The Waterside Conference


Contaminant Control

Chaired By:

Raymond Nims, PhD
RMC Pharmaceutical Solutions, 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:

Gaurav Chauhan
Merck & Co., Inc.
Ron Kelly, PharmD, PhD
Amgen Inc.
Aaron C. Mack
Biogen
Lisa M. Dixon, DVM
USDA APHIS

Topics

  • Analytical Technologies for Raw Material Characterization
  • Raw Material Qualification
  • In-House Testing vs. Vendor CoA
  • Tech Transfer
  • Leveraging CDMO for Speed to Clinic
  • Vendor Qualification
  • Product Comparability
  • Use of Standards
  • Purity and Consistency
  • Acceptance Testing
  • Storage and Release Testing
  • Expired Materials