10.05.16
Alcami has launched its Protect Your Brand offering to help support companies interested in implementing a backup supply option. Under the program, Alcami will initiate tech transfer and execute a customized, phase appropriate qualification plan in advance of potential manufacturing needs without a long-term commitment or annual purchase obligation. This offering can be used for small molecule drug substance and / or small molecule and biologics drug product in support of clinical, launch and commercial supply.
The service, comprised of three supply chain solutions, aims to prevent disruptions from occurring at the earliest concept through to post-approval commercial supply by balancing proactive qualification and ongoing response readiness.
Also, on an annual basis, Alcami will conduct a GAP assessment of the defined process as determined by the client and utilize its scoring system to determine the State of Alcami Readiness. According to the company, the associated levels (1 through 4) allow for Alcami to be production ready in 3, 6, 9 or 12 months.
"Alcami created this offering to quickly bridge unexpected gaps in a given supply chain with no strings attached. We are committed to helping our clients meet their next clinical milestone, launch date and commercial drug supply without interruption while also being proactively prepared on an annual basis for potential future needs," said Syed T. Husain, chief commercial officer of Alcami Corporation.
The service, comprised of three supply chain solutions, aims to prevent disruptions from occurring at the earliest concept through to post-approval commercial supply by balancing proactive qualification and ongoing response readiness.
Also, on an annual basis, Alcami will conduct a GAP assessment of the defined process as determined by the client and utilize its scoring system to determine the State of Alcami Readiness. According to the company, the associated levels (1 through 4) allow for Alcami to be production ready in 3, 6, 9 or 12 months.
"Alcami created this offering to quickly bridge unexpected gaps in a given supply chain with no strings attached. We are committed to helping our clients meet their next clinical milestone, launch date and commercial drug supply without interruption while also being proactively prepared on an annual basis for potential future needs," said Syed T. Husain, chief commercial officer of Alcami Corporation.