Description:
The approval process for ensuring the identity, potency, purity and effectiveness of a biologic is often complex. With the most comprehensive biologics testing portfolio in the industry, Charles River offers protocols to meet global regulatory requirements from biosafety testing and impurity detection to potency determination and lot release programs, our team of scientists and project managers ensure that the most appropriate methods are used for a product.
Areas of Expertise:
• Cell Banking and Storage
• Cell Line Characterization
• Mammalian, Insect, Avian and Other Cell Banks
• Microbial Cell Bank Characterization
• Host Cell Proteins Assays
• Residual DNA Quantitation
• Mycoplasma Testing
• Viral Clearance Studies
• Vaccines and Virus Manufacturing and Testing Services
• Protein Chemistry and Analytical Services