The Bioprocessing Summit


Cambridge Healthtech Institute’s Second Annual

Rapid Methods to Assess Quality & Stability of Biologics
Improving Prediction and Screening
Part of CHI’s 6th Annual The Bioprocessing Summit

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


Assurance of quality and stability of biologic formulations over the course of intended usage is critical in developing safe and efficacious biopharmaceutical products. Increasing regulatory expectations and aggressive development timelines calls for the need of rapid methodologies to predict and assess the quality and stability of biologic formulations.  This second annual conference will discuss regulatory expectations, prediction and manipulation for protein stability and key aspects of thermodynamic stability. It will also discuss real-time and accelerated stability studies and effective use of design of experiment (DOE) for assessment and data comparability from early to late stage development.  We invite you to attend 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


RAPID METHODS FOR COMMERCIAL QUALITY CONTROL LABS

1:00 pm Chairperson’s Opening Remarks

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

 

1:10 Rapid Analytical Techniques for the Commercial Quality Control Laboratories in Preparation for Regulatory Filings

PaulBigwarfePaul Bigwarfe, Jr., Ph.D., Director, Analytical Sciences, Industrial Operations and Product Supply, Regeneron Pharmaceuticals, Inc.

Many new technologies are becoming amenable to the commercial QC laboratory, and their implementation requires special consideration. Using the example of new molecular sizing methods (UPLC and capillary CE based), analytical transfer, validation, method bridging, and specification setting issues will be discussed. In addition, examples of how to introduce assay controls and write procedures for use in a GMP commercial lab will be provided.

1:45 Introduction of PAT to Improve the Efficiency and Robustness of Biopharmaceutical Manufacturing .

 Strancar_AlecAleš Štrancar, Ph.D., CEO, BIA Separations GmbH
During the development of up- or down-stream process of biomolecules, it is essential to have fast, accurate and reliable analytical methods. Examples of PAT in biopharmaceutical manufacturing by using specially designed monolithic HPLC columns, supplied by Agilent or by BIA Separations, to provide rapid, actionable information about the quantity and purity of target molecules in different feed stream samples, will be presented. 

 

 

2:15 High-Throughput Method Development for Product Stability and Impurity Evaluation

Zhenyu Gu, Ph.D., Development Scientist II, Analytical Sciences, Alexion Pharmaceuticals, Inc.

High-throughput analytical methods were developed to evaluate product related impurity, stability and process related impurity. In addition to high-throughput, the new methods demonstrated less assay induced artifacts than the traditional methods. Protein degradation products were characterized by the new method in a much reliable way. Levels of several process-related impurities were determined simultaneously by the new methods because of the good resolution. Previously, each impurity had to be analyzed individually by the corresponding traditional method.

2:45 Refreshment Break


DEVELOPING QUALITY IN BIOPHARMACEUTICALS


KEYNOTE PRESENTATIONS

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

Moderator: 

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.

Topic 1: 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?

Topic 2: 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?

Topic 3: 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

Topic 4: 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


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