The rapid expansion of the global pipeline of gene therapies, many of which originate at the research wings of healthcare providers, has overstretched manufacturing capacity, creating a bottleneck for groups trying to get new treatments to patients.
The need has attracted groups from outside the traditional contract manufacturing space, as illustrated by the creation of a gene therapy plant by ElevateBio, a biotech holding company, to support its portfolio of startups.
Now, Nationwide Children’s Hospital has become a new left-field entrant to the gene therapy sector. The Ohio-based not-for-profit pediatric healthcare system founded for-profit Andelyn Biosciences to “manufacture gene therapy products for the biotechnology and pharmaceutical industry.”
Andelyn begins life with a current good manufacturing practice (cGMP)-compliant facility from the Abigail Wexner Research Institute (AWRI). The institute, which operates out of Nationwide Children’s Hospital, established the facility to support Phase I and II clinical trials of gene therapies.
In taking over the plant, Andelyn will scale up the manufacturing operation. Production of materials suitable for use in Phase III trials will begin this summer but a big change is further down the line.
Andelyn plans to establish the capacity to produce gene therapies at commercial scale. To do so, the contract manufacturing organization (CMO) intends to build a new gene therapy plant that is due to come online in 2023.
Nationwide Children’s Hospital thinks the facility will become the first commercial-scale gene therapy manufacturing plant in Ohio. However, while Andelyn may have a state-wide monopoly, it will face competition from CMOs in other parts of the US that are scaling up capacity to meet rising demand for gene therapy services.
Catalent entered the sector through the acquisition of Paragon and wants to have 10 suites running by the end of the year. Thermo Fisher Scientific is another go-to resource for companies looking for outsourced gene therapy production capacity.
Andelyn’s efforts to carve out a niche in the gene therapy CMO market will be underpinned by the work of AWRI. Nationwide Children’s Hospital opened the 9,000-square-foot manufacturing site in 2009. Since then, the facility has gained experience with multiple recombinant adeno-associated virus (AAV) vector serotypes.
