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This issue questions whether companies are sufficiently investing in regulatory intelligence software and what the potential consequences of Brexit might be for locations outside of the UK and EU. The issue also features articles on microbiology, formulation and biopharma, courtesy of our in-depth focus sections; as well as outlining the…
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...
The Italian Biochemical Institute, Comecer, and Particle Measuring Systems share expertise to develop and manufacture a safer intravenous solution...
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.
ProCellics™ software is available with ProCellics™ GMP bioprocess in-line analyser. ProCellics™ software has been specifically developed to address bioprocess monitoring needs...
22 January 2019 | By SUEZ
Register for our latest webinar on the proposed Annex 1 revision on pharmaceutical water to prepare for future compliance...
The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…
Big data covers every facet of our working life. Every aspect of pharmaceutical research and development involves the generation of huge quantities of data, with the expectation that we can turn this information rapidly into useful knowledge, which in turn can be used to make ‘data-driven’ decisions to better understand…
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...
This In-Depth Focus examines methods to improve efficiency on the production line and explores a LC-MS based multi-attribute method for characterisation and QC testing of protein therapeutics.
22 August 2018 | By Mettler-Toledo
Regulated environments require performance verification (qualification) of UV/VIS spectrophotometers on a regular basis. Instrument performance is the main factor directly affecting the accuracy and repeatability of measurements. Hence, it is important that this is regularly monitored and that documentary evidence is provided. Optical performance verification is conducted to the widely…
8 August 2018 | By SUEZ
The US FDA and European Commission have defined regulations relating to the submission of electronic records in lieu of paper documents, for submission, inspection, and archiving purposes. When ageing analytical equipment is to be replaced 21CFR Part 11 and EU Annex 11 are also topics of discussion. Common questions from…
Sievers M9 Analyzers measure Total Organic Carbon (TOC) and Stage 1 conductivity simultaneously in association with Sievers Lean Lab solutions. They offer simultaneous TOC and conductivity compendia compliance testing for water quality assurance...
This issue recaps the Joint Pharmaceutical Analysis Group's symposium on Continuous Manufacturing, and explores the "perfect technology storm" facing the pharmaceutical sector.
Bioprocesses require automated process control to make quality products consistently and efficiently...
