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Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
Meet the new compact FTIR spectrometer that features an innovative design and software platform to significantly improve reliability and productivity, ideal for busy QA/QC labs and teaching labs.
Leading international partner to the biopharmaceutical industry Sartorius Stedim Biotech (SSB) has today announced that the new SIMCA® 16 software for multivariate data analytics is available from its subsidiary Sartorius Stedim Data Analytics.
This whitepaper serves to illustrate the reasons for exaggerating the extracted surface area to extraction solution volume ratios as is the practice in extractables studies.
Emerging recombinant Factor C (rFC) methods have many advantages to offer pharmaceutical quality control, including improved specificity, robustness, efficiency and alignment with 3R principles. First, global manufacturers have validated rFC and pharmacopoeias worldwide are on the move. Here, Karolina Heed provides an industry and regulatory update.
Microplate-based standard endotoxin tests require time-consuming manual handling steps, the results of which are by no means conclusive. Read how the GO PLATE - part of ENDOZYME II GO - helps to address these issues.
This application note compares Sartorius' Microsart AMP Mycoplasma kit with two other mycoplasma detection kits that are also based on DNA isolation with subsequent real-time PCR analysis.
Eric Haugen, Director Life Sciences Americas, gives an overview of Particle Measuring Systems’ contamination monitoring solutions for aseptic manufacturers.
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…
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...
An influenza vaccine manufacturer has announced it is filing an Annual Strain Update with the US Food and Drug Administration (FDA) in the coming weeks due to advances in influenza vaccine technology.
JEOL introduces new GC/triple quadrupole mass spectrometer with high speed and high sensitivity for trace detection of pesticides, dioxins and regulated chemicals.
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.
