Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing
Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
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Colleagues from biopharmaceutical company MSD reveal what it takes to fully realise the benefits of PAT implementation.
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
Addressing key challenges in the pharmaceutical and biotechnology environmental monitoring market, such as high technology costs, while leveraging key market drivers is critical for the sector to thrive, analysis suggests.
The proposed technique outperformed traditional controllers, supporting improved air quality control in cleanrooms, according to the study.
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
17 February 2025 | By ACD Labs
Process chemists can increase their efficiency by accessing process, analytical, and chemical data from across their organization using Luminata.
4 February 2025 | By Catalent
Gain expert insight into optimizing pharmaceutical micronization while maintaining product quality, optimizing yield, and controlling the cost of goods from formulation through commercial supply.
4 February 2025 | By
Join to explore advanced analytical procedures to handle complex drug analytics and evolving regulations for development and quality control.
A warning letter has been sent by the US FDA to KVK-Tech regarding cGMP violations at their drug manufacturing site, including for data integrity.
24 January 2025 | By LabVantage Solutions
Find out how to take advantage of a connected digital ecosystem to enhance quality control, streamline manufacturing and, ensure regulatory compliance
The HPLC technique provides “significant improvements” over traditional methods for carvedilol determination and has broad applications for pharmaceutical quality control, research suggests.
Dave Elder shares industry thoughts on an ICH Q6(R1) concept paper that aims to revise general principles for uniformity and consistency across ICH Q6 guidelines for test criteria and specifications.
Dr Vladimir Makarov, AI Community lead, The Pistoia Alliance, explains that despite the willingness of the life sciences R&D industry to adopt artificial intelligence (AI), data integrity is a key area that must be addressed to ensure successful integration of this fast-evolving technology.
18 December 2024 | By MasterControl
This webinar explores the major trends impacting life sciences in 2025 and how the pharma industry can capitalise on the latest developments shaping quality management.
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness