ABOUT ROCHE CUSTOMBIOTECH
Biomanufacturing has opened new opportunities in the pharmaceutical industry to address healthcare challenges. The possibilities are endless. The realization of advanced therapies, however, calls for manufacturing that meets stringent quality and regulatory requirements while anticipating risks that can delay or stop production.
Our Roche-quality raw materials are exceptionally well-suited for innovative therapeutic approaches, like mRNA and cell therapies. Starting with products that meet narrow specifications in performance, lot-to-lot consistency, purity and supply is the foundation of robust biomanufacturing.
We complement high-quality content with dedicated tools to monitor, analyze and demonstrate the efficacy and fidelity of manufacturing processes. Our instruments and kits constitute a comprehensive infrastructure to not only meet product release criteria but also ensure maximal production output in a cost and time-efficient manner. Focus on your vision and partner with CustomBiotech to make it a reality.
VIDEOS
Robust And Cost-Effective mRNA Capping
Master the essential strategies for cost-effective and robust mRNA capping at industrial scale. Learn how to successfully evaluate new materials and optimize your synthesis process for maximum efficiency and yield.
A Case Study For Viral Vector Process Impurity Profile: Evaluation Of EndoCleave
Endonucleases are essential for clearing DNA impurities in viral vector manufacturing. Learn how a new enzyme compares to other commercially available options in AAV and LVV production.
Introducing A New GMP-Grade Endonuclease For VV Manufacturing
Explore how a reliable endonuclease, produced under GMP Grade standards, ensures consistent, efficient nucleic acid removal, and supports your regulatory compliance needs.
Solutions For Cell Analysis Metabolite Testing
Learn about a family of instruments that performs precise measurements and enables informed decisions and fast time response.
CONTACT INFORMATION
Roche CustomBiotech
9115 Hague Road
Indianapolis, IN 46250
UNITED STATES
Phone: 1-800-428-5433
Contact: Laura Compton
SOLUTIONS
-
mRNA Raw Materials: Supporting Your Journey To Market
Implementing a quality-by-design approach for manufacturing inputs limits contamination risks and simplifies regulatory compliance. Validated processes ensure consistency when scaling operations.
-
Vaccinia Capping System For mRNA Therapeutics
Backed by over a decade of expertise in capping enzyme production, this system is a robust, scalable solution designed to support production journeys from early R&D to full-scale manufacturing.
-
Propelling Cell And Gene Therapies From Concept To Commercialization
Roche CustomBiotech is committed to advancing cell and gene therapies by offering specialized solutions for manufacturing high-quality cell and gene therapeutics.
-
EndoCleave, An Endonuclease For Viral Vector Manufacturing
Experience the future of viral vector manufacturing with EndoCleave, an innovative endonuclease from Serratia marcescens. It is the smart choice for cost-effective, high-quality viral vector manufacturing.
-
mRNA Raw Materials: A Clear Path To Market
Design your mRNA manufacturing process with the certainty of fit-for-purpose standards for raw materials.
FEATURED INSIGHTS
-
Review the use of a recombinant trypsin in cell culture applications, such as the detachment of adherent cells, in particular with cell lines used in vaccine production.
-
Learn more about the key features of a high-quality recombinant trypsin and how it can benefit your bioprocess with insightful answers to these common questions.
-
Mycoplasma contamination poses a significant risk to biopharmaceutical products and patient safety. See how implementing a rapid NAT-based testing method can enhance efficiency and quality control.
-
For groundbreaking genetic treatments, stringent quality control is non-negotiable. This exploration delves into defining essential attributes and the analytical tools that safeguard their consistent production.
-
Achieving high-quality viral vectors demands rigorous control over contaminants. Learn about enzymatic approaches to significantly reduce nucleic acid impurities in your manufacturing processes.
-
From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
-
While organizations adapt to evolving safety and efficacy standards for mRNA, collaboration remains essential for navigating challenges like differing regional requirements, higher dosing needs, and analytical complexities.
-
Optimizing in vitro transcription (IVT) for mRNA is crucial to improving the stability of these molecules and enabling their large-scale production.
-
Explore antibody development and production, the processes and steps involved, and the screening and selection of antibody candidates.
-
Optimize your mRNA production by identifying an optimum set of conditions for the IVT reaction that produces high-quality mRNA in high yield using a design of experiment (DoE) approach.
-
Learn what some practical considerations are for implementing NAT-based methods, where concrete recommendations are necessary, and how guidelines can remain relevant for new medicinal products.
-
Explore temperature effects on product titer, automated cell culture development workflow, maximizing product life-cycle efficiency with the right DOE strategy, and effective data management.
-
Learn about a solution for streamlining workflow in novel biologics while collecting quality data, by combining single-use microbioreactors with advanced automation and analytical platforms.