Purification Development

Creative Biolabs has extensive experience not only in developing and optimizing processes, but also in scaling up processes and transferring them to cGMP manufacturing in our facility. We are passionate in delivering the best service to fit our client’s requirements, and we work closely with you throughout process development with consideration about reducing timeline and cost, as well as improving process performance.

Background

The fermentation processes that are used by biopharmaceutical manufacturers have shown an increase in the number of therapeutic proteins. However, this increase in turn leads to capacity bottlenecks in the subsequent purification process (known as downstream processing) and is associated with high costs. Downstream processing comprises up to 80 percent of the entire production costs. Producers are increasingly aware of the present need for improvement and have shifted their focus from improving the production process (upstream) to improving the downstream process.

Our Downstream Development Service

With insight gained from our own products, we have established downstream platforms that allow us to quickly enter a product’s manufacturing phase. Our experience also enables us to develop more customized and innovative solutions to meet our customers’ needs. We optimize our downstream processes to remove impurities and increase yields with minimal steps and optimal recovery, leading to cost efficient manufacturing. For microbial processes, we have the ability to purify directly from harvest or to refold proteins from inclusion body preparations. Our process development and analytical teams are fully integrated to ensure we achieve the product quality attributes.

• High throughput process development (HTPD) system,
• Robust DOE platform,
• Standardized downstream unit operations and platform processes,
• Chromatography purification optimization,
• Chromatography resin dynamic binding capacity studies,
• Chromatography resin lifetime, cleaning and aging studies,
• Clarification development,
• Viral inactivation and virus removal filtration development,
• Scale-down process characterization for viral clearance studies,
• Scale-up,
• Risk analysis and cost benefit for various purification process unit operations.

Our Expertise in Downstream Purification

Fig.1 Our expertise in downstream purification.

Purification systems

With the powerful capacity of over 40 different purification systems used for purification development, we ensure a timely efficient solution for our clients. Systems include, but are not limited to:

Highlights

With years of hard working in recombinant protein and monoclonal antibody, Creative Biolabs is quite experienced in the technologies used in discovery and exploration. We provide flexible options for you. Please contact us for more details.

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