OUTSOURCING ARTICLES
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Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers
The U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
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Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And Manufacture
No matter how you approach it, mRNA manufacturing is expensive. The raw materials, technologies, and educated labor force require immense investment. To avoid incurring extra costs and to ensure your strategy is precise and risk averse, identify an experienced partner that prioritizes communication and first-time-right manufacturing.
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The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?"
During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales.
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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.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Explore the potential of polymeric nanoparticles (PNPs) as an alternative to viral vectors. PNPs offer design flexibility, enabling larger payloads, targeted release, and minimized side effects.
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Examine considerations on bringing together the CMC and clinical teams early in the development process, promoting transparency and communication with regulators, and increasing patient access and diversity in clinical trials.
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Learn about the drawbacks of antibiotic resistance that can cause side effects in patients and how an antibiotic-free approach can ease the burden of regulatory compliance and accelerate development.
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Get a full overview of the role CROs play in clinical trials and their impact on site selection, site monitoring, patient recruitment, managing data, and more.
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Explore our study on optimizing In-Vitro Transcription (IVT) conditions for self-amplifying RNAs to achieve high yields, low residual dsRNA, and improved potency, and learn how these advancements can enhance RNA-based therapies.
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Development of RNA-based therapies sits at the cutting edge of vaccine and oncology innovation, in addition to holding promise in dozens of other therapeutic areas.
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Gene therapies rely on efficient, precise methods of delivering genetic material. Examine how combining polymeric nanoparticles with CRISPR therapies is increasing the potential for improved treatment.