CHICAGO and SAN DIEGO, Nov. 12, 2012 /PRNewswire/ -- HumanZyme and PacificGMP today announced a partnership to manufacture clinical grade, authentic human growth factors and cytokines. The companies will make available for the first time, a safe and authentic source of these proteins to regenerative medicine developers to change stem cells into differentiated cell types that will be used to treat various diseases or injuries.
The partnership combines HumanZyme's HumanKineTM growth factors and cytokines with PacificGMP's extensive experience and expertise in manufacturing GMP-certified recombinant human proteins intended for human clinical use. Growth factors and cytokines, which are proteins, provide researchers a means to convert stem cells into specific cell types such as heart cells or neurons. Previous stem cell research is now being translated from the laboratory to regenerative medicine therapies to repair damaged cells from traumatic injuries such as heart attacks or to restore cellular functions that have been lost or are missing in diseases such as diabetes and Parkinson's Disease. While growth factors and cytokines are already available to stem cell researchers, the regenerative medicine community currently lacks access to many clinical grade growth factors and cytokines that are needed to ensure that human cellular therapy trials are conducted in a safe manner.
"PacificGMP has a state-of-the-art manufacturing facility and a very successful track record of manufacturing clinical grade proteins in the large quantities that are needed to support the demand generated by an approved therapy," said Scott Coleridge, CEO of HumanZyme. "We are making our proprietary technology available to PacificGMP to enable the production of our HumanKine growth factors and cytokines which will help allow regenerative medicine companies to advance development of stem cell therapies," Coleridge added.
"HumanZyme's production cell lines and culture conditions have the necessary features for easy adaption to a GMP environment", said Gary Pierce, CEO of PacificGMP. "In addition, the human cells, the serum-free cell culture, and a completely animal component-free process will help ensure that the manufactured proteins are both bioactive and safe; we are pleased that PacificGMP is contributing to the advancement of much needed human cellular therapies, " added Pierce.
ABOUT HUMANZYME, INC.
HumanZyme, Inc. is the global leader in providing highly authentic recombinant human proteins from human cells. Our process is cost-effective and scalable making our proteins suitable for the research, diagnostic, drug discovery and biopharmaceutical markets. HumanZyme leverages its proprietary engineered human cells, expression vector, and cell culture media to ensure high-yield production of recombinant proteins with native human post-translational modifications, such as di-sulfide bonds and glycosylation. We are a leading provider of cytokines and growth factors and a preferred outsourcing supplier of human protein production. Our products and services support a broad range of customers worldwide--from academic and government research institutions to biotechnology and pharmaceutical companies.
PacificGMP is a Contract Manufacturing Organization (CMO) and leader in the industry in applying single-use flexible technology in the development and manufacturing of biologics. Single-use flexible technology eliminates the risk of cross-contamination, has fewer system requirements and significantly reduces the time and cost required for biologics manufacturing. PacificGMP is dedicated to providing our clients a wide range of cGMP and non-GMP services from early stages of Process Design, Development and Scale-up, to Preclinical and Clinical Manufacturing, Purification, Cell Banking and Storage, Autologous and Allogeneic Cell Based Products, Stem Cell Reagent Products, Conjugation, Fill and Finish, Analytical Services, and Regulatory Services.
Sean Doctor, VP of Business Development
SOURCE PacificGMP; HumanZyme, Inc.