Standard testing on finished cell culture media, buffers and reagents products includes tests for sterility, osmolality, pH, endotoxin content and growth promotion or toxicity. Our broad capabilities ensure that we can deliver the quantity and quality liquid solutions that our clients need, on time and in cost-effective packaging.
For serum-free media, we have segregated NAO manufacturing sites in completely controlled and monitored class 10,000, 1,000 and class 100 environments. The formulations support high-density culture without the use of animal-derived components. Only NAO components are used to facilitate regulatory compliance. In this way, you can eliminate the risk of adventitious agents, pathogens, immunoglobulins and pyrogens that may be introduced in serum-supplemented media. Within our serum-free media line, our Pro-Series and Power-Series protein-free media offer unparalleled performance by promoting scalability of bioprocesses, and facilitate downstream purification as no other protein than the one of interest is present in the supernatant. Power-Series are chemically defined formulations for high batch-to-batch consistency.
For our client's more specialized needs, their cell culture media, buffers or reagents formulations and specifications are reviewed by our Project management team experts, who will liaise with production planning, process engineering, manufacturing, purchasing, quality assurance and regulatory affairs departments. This enables us to develop a material procurement and production plan that ensures the final product meets our client's requirements.
Our dedicated BPC packaging area offers the ultimate quality control in custom and standard packaging options. With our sophisticated liquid manufacturing processes and proven methods of closed-system filling, our clients get high quality media in the most flexible and cost-effected configuration. We can custom design and construct a filled or unfilled delivery system to your exact specifications. So whether our clients need cell culture media or a packaging system, Sartorius has the safe, reliable total solution.
In the rapidly changing Biotechnology field, new process and procedures are developing that require the packaging of sterile liquid cell culture media and reagents, in bulk, flexible, single-use container systems. Sartorius-Stedim Bioprocess Containers are designed as single-use containers for packaging of tissue culture media, reagents and buffers, as well as containment and storage vessel for final product yielded from downstream manufacturing processes. We provide standard and custom systems that are: