High-Quality, Customized Bulk Manufacturing of Cell Culture Media
Our capability to deliver high-quality, customized cell culture media for biopharmaceutical, cell and gene therapy, diagnostics, and life science research applications. A single-media formulation of up to 200 L was manufactured under controlled processes to meet specific customer requirements, ensuring consistent performance and a reliable, repeatable supply. The project was supported by defined formulation control, material traceability, and structured documentation, enabling ongoing use across regulated and non-regulated testing and development environments.
Non-disclosure agreement and service agreement was set up with the client to ensure confidentiality and quality assurance in the proposed project. Stocked solution was provided to us for dilution and subsequent filling of vials.
Our team worked closely with the customer in setting up quality control procedures and requirements. Testing and validation of buffers were performed according to requirements for each lot before and after dispensing.
The product was used in diagnostics and hence requires rigorous testing and traceability for each lot. As an ISO-13485 certified facility, 1st BASE manufacturing maintains a stringent quality management system and full documentation from the preparation log to the quality test report.