Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, today announces its first to market Protect Your Brand™ offering to support companies interested in implementing a back up supply option. Under this program, Alcami will initiate tech 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. It’s that simple. This industry leading 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.
Protect Your Brand™ is comprised of three distinct supply chain solutions to prevent disruptions from occurring at the earliest concept through to post-approval commercial supply. The solutions include the following deliverables, which balance proactive qualification and ongoing response readiness. Further customization is possible to meet the needs of each situation.
Concept to Clinic
- Raw Material Vendor Qualification
- Methods Transfer Report
- Clinic Ready Product
- IND Update Support
- Product GAP Assessment
Commercial Level Control
- Raw Material Vendor Qualification
- Methods Transfer Report
- Registration Batches for Filing
- Regulatory Filing Support
- Product GAP Assessment
Post-Commercial / Secondary Supply
- Raw Material Vendor Qualification
- Methods Transfer Report
- Validation Batches for Filing
- Regulatory Filing Support
- Line Extension Support
- Product GAP Assessment
In addition, on an annual basis, Alcami will conduct a GAP assessment of the defined process as determined by the client and utilize its proprietary scoring system to determine the State of Alcami Readiness™. The associated levels (1 through 4) allow for Alcami to be production ready in 3, 6, 9 or 12 months. Details of each option will be provided to allow the desired level to be chosen by the client for their product.
“Alcami has created the Protect Your Brand™ 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.
