BioCenter Offers Cleanroom Space
By Lisa A. Coleman
Baltimore, MD–Targeting the nation`s emerging biotechnology industry, a state-of-the-art biopharmaceutical production facility dubbed BioCenter (Baltimore, MD) will offer multi-user contracted cleanroom space for companies that lack the money and facilities for contamination-controlled production. The BioCenter is the first of its kind in the United States and is expected to be operational by the end of 1995.
The 58,000 ft.2, $26 million facility will be available for biotechnology companies that do not have the facilities to move their product from the research to the production stage. While many companies have adequate R&D facilities, ramping up for production can cost millions. The BioCenter will offer a way to bridge the manufacturing gap. “There`s a need for a facility for companies that are ready to enter this stage of product development without spending millions and millions of dollars in capital assets,” says Jack Rubin, president of Bio Science Contract Production Corp., builder and operator of BioCenter.
“Especially in light of the biotech money crunch, this is a way for companies to get their product to market cheaper and faster than building their own [production facility,]” he adds.
The BioCenter is being funded from the state of Maryland, federal grants, and Bio Science Contract Production Corp.; BioCenter`s land was donated by the city of Baltimore.
Consequently, there will be incentive programs for Maryland companies to use the facility, which is designated as a non-profit corporation.
The BioCenter will have four good manufacturing practices (GMP) cleanroom suites. Each suite has two rooms which can be split for a maximum of eight separate cleanrooms. The production areas of the suites will be Class 100,000 with one of the Class 100,000 cleanrooms having BL3-LS containment capabilities. Purification rooms will be Class 10,000.
Three of the suites will be used for microbial fermentation production and the fourth suite will be a cell culture room. Suites are self-contained with dedicated media, buffer prep and seed rooms. The center will offer 1,500 and 150 liter fermentors and process tanks, 20 liter fermentors, cell culture capabilities, biosafety-cabinets (class IIA), quality control and an analytical support laboratory, processing support including micro- and ultra-filtration, and process chromatography.
Utilities supplied by BioCenter include USP purified water and WFI, clean steam, plant steam, chilled water, and oil-free process air.
Up to 32 clients can use the center annually for an average of three months each. Bio Science will also provide GMP-trained staff to work with contracting companies.
Due to the labor-intensive nature of the work, Bio Science doesn`t expect to see BioCenters popping up across the country. “But, we`ll expand BioCenter if the demand grows,” says Rubin. “We can double the size of the existing building.”
Rubin is optimistic BioCenter will be an evolutionary step in bringing biopharmaceutical products to market. “These are all products that are going to save people`s lives. The faster it gets out there, the more people that will get treatment,” says Rubin.
Editor`s Note: For more information about BioCenter, contact Karen Keep at Bio Science Contract Production, (410) 563-9200 or fax (410) 563-9206. n