Thank you for Subscribing to Life Science Review Weekly Brief
ViroCell Biologics confirms a new agreement to address the worldwide viral vector market for clinical trials.
FREMONT, CA: The field of cellular and gene therapy research and development is rapidly expanding, with a number of products nearing clinical trials. Soon, there will be drugs and treatments available for several genetic diseases due to the advancing technologies. ViroCell Biologics, established by the UK’s most prolific academic viral vector manufacturing team, and Great Ormond Street Hospital for Children NHS Foundation Trust, a world-renowned children’s hospital, has proclaimed a new partnership that will address the global viral vector market immediately for clinical trials.
ViroCell, an innovative Contract Development and Manufacturing Organization (“CDMO”), is tackling the global viral vector supply-demand imbalance impeding the development of breakthrough cell and gene therapies. ViroCell is dedicated exclusively to creating and manufacturing viral vectors and gene-modified cells for clinical studies under GMP conditions. ViroCell’s mission is to be the global supplier of choice for viral vectors used in the translational phase of the developing cell and gene treatments.
Viral vectors are high-value delivery vehicles used to create cell and gene treatments, and their availability and effectiveness are critical to the treatment's clinical success. ViroCell is considered the critical zone between pre-clinical ideas and pivotal clinical trials. The viral vector design and GMP manufacturing bottlenecks are acute: the zone between pre-clinical concept and critical clinical trials. ViroCell is therefore filling the gap between “small volume” academic core labs and “large volume” contract development and manufacturing organizations (CDMO).
John W Hadden II, CEO of ViroCell, comments, “Team ViroCell hasbeen 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 onestop-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 genetherapy. 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.”
ViroCell will more than double the UK’s lentivirus vector production capacity for clinical trials in 2022 as part of the agreement with GOSH, securing the coveted position as the first UK CDMO capable of delivering AAV vectors to the cell and gene therapy (“CGT”) industries.
The production of the vectors will take place in GOSH’s Zayed Centre for Research into Rare Disease in Children. The ViroCell team’s experience manufacturing over one hundred viral vectors for clinical trials over the last two decades, combined with the Zayed Centre for Research’s state-of-the-art cleanroom suites, will enable ViroCell and GOSH to break the logjam that currently prevents promising, novel cell and gene therapies from entering clinical trials.
While commercial-scale CDMOs run at batch sizes ranging from 200L to 2,000L, ViroCell is widely considered the European vector CDMO of choice for batch sizes ranging from 1L to 200L because of its extensive prior expertise and in-licensed, verified manufacturing 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.
Matthew Shaw, CEO at Great Ormond Street Hospital, adds, “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.”