The success of cell and gene therapy products in recent years to treat a host of complex diseases has made production that much more critical. As such, many companies have begun to utilize contract development and manufacturing organizations (CDMOs) to help them successfully create efficacious and safe cell and gene therapy materials. However, many CDMOs have found themselves in a bit of a quandary: How do we traverse the turbulent regulatory waters governing the production of these novel products? Moreover, how has the COVID-19 pandemic affected the regulatory process? Thankfully, the experienced team at Merck has surveyed the landscape and can offer some insight into these critical issues. In this GENcast, we chatted with two team members and picked their brains about some of the challenges currently facing manufacturers in this space. Listen in and hear what they have to say… 

 

Panelists:

Natika Calhoun 
Senior Regulatory Consultant 
Merck

Manjula Aysola 
Senior Regulatory Consultant 
Merck

 

 

The post Navigating the Regulatory Terrain for CDMO’s during Cell & Gene Therapy Production appeared first on GEN – Genetic Engineering and Biotechnology News.

Source