Cell Therapy Development (Process & Analytical)
We know that you are not only interested in starting your regulatory journey quickly, but also in building a solid foundation for your program to weather the maturing regulatory framework of cell therapy.
Our process and analytical development teams are ready to support the technology transfer of pre-clinical, early or late phase programs and will collaborate with you to establish phase-appropriate solutions to expedite your path to patients.
Where We Can Help
Our experienced process and analytical scientists initiate every technology transfer with facility fit and gap analyses to understand your program’s history and current state.
We work with you to map out how to reach your clinical and commercial goals. With the work identified, tech transfer and establishment runs can begin to generate material for your analytical development needs and for pre-clinical studies. Along the way, a dedicated process engineer will work side-by-side with you to ensure a seamless transition from the PD labs into the GMP facility.
Alongside PD, our method transfer scientists will be working with the analytical team to design the protocols needed for uninterrupted transition into our QC laboratories.
Services
This is the first step in understanding your goals for your program and where your product will be used. Our teams leverage a robust package of standardized data collection forms, risk assessment tools, history mapping and phase-appropriate spreadsheets to collaborate with you and ensure no stone is left unturned.
Whether your program is barely past a concept and needs full development services to bring it to life, or a process is established but needs to be updated to meet evolving regulatory guidance, our experienced scientists have created a toolbox of solution options to expedite your journey from lab to GMP cleanroom.
By leveraging automated and closed solutions, our teams can accelerate your program enhancement by capitalizing on our preferred unit operations platform solutions. No matter your program’s clinical phase, get ahead of the regulations and ensure your program is robust, reliable and available for your patients by taking early steps to future-proof your program.
Working side-by-side with the Process Development team, method development starts with a critical assessment of your program, the analytical plan and key process parameters and characteristics. From there, we create a bespoke method plan, and create methods from scratch or modify from our platform method offerings.
If you or your partners have done the work and established your methods, our experienced method transfer team will design a transfer protocol and work closely with the transferring lab to ensure a compliant, seamless transition to our cGMP QC labs.
When your product has progressed and made it to the point of process performance qualification (PPQ) planning and your methods are ready to be validated, leverage our experience to make the last leg of your regulatory journey feel effortless. Our QC labs have experience with cell culture and analytical assay validation for cell therapy programs as well as compendial method verification.
