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Is Your Lab Ready For A LIMS Implementation?
7/25/2024
Deploying a laboratory information management system (LIMS) can boost your quality control lab's productivity, but how are you going about it? This article shares key steps and considerations for setting up your physical lab, controlling inventory, and more.
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Bacterial Endotoxin Testing, Part 2: Prerequisites & Reagent Preparation
7/23/2024
In this second article of a planned series about bacterial endotoxin testing, the author shares best practices about prerequisites and reagent preparation for a gel clot Limulus amebocyte lysate (LAL) test.
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5 Recommendations To Maximize CSV/CSA Outcomes
7/17/2024
The computer system validation (CSV)/computer system assurance (CSA) process is correlated with other departments besides IT and quality. Accordingly, all stakeholders must think ahead and define what they need.
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Bacterial Endotoxin Testing, Part 1: Overview
7/16/2024
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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ChatGPT-4: Practical Applications For The Biopharma Laboratory
7/3/2024
AI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver?
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Periodontitis And Neurological Disease: New Insights For Drug Targeting
6/10/2024
This article discusses the link between periodontal disease and systemic disorders, focusing most on the association between proteases and neurological dysfunction. Therapeutic measures can target these pathological pathways.
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Points To Consider For Assessing Lipid Quality For Lipid Nanoparticle Manufacturing
5/29/2024
Lipid nanoparticles have generated a ton of buzz, but they pose risks that, perhaps, industry and regulators have not taken seriously enough so far.
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EMA Updates Guidance On Inhalation And Nasal Product Quality
5/29/2024
The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.
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FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
5/24/2024
This article provides a summary and analysis of the FDA's new draft guidance, Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products. The public comment period ends July 29.
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Can ICH Q14 Ease Regulatory Risks Around Impurity And Potency Testing?
5/21/2024
Variability is inherent to biologics manufacturing. The trick is to catch it quickly and prevent product quality drift. That’s where the new ICH Q14 comes in.