news
UK enhances ILAP to accelerate access to innovative medicines
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
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Supply Chain
webinar
How a well-orchestrated digital ecosystem drives laboratory efficiency and innovations
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
whitepaper
NSF’s quality management maturity (QMM) assessment model
10 December 2024 | By
NSF’s quality management maturity (QMM) assessment model: future-proofing quality and supporting supply chain robustness
whitepaper
Regulatory Authority Inspection Comparison
26 November 2024 | By
A guide on what to expect during a regulatory inspection and the differences in the approach taken by three of the main regulatory authorities and PIC/S.
whitepaper
Whitepaper: Optimise organisational culture & quality maturity
31 October 2024 | By NSF
Whitepaper - Optimising organisational culture and quality maturity is crucial in promoting consistent, reliable business processes and to minimise supply disruptions.
news
New WHO guidance to support manufacturers to reduce AMR risk
The recommendations offered in the guidance is applicable across different areas of manufacturing, from active pharmaceutical ingredients (APIs), through to formulation and packaging.
whitepaper
Science of scale for spray-dried intermediates
5 August 2024 | By
Speed to market is a critical aspect of developing new pharmaceutical products, and scale-up – or scale-down – can play a key part in that process.
whitepaper
Synthesis and Route Design to Tackle API Complexity
22 July 2024 | By
These longer synthetic pathways present challenges for process chemists hoping to achieve an efficient API manufacturing process.
whitepaper
Application note: Validating recombinant cascade reagents in 3 simple steps
Endotoxin testing continues to evolve alongside the industry’s need for more sustainable methods that reduce ecological impact. Nicola Reid, Associate Director of Endotoxin Products, Charles River Labs, reflects on these developments which are driven by the 3Rs (replacement, reduction and refinement).
whitepaper
Case Study: Franz Ziel’s utilisation of Enzyme Indicators using Fractional Kill Time method
3 June 2024 | By
An EJPPS published study on Enzymatic Indicators in Vaporized Hydrogen Peroxide Decontamination Cycles: Application-related Research focusing on Fractional Kill Time (FKT) and Reverse Fractional Kill Time (RFKT) Studies
news
Impact of EU sustainability directive on supply chains
Pharmaceutical and healthcare companies have shared how they expect the new EU supply chain laws could impact their operations.
article
European Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
video
Webinar: How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation
Melanie Eggers is a Sterilisation Validation Project Support Engineer at Pfizer Belgium. In this webinar, she explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the…
news
EFPIA reaction to European Parliament plenary vote
Following the recent European Parliament plenary vote, EFPIA asserts that aligning the next revision of the pharmaceutical legislation to increase Europe’s competitiveness will be a challenge.
article
2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends
Some of the most sought-after human experiences are health and happiness. Although pharmaceutical companies cannot determine personal happiness, they are working to improve personal health outcomes that can tip the scale. The demand for personalised medicines, cell and gene therapies, hyperresponsive and patient-centric healthcare, real-world data fuelled by artificial intelligence…
