Downstream processing continues to cause headaches for many biomanufacturers. Major improvements caused by vastly improved upstream operational efficiencies and cell culture product yields and the increased need for multi-product, flexible manufacturing space are converging to create an opportunity for a fully disposable purification solution that is economically viable.

BioSMB is that solution.

The use of small, pre-packed columns or separations devices run in a multi-column format and cycled to their lifetime within a campaign can enable true disposability. A BioSMB unit operation is designed with your definition of disposability in mind. Both run time and number of cycles become a choice. The system’s total carrying capacity is user defined with disposable components, thus eliminating the need to size downstream equipment to the product mass generated by the upstream. The integrated, disposable valving allows the user to add more processing power as titers increase without adding complexity.

A BioSMB process takes your existing purification process, using the same chromatographic media or other separation device and runs it as a more efficient, fully disposable process. Even with the most expensive chromatographic media, the saving is significant. Find out how to convert your process to a fully disposable process.

Impact of Disposables on Biomanufacturing

"The use of single-use, disposable products in biomanufacturing processes offers a number of advantages over traditional stainless steel systems — currently the industry standard. These include:

1. Reduced capital investment in equipment and facility infrastructure;
2. Fewer regulatory concerns and time, cost, and labor reductions in validation requirements for cleaning systems, including clean-in-place (CIP) and sterilize-in-place (SIP);
3. Decreased risk of product cross-contamination;
4. Quicker campaign turnaround times;
5. Increased assurance of sterility; and
6. More flexibility in portability, scalability, and facility operations management.

Other factors driving the adoption of single-use technologies include vastly improved cell culture protein yields; a trend toward development of increased potency, lower-dose biotechnology drugs; improved protein-based drug delivery systems; and a greater reliance on niche products in the personalized medicine and therapeutic vaccine industries."¹

¹ Single-Use, Disposable Products: A "State Of The Industry" Update Life Science Leader, July 2009, Cliff Mintz Ph.D.