Centralized Analytical Laboratory White Paper
De-Risk and Streamline your Drug Substance & Drug Product Testing. The development of a new biologic requires effective management of time and risk. The drug manufacturing process will progress in scale and likely location for both drug substance and drug product. Each movement holds a risk for delay, financial burden and loss of key product knowledge, as the company must demonstrate consistency in the product's critical quality attributes. Therefore, successful drug development relies heavily on Chemistry, Manufacturing and Control (CMC) analytical and thorough material characterization. These activities span the entire drug development continuum, with analytical support beginning before the first batch is manufactured and continuing well beyond when the product is released to the market.