CMOs are not only expanding cell-culture and fermentation tank capacity, but they are also expanding their downstream processing capabilities and capacities. Many CMOs are also expanding their process-development expertise and offering new expression systems.
At Avecia, Dr. Taylor noted, “We have significantly extended our offering in a number of support services to offer a more complete service to meet our clients’ needs. These include stability and formulation development. We have also invested over $2 million in new state-of-the-art, development laboratory space to support our pAVEway ™ offering.”
Avecia’s pAVEway system is a protein production platform that offers clients high expression levels. In addition to improved expression systems, Avecia has made significant investments in downstream operations and supply-chain management systems.
“For our late-phase and commercial clients, we have invested multiple millions of dollars this year to add large-scale reversed phase chromatography, enhanced centrifugation capabilities, plus improved supply-chain management systems,” Dr. Taylor concluded.
In June, DSM Biologics reported that it had achieved record yields in producing IgG antibodies using PER.C6® technology. By employing the PER.C6 human cell line and XD™ technology, DSM achieved titers of 27 grams per liter. In addition, they are expanding capacity and investing in further process-optimization technologies, noted King.
“We have recently added two 250 L disposable bioreactors to our facility, and we will add 50 L cGMP capacity for our high-yielding XD technology by the end of this year. We plan to make further investments such as 250 L cGMP capacity for our XD technology and also 1,000 L cGMP fed-batch.”
Cobra Biomanufacturing continues to expand its Oxford facility for the commercial manufacture of GenVec’s TNFerage™ product, which is currently in various clinical trials for pancreatic, rectal cancer, melanoma, and head and neck cancer. “Cobra is currently investing approximately $2.5 million in upgrading our Oxford facility for commercial manufacture of TNFerade in 2009,” Saxby stated.
Cobra is also investing in disposable bioreactor and bioprocessing technologies at its Keele facility. In July, the firm extended its manufacturing agreement with ViroMed to include a long-term research, development, and technical consultancy agreement for all ViroMed’s products.