As a full-service contract manufacturer, we can meet your needs at every stage of the product lifecycle. We offer an extensive breadth of process-development capabilities from cell-line and strain development, using proprietary pAVEway™ and CHO cell line systems, to process development, analytical development, clinical and commercial manufacturing. Both sites are FDA-approved for the production of commercial products.
Our capabilities include, but are not limited to: expertise in producing products from a wide range of cell types including CHO, NS0, SP2/0, hybridoma, E. coli, Pichia pastoris, S. cerevisiae, and Baculovirus; batch, fed-batch and single-use bioreactor production technologies are employed at volumes from 15 L to 5,000 L; production of recombinant proteins/peptides products for therapeutic and vaccine applications from mammalian and microbial expression systems; expert operator of multi-product facilities and a long track record of efficient execution of cGMP manufacturing campaigns.
Most recently we have expanded our manufacturing capacity by adding single-use bioreactor capabilities. We offer our clients the benefits of single-use upstream manufacturing in a proven organization with commercial cGMP compliance standards.
Experience solutions and learn more about how we can assist your development and manufacturing programs, please contact us.