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

41:12 Roche - mRNA capping webinar
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.

5:20 Ensuring The Raw Material Data Package Supports Regulatory Filings
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...

5:48 Navigating Conflicting Raw Material Preferences With Your CDMO
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.

4:29 Reclaiming Control From Your Raw Materials
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...

5:40 Understanding The Real Risk When Using Research-Grade Material For In-Human Testing
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...

4:23 Deciding When Research Grade Raw Materials Are Sufficient
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...

6:52 Balancing Innovation With Manufacturability When GMP-Grade Is Unavailable
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...

4:24 Timing Tech Transfer With Complex Raw Materials
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...

7:15 Building Supply Chain Resilience When Dual-Sourcing Isn't An Option
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...

4:19 Managing Risk With A Platform
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.

54:58 Roche CustomBiotech - EndoCleave webinar
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.

7:03 24_CGL_1920x1080_Seg07
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...

12:25 24_CGL_1920x1080_Seg06
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...

15:48 24_CGL_1920x1080_Seg05
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...

4:22 24_CGL_1920x1080_Seg04
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...

4:29 24_CGL_1920x1080_Seg03
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...

4:23 24_CGL_1920x1080_Seg02
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...

8:41 24_CGL_1920x1080_Seg01
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...

0:25 Roche - Endo
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.

14:08 Cell - QA24_09_cgl_1280x720_seg06
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.

8:04 Cell - mRNA scaling24_09_cgl_1280x720_seg05
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.

4:39 Cell - cold chain24_09_cgl_1280x720_seg04
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.

6:12 Cell - mRNA24_09_cgl_1280x720_seg03
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.

4:57 Cell - Reg24_09_cgl_1280x720_seg02
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.

6:39 24_09_cgl_1280x720_seg01
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.

2:36 CustomBiotech Cedex Family
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

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