Benchmark Standards & Regulatory Expectations to Confidently Characterise Function, Quality & Potency to Fast-Track Clinical Translation
Join Your Analytical Community in London in 2022!
The inaugural Cell Therapy Analytical Development Summit Europe is the leading industry-defining forum in Europe made exclusively for analytical, CMC, QC, process development and regulatory experts.
Next generation cell therapies are emerging as game changing treatments for cancer and beyond, but given their increasing complexities, developing robust, reliable, and in-depth analytical assays is critical to prove their safety and quality to the regulatory authorities.
This year we have unrivalled content showcasing:
- Efforts to harmonise reference standards for state-of-the-art analytical development
- Regulatory experience case studies to hit guidelines and avoid pushback
- Strategies to develop a successful potency assay to determine product activity
- Process transfers demonstrating analytical robustness and product comparability
- New technology to expand and improve your analytical toolbox
- Development and validation of analytical methods to fulfil GMP guidelines
- Best methods to approach final product characterisation by starting with the end in mind
- Automated technologies for improved accuracy, repeatability and speed
… To provide your team with the lessons learned to achieve success in analytical submissions from IMPD/IND through to the clinic and beyond.
Data and learnings will be shared from key European biopharma stakeholders including Cellectis, Gadeta, GSK, and Sanofi and more to support your efforts in developing efficacious, potent and safe cell therapies. Unite with these companies and more this August to fast-track your pipeline into the clinic and beyond.
Testimonials from the 2021 U.S. Event:
“This is a fantastic get-together for analytical, CMC, QC, and process development experts”
Manager, Bristol Myers Squibb
“It was a great opportunity to meet others from the industry and learn about
current practices and challenges in the field”
Principal Scientist, Atara Biotherapeutics
“Great exposure to state of the art knowledge”
CMC Regulatory & Operations Manager, APEIRON Biologics
“It was a valuable and informative conference with relevant topics, speakers, and attendees”
Global Key Account Director, BD Biosciences
2022’s World Class Speaker Faculty Includes
Executive Director, Process & Analytical Development
Vice President, Quality (IL) & Global Regulatory Affairs
Senior Stem Cell Biologist, Head of Cell Therapy
UK Stem Cell Bank, NIBSC
Vice President of Development
Head of Analytical Development, Bioanalytics Genomic Medicine