European Biomanufacturing Summit 2022

We hope you enjoyed the European Biomanufacturing Summit 2022 virtual event where our subject matter experts provided key insights on how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan.

How to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules
  • Preparing your organization to enter the clinical trial stage of your molecule’s development
  • Developing knowledge of critical quality attributes to justify the manufacturing and control strategy
  • Establishing a dossier to support chemistry, manufacturing, and controls (CMC)
  • Providing health authorities with the information to assess the quality of material entering the clinical trial
  • Avoiding delays caused by inadequate CMC supportive evidence or detail
  • Planning for continuing development and considering scientific advice on path to approval
Michele Duggan
Senior Manager, Regulatory Affairs, Thermo Fisher Scientific

Michelle Duggan
Daniela Decina
Senior Director, Regulatory Affairs, Thermo Fisher Scientific

Daniela Decina

Should we have missed out on connecting at European Biomanufacturing Summit 2022, reach out to us to find out more about how we help pharma and new and emerging biotech companies turn pharmaceutical possibilities into realities and get to market faster.

Request a meeting

Please fill out the form below or press submit if you're a return visitor to our site.