GeminiBio Introduces Aseptic Assurance System

Gemini Bioproducts, LLC, a supplier of cell culture reagents and process liquids, a portfolio company of BelHealth Investment Partners, LLC, launched new products designed to improve cell therapy manufacturing processes.
 
Unlike traditional biomanufacturing processes 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. “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.”