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ViroCell Biologics与GOSH达成战略合作,携手消除基因和细胞治疗的“僵局”

04/10/2021

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.

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.

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.