ABOUT ROCHE CUSTOMBIOTECH
From vaccines and immunotherapies to protein replacement and cell reprogramming, interest in mRNA manufacturing has surged. Decades before the pandemic, Roche CustomBiotech has supplied nucleotides and enzymes for mRNA production. We work with many pioneering mRNA companies to develop and manufacture needed raw material solutions. In collaboration with therapeutic manufacturers, our portfolio has evolved to meet the changing needs of the mRNA field. Always abreast with market developments, Roche CustomBiotech enables a new generation of mRNA therapeutics. Our guiding tenet is to minimize variation of products built on our raw materials by ensuring best quality, high performance within narrow tolerances, and reliable delivery.
Remaining at the front of this fast-paced therapeutic space hinges not only on ideas and implementation, but also on speed and quality. Your expertise is coming up with the idea and the implementation; as a long-standing global supplier, Roche CustomBiotech’s expertise in raw materials can help you accelerate development and ensure high quality mRNA. We help you strengthen your supply chain, ease transfers to manufacturing, secure continuous production, and create consistently high-quality products.
VIDEOS
Designing Effective Multivalent mRNA Therapies: Key Regulatory Considerations
How many mRNAs are too many in a multivalent therapy? In this clip, Eliquent Life Science’s Tiffany Lucas and CureVac’s Ulrike Jägle delve into this question, emphasizing the factors that are essential for regulatory success and patient benefit.
AI, Antigen Selection, & Agile Regulation: A Long Road Ahead
Navigating antigen selection for personalized mRNA cancer immunotherapies is a major challenge for industry and regulators. In this clip, CureVac’s Ulrike Jägle articulates why the integration of AI/ML into clinical development presents a significant and ongoin...
Decoding Regulatory Expectations: The Art Of A Successful IND Submission
Companies often underestimate the information required for IND submissions, particularly in a sector that’s as diverse as the mRNA sector. Here, former FDA reviewer Tiffany Lucas shares some of the missteps companies can make when first approaching the FDA with thei...
What The EMA Guidance Means For mRNA: Progress, Limitations, And Future Directions
Advancing RNA panelists Tiffany Lucas and Ulrike Jägle home in on the EMA’s guidance for mRNA vaccine quality, sharing their initial thoughts on the guidance’s strengths, while also addressing its limitations for those of us who may be working wi...
Proactive Partnerships: Engaging FDA And EMA During mRNA Process Development
Panelists Tiffany Lucas and Ulrike Jägle address an audience question about when and how to approach the regulatory agencies for mRNA process development. In addition to listing the different FDA and EMA meeting opportunities available to sponsors, Jägle reminds...
Regulatory Crossroads: Navigating Recent Shifts At The FDA
At the start of the latest Advancing RNA panel discussion, expert Tiffany Lucas outlines the biggest changes happening at the FDA and speculates on how these shifts may impact CBER’s ongoing work in the ATMP/mRNA space.
Breaking New Ground: MHRA Embraces A Future With Patient-Specific mRNA
In this Advancing RNA clip, panelists Ulrike Jägle and Tiffany Lucas unpack the benefits they see to the MHRA's new guidance on mRNA cancer immunotherapies, including the agency’s support for bioinformatics approaches and its burgeoning framework f...
Bioinformatics In mRNA Development: Classification And Integration Conundrums
As both Advancing RNA Live speakers point out in this segment, the MHRA guidance focuses deeply on the critical role bioinformatics and AI/ML approaches will play in the development of personalized immunotherapies. Here, Eliquent Life Sciences’ Tiffany Luca...
Goldilocks & The Guidances: Finding "Just Right" For RNA Regulations
Do we need more specific regulatory guidance for every RNA modality and therapeutic approach? We asked and the Advancing RNA Live audience answered… Here, panelists Tiffany Lucas and Ulrike Jägle address the audience’s responses, as well as shar...
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.
Don't Forget These Important Points When Selecting An RNA CDMO
Together, Omega’s Jeff Atkinson & Sail Biomedicines’ Jim Nolan share their perspectives on the health of the linear mRNA and circRNA outsourcing sector.
How Can Sponsors & CDMOs Collaborate On RNA Analytical/Process Development?
Having worked on both the innovator and CDMO sides of the industry, Advancing RNA LIVE panelist Khaled Yamout outlines where he sees the greatest weaknesses in these critical sponsor-CDMO partnerships and offers guidance.
