POTENCY ASSAYS
Because biological potency assays are as unique as the therapeutics being developed, the requirements of the client are addressed through extensive consultation. Prevalere provides development capabilities and qualification or full validation of potency assays developed internally or transferred from the client. The expertise of our scientists ensures that methods are validated according to the level of quantitation, specificity and robustness you require.
• Our extensive system of standard operating procedures (SOPs) complies with current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) and is regularly updated to meet changing regulatory and industry standards.
• Validated assays can be transferred to the client or potency assessment can be performed for individual lots by Prevalere.
• Reports are customized to meet individual client needs
