2013 Archived Content

August 19-20, 2013

Cambridge Healthtech Institute’s Inaugural

Overcoming Formulation Challenges for Biopharmaceutical Development & Manufacturing

Optimizing Dosage Form and Process Development

Day 1 | Day 2 | Short Courses | Download Brochure 

Monday, August 19

Designing Quality in Biopharmaceuticals: Structural and Formulation Considerations (Shared Session) 

1:00 pm Chairperson’s Opening Remarks

Sujit K. Basu, Ph.D., Senior Director, Drug Product Development, Shire Human Genetic Therapies


Current Trends and Challenges in Biologics Development

Palani PalaniappanPalani Palaniappan, Ph.D., Vice President and Head, Biologics CMC, CMC Center, Millennium: The Takeda Oncology Company - Biography 

Biologics development continues to evolve into newer territories. New modalities such as antibody drug conjugates, fusion proteins, fragments and others are growing in trend. New modalities bring new challenges and opportunities in ways CMC development is carried out including in areas of process, formulation and analytical development. Some recent experiences will be discussed. 


Assessing Higher-Order Structure and Comparability of Protein Therapeutics – a Regulator’s Perspective

Evi StrubleEvi B. Struble, Ph.D., Pharmacologist, Center for Biologics Evaluation and Research, US Food and Drug Administration - Biography 

In this talk, a discussion of factors that influence the structure of protein therapeutics during the production process as well as pertinent regulatory guidance to ensure quality and demonstrate comparability following manufacturing changes will be presented.

2:15 Probing Higher-Order Structure in Protein Pharmaceuticals Using Infrared and Raman Vibrational Optical Activity

Laurence NafieLaurence A. Nafie, Ph.D., Distinguished Professor Emeritus, Department of Chemistry, Syracuse University - Biography 

Vibrational optical activity (VOA), comprised of infrared vibrational circular dichroism (VCD) and Raman optical activity (ROA) have shown enhanced sensitivity to higher order structure (HOS) in proteins. Examples of the sensitivity of VOA to both protein secondary structure and HOS in proteins will be provided as a sensitive new tool for evaluating structural differences between original biopharmaceutical products and their biosimilars.

2:45 Refreshment Break

3:15 Characterizing the Higher-Order Structure (HOS) of Protein Drugs in the Biopharmaceuticals Industry

Steven BerkowitzSteven Berkowitz, Ph.D., Principal Scientist, Analytical Development, Biogen Idec - Biography 

This talk will initially focus its attention on the present capabilities and limitations of the most commonly used biophysical tools employed in the biopharmaceutical industry to characterize the HOS of protein drugs. Attention will then turn to those less commonly used biophysical tools that offer improved capabilities to better satisfy the needs of industry.

3:45 Hydrophobic and Electrostatic Interactions Impact the Drug-Like Properties of a Protein Solution

Ravi Chari, Ph.D., Senior Scientist, Pharmaceutics, AbbVie Bioresearch Center - Biography 

In this study we investigated the unusual behavior of a protein formulation during solubility/stability studies. Both surface mutations and changes in formulation conditions were investigated to improve the drug-like properties, and thus the behavior, of the protein in solution. The underlying mechanism governing this behavior seemed due to hydrophobic interactions. Computer modeling was performed to further elucidate the mechanism.

4:15 Small-Group Breakout Discussions

This session provides the opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Then continue the discussion as you head into the lively exhibit hall for information about the latest technologies.

Topic 1: Choosing the Right Excipients and Their Suppliers for Your Formulation Development

Moderator: Mark Yang, Ph.D., Director, Fill Finish Development, Commercial Process Development, Genzyme, a Sanofi Company

• Excipients that can be problematic
• The same excipient can be stabilizing or destabilizing your protein depending on the vendor-Common problems in excipient sourcing 
• Factors to consider when choosing and qualifying the right excipients and their vendors

Topic 2: Integrating Quality by Design (QbD) in Biopharmaceutical Preformulation and Formulation Development

Moderator: Sujit K. Basu, Ph.D., Senior Director, Drug Product Development, Shire Human Genetic Therapies

• Timing of implementation/integration of QbD in preformulation and formulation development
• Challenges in identifying critical quality attributes and critical process parameters
• Design space and control strategy considerations in the future state

Topic 3: Chemical Degradations in Proteins and Development Strategies to Mitigate and Monitor at Early Stage of Development

Moderator: Yong Quan, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.

• Prediction of chemical degradations (deamidation, isomerization, oxidation, etc.) through protein sequence and structure analysis
• Formulation strategies to mitigate the degradations
• Analytical method for detection - peptide mapping vs. whole protein analysis and hot spot analysis vs. complete sequence analysis

Topic 4: Stability of Freeze-Dried Formulations

Moderator: Dushyant Varshney, Ph. D., Senior Project Manager, Novartis

• Protein aggregation: Does it take place in the amorphous solid or upon reconstitution?
• Rationale choice of excipients
• Rank-order stability prediction based on traditional and emerging methods
• Residual water content and stability

Topic 5: E&L Studies in Biopharmaceutical Formulation Development: Risk-Based Practical Approaches versus Guidelines

Moderator: Joël Richard, Ph.D., Vice President, Peptides, CMC & Engineering, Ipsen

• Regulatory challenges: What guidelines? What thresholds to consider and what rationale?
• Extractable study: What solvents to use? How to exploit the results from a practical point of view?
• Sharing experience on impact on product quality and safety

Topic 6: Reconstitution of High-Concentration Freeze-Dried Proteins

Moderator: Bakul Bhatnagar, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc.

• What attributes should be monitored? Cake surface area, phase behavior of components, cake wetting and hydration, cake displacement, bubbles, effervescence, foam (appearance and height), gel formation, turbidity, viscosity, absorbance of the dissolved phase, dissolution time?
• Reconstitution time: (i) Methodology for the determination of the reconstitution time and definition of the endpoint, (ii) Can strategies based on trial and error for shortening reconstitution times be generalized? (iii)  What constitutes a long reconstitution time?
• Reconstitution aids / devices

5:15 Discussion Report-Outs

5:30 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day

Day 1 | Day 2 | Short Courses | Download Brochure 


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