The Custom Biotech division of Roche Diagnostics offers a range of innovative products and services for the biopharmaceutical and cell therapy markets, customizable to meet your unique quality and regulatory needs. Some specific product categories include research and GMP enzymes for cell isolation and passaging, high resolution automated cell culture analysis system, photometric-based instrumentation for monitoring nutrients and metabolites relevant to cell culture processing and cell health, and mycoplasma test methods for in-process and product release quality assurance. With our extensive industry experience and strong customer orientation, Custom Biotech is committed to helping you achieve success across all stages of the development process.
Biomanufacturing contamination due to Mycoplasma is a very real concern, as it poses a potential health risk for patients. As such, regulatory agencies require biopharmaceutical companies to test for the presence of mycoplasma both during the manufacturing process and in ... Continued
Introduction Glycosylation is the most common type of post translational protein modification. It is also an important factor in manufacturing therapeutic proteins, depending on the mode of action, because it can impact protein stability, biological activity, and the pharmacokinetics of the ... Continued
Cell therapies offer much promise in treating a range of medical conditions, but manufacturing complexity is a challenge when scaling up to clinical and commercial manufacturing. Concerns include developing a process that is efficient and cost effective with consistent, high ... Continued
Automated Collection and Analysis of Bioreactor Samples by Integration of the Seg-Flow Autosampler with the Cedex Bio HT and HiRes Analyzers As biomanufacturing processes become increasingly complex, the FDA has stressed the importance of their Quality by Design (QbD) and ... Continued
We recently finished our Ask the Expert discussion on “Measuring IgG Titer: Need for Real-Time Results, Customization and High Comparability to HPLC.” During this Ask the Expert session, we discussed strategies for at line IgG titer measurement, comparison of this method ... Continued
Introduction The successful implementation of PAT (process analytical technology) involves analysis and monitoring of key attributes within the bioprocess. When measuring critical process parameters, such as IgG titer, the need for high quality data AND real-time access are very important. While ... Continued