GeminiBio's Aseptic Assurance System™ Supports Closed System Manufacturing for Cell Therapies

WEST SACRAMENTO, Calif., March 14, 2024 /PRNewswire/ -- Gemini Bioproducts, LLC ("GeminiBio"), a leading supplier of cell culture reagents and process liquids, a portfolio company of BelHealth Investment Partners, LLC ("BelHealth"), a Florida-based healthcare private equity firm, today announced the launch of new products designed to improve cell therapy manufacturing processes.

Unlike traditional manufacturing processes in the biotechnology industry (e.g., monoclonal antibodies, gene therapies, etc.) where there are extensive downstream purification steps after the initial cell culture process, cell therapy manufacturing has limited purification prior to patient administration. As such and given that the cultured cells for cell therapies (e.g., T-cells, NK cells, etc.) are essentially the drug product, manufacturers must ensure the sterility of their upstream cell culture workflows to reduce the risk of contamination and the potential harm to cell therapy recipients.

To address the risk of contamination in the cell therapy manufacturing process, global regulatory bodies have encouraged the industry to adopt closed system manufacturing technologies that reduce or eliminate open processes. In addition to reducing contamination risk, closed systems can remove labor intensive interventions, reducing the risk of human error, and improving manufacturing efficiency. To support closed system processing by cell therapy manufacturers using human AB serum as a cell culture supplement, GeminiBio is introducing Aseptic Assurance System^™ packaging for all clinical grade human AB serum products.

"By aseptically filling our human AB serum directly into our new Aseptic Assurance System^™ cryo-bags, GeminiBio is allowing our cell therapy customers to eliminate the manual on-site open processing step of transferring bottled serum into another container suitable for manufacturing", said Rob Perry, GeminiBio's Chief Scientific Officer, "and by using the weldable tubing, our customers can perform sterile connections directly to their growth vessels. Not only does this reduce the risk of introducing contaminants during the media transfer process, but it simplifies their workflow, which translates into improved speed and lower costs." 

"In addition to the standard fill size of 100mL of human AB serum in each 750mL cryo-bag, when requested, we work directly with our customers to customize the fill volume within the Aseptic Assurance System^™ cryo-bags", Mr. Perry continued, "which helps to optimize their process. It is very gratifying to help our customers transition to a closed system and simultaneously streamline their workflow."

About GeminiBio 

Founded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life enhancing biotherapeutics by streamlining and improving their cell culture and process liquid manufacturing workflows. The company's products are organized into two core verticals – Cell Culture Solutions and Process Liquid Solutions. Located in West Sacramento, California, GeminiBio has 57,000 square feet of cGMP manufacturing space that is segregated between animal origin free and animal component manufacturing. GeminiBio is an ISO 13485:2016 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820. For more information, visit www.geminibio.com. 

Contact:
GeminiBio: Kim Thompson, [email protected]
GeminiBio: Brian Parker, [email protected]

SOURCE Gemini Bioproducts, LLC