SAN DIEGO, April 24, 2012 /PRNewswire/ -- PacificGMP (San Diego, California), the leader in single-use bioprocessing for development and manufacturing for its client partners, today announced that it manufactured a therapeutic recombinant protease that has been used in a Phase I/II clinical trial. The client recently announced successful completion of the Phase I portion, with no serious or severe adverse events reported, and that data from the study support commencement of the Phase 2 portion of the clinical trial.
"We are pleased to have been able to work with this client to scale-up the complex manufacturing process for this active enzyme and to have manufactured their human clinical trial material," said Leigh N. Pierce, President and Chief Scientific Officer of PacificGMP. "We at PacificGMP are pleased to have been an important part of our client's effort to introduce this therapeutic biologic into the clinic by the end of last year and this accomplishment highlight's our proven track record of delivering high quality clinical material in a timely and cost-effective manner."
Kristin DeFife, Vice President of Operations, continued, "This program consisted of two small scale engineering runs and one scale-up pilot run prior to initiation of a 250 liter bioreactor scale cGMP manufacturing run. The cGMP purification process required a total of 3500 L of approximately 25 different buffers, and roughly 4600 vials of drug product and diluents were aseptically filled. PacificGMP was able to work seamlessly with our client to manage the time line, logistics, and technical aspects of this project to support their clinical trial goals."
PacificGMP is a contract manufacturer and industry leader in single-use technology for development and manufacturing of biologics. Single-use technology eliminates the risk of cross-contamination, has fewer system requirements and significantly reduces the time required to initiate production. Benefits to clients include rapid project turnaround and the most cost effective solution in the industry. PacificGMP partners with drug developers by providing a range of cGMP and non-GMP services from cell line optimization, early process design, development and scale-up, to preclinical and clinical manufacturing, purification, aseptic filling, analytical services and regulatory support. More information can be found by visiting the company's website at www.PacificGMP.com.