The "Golden Idea Of The Platform" & Its Role In mRNA PD
Explore how early-stage companies can implement design space and analytical principles that will help us determine the biggest differences between constructs and how close we may be to a true “platform process.”
Is QbD Actually Possible In mRNA Development Today?
As the panelists of this Advancing RNA LIVE discussion argue, there are several big limitations we face in implementing QBD today for RNA development.
A Double-Edged Sword? Defining "Efficiency" In mRNA Process Development
In this clip from a recent Advancing RNA LIVE event, panelists address a question about where the best opportunities exist upstream and/or downstream to increase mRNA manufacturing efficiencies.
The State Of CircRNA Analytical Development
Advancing RNA LIVE panelist Jim Nolan of Sail Biomedicines fills us in on the extent to which we can rely on the linear mRNA analytical foundations established today.
How Analytical Development Is Informing mRNA Process Development Today
In this clip, Advancing RNA LIVE, panelists, share their perspectives on how advancements in RNA analytical development are complementing and informing process development efforts for linear mRNA.
The Evolutions Of mRNA Analytical Development (So Far)
Linear mRNA analytical development has been rapidly advancing in the past few years and this panel discussion explores some of the biggest changes we’ve seen in the linear mRNA analytical paradigm.
An mRNA Wish-List: What Regulatory Developments Would Make Life "Easier?"
Three regulatory experts share the topics on which they hope to see further agency clarification in the near-term to help mRNA products make meaningful progress toward/through the clinic.
Don't Ignore These Functional Areas In Your RNA Therapeutic's Regulatory Story
Explore two functional areas that Advancing RNA panelists consider most essential to telling an RNA product’s “story” thoroughly to regulators.
How Is mRNA "Shaking Up" Our Regulatory Interactions & Operations Today?
The Advancing RNA Live panelists share several inconsistencies they’ve encountered working with global regulators, as well as on which aspects they’re seeing regulatory agencies applying greater scrutiny in mRNA development today.
The FDA's "Platform" Provision: An Emerging Debate Among Regulators
Though the mRNA industry is excited about the possibilities of the FDA’s yet-to-be-clarified “Platform Provision,” a recent discussion between regulators suggests differences in opinion are emerging.
In Which Specific Areas Do mRNA Makers Need More Regulatory Guidance?
Experts from this Advancing RNA Live panel discuss the results from a poll question revealing the top three areas RNA industry experts would be most interested in seeing additional mRNA-specific guidance from regulatory agencies.
A Snapshot Of The RNA Industry & Its Regulatory Progress
The experts on this Advancing RNA Live panel share their takeaways from several audience poll questions revealing which RNA molecules are getting the lion’s share of attention/development today.
The Pre-IND "Diaries": What Can mRNA Makers Expect From Early FDA Engagement?
Nutcracker Therapeutics’ Oreanna Thomas shares her takeaways from a pre-IND meeting for one of the company’s mRNA therapeutic candidates.
What Learnings Can mRNA Take From The Oligonucleotide Regulatory Paradigm?
ReciBioPharm’s Melanie Cerullo shares where mRNA needs to “catch up” to its oligonucleotide “cousin” molecules and where regulatory differences may be emerging between modalities.
Where Does The mRNA Vaccine Regulatory Paradigm Fall Short For Therapeutics?
This Advancing RNA panel of experts sees a couple of important questions those striving to make RNA therapeutics will find themselves confronting when collaborating with regulators.
Approving The World's First saRNA Vaccine: Arcturus' Regulatory Experience
Explore the behind-the-scenes best practices of the company implemented that led to the approval of the world’s first saRNA vaccine in Japan.
mRNA, TFF, And Next Steps To Tackle mRNA Therapeutic Challenges
Expert panelists provide commentary on specific steps considered to be challenging in mRNA therapeutic development as well as new technologies in mRNA therapeutic development.
Novel Excipients Versus Active Substances And Inflammatory Response
Novel excipients or active substances? In this segment of Risk Reduction In mRNA Therapeutic Development, we address the debate and discuss LNP-related inflammatory response concerns.
mRNA Supply Chain And Critical Component Risks
What challenges do you consider the most formidable in your own mRNA therapeutic development environments?
