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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.
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…
