SPECIAL FEATURE – Outsourcing Analytical Testing: The Gateway to Drug Manufacturing
Drug Development & Delivery
Pharma's reliance on Contract Development and Manufacturing Organizations (CDMOs) to provide method development, process validation, and stability storage testing has experts predicting that the global analytical testing outsourcing market will reach $9.6 billion by 2025.1 But they also expect that CDMOs will be challenged by more rigorous requirements put forth by pharma customers.
"In the future, a major challenge for CDMOs from an analytical testing perspective is the increasing cross-section of drugs designated as highly potent active pharmaceutical ingredients (HPAPIs) – to which both small and large molecules are susceptible," says Cheryl Johnson, Commercial Development Manager of Biotechnology at Alcami. "HPAPIs require special containment procedures, engineering controls, and a culture of diligence with respect to individual safety. Each part of the testing process must be handled with careful consideration to minimize potential for exposure."