news
Revised Annex 1 now effective
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
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Manufacturing
whitepaper
Whitepaper: Sustainable microbial monitoring
This white paper looks at the environmental impact of plate count testing and how on-line microbial detection supports sustainable pharma manufacturing.
news
UK medicines manufacturing to get innovation boost
A multi-million investment is set to enhance UK medicines manufacturing in three key areas: intracellular drug delivery, digitalisation and automation and nucleic acid medicines.
whitepaper
Whitepaper: Are nitrosamines a concern for biologic manufacturers?
Nitrosamine genotoxins in several pharmaceuticals has led to monitoring of manufacturing practices for products considered at risk.
whitepaper
Whitepaper: Navigating nitrosamine impurity testing
Nitrosamine impurities have become a concern in the bio/pharmaceutical industries, due to their carcinogenic properties and presence in medications.
whitepaper
ebook: Benefits of liquid-filled capsules for pharmaceutical development
Discover the benefits of liquid-filled capsules for the formulation of highly potent APIs and drugs that benefit from slow or extended release.
news
CDMO to manufacture SARS-CoV-2 intranasal vaccine
In a collaboration between the Institutes of Health (NIH) and CDMO Exothera, an intranasal vaccine for SARS-CoV-2 will be manufactured for use in a clinical Phase I/II trial in Africa and the US.
webinar
Advantages of automated microbial colony counting
16 August 2023 | By Rapid Micro Biosystems
Watch this webinar with independent microbiology expert Dr Tim Sandle to explore the different technologies, regulatory concerns and validation requirements for automated colony counting methods.
news
CPHI to return to Milan in 2024
CPHI, the global pharmaceutical exhibition will take place in Milan, Italy from 8-10 October 2024.
article
ATRAG formulations for lung disease
Carl-Johan Dalsgaard, CEO of Vicore Pharma speaks to EPR about clinical trials of C21, an angiotensin II type 2 receptor agonist developed to treat rare lung diseases – and the first ever ATRAG to reach clinical-stage development.
news
CDMO expands CGT manufacturing site in Italy
The expansion of the CGT manufacturing site in Milan, Italy, will support viral vector development and manufacturing for late-stage clinical and commercial projects.
news
FDA warning letters highlight CAPA concerns
Several FDA warning letters distributed to pharmaceutical manufacturers in 2023 have warned of numerous corrective and preventive action (CAPA) compliance concerns.
podcasts
EPR Podcast 20 – RNAi Therapeutics – Paul Nioi, Alnylam Pharmaceuticals
In this podcast, Paul Nioi, Vice President of Discovery and Translational Research at Alnylam Pharmaceuticals discusses the clinical development and manufacturing of RNA interference (RNAi) therapeutics.
news
Antibiotic manufactured via continuous-flow for first time
Continuous-flow manufacturing of the antibiotic cefazolin can cover mass production within compact manufacturing facilities and contribute to a stable drug supply, researchers have reported.
news
Next-gen sustainable inhalers on the horizon
Global development and manufacture of the next generation of green inhalers is positioned to be accelerated by a new joint £33 million government-industry investment.
