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This booklet from PQE Group is your opportunity to learn how the new EU directives - EU MDR 2017/745-746 - affect your company. Read on to find out what preparations you can make to ensure that your products comply.
Lubricants have a far more wide-reaching impact on the characteristics of the finished tablet than merely easing their means of production. A study was carried out to investigate precisely what those effects were.
This whitepaper demonstrates the High Performance Liquid Chromatography (HPLC) separation and analysis technique and highlights the importance of using water of sufficient purity as an eluent and how the arium® pro VF system can facilitate this.
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long term API technology development needs.
JRS Pharma present VIVAPUR MCG and outline the benefits of its formulation for application in nasal sprays.
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
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.
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.
The transfer of bulk liquids, such as media, buffer and intermediates, are critically important in biopharmaceutical production processes. This case study describes the performance of AdvantaSil High Pressure Unreinforced Silicone Tubing (APHP) used in a Monoclonal Antibody process for the transfer of buffers in purification.
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.
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
In the present study, the performance of PROSOLV® EASYtab SP was tested in four DC formulations with different model APIs. Each of the selected APIs presented a particular challenge in terms of producing tablets with suitable hardness, weight, uniformity, content uniformity and/or reliable dissolution profiles.
Herewith ACD/Labs presents their web-based software solution to the multiple challenges experienced in screening workflows; offering effective support for high-throughput catalyst screening.
Sartorius' Cubis® II balance series offers customisable modularity to ensure compliance with FDA directive 21 CFR Part II and EU Annex 11. This whitepaper outlines details of the technical solutions that will enable companies to achieve full compliance.
