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March 4, 2025: PRIM-ER Team Develops Innovative Statistical Techniques for Stepped-Wedge Trials

Rethinking Clinical Trials

Stepped-wedge designs can be advantageous when simultaneous rollout of the intervention to all clusters is infeasible, or when withholding the intervention from any cluster would be unethical, or when there is a risk of contamination between intervention subjects and control subjects. Learn more about PRIM-ER.

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Making sub-visible particles visible

Bio Pharma Dive

Sub-visible particles can lower the effectiveness of a drug, which is why regulatory authorities are demanding processes be developed, validated and set up in such a way as to minimize all forms of contamination.

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MIT Scientists Develop Food Sensor That Can Detect Spoiled or Contaminated Food

XTalks

MIT engineers have designed a food sensor , made from an array of silk microneedles, that can pierce through the plastic packaging of foods to sample for bacterial contamination and spoilage. Two kinds of specialized “bioinks” react to the bacterial presence and certain pH levels, which respectively detect contamination and spoilage.

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The right viral safety program can guard against costly bioburden incidents in biopharma development

Bio Pharma Dive

Viral contamination threatens biopharmaceutical development, making viral clearance and safety essential for risk mitigation.

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Some food contamination starts in the soil

Scienmag

Credit: Matt Limmer When most people hear “food contamination,” they think of bacteria present on unwashed fruits or vegetables, or undercooked meat. However, there are other ways for harmful contaminants to be present in food products.

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Mitigating the risks of cross-contamination during Oral Solid Dose (OSD) manufacturing

Pharmaceutical Technology

Additionally, OSD manufacturing approaches are well developed, with processes that ensure a repeatable distribution of ingredients, uniformity in dissolution, and bioavailability, which verify that the drug product is safe and effective. Please check your email to download the Webinar.

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IN FOCUS: Northgate Technologies

Pharmaceutical Technology

NTI have tackled this problem through the introduction of its NEBULAE® SRS system , which filters and recycles the air in surgical theatres, removing potentially harmful contaminates.