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.
Ensuring The Raw Material Data Package Supports Regulatory Filings
The license holder is responsible for data reliability — full stop. Sponsors have two levers to manage that with their CDMOs: the quality agreement and auditing, Lawrence Thompson says in this segment of Cell & Gene Live "Viability On The Line." Your c...
Navigating Conflicting Raw Material Preferences With Your CDMO
Choosing raw materials is both a scientific and a business decision. In a perfect world, you as the sponsor and your CDMO would agree on raw material fitness based on the data. But cost and availability are important factors, too.
Reclaiming Control From Your Raw Materials
The high cost of GMP-grade materials and testing threaten to cripple biotechs and academic labs. Understanding your purpose is the first part of reclaiming control of your product and process. If you want to publish papers, research-grade material should be sufficient fro...
Understanding The Real Risk When Using Research-Grade Material For In-Human Testing
When it comes to putting medicine made with research-grade raw materials into people, experts say: proceed with extreme caution. "There are a lot less controls than you think," says Lawrence Thompson in this segment of Cell & Gene Live "Viability On The...
Deciding When Research Grade Raw Materials Are Sufficient
Qualifying raw materials is an investment, but mimicking the manufacturing process at small scales lowers the risk of throwing out material because it doesn't work at large ones, Lawrence Thompson said during this segment of Cell & Gene Live "Viability On The...
Balancing Innovation With Manufacturability When GMP-Grade Is Unavailable
Some raw materials simply aren't available in GMP. Experts Yan Zhi and Lawrence Thompson describe risk assessment approaches that inform sourcing decisions in this segment from Cell & Gene Live "Viability On The Line." Some investigational therapies requ...
Timing Tech Transfer With Complex Raw Materials
Tech transfer complexity depends on product maturity, but don't assume a straightforward experience just because you have market approval and a commercial product. In fact, the risk is often greater. When outsourcing drug product manufacturing to scale up for clinical...
Building Supply Chain Resilience When Dual-Sourcing Isn't An Option
Crafting a resilient supply chain, one where redundancy is out of the question, is easier said than done. Robust communication with suppliers helps ensure mutual understanding of needs. Preventing waste is a no-brainer but challenging to execute. Thoroughly characterizing...
Managing Risk With A Platform
Once your quality team has defined your priority risks, a platform designation can help whip them into submission. Building a platform alongside novel drug development gives you a template rooted in prior knowledge to control risks for subsequent products.
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.
Unlocking The Full Potential Of AAV-Mediated Gene Delivery | Audience Q&A
In this final segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO addressed audience questions on re-admi...
Addressing Regulatory Challenges Associated With AAVs
In this segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO, the panelists cover the regulatory landscape...
Key Considerations In Safety Monitoring And Manufacturing For AAV Vector Production
In this segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO, the panelists address key safety considerati...
Clinical Development Strategies And Prioritization For AAVs
In this segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO, the panelists discuss the overall clinical d...
Emerging Technologies In AAV Vector Design And CNS Delivery
In this segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO, the panelists discuss promising emerging tec...
Addressing Preexisting Immunity And Expanding To Common Diseases
This segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO addresses strategies for dealing with the challe...
Critical Factors For Early Phase Clinical Trials, Dose Selection, And AAV Capsid Engineering
In this first segment of the Cell & Gene Live, Unlocking the Full Potential of AAV-Mediated Gene Delivery, David Dismuke, Ph.D., Chief Technical Officer, Forge Biologics and Nina Hunter, Ph.D., VP Corporate Strategy at REGENXBIO address the most critical factors to co...
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.
Audience Q&A | From Bottleneck To Breakthrough: Reimagining The mRNA Therapeutics Supply Chain
During every Cell & Gene Live, our expert panelists provide actionable responses to real-time questions from the audience. Here, panelists share information on categorizing raw materials, linear DNA, the future of the mRNA supply chain, and more.
Tips For Scaling mRNA Therapeutics
In this segment, Joseph Barberio of Strand Therapeutics and Christian Moreno of Nutcracker Therapeutics share their insight on what’s needed to achieve success in scaling mRNA therapeutics.
Is Cold Chain Really A Challenge Facing mRNA Therapeutics?
mRNA product storage can be challenging due to extremely low temperature requirements. Here, Joseph Barberio of Strand Therapeutics and Christian Moreno of Nutcracker Therapeutics share their take on existing cold chain challenges.
Tackling The Standardization Issue For mRNA Therapeutics
This segment features a discussion around the obstacles to establishing a standardized production pipeline for mRNA therapeutics across the industry as well as some the approaches being considered to standardize cold chain management protocols for mRNA products.
Regulatory Considerations For The mRNA Platform
Joseph Barberio of Strand Therapeutics and Christian Moreno of Nutcracker Therapeutics share how their companies ensure data integrity and privacy compliance throughout R&D and manufacturing.
Top Bottlenecks Facing mRNA Supply Chain
In this first segment from Cell & Gene Live, we explore the state of the mRNA therapeutics supply chain and the major bottlenecks that exist today, including non-GMP grade reagents to sourcing DNA.
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
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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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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Achieving high-quality viral vectors demands rigorous control over contaminants. Learn about enzymatic approaches to significantly reduce nucleic acid impurities in your manufacturing processes.
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From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
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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.
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Optimizing in vitro transcription (IVT) for mRNA is crucial to improving the stability of these molecules and enabling their large-scale production.
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Explore antibody development and production, the processes and steps involved, and the screening and selection of antibody candidates.
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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.
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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.
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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.
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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.