formulation Development 

1:55 Chairperson’s Opening Remarks

Danny Chou, Ph.D., Senior Research Scientist, Biologics Development, Gilead Sciences

2:00 A Rational Strategy to Stabilize Early Stage Biologic Candidates to Enhance Developability and Enable Successful Transfer from Research into Development

Danny ChouDanny Chou, Ph.D., Senior Research Scientist, Biologics Development, Gilead Sciences

The goal of this presentation is to describe a platform approach to identifying the optimal solution conditions that can stabilize biologics candidates in the discovery/candidate selection stage in a high throughput fashion, whereby, using a very limited amount of protein and commonly available equipment, the development team can assist the drug discovery team in candidate selection and re-engineering of molecules prior to transition into full-scale development.

 


Comparability Studies  

2:30 Comparability Analysis in Early Development

Francis PoulinFrancis Poulin, Ph.D., Scientist II, Genzyme Corporation

Transfer of clinical manufacturing to a new site prior to IND filing can trigger comparability assessments. We developed a multi-tiered strategy to identify differences that can impact mAb CQAs including purity, structure, affinity for target, deamidation, potency, and charge and oligosaccharide profiles. With limited process experience at this stage, selecting representative lots from each site and understanding assay performance are critical to setting comparability criteria. Our strategy is designed to bridge data derived from materials produced at both sites.

3:00 Challenges and Considerations for Preclinical Comparability Studies

Kazumi Kobayashi, Ph.D., Director, CMC Analytical Development, Biogen Idec


Scale-Up and Technology Transfers in Preclinical Development  

3:30 Rapid Production of Biologics in Emergency-Use Response: A Progress Report

Dale Cumming, Ph.D., Chief Science Officer, International Consortium on Anti-Virals, Canada

Anti-viral antibodies are ideal agents in responding to sudden outbreaks of infectious disease if available to patients within months of an outbreak. Accomplishing this goal requires employing cutting-edge GMP bioprocessing technologies and evolving an emergency-use framework with regulatory authorities. We have now completed several “live fire” exercises demonstrating progress in producing multi-gram quantities of anti-influenza antibodies within months and have commenced discussions with regulators.

4:00 End of The Bioprocessing Summit



Day 1 | Day 2 | Short Courses | Download Brochure