Introduction:
This article discusses the efforts of Bespark*bio, a company founded to address manufacturing failures in gene therapy. Bespark*bio provides process development support to gene therapy companies, helping them develop efficient manufacturing processes and identify critical process parameters. The company adopts a Quality by Design (QBD) approach and uses virtual simulations to model process steps. Bespark*bio offers services for a wide range of biotherapeutics, including biologics and bio-nanoparticles.
- Bespark*bio aims to address manufacturing failures in gene therapy, which prevent therapies from reaching the market.
- The company offers process development support to gene therapy companies without internal expertise.
- Bespark*bio adopts a Quality by Design (QBD) approach and uses virtual simulations to model process steps.
- The company’s services include helping companies develop efficient manufacturing processes and identify critical process parameters.
- By assisting companies in early development, Bespark*bio aims to prevent the need for unnecessary experiments and reduce costs.
Conclusion:
Bespark*bio is tackling the problem of manufacturing failures in gene therapy by providing process development support. By helping companies develop efficient manufacturing processes and identify critical process parameters early on, the company aims to prevent production failures and improve the success rate of gene therapy therapies reaching the market. Their approach, which includes a Quality by Design (QBD) methodology and virtual simulations, offers a new and valuable service for gene therapy companies without internal expertise in process development.
