article
Spectroscopy In-Depth Focus 2018
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.
List view / Grid view
Process Analytical Technologies (PAT)
webinar
Advances in automated performance verification for UV/VIS spectrophotometers
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…
webinar
Understanding current CFR 21.11 and data integrity requirements
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…
product
Product Hub: Sievers M9 Analyzers offer simultaneous TOC and conductivity compendia compliance testing
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...
article
Manufacturing In-Depth Focus 2018
This issue recaps the Joint Pharmaceutical Analysis Group's symposium on Continuous Manufacturing, and explores the "perfect technology storm" facing the pharmaceutical sector.
whitepaper
Scientific Poster: Raman spectroscopy technologies enabling scalable process control in bioprocessing
Bioprocesses require automated process control to make quality products consistently and efficiently...
article
Raman In-Depth Focus 2018
In this issue: the applications of vibrational spectroscopy for analysing the molecular component of a solid sample, and Raman as a fast-growing tool for PAT/QbD
article
Issue #2 2018 – Digital Version
In this issue; recent developments in turning promising compounds into drug candidates, reviewing the latest trends in pharmaceutical microbiology and their implications, and a roundtable debate featuring the views of five industry leaders.
article
NIR In-Depth Focus 2018
This In-Depth Focus on near-infrared spectroscopy considers analysis using an innovative SAR-DRM and explores advances in technology that have an application on PAT/QbD.
news
Siemens and Perceptive Engineering combining software solutions for the pharmaceutical industry
Siemens AG and Perceptive Engineering Ltd announce a partnership which offers Perceptive’s PharmaMV and Siemens Simatic Sipat software products closely integrated to provide a versatile solution for advanced control and optimisation applications in both continuous and batch pharmaceutical manufacturing...
webinar
Total Organic Carbon (TOC) and conductivity for state of the art cleaning validation
13 February 2018 | By SUEZ
This webinar is designed to help companies understand that cleaning should be addressed as an ongoing process, including continuous monitoring to ensure removal of all product and cleaning residues and removal of any potential contaminants...
whitepaper
Application Note: Raman-based endpoint detection of a heterogeneous etherification reaction
Regulatory guidelines, from the 2004 U.S. FDA PAT framework to ICH Q8, Q9, Q10 and Q11 documents, have brought a shift to pharmaceutical processes and manufacturing...
article
Biopharmaceutical Development & Processing
This In-Depth Focus looks at QbD and PAT for cutting biopharma attrition rates as well as continuous freeze-drying technology for biopharma products...
whitepaper
Application Note: Raman spectroscopy as a process analytical technology for pharmaceutical manufacturing and bioprocessing
Adoption of Quality by Design (QbD) principles, regulatory support of QbD, process analytical technology (PAT), and continuous manufacturing are major factors effecting new approaches to pharmaceutical manufacturing and bioprocessing...
news
Sperm-sorting device may improve IVF success
Women undergoing IVF may become pregnant with fewer treatment cycles thanks to a device that uses an obstacle course to select the fastest and healthiest sperm...
