news
FDA updates on voluntary valsartan recalls
The FDA has provided guidance on valsartan recalls that have been occuring recently, providing lists of drugs affected, and methods of impurity testing...
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QA/QC
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Paul DiMarco introduces BioSpectra as your provider of critical small molecule excipients and APIs
BioSpectra offers US based, custom GMP manufacturing of small molecules...
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Anne Marie details the benefits of ACD/Labs’ Luminata
Luminata enables assembly of a complete impurity control strategy for pharmaceutical development...
news
Wickham Laboratories Ltd to exhibit at Pharmig 2018
Wickham Laboratories will be exhibiting at Pharmig’s 26th annual conference held on the 28 and 29 November at the Belfry Hotel, Nottingham...
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True supply chain security is an eFingerprint away
Systech is the global technology leader in supply chain security and product authentication. For more than 30 years, we have put technology on the line...
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LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics
For several decades mass spectrometry (MS) has been used in the characterisation of protein pharmaceuticals.1-3 However, its use in the laboratory for quality control (QC) product release testing has been quite limited for a number of reasons, for example: instrument complexity and software are not readily amenable to validation, extensive…
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Integrating data from QC and Production to enable fast, informed decisions
Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…
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RCPE: Spotlight on… Continuous Manufacturing
In this Spotlight on Continuous Manufacturing, RCPE facilitates the adoption of novel manufacturing technologies...
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Wickham Laboratories: Drawing on deep technical expertise
Wickham Laboratories draws on deep technical expertise, backed by decades of global experience, when identifying challenges and providing solutions for a broad range of products and testing scenarios.
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Siemens: Spotlight on… Continuous Manufacturing
In this Spotlight on Continuous Manufacturing, Siemens offers pharmaceutical companies a unique portfolio of products (hardware and software), systems, solutions, and service – considering GxP* regulations – over the entire plant life cycle – as well as professional experience and interdisciplinary expertise...
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Perceptive Engineering: Spotlight on… Continuous Manufacturing
In this Spotlight on Continuous Manufacturing, Perceptive Engineering creates industrially robust solutions using advanced model-based control and monitoring technologies...
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Expert view: The QC micro labs have grown to tackle new challenges
29 October 2018 | By Charles River
Timelines, budgets and regulatory constraints have grown alongside that of the Quality Control (QC) lab’s position in drug development. The main goal of the lab and more widely of the manufacturing industry is to increase safety for the end user and guarantee patients’ health...
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Charles River: Accugenix® microbial identification and strain typing services
Accugenix ® microbial identification and strain typing services, from Charles River, offer unparalleled accuracy in identifying microbes.
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MG2: Spotlight on… Continuous Manufacturing
In this Spotlight on Continuous Manufacturing, MG2 explains why they are the single partner clients need for all productions into hard-shell capsules...
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Butterworth Laboratories Ltd: The expert analytical provider
Butterworth Laboratories provides outsourced analytical chemistry services to the global pharmaceutical and related industries, specialising in raw materials analysis. It has expertise in complex wet chemistry techniques, extensive experience in residual solvent analysis, and full instrumental capability in elemental impurity analysis.
