PacificGMP is a Contract Research, Development and Manufacturing Organization that specializes in single use technology for the development and production of biopharmaceuticals. Manufacturing practices are 100% single use for upstream processes and 90% single use for standard downstream processes. The manufacturing facility is approximately 14,000 square feet and is located in San Diego, CA. The facility contains Research, Development and Analytical labs, as well as Class 10,000 and Class 100,000 manufacturing suites. Manufacturing suites contain Class 100 biosafety cabinets. PacificGMP is equipped for manufacture of biopharmaceuticals for Phase I and II clinical trials and is in compliance with US and EU cGMP requirements.
PacificGMP has extensive experience in the development and manufacturing of proteins, including monoclonal antibodies and recombinant proteins. PacificGMP performs the development and adaptation of cell lines, generation of upstream and downstream processes, manufacturing under GLP for toxicology studies and standard reference material, manufacturing of both master cell banks and drug substances under cGMP standards for human clinical trials (Phase I and Phase II), the manufacturing of cell based therapies for use in human clinical trials (Phase I and Phase II), development and qualification of release assays, fill/finish of drug product, oversight of necessary third party vendors and advising on regulatory matters.
PacificGMP has extensive expertise developing and performing conjugation processes whereby molecules are conjugated to specific proteins.
PacificGMP has manufactured over 30 proteins for use in Phase I and Phase II clinical trials.
PacificGMP’s expertise includes the development of documentary packages sufficient to meet the requirement facing organizations in obtaining regulatory sanction of drug product use in human clinical trials. PacificGMP generates with its partners the CMC sections of Investigational New Drug (“IND”) applications addressing: the process and materials components of product manufacture; the quality assurance and quality control aspects; drug substance and drug product aspects; and the facility and operations aspects of a successful CMC component.
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