Company Profile

PacificGMP is a Contract Manufacturing Organization (CMO) and leader in the industry in single-use technology for development and manufacturing of biologics, including antibodies, recombinant proteins, vaccine and gene therapy products. Single-use technology eliminates the risk of cross-contamination, has fewer system requirements and significantly reduces the time and cost required for biologics manufacturing. Clients benefit from rapid project turnaround and the most cost effective solution in the industry. PacificGMP is dedicated to providing drug developers a range of cGMP and non-GMP services from early stages of process design, development and scale-up, to preclinical and clinical manufacturing, purification and fill and finish.

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Management

PacificGMP team members are experts in single-use technology for bioprocessing, clinical material production and upstream and downstream processing. PacificGMP key scientists have over 100 years combined industry experience and have led or been actively involved in numerous drug development projects from early product development through cGMP manufacture of clinical trial materials and in optimization of upstream and downstream processes. Additionally, our team has extensive experience in assay development in support of both upstream and downstream processes.

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Facilities Overview

PacificGMP’s state-of-the-art multi-product facility has been designed to take full advantage of the advances in single-use, disposable technology. PacificGMP has both Class 10,000 and Class 100,000 production suites, and development, raw materials and quality control laboratories. The facility is licensed by the California FDB and registered with the FDA.

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Partnerships and Alliances

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