As more cellular treatments are approved, the vital function of quality will only grow in importance. Cellular Life Solutions is dedicated to providing scientists and physicians around the world with the highest-quality of goods and services. Customers can expect Cellular Life Solutions to update its processes, products, and services on a frequent basis to sustain their needs as well as regulatory obligations. Cellular Life Solutions' goal is to produce the best starter material possible so that cell treatments can continue to grow in popularity and benefit patients.
Quality Assurance Programs
The success of cell and gene-based therapies is dependent on the quality and uniformity of the starting material. To ensure that consumers receive consistent, high-quality products, Cellular Life Solutions runs thorough validation programs of its facilities, equipment, and processes. The quality system of Cellular Life Solutions is based on stringent regulatory standards as well as industry best practices. Cellular Life Solutions' quality system adheres to current Good Manufacturing Practices (GMP) criteria, which include the following:
- Donors must be eligible.
- Vendor, equipment, and supply qualification.
- Equipment, supplies, and the environment are all being continuous monitoring.
- Procedure development, validation, and upkeep.
- Extensive staff certification and training.
- Documents and records management.
- Deviation management.
- Inspections internal and external.
- Leukopaks, mononuclear cells (MNCs) and/or hematopoietic stem cells (HPC) from stimulated donors are collected of under IRB-approved protocol.
- FDA-approved equipment.
- Leukoreduction System (LRS) Chambers.