Manufacturing

4P capabilities include small scale manufacturing processes for transdermal patches, drug solutions and devices. These include film casting, die cutting, lamination, assembly, and pouching. Transdermal patch manufacturing processes are initially developed to support in vitro and in vivo research studies and then transitioned to clinical manufacturing under FDA current Good Manufacturing Processes (cGMP).

Once proof-of-concept is established in humans and the target performance is achieved, the drug delivery system design is locked and the manufacturing process is transferred to a contract manufacturer for scale-up. 4P has the experience to lead technology transfer to establish a manufacturing process that can be scaled up for pivotal clinical trials at a representative commercial scale. Once the process and methods are transferred, 4P will manage the project to ensure the key milestones related to initiation of pivotal trials are met.