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Full-Time Equivalent Programs: Outsourcing Analytical Testing

Alcami contributed to an article in Drug Development & Delivery titled Outsourcing Analytical Testing: Novel Services Elicit Consistent, Quantifiable, & Faster Results. 

Alcami’s end-to-end analytical testing platform supports clients’ programs through every stage of a product’s life cycle, from early-phase development activities to commercial support for both small and large molecule products. As a fully integrated CDMO, Alcami has expanded its services by adjusting to market and regulatory changes. The expansion of its Extended Workbench offering, development of a quality system with third-party audit reports, and the addition of capabilities like rapid sterility testing address client needs.

“Our Extended Workbench is a Full-Time Equivalent (FTE) program tailored to a client’s specific needs,” explains Michael Freeman, Commercial Development – Laboratory Services. “Dedicated employees focus solely on individual client projects to provide a flexible and controlled outsourcing laboratory service package. An Extended Workbench program can be customized based on product phase and number of products.” Clinical phase development platforms can be designed to be adaptable, granting clients the freedom to adjust priorities based on their needs and results. Programs can also be designed for short-term use with a fixed-cost schedule, providing cost control during a product’s riskier development phase, says Mr. Freeman. Conversely, the Extended Workbench also provides clients with a single vendor laboratory resource for their analytical needs during the established phases of a product and portfolio. He says: “In these stages, where quality control analysis is needed, clients can control their costs and priorities while still performing routine product release, stability, and raw material evaluations.”

Alcami’s efforts to expand its range of services include the introduction of rapid sterility technology and biosimilar analytical capabilities. “We can release clients’ products to market faster, reduce inventory holding times, and provide more robust computer-generated sterility results, eliminating subjectivity and individual analyst observations,” he continues. “Also, as the industry continues to transition to more complex formulations and more biologics come off-patent, our ability to handle complex entities in the coming years is critical.”