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18 April 2019 | By SUEZ
TOC analysis is a widely adopted method for detecting residual product or cleaning agents on manufacturing equipment. Compared to specific methods such as HPLC, TOC can provide better process understanding and efficiency for cleaning validation (CV), verification and continuous monitoring...
15 April 2019 | By European Pharmaceutical Review
Following reports of immune-mediated conditions and problems with the heart and blood vessels (including fatal cases), the EMA (European Medicines Agency) has started a review of the multiple sclerosis medicine, Lemtrada.
5 April 2019 | By European Pharmaceutical Review
The Food and Drug Administration has released a list of 40 drugs used to treat hypertension and heart failure that don’t contain any known carcinogens...
4 April 2019 | By European Pharmaceutical Review
The prescription drug pregabalin is now being treated as a class C drug...
26 March 2019 | By European Pharmaceutical Review
The MHRA has recalled three batches of Losartan tablets due to contamination with the nitrosamine N-nitroso-N-methylamino butyric acid...
21 March 2019 | By Eurofins CDMO
Eurofins CDMO provides full range of drug development and manufacturing services from formulation screening and development, analytical development, stability studies and pre-clinical safety assessment studies to sterile and non-sterile manufacturing, IND/ IMPD and NDA/ CTD services, as well as clinical trial material including packaging and logistics.
8 March 2019 | By Particle Measuring Systems
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
7 March 2019 | By Dr Holger Kranenburg - containment lead at Franz Ziel GmbH, James L. Drinkwater - Head of GMP Compliance at F Ziel GmbH
Active pharmaceutical ingredients (APIs) have been established in the pharmaceutical industry over the course of many years. Containment technologies – ie, those strategies developed to contain the APIs – and qualification practices based on API powder containment have primarily been based on health and safety issues related to operator exposure…
27 February 2019 | By Christian Huck - Leopold-Franzens University
Strong regimentation and economic interests demand the development and implementation of new techniques for process control and analysis in the pharmaceutical industry. The extensive analysis of all deployed materials, intermediates and products leads to a higher degree of process stability and can contribute to a faster compensation for deviations, especially…
22 February 2019 | By European Pharmaceutical Review
In this issue we look at the challenges of shipping temperature-controlled products, the potential use of blockchain for pharma, and using MALDI-TOF for identification of peptides in suspected illegal medicinal products. The edition also includes articles on aseptic containment, legal advice on licensing negotiations and an In-Depth Focus article from…
21 February 2019 | By Telstar
The pharmaceutical industry is increasingly using different sterilisation technologies rather than steam sterilisation. This increase is driven by the need for sterilising thermo-labile products or areas that cannot be dimensioned as a pressure vessel (barrier systems such as Closed Restricted Access Areas or Isolators), under “softer” conditions.
19 February 2019 | By Sciex
Antibody-drug conjugates (ADC’s) are targeted cancer therapeutics that deliver a cytotoxic agent, the payload, to the tumour.
12 February 2019 | By European Pharmaceutical Review
Health Canada has issued a Notice of Compliance with conditions for the first oral drug for acute myeloid leukaemia, a rapidly progressing condition...
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