BD Biosciences to Open New Animal-Free, Antibiotic-Free Cell Culture Media Manufacturing Facility
BD Biosciences, a segment of BD, recently announced the planned opening of its standalone, dedicated “Animal-Free / Antibiotic-Free” AF² (TM) Facility for the cGMP production of cell culture media and supplements at IBC Life Sciences BioProcess International™ Conference & Exhibition in Anaheim, CA. The new plant, which is expected to open in late 2009, will manufacture products that are controlled for animal-origin component raw materials to the tertiary level, the most stringent level of control available.
“We understand how important it is for our bioprocess customers to have access to high-performance media with the lowest possible regulatory risks,” said Tom Isett, Vice President, BD Biosciences – Advanced Bioprocessing. “With BD’s new AF² Facility, we will deliver a new standard for safety and quality for cell culture media that significantly reduces current risks associated with mixed-use plants. So, when coupled with our refined media supplements technology, we will be able to make consistently high-performing animal-free formulations and chemically defined media from a facility that offers high safety and regulatory compliance.”
Originally designed and built for the manufacture of pharmaceuticals, the 90,000-square foot plant in Miami, FL, is currently being outfitted with modern cell culture media milling, blending and sterile liquid filling equipment. The custom and standard cell culture media powder products produced in the AF² Facility will be available in batch sizes of up to 3,000kgs. Large-scale liquid filling capacity enables the production of liquid cell culture media products in batch sizes up to 4,000L. Additionally, animal-free versions of BD’s proven bioprocess yield-enhancers - peptones, hydrolysates and extracts for microbial fermentation and cell culture supplementation - will be transferred to the new dedicated AF² Facility once validated.
Custom blends of basal cell culture media and supplements are available currently via the BD Autonutrient™ Media Design Service and its Custom Product Development Program. However, a new Pilot Lab will be on-line and ready to produce cell culture media samples representative of commercial-scale AF² Facility manufacturing by the end of 2008. The new Miami plant is expected to be open for customer auditing and qualification by October 2009.
With its new manufacturing capability, BD Biosciences will fully serve the culture media needs of bioprocessors working with mammalian, microbial or stem cell lines. BD’s media products are currently used to help produce more than 50 biopharmaceuticals, cell therapy products and bioengineered vaccines – either marketed or in clinical trials – including many of the world’s top marketed biological medicines.²
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