As recipe parameters and final containers vary considerably from batch to batch, manufacturers are forced to accommodate faster product changeover while still protecting sterility. Learn how robotic aseptic fill/finish equipment offers the flexibility to adjust to future growth and the speed-to-market necessary for today's changing industry.
With a focus on niche drugs for targeted patient populations, small batch production will serve a critical role in the future of modern medicine. Explore the manufacturing requirements for small batch production and tips for maximizing process efficiency to reduce waste and improve yield for small batches of drug product.
Catalent Cell and Gene Therapy was searching for a cGMP aseptic filling and closing machine to reliably process a wide range of trayed and nested vials. AST's GENiSYS R systems gave them the flexibility to fulfill a wide range of projects and provide the sterility assurance their customers’ products require.
Small-scale aseptic filling presents a unique set of challenges. Questions regarding how fast a machine needs to run or what material is needed to process can lead to others. Learn what to look for when evaluating small-scale aseptic filling technology.
In the biopharmaceutical world, cell and gene therapies are continuing to gain significant traction. While this technology continues to grow, a number of challenges will inevitably follow. Explore four considerations for aseptic fill/finish challenges in biopharma.
The AST GENiSYS R provides ultimate flexibility for the aseptic filling of liquid pharmaceuticals. Designed with the specific challenges of small-batch production in mind, the GENiSYS R can be built to meet the needs of your facility today and for years to come.
Josh Russell, VP of sales and marketing, describes the AST Quick Delivery program, which makes certain isolated fill/finish equipment available within six months of purchase.
ASEPTiCell® is integrated with isolator barrier technologies to fully enclose and tightly control the aseptic environment for ideal conditions for processing sterile drug products. The system can be configured with a restricted access barrier system (RABS) or an aseptic isolator to provide uninterrupted aseptic conditions during production.
AST’s ASEPTiCell® is a flexible fill/finish system that can efficiently process midsize clinical and commercial batches while meeting all cGMP requirements for cleanliness and sterility.
