According to Cambridge, UK-based Abzena, the acquisition of PacificGMP will propel the firm into the contract biopharmaceutical manufacturing sector by adding services focused on monoclonal antibodies, recombinant proteins, vaccines, and gene therapy products, to its existing manufacturing cell line development offering.
The sector, the firm said, is forecast to reach $3.1bn (€2.7bn) in 2016 and PacificGMP will help establish an operational footprint in the US through its biomanufacturing facilities in San Diego, California.
“PacificGMP has built its business on the use of single-use disposable manufacturing technology, in particular the Wave System,” Abzena’s CEO John Burt told this publication.
“PacificGMP can operate up to 1000L capacity, but substantially higher for perfusion cultures. Prior to the acquisition, Abzena could provide protein production services for research use, but had no GMP manufacturing capacity.”
In 2014, the site doubled its GMP (good manufacturing practice) production capacity from 500L to 1000L for batch and fed-batch production with the addition of a second GE Healthcare System 1000 bioreactor. When run in continuous mode, the system boasts a total perfusion capacity of 30,000L.
The site – which Abzena has said it will continue to invest in - also gives access to a range of single-use technologies, allowing it to further broaden its clinical and commercial bioprocessing service offerings.
The addition of the plant will help Abzena be closer to its core US-based customers, Burt said, whose demand for GMP biomanufacturing – on top of Abzena’s own immunogenicity assessment, protein engineering, ADC bioconjugation, cell line development - helped drive the deal.
The deal was praised by N+1 Singer Equity Research analyst Jens Lindqvist, who said in a note: “The addition of biopharmaceutical manufacturing capability expertise significantly strengthens the offering for the company’s customers on both sides of the Atlantic.”
CDMO vs in-house
“Many emerging companies are not investing in their own GMP manufacturing capacity but utilising outsourced service providers such as Abzena,” he told us.
“Also, whilst major companies do have in-house capability that does not always have the necessary capacity and is largely focused on supply for late-phase clinical development and commercial manufacturing.”