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 

Tuesday, August 20

8:00 am Morning Coffee

Strategic Thinking in Protein Formulation Development 

8:25 Chairperson’s Remarks

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


Accelerated and Forced Degradation Studies in Formulation Development and Stability

Nausheen RahmanNausheen Rahman, Ph.D., Director, Bioprocess Research and Development, Sanofi Pasteur Limited - Biography 

Accelerated and forced degradation are an essential first tool for formulation development. However, the regulatory guidelines for forced degradation regarding biologics have few to no procedural instructions on how to approach forced degradation studies. In this talk, an overview of the methodology used to study forced degradation in vaccines will be provided along with examples for vaccine products which have not been highlighted previously.

9:00 Preformulation and Formulation Development Strategies for Injectable Biopharmaceuticals

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

This talk will discuss practical strategies with case studies on the effective design and use of preformulation and formulation development approaches for injectable biopharmaceutical drug products.


9:30 Extractables & Leachables (E&L) in Liquid Formulations of Biologics: Impact on Drug Product Quality and Safety Profile

Joël RichardJoël Richard, Ph.D., Vice President, Peptides, CMC & Engineering, Ipsen - Biography 

E&L from the primary packaging components can contaminate liquid formulations of biologics. They leach from the surface of glass barrels or are extracted by the formulation from the rubber stoppers and plungers. They can interact with proteins, leading to chemical degradation, modification of their higher order structure or aggregation. These impurities may have a strong impact on quality attributes and immunogenicity profile of the protein formulations.

Wyatt10:00 High-Throughput Screening for Developability and Stability of Biotherapeutics by Dynamic Light Scattering

Champagne_JohnJohn Champagne, Ph.D., Senior Applications Scientist, Wyatt Technology Corp.

Thermal stability, colloidal stability, aggregation and viscosity are key indicators for developability and long-term stability which can be addressed simultaneously by dynamic light scattering. This presentation describes how the DynaPro Plate Reader assesses these factors rapidly and effectively, analyzing hundreds of samples and conditions per hour.

10:15 Coffee Break in the Exhibit Hall with Poster Viewing

Predictive Approaches in Early Formulation Development 

11:00 Controlling Lyophilization Process: Simulations and Modeling

Alina AlexeenkoAlina A. Alexeenko, Ph.D., Assistant Professor, School of Aeronautics and Astronautics, Purdue University - Biography 

We present formulation and validation of a first-principles model of bio/pharmaceutical freeze-drying by coupling product attributes and equipment capabilities into a unified process analysis framework. Applications of the simulations for quantification of design space for different freeze-dryer configurations and product characteristics are discussed. The modeling can be used also for assessment of impact of process deviations on product quality attributes.

11:30 Prediction of Methionine Oxidation in Biologics during the Early Stage of Development through Structural Analysis

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

Oxidation in the side chain of amino acids, most notably methionine, is one of the major chemical degradation pathways that affect the stability and sometimes efficacy of protein drugs during the product shelf life. We have investigated modeling approaches to identify methionine residues that would undergo oxidation through structural analysis to guide formulation strategies to mitigate the challenge.

12:00 pm Characterization Studies for Lyophilized, Biologic Formulations

Willow DiluzioWillow DiLuzio, Ph.D., Associate Director, Pre-Formulation and Formulation, Cambridge Biologics CMC Group, a CMC Center Department, Millennium: The Takeda Oncology Company - Biography 

Characterization studies are crucial to gain a thorough understanding of lyophilized biologic formulations. A QbD approach to formulation characterization will be presented where Design of Experiments is used to development models for how manufacturing and formulation conditions impact product quality and stability. These predictive models can be used to define allowable ranges for manufacturing conditions and formulation parameters to ensure a robust drug product.

12:30 Sponsored Luncheon Presentation (Opportunity Available) or Lunch on Your Own

Optimization Studies for Biologics Formulation and Process Development 

1:55 Chairperson’s Remarks

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

2:00 Reconstitution of Highly Concentrated, Freeze-Dried Proteins: Impact of Processing Conditions and Formulation Variables

Bakul BhatnagarBakul Bhatnagar, Ph.D., Principal Scientist, BioTherapeutics Pharmaceutical Sciences, Pfizer, Inc. - Biography 

Long reconstitution times are encountered during development of high concentration freeze-dried protein formulations. Several empirical strategies have been adopted to reduce the reconstitution times by altering: processing variables, formulation variables, reconstitution diluent, and reconstitution method. The impact of processing conditions (ice nucleation temperature, conservative vs. aggressive drying) and phase behavior of formulation components on the reconstitution times will be described.

 2:30 Acid-Base Relationships in Freeze-Drying: Stability Implications

Dushyant VarshneyDushyant Varshney, Ph. D., Senior Project Manager, Novartis - Biography 

Stability of freeze-dried formulations depends on various factors, including residual water content, global and local molecular mobility, crystallinity of lyoprotector and other excipients, retention of the native structure by protein molecules, and apparent solid-state acidity. Methods for measuring the apparent acidity in the frozen and freeze-dried materials are reviewed, and examples of relationships between the acidity and stability are discussed.

3:00 Foam Drying Feasibility for Biologics and Vaccines

David ThomasDavid A. Thomas, Principal Scientist, BioTx Pharm. Science, Pfizer, Inc. - Biography 

Foam Drying is an underutilized and poorly understood technique that has a number of potential advantages over freeze drying. This presentation will describe an evaluation of the feasibility of Foam Drying for vaccine suspensions and biologics. The quality parameters were compared with conventional freeze drying. Equipment and formulation considerations for implementing a foam drying cycle are also discussed.

 3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

Streamlining Early and Late Stage Development 

4:15 Minimize the Risk in Process Transfer by Streamlining the Early and Late Stage Formulation Development

Mark YangMark Yang, Ph.D., Director, Fill Finish Development, Commercial Process Development, Genzyme, a Sanofi Company - Biography 

Excipient sourcing, vendor qualification, container/closure selection, and regulatory compliance may not be as important for early formulation development, but they can present huge challenge for late stage process development and transfer activities. The importance of streamlining the development process, developing a robust formulation, and ensuring its compatibility with the fill finish process will also be discussed with case studies.

 4:45 Overcoming Challenges in Process Development of Biologics: Some Case Studies

Kishore RavuriKishore Ravuri, Ph.D., Group Leader, Late-Stage Pharmaceutical and Processing Development, Biologics Europe, F. Hoffmann-La Roche Ltd. - Biography 

Process development of mAbs poses many challenges especially in high concentrated formulations and in new formats. It is of importance that formulation development takes into consideration aspects of processability and manufacturability to ensure an efficient commercial production of the mAb. This presentation focuses on  aspects of process development which can pose potential challenges. A QbD based approach to process development ensures maximum risk mitigation as wells as a robust process development. Some recent case studies are presented illustrating how some challenges in process development were overcome with this approach.

5:15 End of Day & Registration for Dinner Short Courses

6:00 Dinner Short Courses*

*Separate registration required

Day 1 | Day 2 | Short Courses | Download Brochure 


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