Contributing Editors
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Are KRAS Inhibitors Poised To Cure Cancer?
8/21/2023
The KRAS gene, a crucial component of cell signaling pathways involved in cell growth and division, is frequently mutated in various cancers. By targeting the gene, KRAS inhibitors aim to block the aberrant signaling that promotes cancer cell proliferation. Amgen's sotorasib became the first approved KRAS inhibitor, opening up an exciting field.
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Vendor/Supplier Management To Maintain A Drug’s Safety Profile In End-To-End Supply Chain Planning
8/17/2023
FDA 21 CFR 211 requires vendor qualification as a part of the validation process and EU GxP requirements expect robust vendor management, and we expect regulators to issue firmer guidance sooner rather than later. Don't let your pharma/biotech fall short.
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FDA Issues Second DSCSA Warning Letter — What Does This Mean?
8/16/2023
In June 2023, shortly before final requirements of the Drug Supply Chain Security Act (DSCSA) must be met come November, the FDA issued a warning letter to Safe Chain Solutions, LLC addressing DSCSA violations related to repeated instances of distributing costly counterfeit antiviral drugs that Safe Chain had sourced from unauthorized trading partners. Let's look more closely at the emerging themes so that you can avoid a similar warning letter.
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CGMP Requirements For Automated Facility Monitoring Systems
8/15/2023
To assess facility control, most organizations use facility monitoring systems to monitor the manufacturing workspaces continuously. Let's take a deeper look at current good manufacturing practice (CGMP) requirements for the design and operation of such automated systems, including a look at total particle counting.
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Balanced Sourcing Of Custom Media/Buffer Formulations: The Case For Outsourcing
8/10/2023
Nothing is risk-free; now more than ever, all sourcing options have pros and cons that we need to assess to find the best fit. In this first article of a two-part series, we share three compelling reasons to consider outsourcing, along with key considerations for each.
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The ADC Market To Triple By 2030, Driven By Big Pharma Developments
8/8/2023
After two decades of trial and error in antibody–drug conjugates (ADC) development, the field is poised to deliver a plethora of targeted drugs to treat a wide range of tumor types. Let's take a look at new market research and some notable recent developments in the space.
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4 Tips To Leverage Your Ingredient Supplier For Faster Formulation
8/3/2023
Speed to formulation plays a critical role in recouping the investment for a new drug. Many ingredient suppliers have an experienced analytical group and material scientist group, and drug developers should reach out and leverage that expertise with these four strategies.
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Financial Leadership Of Strategic Procurement: 4 Foundational Steps
8/2/2023
Efficiently managing a diverse supply base is crucial for drug companies to maintain growth, profitability, and compliance. While the procurement function can be organized under various executives, the relationship between the CFO, procurement, legal, and buying departments is very important.
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5 Promising Applications Of RNA Therapeutics
7/28/2023
Ribonucleic acid (RNA), once considered a mere messenger molecule, has now emerged as a versatile tool in the development of novel therapies. In this article, we will delve into the world of RNA therapeutics, exploring their potential and five applications that could impact the future of medicine.
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An Independent Expert’s Guide To Picking Nanoparticle Manufacturing Equipment
7/26/2023
Until recently, nanoparticle manufacturers had to change equipment between preclinical, clinical, and commercial phases. Advances in technology offer more flexibility allowing manufacturers to turn up the dial on the same machines — from early development all the way to commercialization.