Flyer: API commercialisation
Eurofins CDMO works closely with clients to provide phase-appropriate solutions to balance any immediate and long-term API technology development and commercialisation needs.
List view / Grid view
Whitepapers & App Notes
Whitepaper: The performance of PROSOLV® EASYtab SP in four medium-dose
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.
Application note: Improving the efficiency of catalyst screening in drug substance development
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.
Whitepaper: Cubis® II Pharma Compliant by Design
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.
Application note: Conductivity bridge study – from benchtop metre and probe to automated Sievers M9
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.
Whitepaper: Emerging trends in regulatory expectations
Regulatory expectations nowadays focus on harmonisation of global regulations. This whitepaper by PQE looks at current and emerging trends in regulatory expectations.
Flyer: Your drug development partner
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.
Booklet: How to reduce hazards in the chromatography lab
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.
Whitepaper: Analytical criteria in bacterial endotoxin testing using LAL and rFC
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…
Whitepaper: Head-to-head comparison of hydrogen peroxide and steam sterilisation
The pharmaceutical industry is increasingly using different sterilisation technologies rather than steam sterilisation. This increase is driven by the need for sterilising thermo-labile products or areas that cannot be dimensioned as a pressure vessel (barrier systems such as Closed Restricted Access Areas or Isolators), under “softer” conditions.
Flyer: Biologicals drug substance and drug product
Eurofins CDMO provides a full suite of drug development services encompassing development of the bioprocesses, formulation screening, analytical development, pre-clinical testing, sterile and non-sterile bio-manufacturing of clinical trial batches and orphan drugs.
Application Note: Sensitive quantitation of the ADC ado-trastuzumab emtansine free cytotoxic drug DM1 in serum using MicroLC-MS
Antibody-drug conjugates (ADC’s) are targeted cancer therapeutics that deliver a cytotoxic agent, the payload, to the tumour.
Application Note: Highly selective bioanalytical quantitation method for analysis of R and S amlodipine enantiomers in human plasma using LC-MS/MS
Amlodipine is an angioselective calcium channel blocker used to treat high blood pressure, chest pain and other conditions caused by coronary artery disease.
Whitepaper: Solubility: Importance, measurements and applications
The solubility of a compound in organic solvents or water is equally important for screen design and later for process development.
Flyer: Sterile manufacturing – finished dosage forms
Eurofins CDMO provides a wide range of aseptic processing services for all drug product configurations with flexibility to accommodate a wide range of compounds, primary packaging systems, batch sizes and fill volumes to help develop your Active Pharmaceutical Ingredient or bulk product into Finished Dosage Forms for use in clinical…
