Expansion of its operational capacity will allow PacificGMP to increase its large scale clinical manufacturing projects for its research clients, customers and partners.
Gary Pierce, CEO of PacificGMP, told BioPharma-Reporter.com that the company is seeing significant increase in early stage clinical manufacturing needs from universities, research institutions, and small and medium-sized biotech companies over the last 12 to 18 months.
This second System 1000, with a 500 L working volume, increases PacificGMP’s large scale GMP production capacity to 1000 L for batch and fed-batch production. In addition, it provides an additional 15,000 L of production capacity when run in perfusion mode. The addition provides PacificGMP a total perfusion capacity of 30,000 L to undertake more projects.
Pierce explained that perfusion mode “is more of a narrowly tailored solution when someone has a valuable protein that might be effective but the productivity of the cell line is poor.” And unlike batch production, where “you just plug in the material off the bat,” fed batch involves feeding agents more periodically, as well as removing debris to induce growth.
PacificGMP recently completed a technically challenging 6,000 L production run in continuous-perfusion mode using its original System 1000. This mammalian expressed protein is the 31st clinical lot production manufactured by PacificGMP for use in human clinical trials.
PacificGMP is also employing single-use technology at its California manufacturing facility. The benefits of single-use technology include the elimination of the risk of cross-contamination, fewer system requirements and significant reductions in the time required to initiate production.
“The economics of the biotechnology industry favor quality contract research and contract manufacturing and we are very excited about our prospects for long-term growth,” Pierce said.
He added that within the next 12 months, the company is looking to add an additional clean room, as well as looking at “doubling the amount of production space we have because we’re seeing more projects,” which is a “great sign for biotech…they’re getting their therapies funded and tested.”
“We are committed to helping clients to quickly meet their early-stage production needs with the highest quality assurance and the lowest capital costs,” said Pierce. “We will continue to invest in our capacity to do so.”