Industry Insights
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Leveraging AI And Data Science For Biologics Characterization
9/12/2025
Modern analytical tools produce more data than we know what do with. Artificial intelligence helps condense, interpret, and utilize what's most meaningful.
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FDA Issues Guidance On Clinical Trials During COVID-19
3/25/2020
In line with the challenges created by the COVID-19 pandemic, the FDA provided some recommendations with regard to the conduct, monitoring, and data aspects of ongoing and future clinical trials. Some of the key considerations for sponsors are below.
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Critical Considerations In Outsourcing Nanotechnology Drugs
3/27/2019
If the mission statement of nanotechnology is “to perform precise interventions at the cellular or molecular level to improve health and promote quality of life,” then the contract manufacturer might seek a mission statement such as, “to enable novel therapy in a safe, effective way, advancing medical science one medicine at a time.”
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Pocket Guide To Medtech's Market Outlook In 2021
5/3/2021
Despite experiencing vulnerability in 2020 due to the pandemic, both medtech original equipment manufacturers (OEMs) and contract development and manufacturing organizations (CDMOs) are positioned to perform strongly in 2021. This article summarizes Alira Health’s findings from its new 2021 MedTech Contract Manufacturing Report.
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Synthetic Oligonucleotides: Regulatory, Analytical & Manufacturing Considerations
5/28/2021
In early March 2021, more than 300 professionals in regulatory, industry, and academic roles attended the USP's virtual Workshop on Therapeutic Peptides and Oligonucleotides. Building on regulatory considerations and control strategies, the workshop explored innovative techniques being used to analyze synthetic oligonucleotides, ensure quality, and reduce waste.
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The Principles Of Green Chemistry: Safer Solvents And Auxiliaries
11/11/2025
Solvents account for the majority of the environmental impact in chemical synthesis. Consider adopting safer alternatives and implementing reuse strategies to reduce waste, emissions, and toxicity.
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Key Takeaways From The FDA's New Continuous Manufacturing Guidance
3/15/2019
The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.
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Further Adapting New Bioprocess Technology In An Era Of Change
5/8/2020
Biopharma 4.0 is becoming more tangible every day. Catch up on the initiatives and programs that are defining the application of Industry 4.0 principles for MilliporeSigma technologies and services.
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RSV Challenge Model For Anti-RSV Therapy
3/27/2025
Utilize advanced rodent models to accelerate the preclinical testing of your anti-RSV therapies and vaccines, advancing the fight against this widespread respiratory infection.
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Soluble Versus Insoluble Expression In Microbial Fermentation
Expression of inclusion bodies has historically suffered a bad reputation in the industry. So, how do these two routes, soluble and insoluble, compare in terms of their advantages and challenges?