Newsletter | June 25, 2025

06.25.25 -- The "Tides" Have Changed: Outsourcing Oligos & Peptides

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Webinar: CRISPR meets LNPs: A new era in cell and gene therapies

Join industry experts as they present new data demonstrating the potential of CRISPR-LNPs for multiplex gene editing in primary human T cells. Explore how non-viral delivery platforms like LNPs could reshape the future of cell and gene therapy—from manufacturing and regulation to clinical translation. Click here to learn more.

FEATURED EDITORIAL

The "Tides" Have Changed: Outsourcing Oligos And Peptides

Shifting demand for oligos and peptides drove innovation in CDMO partnerships and reshaped outsourcing relationships. In this Outsourced Pharma Live panel, industry experts shared best practices for outsourcing these specialized therapeutics, with a focus on capacity, regulatory challenges, and technology transfer.

First AMT Program OK'd Under New FDA Designation — What To Know

The FDA's new Advanced Manufacturing Technology program has its first recipient, a development expected to reveal the specific ways the program benefits drug innovators.

The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?"

During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. 

INDUSTRY INSIGHTS

Optimize Your RNA-LNP Delivery With Ionizable Lipids

Ionizable lipids play a crucial role in optimizing LNP delivery. Discover how lipid nanoparticles revolutionize intracellular drug delivery to enhance RNA vaccines, cell therapies, protein replacement, and gene editing.

mRNA Process And Cost Modeling: A Tool To Optimize Process Development

Demand for mRNA-based medicine production continues to increase, as do investments in prophylactic and therapeutic indications. Explore a cost-model that compares all modalities.

5 Trends Impacting CMOs In 2025

In 2025, CMOs will navigate Annex 1 compliance, the BioSecure Act’s uncertainty, AI-driven drug development, supply chain challenges from tariffs, and pandemic preparedness strategies.

How Automation Can Accelerate Clinical Research And Outbreak Response

Learn how AI-driven automation and organ-on-a-chip technology can accelerate infectious disease research, enhance assay efficiency, and improve vaccine development for emerging global health threats.

Navigating Challenges In Progressing Breakthrough RNA Therapeutics

RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.

CQA Assessment Of LNP-Encapsulated IVT mRNA

Learn about issued guidelines on Critical Quality Attributes for IVT mRNA vaccines and biotherapeutics to focus on drug substance and LNP-encapsulated drug product assessment using an analyzer system.

Demystifying CRISPR gRNA Chemical Modifications

Chemical modifications on CRISPR gRNAs enhance stability, editing efficiency, and reduce immune responses, enabling in vivo applications and clinical success.

LBA Vs. LC-MS: Competing Technologies At A Development Crossroad

Watch as bioanalytical experts Shane Karnik, MS, and Matt Hartle, Ph.D., explore why many sponsors are reevaluating the use of LBA for large molecule protein analysis in favor of LC-MS.

Large Scale Purification Of Oligonucleotides With IEX

As oligonucleotide-based drugs gain momentum in therapeutic development, refining their manufacturing processes through solutions like ion exchange chromatography (IEX) becomes crucial.

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Delivery remains RNA therapeutics' biggest hurdle—especially beyond the liver. In this Advancing RNA Live, Anna Rose Welch is joined by experts exploring nonviral, non-LNP delivery solutions pushing the boundaries of coding and noncoding RNA. Hear what makes these novel vehicles promising and learn how companies are tackling the scientific and operational challenges that stand in the way. Don’t miss this deep dive into the future of RNA drug delivery innovation.