The Waterside Conference

Contaminant Control

Chaired By:

Raymond Nims, PhD
RMC Pharmaceutical Solutions, Inc.

S. Steve Zhou, PhD
Microbac Laboratories, Inc.

Topics

  • Host Cell Proteins
  • Host Cell DNA
  • Sterility and Endotoxins
  • Mycoplasma
  • Viral Contaminants and Clearance
  • Rapid Microbial Testing
  • Regulatory Expectations
  • Particulates

Cell Banking
& Characterization

Chaired By:

Fang Tian, PhD
American Type Culture Collection (ATCC)

Linda Fröderberg Roth, PhD
AstraZeneca R&D

Jean Qiu, PhD
Nexcelom Bioscience LLC

Topics

  • Cell and Tissue Procurement
  • Cell Line History and Authentication
  • Regulation and Governance
  • Cold Chain Management
  • Cell Bank Management
  • Stability and Characterization
  • Contaminant Identification and Clearance
  • Cryopreservation
  • Cell Line Development

Raw Materials Science
& Control

Chaired By:

Lisa M. Dixon, DVM
USDA APHIS

Aaron C. Mack
Biogen

Ron Kelly, PharmD, PhD
Amgen Inc.

Gaurav Chauhan
Merck & Co., Inc.

Stefan Yohe, PhD
Genentech, a Member of the Roche Group

Topics

  • Characterization & Data Trending
  • Qualification for Rapid Release
  • Technical Transfer
  • Leveraging CDMOs for Speed to Clinic
  • Use of Standards
  • Reduced On-Site Audit Requirements
  • Digital vs Paper Documentation
  • Importation of Unique Animal Materials
  • Risks from Hydrolysates and Animal-Derived Components
  • Assurance Transfer for M&A and Going Out of Business
  • Proprietary Media and Other Components
  • Procurement Issues and Optimization