Table of Contents

INTRODUCTION 

TESTING PROGRAM DESIGN
Introduction
Regulatory Documents
Biosafety Testing Program Design
Biosafety Program Implementation Timeline

CELL BIOLOGY / CELL BANKING & STORAGE
Available Cell Lines
Cell Line Expansion & Characterization Assays
Species Identification
Creation of Master Cell Banks
Cryostorage
Cell Banking Under GMP Guidelines

MYCOPLASMA, ENDOTOXIN & STERILITY TESTING
Mycoplasma Detection and Identification Assays
Bacterial Endotoxin (LAL) Tests
Sterility Tests
Bioburden Tests

MOLECULAR BIOLOGY TESTING
Adventitious Agent Detection by PCR
Mycoplasma PCR Program
Residual DNA Testing Program
Reverse Transcriptase Assays

VIROLOGY TESTING
In Vitro Assays for Viral Contaminants
In Vivo Assays for Viral Contaminants
Detection of Viruses by Specific Antibody Generation
Virus Detection Assays
Electron Microscopy Assays

IN VIVO ASSAYS
General Safety Test
Rabbit Pyrogenicity Test
In Vivo Tumorigenicity

GENOTOXICOLOGY
Bacterial Reverse Mutation
In Vitro Assays
In Vivo Assays

VIRAL CLEARANCE STUDIES
Study Design
Virus/Organism Selection
Quality Program for Virus Stocks
Virus Assay Validation
Regulatory Documents

ANALYTICAL SERVICES
Recommended Testing Regimen
Introduction to Testing Services
Analytical Assays