VIDEOS

• 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.