The rising demand for protein-based biotherapeutics, particularly monoclonal antibodies (mAbs), requires accelerated product development and enhanced scale-up capabilities. Small and mid-sized biotech companies can face challenges with rapidly identifying an optimal medium and feed, as well as developing a process that maximizes productivity and enables seamless scaling. Additionally, there are often difficulties with maintaining consistent production levels and product quality when scaling. This can lead to increased development costs and delays to commercialization.

A study by the Zurich University of Applied Sciences (ZHAW) highlights the effectiveness of a top-down scaling strategy, where large-scale processes inform the smaller-scale operations. This approach was used in evaluating CHO-K1 feeding strategies-such as bolus versus continuous-with Gibco™ Efficient-Pro™ Medium and Feed 1. The results demonstrate that a robust, consistent, and scalable fed-batch process can be efficiently and rapidly developed using the Efficient-Pro System and a top-down scaling approach.

The use of an optimized and validated catalog system, designed for scalability, can help accelerate a CHO workflow from process development to manufacturing. Animal origin-free (AOF) and chemically defined (CD), the Efficient-Pro System is available in liquid and Gibco™ Advanced Granulation Technology™ (AGT™) formats. The system is also available in various packaging sizes from a harmonized global network of CGMP facilities to support flexibility, supply assurance, and seamless scale-up.

Biotech companies, now more than ever, face greater challenges in rapidly and efficiently developing optimized, scalable upstream production processes and decreasing time-to-market. Gibco products, such as the Efficient-Pro System, can help them set the pace and scale their cell culture with confidence. For further support, industry-experienced field application scientists from Thermo Fisher Scientific can provide valuable insights for rapid and seamless process development. In addition, service offerings are available for more extensive process optimization, comprehensive bioproduction analytics, and regulatory support.

• Biotech companies developing protein-based biotherapeutics can face challenges with rapidly identifying an optimal medium and feed, as well as developing a process that maximizes productivity and enables seamless scaling.
• A study by the Zurich University of Applied Sciences (ZHAW) highlights the effectiveness of a top-down scaling strategy, when evaluating CHO-K1 feeding strategies with Gibco™ Efficient-Pro™ Medium and Feed 1.
• The results demonstrate that a robust, consistent, and scalable fed-batch process can be efficiently and rapidly developed using the Efficient-Pro System and a top-down scaling approach
• Animal origin-free (AOF) and chemically defined (CD), the Efficient-Pro System is an optimized and validated catalog medium and feed system, designed for scalability to help accelerate a CHO workflow from process development to manufacturing.
• For further support, industry-experienced field application scientists from Thermo Fisher Scientific can provide valuable insights and support for rapid and seamless process development.