Quality & Documentation
Our cell culture media, sera, and reagents are manufactured by qualified partners operating under ISO-aligned quality management systems. We supply documentation on request and work with customers application by application.
Manufacturing
Our manufacturing partners run quality management systems aligned with ISO 9001 (general quality), ISO 13485 (medical devices and cell culture for clinical use), ISO 45001 (occupational health and safety), and ISO 14001 (environmental management). Specific certifications applicable to a given product or production run are documented on the Certificate of Analysis.
Documentation we provide
- Certificate of Analysis (CoA) — lot-specific quality parameters including pH, osmolality, endotoxin level, sterility, and (where relevant) cell-growth performance.
- Material Safety Data Sheet (MSDS) — for hazard identification, transport, and storage.
- Formulation summary — qualitative composition for media and supplements.
- Stability data — for products with formal stability studies on file.
- Animal-origin statements — for serum products and animal-component-free (ADCF) media.
Quality testing
Production lots are tested for the standard cell-culture quality parameters relevant to the product type:
- Sterility — by membrane filtration where applicable.
- Endotoxin — typically ≤1 EU/mL for cell-culture media; tighter limits available on request.
- pH and osmolality — verified to product-specific ranges.
- Cell-growth performance — qualified for the target cell line where the product is workflow-specific.
- Mycoplasma — verified absent in production lots and source materials where applicable.
Regulatory context
Most of our catalog is supplied for research use. Where customers require GMP, cGMP, or clinical-grade material — including for cell and gene therapy programs — we work with our manufacturing partners to route through the appropriate quality channel and supply the documentation that programs need (GMP Quality Manual reference, lot-specific GMP CoA, change-control history, etc.). Contact info@cellculturemedia.bio with your specific regulatory requirements and we will confirm what is available.
Custom and contract work
For custom formulations and contract manufacturing, the quality framework is set on a per-program basis — including specifications, change controls, and qualification studies. Custom programs typically start with a brief on the custom media page.
Need a CoA, MSDS, or quality dossier?
Email us with the SKU and we will share the relevant documentation within one business day.
Email our team