Krystal Biotech continues internal buildout with second facility
Last year, the Pennsylvania-based biotech opened its first current good manufacturing practice (cGMP) plant for the production of its lead candidate. At the time, the US biotech stated that it planned to complete a second facility in 2020.
The timeline for the completion of the second facility has been adjusted to having the space “functionally ready in time for the anticipated launch of our lead therapeutic,” stated the company’s CEO, Krish Krishnan. According to the biotech, this could see the facility receive regulatory validation in the next 12-15 months.
As part of the process, Krystal Biotech announced that it had broken ground on its Findlay Township facility, which will have the ability to produce commercial gene therapy medicines.
Krishnan stated that having the ability to manufacture its product in-house represents a ‘competitive advantage’ for the company.
This follows on from comments made when BioPharma-Reporter previously spoke to the CEO, during this time he stated: “There are so many gene therapy players and so few manufacturers – which causes a choke point, in terms of time and cost.”
As a result, the company decided to build out its own capabilities – a decision which would seem to have paid off, with the capacity constraints that have been noted at contract development and manufacturing organizations (CDMOs) working on cell and gene therapies.
As a result, companies that have invested in their own manufacturing have been bought out for a premium based on such capabilities.
According to a spokesperson for the company, the 100,000-square-foot cGMP facility will cost between $75m-100m (€68m-90m) and create an initial 75 positions, which could increase to a total of 200 positions once the plant is fully operational.
As well as being able to produce its therapies in-house, the investment will add testing, packaging, labeling and distribution facilities – providing the biotech with fully integrated capabilities for the manufacture and supply chain-readiness of its pipeline of therapies.
Krystal Biotech’s lead candidate is B-VEC, which is a gene therapy candidate for the treatment of dystrophic epidermolysis bullosa – an incurable skin blistering condition caused by a lack of collagen protein in the skin.
B-VEC has received fast-track designations from both the US Food and Drug Administration and European Medicines Agency.
