
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

Opening Possibilities In Glycosylation
Achieving desired glycosylation for therapeutic proteins can be difficult. Explore innovative approaches to optimize this critical quality attribute.

Optimization Of Glycosylation
Optimize your therapeutic protein's glycan profile. Learn about a straightforward, enzymatic approach to gain greater control over this critical quality attribute.

IVGE Scale-Up And Value
Achieve precise, optimal glycan structures without sacrificing vital protein output. Explore a scalable technique to improve therapeutic quality and significantly shorten your production timelines.

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 EndoCleave, 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
-
Discover In Vitro Glycoengineering
Variations in glycosylation can impact your therapeutic protein's safety and efficacy. Take control of this critical quality attribute with in vitro glycoengineering for predictable outcomes.
-
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.
-
Powering Excellence In Your Development And Manufacturing Process
Streamline your biologics workflow, from initial development to final manufacturing, with comprehensive and high-quality solutions for consistency and efficiency.
-
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
-
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.
-
Discover how to gain precise control over one of the most common and critical forms of protein modification for therapeutic benefit and stability.
-
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.