Upstream Process Development

We offer state-of-the-art cell culture development labs and a non-GMP pilot plant specializing in the process development, characterization and validation and process scale-up for successful cGMP clinical and commercial manufacturing We provide extensive experience in traditional fed-batch, continuous and/or intensified processes to support all stages of drug development from pre-clinical to commercial production.

Although we have developed hundreds of processes using our WuXia^TM cell line and well-vetted cell culture platform, multiple processes have successfully been developed, scaled and transferred to GMP manufacturing using cell lines and processes developed by third parties or by our clients. Our team is highly experienced in the technology transfer of processes into our labs as well as the transfer of processes to our GMP manufacturing teams across a wide-range of molecule types.

With over 300 dedicated and skillfully trained scientists, we provide the capacity to support more than 50 programs simultaneously at various development stages. Over 100 projects have been successfully delivered to global IND since 2015 with a 100% approval rate.

Product Quality Optimization

Product quality optimization is an essential part of bioprocess development. We have developed a comprehensive toolbox for the optimization of various product quality attributes, that include:

• Aggregation control
• Charge variant control
• Glycosylation optimization
• Sialic acid content optimization
• ADCC and CDC activity optimization