Viral Clearance Studies for Gene Therapies—Easier Said Than Done

Viral Clearance Studies for Gene Therapies—Easier Said Than Done

While incidents of biotherapeutic viral contamination have occurred, due to well-established knowledge of the potential sources of contamination and procedures to prevent it, the industry has an impressive track record. Biologics are susceptible to viral contamination...
Gene Therapy CMC & Manufacturing Approaches Are Maturing

Gene Therapy CMC & Manufacturing Approaches Are Maturing

The gene therapy sector is maturing and the industry is poised to be able to produce products in more consistent and scalable ways. Although the COVID-19 pandemic caused some delays, on the whole, projects are moving forward as planned. I had the opportunity to speak...