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 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
The guidance can be viewed on the FDA’s web site.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Filter Sizing for Process Optimization in Life Sciences Sterile Filtration
April 24th 2025Bench-scale filterability studies play a critical role in optimizing sterile filtration in biopharmaceutical manufacturing. By guiding the selection and sizing of filters, these studies help streamline processes, improve scalability, and reduce costs. Through data-driven case studies, this paper highlights how the strategic use of pre-filters and membrane materials can maximize throughput and minimize filter fouling.
VERAXA and Voyager to Create Combined Business for Advancing Pipeline of Next-Gen Cancer Therapies
April 23rd 2025The proposed business combination would create a publicly traded, clinical-stage biopharmaceutical company that will focus on developing a pipeline of next-generation cancer therapies.