OUTSOURCING ARTICLES

• Shifting Sands Scales: Manufacturing Considerations For Small-Scale mRNA Production

  Though mRNA may, in theory, be the “perfect technology” for scaling up/out and down, several industry experts from a panel during Cytiva’s recent RNA-LNP Summit explained that the successful transition from large to small-scale, high-quality mRNA production demands specific manufacturing capability improvements/advancements. In the first of this two-part article, I outline a few of these important manufacturing and outsourcing considerations that must accompany our shift to smaller scales.

• Great siRNA Science Or Savvy Business Acumen? You Need Both

  Silence Therapeutics has two wholly owned siRNA therapies now in clinical trials and one partnered program with AstraZeneca. Silence's CEO discusses the need for good science, making smart business decisions, and cultivating partnerships.

• A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services

  These recommendations guide cell and gene therapy companies through the selection process for innovative tools, technology, and services with an eye to enable forward compatibility from early to later stages of development. 

• From "Up & Coming" To "Fully Formed": Maturing Our mRNA Outsourcing Partnerships

  In the first- of this three-part article series, several mRNA execs share their perspectives on the world of partnering in the RNA therapeutics space, assessing first the current state of CDMO partnerships and how they anticipate this critical supportive infrastructure will grow in the years ahead.

• Have We Got Novel Drug Production And Compliance Timelines All Wrong?

  Drug developers might want to consider longer-term approaches to meeting manufacturing and regulatory requirements.

• Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products

  FDA has released the new draft guidance for industry, Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products. This article provides a summary — and shares what is shocking about the guidance.