FORMULATION ARTICLES
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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The mRNA Supply Chain Revolution: Materials, Methods, And Momentum
mRNA innovation now hinges as much on manufacturing materials as on molecular design, with novel inputs shaping performance, cost, and scalability. As these less-mature materials move rapidly into production, strategic material selection and supplier alignment are becoming critical to manufacturing resilience and long-term success.
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A Year Of Separation: Which Advanced Modalities Are Built For Commercial Scale In 2026?
In 2026, advanced therapies diverge: winners pair proven biology with scalable manufacturing, delivery, and workflow fit, while others advance more slowly under operational and economic limits.
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2026 Outlook: How Modality Maturity, Delivery, And Data Will Reshape RNA Therapeutics
As RNA therapeutics mature, 2026 will reward execution over novelty. Delivery, data-driven design, and modality specialization will determine which RNA platforms scale clinically and commercially.
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Designing mRNA For The Next Generation Of Therapeutics
mRNA’s next leap goes beyond vaccines. This piece explores how tuning sequence design, structure, and longevity enables controlled protein expression for cancer, rare disease, and regenerative uses.
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The Great Cell Therapy Reset: Solving The Industrial Math Of Living Drugs
The cell therapy sector is experiencing a paradigm shift in manufacturing: from bioreactor (ex vivo) to body (in vivo).
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Industry experts discuss current and future trends, formulating successful lipid compositions and navigating the constantly evolving genomic medicine landscape.
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Examine how a 21‑mer oligo was synthesized and purified through systematic resin screening, method optimization, and successful scale‑up to build reliable, high‑purity chromatography workflows.
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Review the fundamentals of CRISPR technology, development, and its use to manipulate genes in different ways, such as altering their nucleotide sequences or changing their expression.
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Explore key considerations for manufacturing RNA-LNP drug products surrounding process and analytical development, automation, environmental monitoring, and strategic collaborations.
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Monoclonal antibodies (mAbs) stand as pivotal drug products and biochemical reagents in the 21st century. Explore how mRNA-encoded antigens could revolutionize antibody discovery.
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Lipid nanoparticles (LNPs) have played a crucial role in COVID-19 vaccine development as efficient mRNA delivery systems, exhibiting versatility and effectiveness in accelerating the process.
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Here, we highlight three important process considerations across the RNA-LNP manufacturing workflow which includes limit size behavior, in-line dilution and downstream tangential flow filtration (TFF).