As part of the partnership, ViroCell will more than double the UK’s lentivirus vector manufacturing capacity for clinical trials in 2022 and become the first UK CDMO to be able to deliver AAV vectors to the cell and gene therapy markets.
ViroCell specialises in the design and GMP manufacture of viral vectors and gene modified cells for clinical trials. Specifically, it focuses where the viral vector design and GMP manufacturing bottleneck is most acute: the zone between pre-clinical concept and pivotal clinical trials. ViroCell therefore sees its role as filling the gap between small volume academic core labs and large volume CDMOs.
Dislodging the logjam
The production of the vectors will take place in GOSH’s Zayed Centre for Research into Rare Disease in Children.
“The ViroCell team’s track record of manufacturing more than one hundred viral vectors for clinical trials over the last 20 years coupled with the Zayed Centre for Research’s state-of-the-art clean room suites will enable ViroCell and GOSH to dislodge the logjam that currently prevents promising, novel cell and gene therapies from entering clinical trials,” say the partners.
While commercial-scale CDMOs operate at batch scales between 200L and 2,000L, ViroCell operates in the 1L to 200L batch size area.
John W Hadden II, CEO of ViroCell, commented: “Together ViroCell, GOSH, and the Zayed Centre for Research have created a global one-stop-shop for viral vector manufacturing and gene-modified cell manufacturing for translational cell and gene therapies. We are proud to be partnered with such a prolific clinical research team that boasts a stunning track record of academic innovation in cell and gene therapy. We embrace GOSH’s commitment to bring novel therapies into the clinic for inherited or childhood diseases and commit to help GOSH speed the manufacture of viral vectors for those interventions.”
Founded in 1852, Great Ormond Street Hospital is one of the world’s leading children’s hospitals with more than 252,000 outpatient and 43,000 inpatient visits every year. It is also known for its research into the rarest, most complex and often life-threatening conditions. The Zayed Centre for Research into Rare Disease in Children opened in 2019.
"We are exceedingly pleased to be partnering with ViroCell to accelerate the transition of discovery science into the clinic and expand access to viral vectors,” said Matthew Shaw, CEO at Great Ormond Street Hospital.
“We see this as a key to unlocking the innovation engine of the Great Ormond Street Hospital for Children and its academic collaborators, ultimately delivering better outcomes for patients. Given ViroCell’s international network of collaborators, we expect that vectors for projects from around the world will be manufactured at the Zayed Centre for Research, and this may also expand the number of clinical trials that we can offer to our patients at GOSH.”