FDA Releases Guidance Detailing Cooperative Manufacturing Agreements

The FDA has released its guidance on acceptable terms for cooperative manufacturing arrangements for short supply, divided manufacturing, and shared and contract manufacturing for licensed biologics. The guidance is meant to assure that safety, purity, and potency of biological products are not compromised as a result of flexible manufacturing arrangements.

In a shared manufacturing agreement, two or more companies are licensed and responsible for specific aspects of the manufacture of a product, but none is licensed for all of the manufacture of the product. The FDA will consider a manufacturer eligible for separate licensure if that manufacturer is instrumental in product development and performs several final manufacturing steps, including sterile filling, lyophilization, labeling, packaging, and final release testing. Each manufacturer must submit a separate BLA describing the manufacturing facilities and operations applicable to the preparations of that manufacturer’s biological substance or product that includes: the extent of manufacturing and testing performed by that participating manufacturer, manufacturing methods, and stability data.

Divided manufacturing is when two or more manufacturers, each registered with the FDA and licensed to manufacture a specific biological product in its entirety, participate jointly in the manufacture of that product. In divided manufacturing agreements, the roles of each manufacturer should be described in the original application, or supplements to the manufacturer’s BLAs.

The guidance states that source materials that are in short supply can be obtained from unlicensed facilities if

• manufacturing at the unlicensed location is limited to initial and partial phases

• the name and location of the unlicensed facility are registered with the FDA

• the manufacturer explains why it is necessary to obtain the materials from the unlicensed facility and the FDA agrees.

The guidance can be viewed on the FDA’s web site.