OUTSOURCING ARTICLES
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![GettyImages-660677728-sand-dune]( "Shifting <s>Sands</s> <i>Scales</i>: Manufacturing Considerations For Small-Scale mRNA Production")
ShiftingSandsScales: Manufacturing Considerations For Small-Scale mRNA ProductionThough 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.
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![businessman and doctor shake hands-GettyImages-959307838]( "Great siRNA Science Or Savvy Business Acumen? You Need Both")
Great siRNA Science Or Savvy Business Acumen? You Need BothSilence 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.
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![Home Improvement construction tools-GettyImages-1396466280]( "A Guide To Selecting Cell & Gene Therapy Tools, Tech, & Services")
A Guide To Selecting Cell & Gene Therapy Tools, Tech, & ServicesThese 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.
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![GettyImages-532447321-children-kids-workout-exercise]( "From \"Up & Coming\" To \"Fully Formed\": Maturing Our mRNA Outsourcing Partnerships")
From "Up & Coming" To "Fully Formed": Maturing Our mRNA Outsourcing PartnershipsIn 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.
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![GettyImages-2036497686-lab-team-collaboration-laboratory-tablet-computer]( "Have We Got Novel Drug Production And Compliance Timelines All Wrong?")
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.
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![FDA-GettyImages-679546546]( "Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy Products")
Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy ProductsFDA 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.
OUTSOURCING VIDEOS
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner.
Having worked on both the innovator and CDMO sides of the industry, Advancing RNA LIVE panelist Khaled Yamout outlines where he sees the greatest weaknesses in these critical sponsor-CDMO partnerships and offers guidance.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![Outsourcing Business Human Resources--GettyImages-1305829382]( "Strategies For A More Secure Outsourcing Bottom Line")
A panel of experts from across the pharmaceutical/biopharmaceutical industry recently shared their experiences in mitigating financial risk before partnering with a contract research organization (CRO).
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![GettyImages-1313742092 tech partner]( "The Execution Stage Of Technology Transfer")
What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.
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![GettyImages-1288118586 cell development]( "Expectations On The Pathway To GMP For Gene-Modified Cell Therapies")
Learn how a robust understanding of the RNP’s critical process parameters and CQAs is crucial for ensuring product consistency, enhancing patient safety, and maintaining regulatory compliance.
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![GettyImages-1434150674-lab-microscope-team]( "Efficient, Large-Scale Transfection Of T-Cells Using Flowfect® Technology")
The objective of this study was to test transfection of T-cells with GFP mRNA for evaluation of cell viability, transfection efficiency, and post-transfection growth using Kytopen’s Flowfect® technology.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway")
Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
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![GettyImages-1387090964 cell and gene therapy]( "Moving CGTx Clinical Development Forward In 2023")
Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.
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![RNA abbreviation of ribonucleic acid-GettyImages-1453953422]( "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.
