Expansion complete! AGC and eXmoor CDMO facilities now open

AGC Biologics has completed its plasmid DNA (pDNA) and messenger RNA (mRNA) line expansion at its Heidelberg, Germany site.  eXmoor Pharma has opened the doors to its cell and gene therapy (CGT) facility in Bristol, UK.

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In September 2021, contract development manufacturing organization (CDMO) AGC Biologics announced its plans to expand its Heidelberg, Germany facility to increase its manufacturing capacities for customer pDNA and mRNA projects by adding an additional manufacturing line.

The firm has now completed the expansion and said it provides flexibility for its customers by having the ability to produce different projects simultaneously while reducing timelines. In turn, AGC claimed it can support more developers who require pDNA and mRNA materials.

DepositPhotos/VadimVasenin

“The new addition to Heidelberg is a remarkable achievement for this site. We have integrated the latest single-use technology to support our unique plasmid DNA and messenger RNA offering,” said Dieter Kramer, site general manager, AGC Biologics Heidelberg.

“This expansion complements our comprehensive capabilities and allows us to offer scalability for manufacturing and serve more developers in need of these materials worldwide.”

The additional line includes optimized personnel and material flow, chromatography, laminar flow, single-use bioreactor technology, clean rooms for fermentation, and warehouse space. The expansion, of which financial details have not been disclosed, also has added independently operated manufacturing units for upstream and downstream pDNA processing, mRNA production, linearization, and a filling unit to ensure compliance, flexibility, and quality for each project.

eXmoor

Meanwhile, eXmoor, which launched as a CGT CDMO in May with $35 million in funding has opened its 65,000 square-foot facility in Bristol, UK.

The plant has been designed to develop and manufacture viral vectors and autologous and allogeneic cell therapies. eXmoor said it includes manufacturing cleanrooms, support spaces for all types of CGTs, as well as process and analytical development and quality control laboratories.

“The opening of this facility marks a landmark achievement for us, as we bring our 19 years of translation consulting and process development experience to directly enable the rapid development of life changing therapies in the UK and beyond,” said Angela Osborne, CEO of eXmoor. 

“To date, we have completed more than 500 projects, including the design of 37 CGT manufacturing facilities. Our Cell and Gene Therapy Centre represents the culmination of all that experience.”

It doesn’t stop there!

Earlier this month, Thermo Fisher Scientific expanded its biologics site in St. Louis, Missouri by adding two production suites to support manufacturing of biologics.

The 58,000 square-foot unit is run by CDMO Patheon, which Thermo Fisher acquired in 2017 for $7.2 billion. The expansion is set to create 169 jobs at the St. Louis site, despite the closure of the CDMO’s operations in Florida (gene therapy facility), and New Jersey (cell therapy facility).

Furthermore, MilliporeSigma – the life sciences division of Germany’s Merck KGaA – opened two messenger RNA (mRNA) drug substance manufacturing facilities in Darmstadt and Hamburg, Germany in October. As a result of the expansion, the CDMO said it is the first to offer integrated services for all stages of mRNA development, production, commercialization, and testing.

Last month, CDMO WuXi Vaccines opened an 8,500 square-meter vaccine manufacturing site, located near Shanghai, China. The site’s drug substance manufacturing area includes two cell culture lines and one purification line capable of scaling up production from 50 to 1,000 L, with reserved capacity for up to 2,000 L.

The firm said it expects to employ up to five hundred people at the facility.