Over the last several years, many steps within biotherapeutic manufacturing have become 'disposable' through the implementation of specialized technology designed to reduce not only cost of goods but also contamination events, all while increasing operational flexibility.

The implementation of SMB in a sanitary environment is simply not practical without a disposable flow path and disposable valving. BioSMB technology provides the first and only fully disposable flow path for purification processes that provides both an economic and operational benefit. BioSMB systems offer improvements in productivity, flexibility in manufacturing configurations, decrease in manufacturing facility footprint and buffer tank requirements, as well as overall cost savings.

The fully disposable fluid path enabled by BioSMB technology brings the following benefits to bioprocess:

• Decreases clinical manufacturing costs of monoclonal antibodies by 80% and increases flexibility for new high titer processes;
• Fully realizes the recent gains in bioreactor productivity by purifying more product more efficiently in existing facilities;
• Reduces costs while meeting the high volume requirements for monoclonal antibody (MAb) therapeutics, follow-on biologics (biosimilars), and other biotherapeutics;
• Enables fully disposable and portable vaccine production for seasonal flu, pandemics, and bioterroism;
• Modernizes manufacturing processes by increasing flexibility and lowering capital expenditure therefore enabling retrofitting of single product facilities to multi-product manufacturing facilities.

The Future: Fully Continuous Biomanufacturing

At present, all biotherapeutics are being manufactured in a series of unit operations that are operated batch-wise. The result is that the operation involves many intermediate hold steps, each of which requiring a hold tank or a buffer bag. Eliminating these hold steps would allow significant enhancement of facility utilization and generate substantial cost savings associated with the bags or cleaning the tanks. If BioSMB is used as way to link several continuous processing steps, one could envision a fully continuous process, the gold standard of process efficiency. Tarpon is presently investigating this with partners and other collaborations.