Platinum Sponsor
Roche CustomBiotech
The CustomBiotech 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.
Associated Experts
Job Title: International Product Manager
Job Title: Lead Technical Support Consultant
Associated Content
Rapid Qualification Strategy of a Real-Time PCR Mycoplasma Detection Kit for an MSC-based Cell Therapy
Despite the forward progress, a stumbling point for cell and gene therapies has been that the condensed clinical development timelines, complex manufacturing processes, short shelf-life of the products, and supply chain challenges make it difficult for developers to ensure timely testing of quality and safety attributes....Continued
Qualification of a Rapid In-house PCR-based Mycoplasma Assay for Screening of Cell Therapy Products
I was fortunate to be able to interview Lisa Dreolini, Research Assistant in the Holt Lab at Canada’s Michael Smith Genome Sciences Centre (GSC) in Vancouver and lead author of the study. We discussed the qualification process and she provided information for others who are interested in following a similar approach....Continued
Rapid Mycoplasma Testing for Biologics – Frequently Asked Questions
Cell and gene therapies are poised to revolutionize healthcare, however manufacturing of these products poses new challenges for quality and safety assurance strategies. This is especially true in testing for mycoplasmas, an ubiquitous and practically ... Continued
Qualifying a rapid qPCR mycoplasma test approved for CAR-T clinical studies
Like other biologics, most cell therapy products require microbial testing including, mycoplasma, sterility, and endotoxin analysis as part of the final product release criteria. However, cell therapy products have unique QC product release requirements that ... Continued
Rapid Mycoplasma Testing for Biomanufacturing Applications
Increasingly the quality of raw materials used in cell culture media and supplements is being closely examined for any potential negative impact on cell culture or the final product quality. One area of concern is ... Continued
Real-time Mycoplasma Contamination Detection for Biomanufacturing
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 ... Continued
Glycosylation Overview and How to Control Glycosylation using In Vitro Glycoengineering
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, ... Continued
Automated Collection and Analysis of Bioreactor Samples to Enable Quality by Design Initiatives
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 ... Continued
Real Time IgG Titer Measurement Enables PAT (Process Analytical Technology) Implementation
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 ... Continued
Measuring IgG Titer: Need for Real-Time Results, Customization and High Comparability to HPLC
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 ... Continued
Cedex Bioprocess Analyzers for Vaccine Manufacturing
The 8th Annual Vaccine Industry Excellence (ViE) Awards took place earlier this month at the World Vaccine Congress. Awards were given to recognize those who have “done outstanding work in the field, honor those who ... Continued