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Editorial: Outsourcing Analytical Testing - The Gateway to Drug Manufacturing

Sotax_G1A7968_1-1.jpgAlcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Outsourcing Analytical Testing: The Gateway to Drug Manufacturing."

Alcami: Customizing Programs to Meet Accelerated Product Timelines

Alcami is a CDMO that offers fully integrated, comprehensive analytical testing to support technologies for every stage of development. Its laboratory services platform is comprised of analytical testing and development services for small molecule and biologics drug products, as well as specialized offerings such as elemental impurities, abuse deterrence, and extractables and leachables. In addition, formulations development scientists address challenges related to new chemical entities.

Because Alcami’s portfolio touches on all phases of development, advancements in technology and regulatory requirements are closely monitored. “The industry has changed drastically over the years and analytical testing has evolved with it,” says Cheryl Johnson, Commercial Development Manager of Biotechnology, Alcami. “Control of impurities, excipient selection, and packaging safety are a few examples where increased awareness has led to higher expectations of analytical testing capabilities to satisfy regulatory requirements.”

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Topics: Thought Leadership Editorials Analytical Testing