Advances in Single-Use Platforms for Commercial Manufacturing

Welcome to “Advances in Single-Use Platforms for Commercial Manufacturing.” This special report explores recent advances in single-use process platforms for commercial production of biopharmaceuticals. Enormous developments have been made in single-use systems, allowing biomanufacturers to adopt the technology in critical applications within their commercial-scale facilities. The authors illustrate how companies can work with teams of experts from supplier organizations to implement end-to-end single-use bioprocesses at scales up to 2,000 L by carefully considering the approach from the earliest stages in process development. Finally, the report examines how cutting-edge developments in sensors and data analysis methods give biomanufacturers significantly improved control of their bioprocesses than they have ever experienced before. Each expert contributor presented on his or her respective topic to audiences at the Biotech Week Boston conference in 2017. We hope you’ll find this report enjoyable and that it will be an invaluable resource for considering your own approach to implementing single-use process platforms. — Cheryl Scott, senior technical editor, BioProcess International

Control of Single-Use System Supply Chains: Accelerate Adoption Into Commercial Production Facilities
Sartorius Stedim Biotech’s group vice president of marketing and product management in fluid-management technologies introduces the topic of advances in single-use platforms for commercial manufacturing. Biotechnology companies increasingly are implementing such to improve speed, efficiency, flexibility, and costs. They and their suppliers are combining expertise with a science-led approach to gain end-to-end control of commercial biomanufacturing. Control of materials, production processes, and quality can reduce variability, ensure consistent compatibility with biological systems, and increase process integrity.

Exploring the Science Behind Single-Use Container–Closure Integrity Assurance
Together, Sartorius Stedim Biotech’s senior fluid-management technologies product manager and a senior engineer in integrity testing solutions focus on integrity testing of disposable container–closure systems. The company is researching links between bag defects, liquid leaks, and microbial ingress. The results should help it develop sophisticated integrity-testing strategies at its own production facilities as well as for customer’s biopharmaceutical production sites. As part of these strategies, the authors explain, the supplier will correlate its own integrity tests with bacterial aerosol challenge tests.

Single-Use Production Platforms for Biomanufacturing
Sartorius Stedim Biotech’s director of marketing for integrated solutions addresses the uncertainty faced by product sponsors trying to accelerate biologics to market. Bioprocesses must meet stringent quality requirements with efficiency to provide the lowest possible overall costs. This supplier is helping with end-to-end single-use production platforms and a robust single-use supply chain. The company has incorporated data analytics to enable its customers to make sense of process data and use the resulting knowledge to improve product quality and process efficiency.

Control of Critical Process Parameters Using In-Situ Analytics
A technology expert in process analytics at Sartorius Stedim North America describes how bioprocess engineers can improve control of their bioreactors using dedicated, real-time, on-line sensors. Those will allow the industry to develop more controlled and automated single-use platforms that deliver consistent product quality and improve productivity. Novel process analytical technology (PAT) tools set the foundation for advanced process control strategies using multivariate data analysis.

Prescriptive Analytics for Bioprocessing Platforms
Sartorius Stedim Data Analytics lead data scientist explores the subject of PAT in greater detail. The biopharmaceutical industry is gaining confidence in single-use bioprocessing technology, implementing such systems into the most critical applications of commercial biomanufacturing. By combining data-driven analytics with mechanistic modeling, suppliers should be able to improve the “observability” of key quality parameters.

Final Thoughts: Single-Use Platforms
Sartorius Stedim Biotech’s technical content manager puts it all into historical and technical perspective. Advances in single-use production platforms are expediting their adoption into commercial biomanufacturing. Users gain a competitive edge with highly optimized and flexible processes that they can implement rapidly, secure in the knowledge that supply of necessary materials will be assured.