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

Achieving cost-effective manufacturing while maintaining high quality standards today is one of the biggest challenges facing companies outsourcing mRNA/RNA development. In turn, panelists Qian Ruan, Andy Geall, and Alex Aust reflect on how and where they’ve seen the costs of mRNA-LNP manufacturing evolving/fluctuating in recent years.

Meet our OligoProcess™ oligonucleotide synthesizer – exceptional scale ranges in 3 different scale designs to fit your needs up to 1800 mmol and beyond.

Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.

Peptones can significantly boost CHO cell bioprocessing. We analyze their impact on diverse CHO cell lines using real-world data to assess their effects on titer, protein quality, and cell growth.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS

  • 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.

  • Examine how a centralized logistics hub can transform the distribution of ATMPs, ensuring that sensitive therapies reach patients safely and efficiently.

  • Both physical and chemical nonviral gene delivery systems for ex vivo genetic modification offer advantages over viral vectors, including smaller scale production and the low risk of immunogenicity.

  • Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.

  • Find out more about the key steps for successful mRNA vaccine production, which encompasses mRNA manufacturing, and ways that you can save valuable time from the start of manufacturing.

  • Assimilate how advanced therapy supply chains are evolving toward patient-centric, risk-managed, digitally connected models to support scale, reliability, and regulatory confidence globally today.

  • Explore a study proving how synthetic single guide RNAs were used to optimize the editing conditions for resting human CD4+ T cells and maintain high cell viability for several weeks post Nucleofection.