The deal – financial details of which have not been divulged – will see PharmaCell provide cGMP manufacturing for a number of potential gene therapies going through the clinical development process from its facilities in The Netherlands.
“PharmaCell has experience and a strong track-record in supporting clients with the transition from clinical to commercial manufacturing,” Alexander Vos, CEO of the contract manufacturing organisation (CMO), told Biopharma-Reporter.com.
“We have done and are doing this for multiple clients [and] have the infrastructure and know how, in terms of facilities, quality systems and staff to take on such projects successfully.”
Tech transfer
Orchard’s pipeline includes a therapy for ADA-SCID – a rare inherited disorder of the immune system – and rare neurodegenerative lysosomal storage disease Sanfilippo syndrome type A. Both are being targeted by candidates made using the firm’s ex-vivo autologous gene therapy technology.
The platform consists of genetically correcting stem cells taken from the patient using a lentiviral vector carrying a functioning copy of the faulty gene, and then transplanting them back into the body by IV infusion.
In November last year, Orchard inked an alliance with gene and cell therapy firm Oxford BioMedica for process development services and cGMP-grade manufacture of lentiviral vectors.
“We will work in very close collaboration with Orchard staff to transfer the technology, meaning we will literally work side-by-side with their staff in their facilities to observe as well in our facilities to implement the technology,” Vos said.
PharmaCell has two facilities in The Netherlands; a facility in Maastricht, and a facility in neighbouring city Sittard-Geleen bought from cell therapy firm TiGenix in 2014 for €5.7m ($6m).
“For any project there is some additional investment, but largely we can service the [Orchard] collaboration from our existing resources,” Vos added.