Production Featured Articles
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Secrets To Successful Development For Emerging Biotechs
7/26/2024
Emerging biotechs are behind many of the pharma industry’s latest therapeutic innovations. And while CDMOs are eager to work with them, they must learn to accommodate their unique needs.
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Illuminating The Pathway To Efficient Drug Development For Small Biotechs
7/26/2024
To guide a biotech through successful drug development, there are three key areas a CDMO should focus on: equipment and instrumentation, organization and personnel, and systems and processes.
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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
7/25/2024
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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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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X-Ray Detection Buyer's Guide - How To Maximize Performance, ROI, & OEE
7/23/2024
How do you choose the right x-ray inspection system? This guide highlights everything you need to know to choose a system to meet your detection goals in a way that maximizes ROI and OEE.
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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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Less Mess, Less Stress, Best Expressed: A Superior Alternative To Spray Drying
7/16/2024
Spray drying and hot-melt extrusion are well-established processes, but each can be outperformed in terms of bioavailability, cost-savings, manufacturing speed, environmental impact, and more.
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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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CAR T Set The Pace So All Can Win The Cell Therapy Race
7/15/2024
Gain insight into the modest origins of cell therapy manufacturing and how this history has paved the way for future advancements from Bill Shingleton, R&D Leader at Cytiva.