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CellGenix® GMP Quality

SAFETY

Although GMP grade raw materials are not intended to be part of the final cell therapy product, they do come into contact during manufacturing and could, therefore, have an influence on the safety of the final drug product.

To ensure the safety of your cell therapy product we offer:

• Raw material and supplier control and traceability for all our production materials
• Animal-derived component-free and serum-free products (ADCF and serum-free policy)
• Dedicated animal-free GMP facility
• The use of fully traceable and well-characterized master cell banks
• Low endotoxin and host-cell protein levels

Endotoxins can have profound effects on cell viability as well as cellular behavior and functions. This is especially the case for T cells. To make sure endotoxin levels do not influence the safety and reproducibility of your cell therapy product, we offer extremely low endotoxin levels for our CellGenix® GMP cytokines.

GMP COMPLIANCE

Our GMP grade raw materials are manufactured following all applicable GMP guidelines to provide documented evidence of purity, potency, consistency, and stability.

We offer the highest GMP quality standard:

• ISO cleanrooms for the entire production process and automatic filling equipment
• Raw material documentation and traceability
• Manufacturing and QC according to SOPs
• Qualified and trained personnel
• Validated and consistent processes (manufacturing, cleaning, QC methods)
• Monitoring of product quality by in-process controls (IPC)
• Product release according to pre-defined specifications by an authorized person
• Stability program

Quality assurance performs internal quality audits on a regular basis. We in addition audit our suppliers for critical components prior to allowing these products to be used in our manufacturing process.

We have a continuous improvement process in place in which we closely monitor the complete manufacturing process up to final product performance and feedback from the market. Corresponding corrective and preventative action (CAPA) programs are executed.

REGULATORY COMPLIANCE & SUPPORT

To obtain a market authorization for your cell therapy product it is crucial that your GMP-grade raw materials are compliant with international guidelines and local requirements.

Our products are compliant to:

USP <1043>, USP <92>, Ph. Eur. General Chapter 5.2.12 and ISO Technical Standard 20399 (part 1, part 2, part 3), as applicable
• ISO 9001:2015 certified quality management (QM) system
• Manufacturing in compliance with relevant GMP guidelines
• Change control process, OOS procedure, deviation process, etc. are in place

Our QM system is constantly improved and regularly inspected by a certified body. In addition, audits are conducted by customers on a regular basis.

We offer the following regulatory support on GMP grade raw materials:

• Auditing of our production site upon request
• Drug Master Files for cross-reference (USA and Japan only)
• TSE Certificates (upon request)
• Change notifications prior to relevant changes (with or w/o QM agreement)
• On-demand, customized documentation for regional authorities