LNP Stability In mRNA Therapeutics
Learn more about LNP complexity, fragility, and other lipid nanoparticle considerations in this segment from the Bioprocess Online Live digital event Risk Reduction In mRNA Therapeutic Development.
Addressing Safety Risks In mRNA Therapeutics
Safety of mRNA vaccines and therapeutics is paramount to approval, but process dependent. Listen to this discussion which addresses safety risks and how mRNA developers are tackling the challenges.
Therapeutic Market Opportunities For mRNA
In this segment from the Bioprocess Online Live digital event Risk Reduction In mRNA Therapeutic Development, hundreds of audience members tell us what forms of vaccine and therapeutics they’re developing.
Chromatography And Column-Free Processes
Listen in on a discussion surrounding questions about chromatography and column-free processes in the development of mRNA vaccines and therapeutics.
Risk Reduction In mRNA Therapeutic Development: Meet The Panel
Listen in on a discussion reviewing key drivers behind the flurry of activity in mRNA therapeutic development and begin to address the rate-limiting risks to mRNA therapeutic development.
mRNA Raw Materials To Scale Up Your Manufacturing
Learn more about CustomBiotech's mRNA raw materials pipeline and strict quality criteria that are designed to support the success of our customers’ manufacturing scale-up and regulatory drug approval.
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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![Cedex Bio Analyze and HT Analyzer]( "Propelling Cell And Gene Therapies From Concept To Commercialization")
Propelling Cell And Gene Therapies From Concept To CommercializationRoche 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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![Roche - brochure]( "Uncoupling Yield From Quality: The Glycoengineering Advantage")
Uncoupling Yield From Quality: The Glycoengineering AdvantageStreamline your biologics workflow, from initial development to final manufacturing, with comprehensive and high-quality solutions for consistency and efficiency.
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![cedex]( "Advance The Potential Of Your Cell Culture")
Advance The Potential Of Your Cell CultureExplore modern solutions for monitoring and analyzing cell culture in the pharmaceutical and biotech sectors.
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![MRNA Technology-GettyImages-1366661187]( "mRNA Raw Materials: A Clear Path To Market")
mRNA Raw Materials: A Clear Path To MarketDesign your mRNA manufacturing process with the certainty of fit-for-purpose standards for raw materials.
FEATURED INSIGHTS
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![Roche - glycolysation brochure]( "Rethinking Glycosylation: A Primer On Enzymatic Control")
Discover how to gain precise control over one of the most common and critical forms of protein modification for therapeutic benefit and stability.
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![GettyImages-2183428951-biomanufacturing]( "The Evolution Of Nucleotide Production")
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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![GettyImages-1403976499 vaccine, development]( "Navigating The Regulatory Landscape For mRNA-Based Therapeutics Post-COVID")
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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![GettyImages-2017789595 lab, research]( "Essential Strategies For IVT Optimization")
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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![GettyImages-1438509986-isolated-rna-lipid-nanoparticle-LNP]( "Reducing Risk In mRNA Therapeutic Development")
Advancements in purification, delivery mechanisms, and stability during storage and transport will enable the future of mRNA-based therapies.
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![mRNA GettyImages-1356994723]( "The Future Of mRNA: Four Key Focuses For Industry")
Compared to traditional protein-based therapies, mRNA drugs exhibit unique pharmacokinetic profiles and can be rapidly developed, making overcoming their challenges critical for the industry.
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![Molecule mRNA-GettyImages-1428646288]( "Optimized Performance Model For Yield And Quality Of The mRNA Product")
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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![GettyImages-1357908552-rna-ribonucleic-acid]( "Expand Your Toolbox For Quality mRNA Manufacturing")
Explore guidelines for the use of SP6 RNA Polymerase in mRNA synthesis and your mRNA production processes.
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![iStock-1295693748-mRNA]( "Modulate mRNA Therapy Effectiveness Using Modified Ribonucleotides")
Learn about the problem of immunogenicity of mRNA, modified mRNA via in vitro transcription production, and choosing fit-for-purpose modified ribonucleotides.
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![GettyImages-1356994684-epigenetics-rna]( "Understanding mRNA Technology As A Platform For Biopharma")
Explore the advantages of mRNA technology, the process steps of large-scale mRNA production, and the effect of common contaminants on mRNA manufacturing.
