Cambridge Healthtech Institute’s 6th Annual

Rapid Methods to Assess Quality & Stability of Biologics

Improving Prediction and Screening

August 13-14, 2018


Increasing regulatory expectations and aggressive development timelines call for rapid methodologies to predict, assess and assure the quality and stability of biologics throughout the shelf life. The sixth annual Rapid Methods to Assess Quality & Stability of Biologics conference will bring together experts in analytical and formulation development to discuss regulatory expectations, prediction, measurement and manipulation for protein stability and instabilities in early and late-stage development. We are seeking case studies, unpublished and innovative work on methods employed in real time and accelerated stability studies for proteins, cell and gene therapy products, high-throughput analytics, multi attribute methods, HOS, use of DOE and QbD and immunogenicity.


Preliminary Agenda


ANALYTICAL CONTROL STRATEGY FOR EARLY AND LATE-STAGE DEVELOPMENT

KEYNOTE PRESENTATION: Challenges in Down-Stream Processing and Analytics of a Large Diversity of Molecules/Formats in the Discovery Setting

John E. Harlan, PhD, Head, Purification Group, Discovery Organization, AbbVie

Analytical Strategies for Development of Biopharmaceuticals: One Size Fits All

Zahra Shahrokh, PhD, CSO, STC Biologics


METHODS FOR SCREENING ANALYTICAL PROPERTIES OF NOVEL FORMULATIONS

Methods to Characterize the Biophysical Properties of Nanoparticle-Based Medicines

Mark Brader, PhD, Research Fellow, Moderna Therapeutics, Inc.

Rapid Amino Acid Analysis (AAA) Methods for Protein Concentration in Novel Drug Delivery Platforms

Scott Chamberlain, Senior Research Associate, Protein Analytical Chemistry, Genentech


RAPID PREDICTION AND SCREENING OF FORMULATION STABILITY

Chemical Stability Screening in Early Stage Antibody Discovery

Tingwan Sun, PhD, Senior Scientist, Protein Analytics, Adimab LLC

Towards an Improved Predictor for Shelf Stability: Using Denaturants to Measure Interactions between Partially Folded Proteins

Robin Curtis, PhD, Senior Lecturer, Chemical Engineering and Analytical Science, University of Manchester

(Tentative) Mechanism for the Screening of Patchy Anisotropic Interactions in Protein Solutions Using Hydrophobic Excipients

Prasad Sarangapani, PhD, Staff Scientist, Protein Biochemistry, Regeneron Pharmaceuticals

How to Accelerate and Improve Your Odds of Success in Biopharmaceutical Discovery and Development: Simultaneous Developability and Formulation Screening by One Platform Strategy

Danny Chou, PhD, President and Founder, Compassion BioSolution; Former Senior Research Scientist, Biologics Development, Gilead Sciences


STUDY DESIGN, DOE, ROBUSTNESS AND PRODUCT QUALITY

How to Utilize Design of Experiments (DoE) Principles for the Development of High Throughput, Robust Methods for the Assessment of Product Quality

Jeremy Springall, PhD, Scientist I, Analytical Sciences, MedImmune, a member of the AstraZeneca Group

Sampling Statistics for Subvisible Particle Analysis of Drug Products

Marina Gühlke, PhD, Analytical Scientist, Coriolis Pharma




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