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Cambridge Healthtech Institute’s Third Annual
High-Concentration Protein Formulations
Overcoming Challenges in High Viscosity, Aggregation and Stability
Part of CHI’s 6th Annual The Bioprocessing Summit

August 20-21, 2014 | Renaissance Waterfront Hotel | Boston, Massachusetts

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

Thursday, August 21

8:00 am Registration and Morning Coffee


8:25 Chairperson’s Remarks

JanJezekJan Jezek, Ph.D., CSO, Development, Arecor Ltd.



8:30 Challenges in Developing High-Concentration Liquid Formulations for Novel Biologics Formats: Fusion Protein, Bi-Specifics

KapilGuptaKapil Gupta, Ph.D., Senior Fellow, Integrated Biologics Profiling, Novartis Institute of Biomedical Research

In recent years, the biologics pipeline in many organizations is maturing from simple monoclonal antibodies to more complex molecular formats such as Fc-fusion, bi-specifics and multifunctional molecules. These new formats demonstrate superior biological characteristics but bring significant challenges in high-concentration liquid formulation development due to unfavorable physical-chemical properties. This talk will provide an overview of challenges encountered in formulation developability assessment of novel biologics formats.

9:00 Manufacturing High-Concentration Monoclonal Antibody (mAb) Formulations via Spray Drying Technology

YuhFunMaaYuh-Fun Maa, Ph.D., Principal Engineer, Pharmaceutical Processing & Technology Development, Genentech, Inc.

This study evaluated a pilot-scale spray dryer against a laboratory-scale dryer to spray dry multiple mAbs in consideration of scale-up, process optimization, impact on mAb stability, and feasibility of a high-concentration preparation. The outcome of the study demonstrated mAb chemical/potency stability, performance comparability of the scaled-up process, and the ability of concentrating mAb to >300 mg/mL This study offers a commercially viable spray-drying process for high-concentration mAb manufacturing option.

9:30 Challenges in Developing High-Concentration Stable Formulation for Biologics

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

The development of a stable formulation is critical for any effective vaccine or biologics to prolong its shelf life, maintain its functionality, and efficacy. Most of the biologics are needed at a very high concentration for clinical and logistical reasons. One of the major challenges in developing a stable formulation for biologics at high conc. is how to prevent the protein from aggregation/precipitation therefore loosing its potency and clinical efficacy. I will present a case study on the development of a high-concentration formulation.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


10:45 Overcoming the Need for High Protein Concentrations for Subcutaneous Drug Delivery Using a Novel Excipient

DavidGoldDavid Gold, Ph.D., Associate Director, Business Development, Halozyme Therapeutics

Traditional subcutaneous drug delivery for biologics can require highly concentrated formulations in order to minimize the volume administered. Addition of a novel recombinant hyaluronidase excipient (rHuPH20) to the formulation can allow for larger volumes to be delivered. This excipient opens up channels within the subcutaneous space by depolymerizing its target substrate, hyaluronan. Further, the molecule has been shown to be compatible with a wide range of biologics, including antibodies, peptides and other therapeutic proteins.

11:15 Alternative Methods of Formulating High-Concentration Proteins to Overcome Administration Challenges

JanJezekJan Jezek, Ph.D., CSO, Development, Arecor Ltd.

With increasing competition in the biopharmaceutical market there is a strong trend toward improving convenience of administration. A switch from intravenous infusion to a convenient subcutaneous injection often requires an increase in protein concentration, leading to stability and injectability issues. The talk will describe innovative approaches, to processing and formulating concentrated protein compositions to enable development of commercially viable products. The novel approaches also have a benefit of additional IP protection of the resulting products.

11:45 Challenges in Reconstitution of High-Concentration Protein Formulations

PoojaSanePooja Sane, Doctoral Candidate, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut

Co-Developed by: Robin Bogner, Ph.D., Associate Professor, Department of Pharmaceutical Sciences, School of Pharmacy, University of Connecticut

Lyophilized highly concentrated protein formulations are notorious for their long reconstitution times posing problem for administration to patients. Several strategies have been reported to reduce the reconstitution times. A review of those strategies and our analysis of the wetting behavior, hydration and disintegration rates to identify potential causes of long reconstitution times will be presented.

12:15 pm End of Conference 

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


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