Gene therapy contract manufacturer Forge Biologics is partnering with life science company Labcorp to accelerate the development and production of novel gene therapies for patients.
The collaboration, announced last week, will offer clients coordinated manufacturing and drug development services for adeno-associated viral (AAV) gene therapies, which use modified viruses to deliver DNA to specific cells to treat diseases.
“Labcorp’s comprehensive gene therapy drug development capabilities and scientific expertise, combined with the full suite of AAV manufacturing capabilities from Forge, will enable us to enhance and accelerate the AAV gene therapy development experience for our customers,” Labcorp VP and Enterprise Head of Cell and Gene Therapy Dr. Maryland Franklin said in a statement.
Forge has 20 cGMP suites making it one of the largest AAV manufacturers worldwide, with its leadership team having amassed 200 years of gene-therapy experience collectively, according to the release.
Together, the companies aim to reduce clinical timelines for the therapies, analytical development constraints and potential regulatory challenges related to manufacturing and development.
As emerging gene therapies target larger patient populations, the manufacturing of AAVs — a critical component in gene therapy products — will need to scale to meet demand. As a result, large contract development and manufacturing organizations have invested heavily in this space over the past few years, consulting firm McKinsey & Co. reported last year.
In February, contract manufacturer PackGene Biotech broke ground on a facility in Houston, which will include AAV manufacturing services to accelerate gene therapy product development.
The Food and Drug Administration expects it will approve 10 to 20 cell and gene therapy products a year by 2025, based on current clinical success rates.
