Construction begins on new WuXi microbial manufacturing site
The new manufacturing site features automation capabilities to ensure efficient production and supports advancement of potential next-generation microbial therapies.
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Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorisation and licensing for manufacture and sale of drug products and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.
The new manufacturing site features automation capabilities to ensure efficient production and supports advancement of potential next-generation microbial therapies.
MHRA’s publication is intended to support European developers of phage-based medicinal products to effectively navigate related regulations.
This exclusive report addresses the key obstacles and innovations shaping pharmaceutical environmental monitoring, from QC and contamination control, to the impact of advanced technologies and regulatory changes. Discover practical solutions you can implement to drive progress for your organisation.
Overcome matrix interferences in RNA–LNP endotoxin testing with LAL-based methods & recombinant factor C assays. Learn more in this whitepaper.
11 April 2025 | By European Pharmaceutical Review
During this virtual panel, industry experts will explore the latest innovations and major challenges of drug formulation in the pharmaceutical industry.
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.
Dave Elder reflects on the array of applications for AI to facilitate successful drug development, though proof remains elusive.
EPR Issue 1 includes articles on manufacturing, drug delivery, process analytical technology (PAT), RNA therapeutics and more.
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
24 January 2025 | By
Discover how Bruker Benchtop NMR integrates with synTQ software, enhancing process monitoring and complementing IR and Raman techniques in the PAT framework
15 January 2025 | By
NSF invites pharmaceutical professionals to tune in to its new groundbreaking podcast series “Compliance Unlocked” and join the conversation on critical industry issues.
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness