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This application note discusses the desired future state for measuring conductivity of compendia water samples and how the Sievers M9 TOC Analyzer with Conductivity enables users to reach this state.
Regulatory expectations nowadays focus on harmonisation of global regulations. This whitepaper by PQE looks at current and emerging trends in regulatory expectations.
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.
As maintaining the health of the chemist is of top priority, one should recognise potential dangers that can jeopardise the safety of laboratory staff and install measures to sufficiently protect the scientists.
This article covers the analytical criteria that apply to Bacterial Endotoxin Testing (BET) using Limulus Amebocyte Lysate (LAL) or recombinant Horseshoe crab Factor C (rFC) for the bioactivity determination of endotoxin in aqueous solutions, such as pharmaceuticals and medical device extracts. It explains the importance of these criteria for accurate…
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.
Eurofins CDMO provides a full suite of drug development services encompassing development of the bioprocesses, formulation screening, analytical development, pre-clinical testing, sterile and non-sterile bio-manufacturing of clinical trial batches and orphan drugs.
Antibody-drug conjugates (ADC’s) are targeted cancer therapeutics that deliver a cytotoxic agent, the payload, to the tumour.
Amlodipine is an angioselective calcium channel blocker used to treat high blood pressure, chest pain and other conditions caused by coronary artery disease.
The solubility of a compound in organic solvents or water is equally important for screen design and later for process development.
Eurofins CDMO provides a wide range of aseptic processing services for all drug product configurations with flexibility to accommodate a wide range of compounds, primary packaging systems, batch sizes and fill volumes to help develop your Active Pharmaceutical Ingredient or bulk product into Finished Dosage Forms for use in clinical…
Multi-component methods for the detection of different compound classes, such as vitamins and amino acids, have been established and are widely used to analyse a broad range of samples.
A complete workflow to quantify intact therapeutic proteins in plasma matrix has been developed, covering three critical components in preclinical sample analysis: target protein enrichment/purification, LC/MS data acquisition and quantitative data analysis.
The Monocyte Activation Test (MAT) is used to detect or quantify pyrogenic substances that activate human monocytes.
Contamination, microbiological or otherwise, is a key safety concern in the development and manufacture of all pharmaceuticals and medical devices.
