A Guide to Integrating QbD in Gene Therapy CMC Programs

A Guide to Integrating QbD in Gene Therapy CMC Programs

Cell and gene therapies have a potential, unlike anything we’ve ever seen before in medicine. With the power to deliver curative relief to patients suffering from debilitating conditions — many of which have no treatment options — the cell and gene therapy field...
The Bustling Cell and Gene Therapy CMO Scene

The Bustling Cell and Gene Therapy CMO Scene

Pharma’s new and exciting era of targeted therapeutics has the potential to be a turning point for modern medicine. The buzz has led to a flurry of investment in the cell and gene therapy space. According to a recent Alliance for Regenerative Medicine report, nearly...
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...