As the need to accelerate biopharmaceutical development around the world continues to grow, biomanufacturers face a host of challenges so they, too, can grow. Increasing process productivity, reducing cost, mitigating risk, and bringing products to market faster are just a few of the issues frequently addressed. But with support in process development, cGMP manufacturing and training, accelerating bioprocess development can become less challenging.
Several biomanufacturers have successfully navigated these issues in collaboration with GE Healthcare’s Fast Trak Services. Whether it was through process and analytical development, process scale-up, or manufacturing of drug material for use in toxicology studies, recent collaborations have yielded remarkable results. The following case studies describe projects in which collaborative efforts resulted in fast resolutions to common biomanufacturing challenges.
Pfizer in China
Working with a service provider is one strategy that biosimilar manufacturers can pursue to facilitate speed to market. Implementing single-use technology is another. To achieve regulatory approval for two biosimilar monoclonal antibodies (MAbs) in China, Pfizer initiated a collaboration with GE’s Fast Trak Services. GE and Pfizer staff worked side-by-side to convert Pfizer’s existing stainless steel processes to single-use technologies and to generate material for comparability testing in less than 6 months. The companies continue to work together as they build a prefabricated cGMP-compliant KUBio™ facility and prepare material for preclinical studies.
Roivant Sciences in Switzerland
Farber disease is a rare lysosomal storage disorder caused by a defect or deficiency in the enzyme acid ceramidase. The deficiency causes intracellular accumulation of ceramide that leads to inflammation and tissue damage. Today, there is no specific treatment for Farber disease, but bone marrow transplantation can alleviate the symptoms. In this case study, Roivant Sciences worked with GE’s Fast Trak Services to develop a cGMP biomanufacturing process for their Farber disease treatment to provide material for toxicity studies.
mAbxience in Spain
A Spanish biosimilars company, mAbxience engaged GE’s Fast Trak Services to improve a first-generation process established by a third-party contract manufacturer. To achieve manufacturability and purity required for phase 1 clinical trial materials, Fast Trak scientists focused on improving the affinity chromatography (AF) capture step and intermediate purification and polishing steps while keeping the same process materials. They also developed a purification scheme more suitable for manufacturing scale.
A Flavivirus Project
Flavivirus vaccine development and production constitute many challenges and can be both space-and resource-consuming. In this final case study, an overview of modern tools and solutions is discussed, highlighting how they add flexibility and speed to both upstream and downstream operations in flavivirus vaccine production. Single-use production bioreactors and chromatography purification columns mitigate cross-contamination risk and support increased operator safety, while reducing time to market by eliminating costly and time-consuming cleaning operations. For downstream processing, modern chromatography resins offer high selectivity and excellent pressure and flow properties for high productivity in manufacturing-scale purifications. The use of such resins can increase purity and yield of a flavivirus vaccine manufacturing process.