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Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness

Durham, NC (USA) – October 25, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit Australian biopharmaceutical company dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low and middle-income countries. MDGH recently received U.S. Food and Drug Administration (FDA) approval of moxidectin, a novel new drug for the treatment of river blindness (onchocerciasis). MDGH utilized Alcami’s advanced analytical testing services and industry-leading accelerated turnaround time offering to meet critical approval deadlines.

Topics: Company News Analytical Development Analytical Testing Development Drug Product

The Role of Full Time Equivalent (FTE) Programs

An FTE agreement is considered a comprehensive analytical service that allows pharmaceutical and biotech companies flexibility, freedom, and consistent control of outsourced laboratory needs.

Drug developers with an abundance of overflow lab testing or limited lab space and staffing are ideal candidates for what Alcami calls an Extended Workbench program. Additional support may also be critical if the US Food and Drug Administration (FDA) approves the acceleration of your drug product. The chart below is a summary of the FDA’s drug development descriptions for when a product has significant implication on a patients’ welfare (FDA, 2018).

Topics: Analytical Development Analytical Testing Development Drug Product

Alcami’s Extended Workbench Supports Commercial Supply of Flexion Therapeutics’s ZILRETTA® (triamcinolone acetonide extended-release injectable suspension)

Durham, NC (USA) – June 13, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announced the expanded deployment of its Extended Workbench laboratory services program to support the ongoing manufacturing and development of ZILRETTA® (triamcinolone acetonide extended-release injectable suspension). ZILRETTA is the first U.S. Food and Drug Administration (FDA) approved product from Flexion Therapeutics, Inc., a Massachusetts-based biopharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (OA). Flexion utilized Alcami’s Extended Workbench to support ZILRETTA from Phase 2 clinical trials through commercial launch and is using the program for the release and stability testing of commercial batches.

Topics: Company News Analytical Development Analytical Testing Development Drug Product

Alcami Announces Industry-Leading Analytical Testing Turnaround Time

Durham, NC (USA) – May 8, 2018 – Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, today announces the advancement of the drug development process with the company’s new, dramatically-reduced analytical testing turnaround times. Alcami continues to set the industry standard with its analytical testing offering, and through operational excellence, streamlined processes, and technical knowledge and expertise, has reduced timelines by up to 30 percent.

“At Alcami, your timeline is our timeline,” said Alcami Chief Commercial Officer, Syed T. Husain. “We have made efficient, rapid, and reliable turnaround time a priority, as part of our commitment to bring our clients’ products through the clinic and to market first, while delivering the highest level of quality and finest customer experience in the industry.”

Topics: Company News Analytical Development Analytical Testing Microbiology Development

Editorial: Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs." The article includes Alcami, along with other CDMOs highlighting their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

Topics: Thought Leadership Editorials CDMO Development Manufacturing