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This application note from SUEZ outlines the factors that companies should consider when choosing their cleaning validation procedure, highlighting the benefits of TOC analysis over HPLC.
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...
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.
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...
The prescription drug pregabalin is now being treated as a class C drug...
The MHRA has recalled three batches of Losartan tablets due to contamination with the nitrosamine N-nitroso-N-methylamino butyric acid...
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.
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
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…
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…
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…
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.
Antibody-drug conjugates (ADC’s) are targeted cancer therapeutics that deliver a cytotoxic agent, the payload, to the tumour.
Health Canada has issued a Notice of Compliance with conditions for the first oral drug for acute myeloid leukaemia, a rapidly progressing condition...
11 February 2019 | By Particle Measuring Systems
Following the patent of the "Espresso" innovative infusion device, the Italian Biochemical Institute (IBI) "Lorenzini" commissioned Comecer to construct a new isolated filling line.
