Cambridge Healthtech Institute’s 6th Annual

Overcoming Formulation Challenges for Biopharmaceuticals Development

Hot topics, Platform Technologies, Case Studies and Highlights from Industry

August 13-14, 2018


The popular sixth annual Overcoming Formulation Challenges for Biopharmaceuticals Development conference will cover latest trends and challenges in formulations development of novel biologic formats, process optimization, manufacturing, and device and packaging considerations for existing and emerging protein therapeutics. We are seeking case studies, especially unpublished and innovative work on co-formulation, formulation of novel biologics, effective scale up strategies, excipient induced instability, process challenges, fill finish challenges, and predictive tool for rapid formulation and stability screening.


Preliminary Agenda


FORMULATION DEVELOPMENT CHALLENGES AND STRATEGIES OF NEW MODALITIES

A Holistic Approach to Formulation Development: From Cell Line to Drug Product Development

Mehak Mehta, PhD, Scientist I, Technical Development, Biogen

Preventing Photo-Induced Degradation of an ADC

Amit Gangar, PhD, Scientist II, Analytical and Pharmaceutical Sciences, ImmunoGen, Inc.

Effect of Light Source and UV Quotient on Monoclonal Antibodies Stability during Manufacturing and Storage

Haresh T. More, PhD, Research Investigator II, Parenteral Science and Technology, Bristol-Myers Squibb


POLYSORBATE AND NEW EXCIPIENTS

Analytical Strategy for Polysorbate Degradation in Biopharmaceutical Products

Andrea Hawe, PhD, CSO, Coriolis Pharma Research GmbH

Polysorbate 80 and EDTA Containing Formulations

Melissa Yarbrough, Pharmaceutical Research and Development, Pfizer, Inc.

Oxidative Degradation of Polysorbate: Novel Mechanisms and Effects of Formulation Buffers

Christian Schoneich, PhD, Distinguished Professor and Chair, Pharmaceutical Chemistry, University of Kansas

Just below the Surface: New Excipient Alternatives to Polysorbate Surfactants

Philip Wuthrich, Senior Scientist, Research, Research & Development, ReForm Biologics


STABILITY STUDIES, DEVELOPABILITY, ROBUSTNESS, AND SCALE UP

Considerations for Designing Robust Clinical In-Use Studies

Atul Saluja, PhD, Associate Director, Global Pharmaceutical Development Biologics, Sanofi

An Intercompany Perspective on Biopharmaceutical Drug Product Robustness Studies

Speaker to be Announced, Biophorum Operations Group (BPOG)


NEW DEVELOPMETS IN LYOPHILIZATION AND ALTERNATIVE DRYING TECHNIQUES

Spray Drying – Next-Generation Thermostabilization Technology for Biopharmaceuticals

Sonia Bedi, PhD, Investigator, Biopharm Product Sciences, Biopharm R&D, GSK

Process Monitoring by Mass Spectrometry during Freeze Drying

Jason Stewart, BS, Senior Associate Scientist, Pharmaceutical Research and Development, Pfizer, Inc.




For more details on the conference, please contact:
Nandini Kashyap
Conference Director
Cambridge Healthtech Institute
Phone: 781-972-5406
Email: nkashyap@healthtech.com


For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z

Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412
Email: cbenton@healthtech.com


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Premier Sponsors:

Millipore Sigma
Unchained Labs