ViroCell Biologics and GOSH announce partnership to dislodge gene and cell therapy 'logjam'

28 Sep 2021, 8:45 a.m.

ViroCell Biologics (ViroCell), founded by the UK’s most prolific academic viral vector manufacturing team, and Great Ormond Street Hospital for Children NHS Foundation Trust (GOSH), a world leading children’s hospital, have today announced a new partnership that will immediately address the global viral vector manufacturing bottleneck for clinical trials.

Lab technicians in GOSH laboratory

ViroCell, an innovation-driven Contract Development and Manufacturing Organization (CDMO), is addressing the global viral vector supply demand imbalance that constrains the manufacture of novel cell and gene therapies. ViroCell focuses exclusively on the design and GMP manufacture of viral vectors and gene modified cells for clinical trials. ViroCell aims to be the global viral vector supplier of choice during the translational phase of development of novel cell and gene therapies.

Viral vectors are harmless viruses that we can use to ‘trick’ cells into accepting new genes. They are highly complex to make and their availability and effectiveness dictates whether a clinical trial of gene or cell therapy will work. ViroCell is focused where the viral vector design and Good Manufacturing Practice (GMP) manufacturing bottleneck is most acute: the zone between pre-clinical concept and pivotal clinical trials. ViroCell is therefore filling the gap between 'small volume' academic core labs and 'large volume' CDMOs.

As part of the partnership with GOSH, ViroCell will more than double the UK’s lentivirus vector manufacturing capacity for clinical trials in 2022 and secure the coveted position as the first UK CDMO to be able to deliver AAV vectors to the cell and gene therapy (CGT) markets.

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.

While commercial-scale CDMOs operate at batch scales between 200L and 2,000L, ViroCell is regarded as the European vector CDMO of choice in the 1L to 200L batch size based on its deep prior experience and in-licensed, validated production technology platforms. ViroCell’s team built one of Europe’s most productive academic core labs before spinning out in 2020 and is now supported by a prolific Scientific Advisory Board of internationally leading innovators.

“Team ViroCell has been impressed with the laser-focus, record speed and unyielding commitment of the GOSH transaction team, GOSH Executive Management and Board, and the GOSH Children’s Charity to make this partnership a reality. 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.”

John W Hadden II, CEO of ViroCell.

"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. 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.”

Matthew Shaw, CEO at GOSH.

Notes to editors

ViroCell

ViroCell Biologics’ mission is to be the design and GMP-compliant viral vector manufacturer of choice for corporate and academic cell and gene therapy innovators preparing for and during their clinical trials. ViroCell specializes in batch sizes between 1L and 200L, deploying adherent or suspension cell processes. ViroCell is an active in-licensor of proven manufacturing technologies to enable clients to start clinical trials on a scalable platform, anticipating future scale-out to larger CDMOs upon successful clinical development, with an eye to deliver value to clients by reducing cost, and most importantly saving time and reducing regulatory risk. Initially, ViroCell will manufacture lentivirus, gamma-retrovirus, and AAV vectors and gene-modified cells for clients.

ViroCell is also investing to develop the next generation of viral vectors for the targeted introduction and expression of therapeutic genes in specific cell types, including vectors for direct injection as drug products to patients.

For more information, please visit www.virocell.com.

Great Ormond Street Hospital for Children NHS Foundation Trust

Founded in 1852, Great Ormond Street Hospital is one of the world’s leading children’s hospitals with the broadest range of dedicated, children’s healthcare specialists under one roof in the UK. With more than 252,000 outpatient and 43,000 inpatient visits every year, the hospital’s pioneering research and treatment gives hope to children from across the UK with the rarest, most complex and often life-threatening conditions. As an international centre of excellence in child healthcare, our patients and families are central to everything we do – from the moment they come through the door and for as long as they need us.

For more information, please visit www.gosh.nhs.uk

Zayed Centre for Research (ZCR) into Rare Disease in Children

The Zayed Centre for Research (ZCR) into Rare Disease in Children opened to patients in October 2019 thanks to a transformational £60m gift from Her Highness Sheikha Fatima bint Mubarak, wife of the late Sheikh Zayed bin Sultan Al Nahyan, Founder of the United Arab Emirates. It is the only Centre of its kind in the world and brings together pioneering research and clinical care under one roof to help drive forward new treatments and cures for children with rare diseases.

www.gosh.org/what-we-do/research/zayed-centre-research-rare-disease-children/

Great Ormond Street Hospital Children’s Charity

Great Ormond Street Hospital Children’s Charity needs to raise money to support the hospital to give seriously ill children, the best chance for life. The charity funds research into pioneering new treatments for children, provides the most up to date medical equipment, funds support services for children and their families and supports the essential rebuilding and refurbishment of the hospital. You can help us to provide world class care for our patients and families.

For more information visit www.gosh.org

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