OUTSOURCING ARTICLES
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Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides?
Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.
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Sourcing Plasmid DNA From CDMOs Got More Challenging — Here's Why
The demand for plasmid DNA products is intrinsically linked to unique market conditions and funding environments. Here's what's driving them.
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CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides
Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.
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Shifting
SandsScales: 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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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.
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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.
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Learn about the first end-to-end cGMP facility that was developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.
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From fermentation to formulation, mRNA manufacturing requires a toolbox of technologies, services, and expertise. Explore our portfolio of solutions for making, purifying, and formulating mRNA.
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See how a next-generation rAAV production platform delivers high yields and superior product quality across various serotypes and genome lengths through innovative process optimization.
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CMO invests in solution to ensure data integrity and meet regulatory requirements as they expand their oligonucleotide manufacturing and analysis services.
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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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Explore compelling reasons to digitize your qualification documents and the benefits of a sustainable and efficient approach that utilizes digital tools to enhance your equipment qualification process.