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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 Testing Development Analytical 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: News & Events Analytical Testing Development Analytical Development Drug Product

Case Study: Implementing Serialization

The Food and Drug Administration (FDA) issued a draft guidance listing the enforcement of product identifiers under the Drug Supply Chain Security Act.  Specifically, this draft guidance addresses the requirement in section 582(b)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1(b)(2)) that manufacturers “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” beginning no later than November 27, 2017.  Ultimately, the FDA recognized the massive undertaking of such a requirement and extended the deadline to November 26, 2018.

Alcami began implementing serialization in 2015 to achieve the aggressive timelines and develop the necessary documentation needed to meet compliance.

This case study shows how Alcami has successfully transferred clients into the new serialization program.

Topics: Regulatory Compliance Serialization Drug Product Case Study

Case Study: Orphan Drug Product

According to the Food and Drug Administration and the Orphan Drug Designation program,  orphan status is applicable to drugs and biologics which are defined as “those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.” Due to the high costs and low demands of the drug product, it is important to efficiently use your API supply during the formulation process. This case study presents how Alcami successfully helped a client overcome an API supply shortage using Quality by Design studies to successfully formulate an orphan drug product. 

Topics: Oral Solid Dose API Drug Product Formulations Orphan Drugs Case Study

Video: Charleston Regional Development Alliance Features Alcami

Alcami's Charleston, South Carolina site is featured in a video produced by the Charleston Regional Development Alliance. Be sure to check out the video to see our facility, meet our team, and learn more about the growth in the Charleston area, and the role that Alcami plays.

Topics: News & Events Drug Product Videos Parenteral Manufacturing

Alcami Announces Completion of Site Investment and Expansion in Drug Product Manufacturing and Development Facilities

Wilmington, NC - September 8, 2016 - Alcami Corporation, a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, today announces additional laboratory-scale capabilities to support prefilled syringes in Wilmington, NC and the successful completion of previously announced investments in Charleston, SC.

Alcami has invested in state of the art, semi-automated vacuum stopper equipment in Wilmington, NC, to generate prefilled syringe samples that can be used to screen & select components, complete compatibility studies, and conduct developmental stability studies.  With this equipment, Alcami can generate bench/pilot scale representative samples, minimizing the amount of Active Pharmaceutical Ingredient (API) required to generate this critical data.

Topics: News & Events Drug Product Parenteral Manufacturing

Additional Equipment and Capacity for Drug Product Manufacturing in Wilmington, NC

Wilmington, NC –December 21, 2015 – AAIPharma Services Corp./Cambridge Major Laboratories, Inc. (AAI/CML), a leading provider of custom manufacturing and development services for the pharmaceutical and biotechnology industries, today announces additional capabilities and capacity for oral solid manufacturing in its Wilmington, NC facility. These investments have been driven by the significant growth in our drug product portfolio, particularly for orphan drugs and rare disease therapies.

Topics: News & Events Drug Product