Sartorius AG services

For more than 25 years, Albumedix has manufactured the highest-quality recombinant human albumins available?from our commercial-scale manufacturing?facility,?operating at ICH Q7 GMP standards. Certified by the MHRA, as well as having been inspected by?other world-leading authorities, it`s safe to say we know a thing or two about upholding high quality and regulatory standards. Through our proven systems and processes, our QC, QA and validation experts are available to lessen your quality and analytical challenges by providing assistance with:

For more than three decades, Albumedix has pioneered albumin science, enabling us to experience a multitude of possibilities and benefits that albumin can provide. Simultaneously, we have learned a lot about the characterization challenges that working with and implementing  protein-based solutions can present. Are you spending valuable time developing assays to account for albumin interaction? If so, we can help! Using our extensive experience in modulating albumin to optimize performance, our technical team can work side by side with you to develop robust and reliable methods tailored to suit your application.

Navigating the complex and ever-evolving regulatory landscape can be difficult. As `time to market` continues to be a challenge across the life science industry, in-depth knowledge and strategic oversight into the regulatory realm is becoming an increasingly important consideration.

Service offering that ensure optimal performance of your equipment and reducing potential downtime. Accurate and reliable results, while protecting your investment. Customized service contracts available.

Whether you are just starting to set up a cell culture lab, experiencing process limitations, seeing batch-to-batch variations of your current medium/process or having troubles in your scale-up – we are your trusted partner for scientific consulting. With years of experience in cell culture technologies, medium development and medium production in liquid and powder form we deliver rapid and targeted support to your challenges.

Lot-to-lot variation is a well-known effect in media production and can occur even in chemically defined media. It can be caused e.g. by change of raw materials, minor changes in the powder production process or the solubilization procedure. Furthermore, lot-to-lot variation can occur due to impurities in raw materials. Components such as amino acids in USP/pharma grade with ≥ 98-99% purity may still contain foreign amino acids and trace metals. To evaluate variation in your media lots, we highly recommend biological performance tests and respective analytics. For that, we can establish and perform routine lot testing.

We are happy to help if you lack the capacities, expertise, certified conditions or the corresponding equipment to manufacture your product. Together with you, we will find an optimal solution for your needs and offer fast services and delivery times.

Xell offers targeted, rapid and efficient services for the development of custom cell culture medium and feed and is your ideal partner to find solutions that meet your cell line’s individual needs. Depending on the application and in close collaboration with you, we carefully choose individual target values for process performance. Following a streamlined workflow, we combine powerful spent media analysis with intelligent DoE and process simulations in order to reach your objectives in the most efficient way. Cell lines for development include e.g. CHO, HEK, Hybridoma and BHK while targets comprise protein production, transfection, vaccine, production and AAV / lentivirus production or gene therapy applications.

Process development such as feed strategy optimization can take up a lot of time and resources. With our long-standing experience in cell culture technologies and medium development we can provide process development services including: Development/optimization of a feeding strategy. Metabolic optimization of feeding. Optimization of seed trains and handling procedures. Parameter profiles, e.g. pH, temperature, DO. Development/optimization of perfusion processes.

Cell culture medium and feed selection typically involves screening and benchmarking of alternative off-the-shelf culture media from several suppliers. With our long-standing experience in cell culture technologies and medium development we can provide expertise and resources for these routine studies. We will include any chemically defined media of your choice and are not limited to media produced by Xell.