Cambridge Healthtech Institute's Tenth Annual

Optimizing Biologics Formulation Development

( 生物制剂处方开发的最佳化 )

A Best Practices Exchange for Resolving the Challenges of Formulating Novel Biologic Drug Products

2018年1月8日 - 9日

 

Cambridge Healthtech Institute's Tenth Annual Optimizing Biologics Formulation Development is an essential international gathering of analytical and formulation scientists from leading industry companies, offering an exchange of scientific developments and emerging technologies in an environment that encourages discussion with colleagues. For 2018, the conference focuses on a set of best practices for resolving key formulation development challenges. Each talk in the program will be presented by a different industry or academic group to ensure the widest possible range of perspectives.

This important annual congress kicks off the weeklong PepTalk Formulation & Stability pipeline, which also includes separate meetings on Lyophilization and Drying Technologies and Protein Aggregation. By attending, you may also participate in the full set of eight PepTalk pipelines, including three-meeting sets on analytics and impurities, process technologies, protein engineering, antibody therapeutics and more.

Preliminary Agenda

KEYNOTE PRESENTATION:
An End to End Approach to Formulation Development: Considerations from Cell Line to Drug Product Process Development

Kapil Gupta, Ph.D., Associate Director, Protein Pharmaceutical Development, Biogen


Present and Future Trends in Biotherapeutic Device-Mediated Delivery Technologies

Didier Pertuy, Vice President, Global Drug Device Integrated Development, Sanofi, France


CO-FORMULATION AND CO-ADMINISTRATION

The Challenges and Considerations of Protein and Peptide Coformulations

Becky Davis-Harrison, Ph.D., Research Scientist, BioTechnology Discovery Research, Eli Lilly and Company

Challenges in mAb Combination Drug Products:  A CMC Overview

Jiali Du, Ph.D., Scientist, Formulation Sciences, MedImmune

Case Study: Clinical In-Use Stability Evaluation: Co-Administration of Two Antibody Therapeutics

Zhen Wu, Ph.D., Senior Scientist, AbbVie


CELL AND GENE THERAPIES

Gene Therapy Formulation

Arun Alphonse Ignatius, Ph.D., Principal Scientist, Pfizer

Biophysical Characterization of mRNA Loaded Lipid Nanoparticles

Flaviu Gruia, Ph.D., Principal Scientist, Drug Product Analytical Development, Moderna Therapeutics


PROTEIN FORMULATION CHALLENGES

Formulation Challenges for Low and High Concentration Proteins

Shiang Gwee, Scientist, Drug Product Sciences, MacroGenics, Inc.

Pulse Proteolysis: A Novel High-Throughput Tool for Formulation Screening

Lavanya Iyer, Ph.D., Research Investigator, Bristol-Myers Squibb

Characterization and Control of Interfacial Antibody Adsorption and Aggregation

Ian Shieh, Ph.D., Technical Development Scientist, Genentech

Formulation of Hard-to-Stabilize Biopharmaceuticals

Phil Morton, Ph.D., Science Director, Bioprocess Characterization, Albumedix


PREFORMULATION STUDIES

Think Big, Go Small:  A Screening Approach Utilizing Small Volumes to Optimize Formulation Selection to Provide Scale Down Models to Support Manufacturing

William Callahan, Ph.D., Senior Scientist, Amgen


SURFACTANTS AND EXCIPIENTS

Challenges and Solutions in Polysorbate Degradation

Steven LaBrenz, Ph.D., Scientific Director, Janssen R&D

Poloxamer 188 as an Alternative Surfactant

Tarik Khan, Ph.D., Group Leader, Late-Stage Pharmaceutical and Processing Development, F. Hoffmann-La Roche Ltd., Switzerland

Prospects for the Identification and Application of Excipient Mixtures and Novel Excipients

Christoph Brandenbusch, Ph.D., Group Leader, Biochemical and Chemical Engineering, Technical University, Dortmund, Germany


* 活动内容有可能不事先告知作更动及调整。