PepTalk 2017
PepTalk 2017
Archived Content

Pipeline 5 Header 

Third Annual
Protein-Device Combinations
Integrating Protein Formulations with Parenteral and Alternative Administration Devices
January 21-22, 2013 


Day 1| Day 2 | Download Pipeline 5 Brochure | Download Formulation and Packaging Flyer 


7:15 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


Combo Products: Formulation and Device Challenges 

8:15 Chairperson’s Remarks

Anand Subramony, Ph.D., Principal Fellow & Head, Novel Delivery Technologies & Therapeutics (NDT), Novartis Institutes for BioMedical Research, Inc.

8:20 Combination Product Development for High Concentration mAb Therapeutics

Thomas Scherer, Ph.D., Scientist, Late Stage Pharmaceutical Development, Genentech, Inc.

The interactions of proteins at high concentrations are associated with several challenges of therapeutic mAb development, including solution opalescence, high viscosities, and undesirable phase transitions. Light scattering experiments and orthogonal characterization of solution behavior of mAbs will be presented to discuss the current state of understanding of the underlying biophysics. Protein-cosolute interactions will be discussed as mechanisms for tailoring formulations to achieve acceptable product properties.

West Pharma8:50 Innovative Approaches to User-Centric Combination Product Development

Bart Burgess, Principal, Self-Injection Systems, West Pharmaceutical Services

In competitive therapeutic areas, drug-device combination products take on ever greater importance to facilitate self-administration and to ensure patient satisfaction and compliance. The development of such systems, however, is often slowed and compromised by the demands of various internal stakeholders and strictures associated with commonly used primary drug containers. This presentation will outline an approach to development of an integrated self-injection system that addresses these issues while optimizing user experience.

9:20 High Dose Biologics Delivery: Formulation and Device Approach

Weiguo Dai, Ph.D., Scientific Director, Janssen Fellow, Drug Product Development, Janssen Research & Development

Delivery of high dose biologics in subcutaneous or intramuscular route has been long desired, but remains a significant challenge. The presentation will discuss the key challenges and approaches in the delivery of high dose biologics, and in particular focus on the latest advances and developments in both formulation and delivery device approaches to tackle this challenge. The case studies will be presented to discuss unique advantages and limitations of both approaches.

9:50 Sponsored Presentation (Opportunity Available)

10:05 Coffee Break in the Exhibit Hall with Poster Viewing


Integrating Formulations with Devices 


10:45 Cavitation-Induced Protein Aggregation

Theodore RandolphTheodore Randolph, Ph.D., Professor, Chemical and Biological Engineering, University of Colorado, Boulder; Co-Director of the University of Colorado’s Center for Pharmaceutical Biotechnology

During fill-finish operations or as a result of handling in vials, liquid formulations of proteins can cavitate. Collapse of cavitation bubbles leads to production of free radicals, protein aggregation, and particle formation. This talk will offer insight into the potential role of cavitation in process-induced protein aggregation and discuss new mechanism for protein instability during processing.

11:15 Composition Dependent Observations during a Platform Development of a Highly Concentrated mAb

Jonas Fast, Ph.D., Senior Scientist, Early Stage Pharmaceutical Development, F. Hoffmann-La Roche

During a platform development of a monoclonal antibody formulation significant composition-dependent physical bulk properties and chemical degradations were observed. The driving forces of these observations were investigated.

11:45 Formulation and Primary Packaging Development for Biosimilars: Concepts and Case Studies

Jennifer Kronthaler, Ph.D., Researcher, Pharmaceutical Development, Sandoz Biopharmaceuticals

Development of biosimilars requires specific screening and analytical techniques to identify a formulation delivering protein quality, stability, and the desired clinical effect. To achieve a biosimilar drug product certain attributes of the pre-filled syringe or vial, quality of excipients, process-related impurities from drug substance and drug product process need to be considered. Case studies and lessons learnt will be linked to our QbD based development concept. Opportunities for the biosimilar product to gain competitive advantage will be discussed.

Buzz Session Info  

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12:15 pm Close of Morning Session

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

2:00 BuzZ Session A  (Please visit our website for a listing of topics.)

2:45 Refreshment Break in the Exhibit Hall with Poster Awards

3:30 BuzZ Session B  (Please visit our website for a listing of topics.)

4:15 End of Conference

4:15-4:30 Registration for Short Courses

4:30 – 7:30 Recommended Dinner Short Courses (SC5-9)*

*Separate Registration Required

Day 1| Day 2 | Download Pipeline 5 Brochure | Download Formulation and Packaging Flyer