MANUFACTURING ARTICLES

  • Is mRNA Manufacturing Overbuilt?

    mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.

  • What Oligo Manufacturing Risks Are We Underestimating?

    Earlier this year, I attended the OPT Congress, where I had the great fortune of meeting consultant Marc Lemaitre. I recently sat down with Lemaitre for a follow-up interview to gauge some of the evolutions he’s been watching within the CMC landscape for oligo development. Here, he digs into the shifts in quality he’s noted, pointing out some of the potential pitfalls we may encounter in our manufacturing that could stand to impact the overall quality of our oligos. 

  • RNA Oligonucleotide Synthesis: How Advanced Manufacturing Technologies Are Accelerating Innovation

    From a tech perspective, the manufacturing objective is shifting toward integrated process optimization. Automated reaction control, multivariate analytics, and more can connect molecular quality with operational performance. 

  • What Baby KJ Taught Us About mRNA COGS

    Here, in part 2 of this three-part series, I share a few details that came to light about the COGS behind Baby KJ’s therapy production. Obviously, we know why it’s important to keep these figures in mind as we move forward; but I particularly liked Strauss’ reminder that it’s our job to “think systematically about how we’re going to create a safety net of sustainable, accessible product that can be widely distributed at an affordable cost.”

  • Analytical Platforms: The Foundation Of The Next Generation Of RNA Therapeutics

    RNA therapeutics are entering a new era where analytical platforms drive scalability, regulatory confidence, manufacturing flexibility, and the development of increasingly complex products.

  • A New Purification Strategy For The Removal Of dsRNA Impurities From IVT mRNA Products

    NIST research introduces a gentle SEC method that separates dsRNA impurities from IVT mRNA by tweaking buffer pH, achieving 81.8% target recovery without transcript damage.

MANUFACTURING VIDEOS

Advance from development to manufacturing with expert-led, hands-on, or virtual courses that strengthen process understanding and scale-up skills designed to support every stage of your molecule’s journey.

Nanomedicine is a branch of medicine that seeks to apply nanotechnology for disease prevention and/or treatment, imaging, diagnosis, monitoring, and the repair and regeneration of biological systems.

Explore a structured approach to optimizing and scaling plasmid DNA production using E. coli, with insights into key growth parameters, benchtop feasibility, and pilot-scale performance.

The right bioanalysis CRO accelerates progress, while the wrong one can derail outcomes. When every provider claims speed and credibility, how do you confidently choose the right partner?

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

  • Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

  • This technical note describes the identification, relative quantification, and structural confirmation of the chain-shortened metabolites of a phosphorothioated oligonucleotide.

  • Freezing doesn’t ensure consistency. Standardized cryopreservation removes site‑to‑site variability, providing predictable starting materials and lowering scientific and operational risk.

  • Venkata Indurthi, Ph.D., discusses key considerations for the production of RNA and strategies for successful scaling for commercial manufacture. Learn more about messenger RNA and self-amplifying RNA manufacturing processes.

  • 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.

  • The biopharmaceutical industry is in the midst of a period of rapid growth. It is also experiencing increasing uncertainty, diversification of modalities, and cost pressure. To address these challenges, the industry will need to embrace the facility of the future – a new biomanufacturing paradigm. This infographic identifies market trends challenging biopharmaceutical companies, business drivers to meet market needs, as well as requirements and aspirations for the factory of the future.

  • In vitro transcribed mRNA revolutionizes biotherapeutics, which necessitates thorough quality assessments. See how an analyzer system enhances encapsulation efficiency and CQAs in IVT mRNA workflows.