whitepaper
Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
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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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Whole genome sequencing and analysis of live biotherapeutic products
Here, Snehit Satish Mhatre and Michael Timm of Eurofins discuss considerations and recommendations for the testing of live biotherapeutic products.
whitepaper
Whitepaper: Single-use technologies in biosimilar development
ImaLINK™ manifold, which is designed to minimise the need for fittings, connections or assembly of all leak points, entrapment areas are eliminated.
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The lingering menace of diethylene glycol / ethylene glycol adulteration
Although it was first identified in the 1930s, diethylene and ethylene glycol contamination remains an issue today, as Dave Elder explains.
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European Pharmaceutical Review Issue 6 2022
This issue includes articles on Raman mapping of pharmaceutical tablets, delivery options for mRNA therapeutics, the use of high-throughput analytics for clonal cell selection and much more...
news
Catalent opens one of largest cell therapy manufacturing facilities in the world
Sited in Belgium, Catalent has opened one of the largest commercial-scale cell therapy manufacturing facilities in the world.
news
CPI opens £88 million manufacturing innovation centre
CPI has opened its Medicines Manufacturing Innovation Centre in Scotland to focus on efficient, sustainable manufacturing and advance medicine research.
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EMA launches quality control group to aid medicine innovation
A new regulatory group, part of the European Medicines Agency, will aid innovative approaches for the development and quality control of medicines, including new technologies for EU patients.
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Using UHPLC-MS/MS for trace detection of β-lactam antibiotics
Researchers demonstrate ultra high performance liquid chromatography with triple quadrupole mass spectrometry to detect and quantify trace amounts of cephapirin and ceftiofur.
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Innovation in pharma manufacturing quality systems
Over the last 10 years, there has been an important change of focus in pharma towards biotech products and personalised therapies. These important new treatments are now emerging into manufacturing, with implications for the way that quality is monitored, managed and assured. Dr Eduard Cayón sets out some practical advice.
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GAMP 5 update: computerized system expectations for pharma manufacturers
The International Society of Pharmaceutical Engineering’s GAMP® 5 guidelines steer validation practices for pharma companies to meet computerized system expectations. Members of the GAMP steering committees, Lorrie Schuessler, Charlie Wakeham and Stephen Ferrell, share the some of the key changes in the second edition update and how these should be…
news
Swedish innovation agency invests in new ATMP QC method
A new project funded by Swedish innovation agency Vinnova, will help develop an AI-based quality control method for ATMP manufacturing.
whitepaper
Case study: Reduce plate counting costs and delays
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
whitepaper
Under the microscope: How AI can help minimise compliance risks
Dr Joe DiCapite, Vodori Director of Strategy, discusses why he believes a revolution in material review software is coming.
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Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
