Cell and gene therapies are transforming how patients with cancer and genetic diseases are treated. Although the therapeutic opportunities for patients are promising, the stakes for drug developers are high. Companies wishing to scale up the manufacture of cell and gene therapies from translational testing to clinical trials must address complex challenges and begin integrating GMP solutions for cell and gene therapy.
Traditionally GMP solutions for cell and gene therapy are not implemented until later in the process, however the use of research grade materials in the transitional phase may lead to invalidated experiments, new filings being needed, and more back and forth with regulatory agencies to defend decisions made earlier on, right at the finish line.
At Lonza, we know the stakes are high for cell and gene therapy developers, and time-to-market is critical. That’s why greater process efficiency, solid regulatory expertise, and having future scale-up in mind are vital. To maximize your chance of success, we’ve crafted a series of GMP solutions for cell and gene therapy based on these core principles. Using TheraPEAK® Products you can better plan the development of your therapy, from discovery right through to commercialization.
