Miami-Dade county, Florida, USA
Culture media and supplements for biopharmaceutical production
BD Biosciences, a division of the New Jersey based medical technology company BD (Becton, Dickinson and Company), launched a new cell culture media and supplement production facility in October 2010. Located in Miami-Dade county, Florida, the new facility is the first antibiotic-free and animal-free cell culture media and supplements manufacturing facility in the pharmaceutical industry.
The $59m cGMP compliant facility was earlier owned by IVAX Pharmaceuticals but never began operations despite having a developed manufacturing infrastructure. BD invested $20m in renovating the facility according to its customer’s requirements. The facility is expected to create 50 jobs by 2013.
The 90,000ft² production facility is spread over two storeys. It is fully integrated with a modular clean room design and zoned HVAC systems and terminal ULPA (ultra low particulate air) filters. It features state-of-the-art cleaning systems including CIP and SIP that reduces contamination risk and ensures product safety. There are separate gowning, de-gowning and material air locks zones.
The facility accommodates segregated manufacturing areas for liquid cell culture media, powder cell culture media and supplements. The liquid cell culture media manufacturing area occupies 20,000ft² across the two floors. The first floor includes an ISO 7 liquid media filling room and a water for injection (WFI) room for USP purified water (UPW), WFI and pure steam generation. A dedicated space for material staging is also available.
The second floor of this area includes a large tank room and a small tank room (both ISO7 classified) and a QC lab. The large tank liquid formulation room is installed with two 2,000l tanks with recirculation loop validated to handle up to 4,000l lot size. Positive pressurisation in the area minimises bioburden, ensuring environmental control.
The small tank liquid formulation room is equipped with 200l, 400l and 600l fixed tanks installed over calibrated load cells to ensure accurate formulation. The quality control lab includes a USP sterility testing area with pass through autoclaves. Laboratory equipment includes Beckman Coulter Vi-cell and thermo (Nautilus) laboratory information management system (LIMS). The liquid manufacturing area also houses flexible packaging suites with filling capabilities ranging from 1 litre bottles to 200l bags.
The 20,000ft² powder cell culture media manufacturing area houses two milling suites and a blending suite. The class ISO 8 milling suites are equipped with gravity fed milling technologies including Hosokawa Alpine UPZ Pin mill that offer superior particle size consistency, minimal heat and easy cleaning features. Both the suites include dedicated material staging area and have a filling capability of between 1l and 200l.
The blending suite located on the first floor offers a fully scalable lot size capability ranging between 30kg and 3,000kg. It includes flexible packaging suites with filling capabilities varying from 500g bottles to 50kg containers.
The facility will produce high-yield cell culture media and supplements for biopharmaceutical production. It will develop complete catalogue and custom formulations for microbial fermentation, mammalian cell culture and stem cell culture. Animal free raw material will be used up to the tertiary level, thereby reducing significantly the risks related with mixed use plants.
The company qualified for state and local incentives amounting to $1.4m and enterprise zone benefits for setting up the plant in Miami-Dade County. The county’s economic development partnership, the Beacon Council, helped BD procure the incentive package, which include Florida Qualified Target Industry (QTI) tax refund and a Miami-Dade County Targeted Jobs Incentive Fund (TJIF). The performance based incentives will be given to the company if it meets certain commitments related to investment and job creation.