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.

Occupying over 47,000 sq. ft of building space and expanding over the next several years, our upstream development labs are equipped with a wide variety of cell culture production systems and analytical tools such as 1L to 15L traditional glass bioreactors, perfusion systems to support intensified and/or continuous processes, high throughput AMBRTM systems (AMBR15 and AMBR250), Finesse and Applikon Controllers with Delta V systems, Wave bioreactors, and Cedex Bio HT high throughput bio-analyzers.

IND-enabling cell culture activities
Early stage (Phase I-II) and late stage (Phase III) cell culture process development
Stand-alone projects

Clone selection, process optimization, scale-up and toxicology material production
Technical transfer to GMP production teams

Technical transfer
Commercial process development
Process characterization and validation
IND and BLA CMC dossier support

Media screening and adaptation
Material generation at various scales of production
Process or unit step development and optimization – including harvest steps

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.

Cell Culture Process Development Case Studies

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

Upstream Process Development

Cell Culture Process Development Case Studies

Product Quality Optimization

Product Quality Optimization Case Studies