A new cell culture media and supplement production facility will be opened by BD Biosciences in Miami-Dade County this month. The building was designed to support a number of advanced technologies and operating procedures.
GEN interviewed William James, the director of operations at BD Biosciences-Advanced Bioprocessing, to learn more about the company’s new AF2™ facility.
GEN What drove the need to set up this facility?
James Our customers were the driving force behind building this animal-free, antibiotic-free manufacturing site. For them, this facility is all about risk reduction throughout the supply chain, especially those associated with animal-origin materials.
The Advanced Bioprocessing team worked with our customer advisory board representing top global biopharmaceutical companies, which provided the input that documented the need, the concept, and, ultimately, the facility’s design.
One key insight was the increasing global regulatory requirements that lead our customers toward stricter control of their raw materials in light of BSE and other biological contaminant concerns. This reinforced our belief that a significant and growing need exists today in the biopharmaceutical industry to eliminate the presence of animal-origin raw materials completely in the facility and the supply chain. Input from our customer advisory board also steered us toward the next level of risk reduction—a new stand-alone facility— rather than segregating an area at an existing plant.
With this input from our customers as well as an assessment of our capabilities and the competitive landscape, BD decided to establish the facility in Miami. The building had been constructed by a pharmaceutical company to industry standards, but it never entered operations. We, therefore, were able to take a building that met many of our needs and retrofit it for our specific customer requirements. It allowed us to bring the facility online in a shorter time frame for our customers.
GEN What types of operations will take place in the new facility?
James AF2 offers both dry powder and liquid cell culture media and supplement manufacturing. It has the capability to produce aseptic fill solutions in customized flexible packaging. As a fully integrated production facility, it integrates cell culture media and supplement manufacturing capabilities, with the ability to produce both complete catalog and custom formulations for microbial fermentation, mammalian cell culture, and stem cell culture.
The facility employs state-of-the-art pin milling and blending technologies to help ensure product integrity and consistent performance. It also has a rigorous cleaning program, including clean-in-place (CIP)/sterilize-in-place (SIP) procedures, that is consistent with pharmaceutical standards to help reduce the risk of cross-contamination and maintain product safety.
GEN What are the new facility’s key distinguishing features?
James AF2 is the industry’s first and only fully dedicated, integrated, animal-free and antibiotic-free cell culture media and peptone/supplement production facility for liquid and powder products.
The facility’s technology is complemented by high levels of process and environmental controls that enable us to produce high-quality products while helping to minimize overall supply chain risk for our customers. For example, all materials and workers entering the facility follow a strict unidirectional flow to prevent contamination. Processed products leave the facility in a similar fashion. In addition, the production of liquid and powder products is segregated to help prevent cross-contamination.
When our biopharmaceutical customers visit the facility, they immediately recognize how much it resembles their own manufacturing facilities. The plant was designed with our biopharmaceutical customers in mind from the physical layout to the equipment and systems.