Service
Regulatory agencies worldwide require a continuous and well-controlled supply of the specific cell lineage utilized in your manufacturing process. WuXi Advanced Therapies’ team of experienced cell culture and bioanalytical specialists will manufacture your bank and provide all the analytical support and documentation required to release it under industry recognized quality assurance standards.
Tell us about your Cell Banking needs
Our team has successfully manufactured, characterized, and released dozens of cell banks.
Our team has manufactured and released dozens of cell banks across a wide variety of cell types for products in all phases of production from pre-IND to commercial.
We will help you demonstrate and document recovery viability, growth, biosafety and genetic characterization and provide a QA-approved Certificate of Analysis (COA).
Whether you need research, working, master or end of production cell banks, we can provide the guidance, manufacturing and testing support you need to meet regulatory guidelines.
Our team can work with you as needed to verify and optimize your cell growth and expansion plan and scale to produce anywhere from 10-1,200 vials.
We can manufacture, test and characterize your cell banks at the same site, with all activities managed by a single project manager.
You will have the opportunity to leverage pre-existing batch records for your cell bank. By leveraging our batch records, you can shave weeks off your production timeline and capitalize on GMP ready documentation that has already been proven to result in successful production.
You will have the opportunity to leverage pre-existing batch records for your cell bank. By leveraging our batch records, you can shave weeks off your production timeline and capitalize on GMP ready documentation that has already been proven to result in successful production.
WuXi Advanced Therapies combines industry leading bioanalytical testing services with on-site manufacturing. All services are performed at our campus in Philadelphia, Pennsylvania. Our team will manufacture your bank and test for recovery viability, growth, biosafety and genetic characterization.
Our quality systems have been audited by numerous clients and the US FDA. We have supported more than 30 advanced therapy IND and BLA approvals and released dozens of cell banks. We also employ stringent raw materials release programs, thorough seed stock contamination acceptance screening and validated change-over and cleaning procedures.
Our team has experience using a variety of cell culture platforms including:
Your cell bank(s) will be produced and tested under a single work order, saving you time and effort in contracting. You will also be assigned a single project manager who will coordinate all activities related to both manufacturing and testing, saving you time and reducing risks related to communication issues.
Our team has experience with a wide array of cell lines ranging from mammalian to canine and more.
Embryo
Ovary (CHO)
Kidney (MDCK)