PROCESS
ANALYTICS
REGULATORY
No compromise between QUANTITY and QUALITY !
As a leading One-Stop-ATMP-Shop provider, we are committed to meet your specific needs while respecting the regulatory framework in force.
Our teams have a perfect understanding of the complex journey of ATMP development and can quickly identify bottlenecks in each development steps :
Clinical grade Tissue and Cell Sourcing Through a strong partnership with Hospital/Clinic network, we propose a wide range of Good Manufacturing Practices (GMP) grade materials to facilitate your clinical Development.
Process Development From UpStream to DownStream Process Development, we provide tailored solutions to bring robustness, cost-control and time-saving to your process.
Analytical Development Our Quality by Design (QbD) approach defines the framework for cell product production. We pay close attention to the product specification parameters in order to better characterize the manufacturing process and the quality of the final product while respecting regulatory compliance.
Good Manufacturing Practices (GMP) Manufacturing Our experienced Team is working daily in a new state-of-the-art facility authorized by the National Agency for the Safety of Medicines and Health Products (ANSM). We provide services from Technology Transfer to Clinical manufacturing with fully equipped R&D labs, QC labs and Grade-B cleanroom suites to advance ATMPs from lab to market.
Analytics Cell-Easy has strong experience in developing Analytical methods for ATMPs. We perform method development, including GMP-compliant method validation and stability studies.
Our highly skilled Analytical Development team as well as our well-established GMP certified partners enables our customers to access high value-added services for Product development success.
Make the right Analytics decision in a reduced time with our Cellanalytics platform
Fill & Finish From allogeneic to autologous products, we are able to adapt and propose the best solution to meet your specific need.
We offer complete Fill & Finish Services for liquid-formulated drug products :
Regulatory Support The Quality by Design approach used at Cell-Easy corresponds to the requirements of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the submission of Investigational Medicinal Product Dossier (IMPD) or Investigational New Drug (IND) application.
Our qualified Quality Assurance (QA) team supported by a robust Quality Management System (QMS), has all the necessary procedures in place for Cell Bank and Drug Substance batch release and for Drug Product batch certification for use in clinical trials. Our QMS combined to stringent QC procedures allows for complete control and traceability of your ATMP manufacturing process.
Clinical ATMP value chain YOU are a Scientist, a Clinician, a Drug developer company…
YOU make part of the outstanding Advanced Cell & Gene Therapy success value chain !
Whoever you are, Cell-Easy is the perfect CDMO committed to support you in your success and to be the missing link between each of you.
Our fast-growing network will be your next key success factor.
