Alcami, a provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, has introduced Protect Your Brand, its program for implementing a back-up supply option. Under this program, Alcami will initiate technology transfer within a month of inquiry and execute a customized, phase-appropriate qualification plan in advance of potential manufacturing needs without any long-term commitment or annual purchase obligation. This program can be used for small-molecule drug substances and/or small-molecule and biologics drug products in support of clinical, launch, and commercial supply.

Protect Your Brand is designed with three supply-chain solutions to prevent disruptions from occurring at the earliest concept through to post-approval commercial supply, according to the company.

In addition, on an annual basis, Alcami will conduct a GAP assessment of the defined process as determined by the client and use its proprietary scoring system to determine what it terms the State of Alcami Readiness. The associated levels (1 through 4) allow for Alcami to be production ready in three, six, nine or twelve months. Details of each option will be provided to allow the desired level to be chosen by clients for their products.

Source: Alcami