news
Are closed systems the future of CGT sterility testing?
Researchers have identified, for the first time, a sensitive, low-risk, closed-system for the detection of fungal contaminants in cell and gene therapy (CGT) products.
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Good Manufacturing Practice (GMP)
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.
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Article: Outsourcing biologics: key considerations
PCI’s Tim Roberts discusses key factors when outsourcing the clinical and commercial supply of biologics, and what makes a strong CDMO partnership.
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Case study: Reduce plate counts with rapid microbial monitoring
Find out how a pharma company maintained product quality and reduced plate counts by 25 percent using a rapid microbial monitoring analyser – the 7000RMS.
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Update on setting occupational exposure limits
Here, EPR summarises a recent review, outlining the critical considerations when setting occupational exposure limits (OELs), with a focus on HPAPIs.
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ebook: Proactive clinical supply planning
The importance of thoroughly planned resupply strategies in maintaining clinical supply inventories as studies move into late phase.
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Article: Clinical and commercial outsourcing
The demand for biologics and high potent medicines is forcing the industry to consider alternatives, such as outsourcing and integrated solutions.
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Is FTIR the future of cleaning verification?
Here, EPR explores the application of Fourier Transform Infrared spectroscopy (FTIR) in pharmaceutical cleaning verification.
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ebook: Early drug development strategies for clinical success
Learn the benefits of collaboration between the pharmaceutical scientists and clinical supply services teams.
webinar
Implementing state of the art technology to characterise polysaccharide vaccines
12 May 2022 | By Bruker
In this on-demand webinar, experts will discuss state of the art technology to characterise polysaccharide vaccines and relative implementation in biopharma development and manufacturing.
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Whitepaper: Data integrity and 21CFR.11 for 7000RMS implementation
Learn about 21CFR.11 and Annex 11 requirements and how you can implement a rapid bioburden analyser designed to meet compliant operation needs.
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Defining best practice for continuous manufacture of OSD forms
The International Society for Pharmaceutical Engineering (ISPE) has published the Good Practice Guide: Continuous Manufacturing of Oral Solid Dosage Forms, in a bid to increase uptake.
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On-demand webinar: Mould contamination, investigation and remediation challenges
Most industries face mould contamination issues, including medical products, hospitals, cosmetics, paint, among others. Learn more about mould and what you can do to combat it.
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Essential requirements for autologous cellular therapies
Edward Samuel, EVP Technical Operations at Achilles Therapeutics, explains why industrialised manufacturing and scale-up of autologous cellular immunotherapies will require fully closed systems and process automation.
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Article: Choosing a CDMO for high potent manufacture
How to select a CDMO partner for the development and commercial manufacture, packaging and launch of products containing highly potent APIs.
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Guide: Analytical applications in pharmaceuticals
The examples of common applications in the pharmaceutical industry for titration, UV/VIS spectroscopy and physical values are presented in details.
