GEN BD points out that with this new facility the company has instituted the industry’s most stringent, tertiary-level animal-free policy. How was this accomplished and what does this mean to your customers?
James It’s remarkable that no industry standards exist regarding the definition of “animal-free.” As a result, biopharmaceutical companies may have trouble determining what animal-free really means when they are dealing with their suppliers. Our policies and protocols help make this information clear and transparent for our customers, raising the bar by which raw materials are sourced and measured.
We designed the AF2 facility to help significantly reduce the risks that could be associated with mixed-use plants and to help provide consistently high-performing formulations and chemically defined media. We expect that this level of safety will help speed our customers’ product development cycles by reducing risk and regulatory uncertainty.
The Advanced Bioprocessing team implemented a raw material and supplier qualification and management program to help ensure that all ingredients (primary), ingredient components (secondary), and ingredient subcomponents (tertiary) utilized in the facility are not of animal origin.
To accomplish this, all raw material suppliers are qualified through a process that involves collecting detailed information on the raw material, including manufacturing processes, and capturing this information in the quality system documentation. This means that we ensure that primary-, secondary-, and tertiary-level raw materials for our cell culture media and media supplements are animal-free. In addition, the facility has never had antibiotics in the manufacturing areas, and our procedures will help ensure that it never will.
GEN Talk about the “pharma-like” manufacturing setup and operational aspects of the new facility. What features were incorporated into this design and what are the main benefits of taking this approach?
James We set out to construct a facility that, in essence, would serve as an extension of our customers’ own manufacturing facilities. In AF2 our customers find completely segregated liquid and powder manufacturing areas with zoned air-handling systems and terminal ULPA (ultra low particulate air) filters. They also see advanced modular cleanroom systems and a continuous nonviable particle measurement system for environmental control and monitoring, as well as automated CIP and SIP cleaning processes.
Our water system meets USP requirements, generating USP pure water for injection and pure steam. The facility design promotes unidirectional flow of raw materials, personnel, and products, including separate areas for gowning, de-gowning, and material air locks. Finally, we have full-viewing corridors throughout manufacturing areas to facilitate audits while maintaining environmental control.
Of course, having the facility is only part of the answer to customers requesting safe and effective products. We designed and implemented our quality system with biopharmaceutical requirements in mind and consistent with our customers’ own systems. From equipment and process validation that is consistent with FDA and ICH guidelines to rigorously managed incoming material controls and inspections to an automated change-notification system that provides customers with advance notice of significant product changes to fully validated quality-control methods, our quality system is based on the GMPs defined in 21 CFR Part 210/211.
Supplier confidence is critically important in any industry. This is especially true in the heavily regulated world of biopharmaceuticals, where problems could have serious consequences for patients and the companies that make the therapies and vaccines.
Biopharmaceutical companies spend a considerable amount of time and resources validating that their suppliers follow established, quality-controlled processes and use advanced technologies to help mitigate risks. Biopharmaceutical companies that have seen AF2 have expressed confidence in our ability to help them manage risk in this important part of the supply chain.