Navigating the Regulatory Terrain during Cell & Gene Therapy Production

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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. Many companies have begun to ramp up production timelines, so as to meet patients’ needs, while still producing efficacious and safe cell and gene therapy materials. However, many biomanufacturers 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 MilliporeSigma 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
MilliporeSigma

Manjula Aysola
Senior Regulatory Consultant
MilliporeSigma

 

 

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