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Cambridge Healthtech Institute’s Second Annual
Overcoming Formulation Challenges for Biopharmaceutical Development
Optimizing Dosage Form and Process Development for New Biotherapeutics
Part of CHI’s 6th Annual The Bioprocessing Summit

August 18-19, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts

Formulation optimization and process development are the critical steps in developing a protein as a therapeutic product. This popular second annual conference will cover latest trends and challenges in biologic formulations, dosage form optimization, process development and product manufacturing for existing and emerging protein therapeutics. Scientists from around the world will share stories especially unpublished and innovative work, on the use of the effective scale up strategies from R&D to production, process optimization, emerging technologies, and qualification of tools to characterize the quality attributes at different stages of the product lifecycle.

We invite you to join the discussions to learn from and network with the leading experts from around the world.

Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 

Monday, August 18

8:00 am Pre-Conference Registration and Morning Coffee

9:00-11:30 Short Course*: QbD Strategies for Formulation Development of Protein Therapeutics 

*Separate registration required

11:30 Main Conference Registration


1:00 pm Chairperson’s Opening Remarks

MarkYangMark Yang, Ph.D., Director, Fill Finish Development, Commercial Process Development, Genzyme, a Sanofi Company


1:10 Challenges in Developing Stable Formulations for Vaccines and Biologics

Indresh K. Srivastava, Ph.D., Vice President, Product Realization; Protein Sciences Corp.

The development of a stable formulation is critical for any effective vaccine to prolong its shelf life. One of the major challenges in developing a stable formulation is to ensure that the immunogen is kept in the correct conformation therefore preventing aggregation, degradation etc. and its impact on potency of the vaccine. I will discuss approaches for stabilizing the rHA antigen during the storage. In addition, I will present a case study on the development of a stable formulation for a new biologic.

1:45 Considerations in Formulation Development of DNA-Based Vaccine

Min Huang, Ph.D., Principal Scientist, Pharmaceutical R&D, Pfizer, Inc.

There are unique challenges in formulation development of plasmid DNA based vaccines. Considerations in formulation, stability, viscosity, container closure selection, shipping, process development etc will be discussed. Detailed case studies will be presented to highlight these challenges and share knowledge and technologies that potentially overcome some of these challenges.

2:15 Development of Stable and Efficacious Adjuvanted Protein Vaccines

YuhongZengYuhong Zeng, Ph.D., Senior Scientist, Alcon Laboratories, Inc.

Besides stability, another challenge for vaccine formulation development is the adsorption of antigens to adjuvant. The effect of antigen-adjuvant interactions on the vaccine efficacy still remains controversial. In this talk, a case study with a smallpox vaccine will be presentedto address these formulation issues. A systematic approach employed in the study to optimize the stability and efficacy of the formulation will be discussed in details.

2:45 Refreshment Break



3:15 Quality by Design Method Development Using a Platform Approach for Multiple Commercial Biological Products

JianmeiKochlingJianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company

Analytical method development process has evolved along with industry’s significant understanding of the “Quality by Design” concept”. Quality by design approach analytical methods development relies upfront understanding of targeted method attributes and acceptance criteria, process and product knowledge, and the incorporation of the modern technology. In this presentation, the method development process as well as case studies will be presented for the QbD methods development using a platform approach.

3:45: Panel Discussion: Consideration and Expectations for Assessing Quality and Stability of Biopharmaceuticals

• Current regulatory requirements vs. requirement 10 years ago
• Implications of improved method quality with new technologies vs. continuous use of the old technologies
• Requirements for early stage vs. late stage development


Mark Yang, Ph.D., Director, Fill Finish Development, Commercial Process Development, Genzyme, a Sanofi Company
Panelist:Ernesto Freire, Ph.D., Professor, Biology and Biophysics, Johns Hopkins University
Jianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company
Paul Bigwarfe, Jr., Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc
Aleš Štrancar, Ph.D., CEO, BIA Separations GmbH

4:15 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 moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. At the end of the session, each moderator will summarize the topics being discussed, the findings and conclusions (if any), and share with the audience.

8.    Polysorbate 80, How Much does it Remain After Filtration?

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

  • For PS80, there is an equilibrium among micelle, monomer, and monolayer
  • PS80 micelle has a diameter of ~10nm, can it go through UF/DF membranes, how and how much?
  • How much PS80 in the formulation is enough?

9.    Will Shear-Stress Generated from Filling Pump have any Impact on the Quality of Biologics Drug Product?

Moderator: Zhiqing (Zach) Zhu, Ph.D., Research Investigator, Drug Product Science and Technology, Bristol-Myers Squibb Co.

  • Is the shear-stress related to filling pump parameter settings (e.g. rpm, acceleration speed)? If yes, which parameter setting is crucial?
  • Will different pump settings influence the drug product quality (e.g. shelf-life)? If yes, then are there any mitigation recommendations?

10.    Understanding and Controlling Protein Aggregation

Moderator: Thomas Laue, Ph.D., Professor, Biochemistry and Molecular Biology; Director, Biomolecular Interaction Technologies Center (BITC), University of New Hampshire

  • What features of a protein influence its solubility and aggregation?
  • How much can the solvent mitigate poor solubility?
  • How aggregation should be checked at the Discovery/Development interface

11.    Comparison of Common and Emerging Technologies for the Analysis of Protein Aggregation

Moderator: Jianmei Kochling, Ph.D., Director, Quality Science and Analytical Technology, Genzyme, a Sanofi Company

  • How to determine reversible vs. irreversible aggregates?
  • Why do we need orthogonal tools for characterization of aggregates?

5:15 Discussion Report-Outs

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

7:00 End of Day

Suggested Short Course*

Accelerated Stability Testing of Biologics 

Tuesday, August 19, 6:00-8:30 pm

*Separate registration required

Day 1 | Day 2 | Short Courses | Download Brochure | Speaker Bios 


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