Whitepaper: Enabling single-software multiple attribute methodology (MAM) for assessment of biopharmaceutical product quality attributes
Application of BioPharmaView™ 3.0 Software for a Streamlined MAM Workflow...
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Whitepapers & App Notes
Whitepaper: The effect of silicification on the roller compaction performance of MCC
Roller compaction, or dry granulation, is a manufacturing method for pharmaceutical and nutraceutical tablets that continues to gain importance...
Whitepaper: Applying single-use efficiencies to room-to-room fluid transfer
This white paper explains how a wall pass-through system that incorporates single-use processes can reduce contamination risks and the use of valuable natural resources and waste disposal while increasing productivity and efficiency...
Handbook: Thermal analysis in practice: tutorial examples
Before you can begin to develop a method, you must be clear about the information and the quality of the data you want to obtain from a sample. This very often determines the possible techniques and methods that can be used...
Application Note: Applying QbD in Process and Impurity Control Strategy Development
Global regulatory authorities continue to push Quality-by-Design (QbD) on pharmaceutical groups and their supporting corporate informatics infrastructure...
Handbook: Thermal analysis in practice: tips and hints
This new handbook is designed to help you navigate through the different measurement techniques, method parameters and sample preparation procedures. The aim is to provide you with useful tips and hints on how to obtain the best possible results from your measurements...
Application Note: Identification of counterfeit phosphodiesterase inhibitors using NIR spectroscopy and chemometrics
The counterfeiting of pharmaceuticals for economic gain is a growing problem in a modern society within which medicines play a major role...
Handbook: Pharmaceuticals: collected applications
In this handbook, collected applications for pharmaceuticals are examined...
Application Note: Real-time quality prediction of continuously produced pharmaceutical granules
Continuous manufacturing approaches have been gaining interest in the pharmaceutical industry. They allow shorter production times, enable novel reaction pathways, increase assurances of product quality and help to realise cost savings...
Handbook: Evolved gas analysis: collected applications
Mass spectrometry is an extremely sensitive method for the detection and identification of traces of gaseous substances. The technique can quantify atoms or molecules and provide chemical and structural information (functional groups and side chains) on the compounds analysed...
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...
Handbook: Validation in thermal analysis: collected applications
It is important to realise early in your project that if you are validating a computerised system, you do not just concentrate on the computer hardware and software. Validation encompasses more, as will be discussed within this handbook...
Application Note: Raman-based nutrient control in bioprocessing optimizes viable cell density and protein glycation
Production of protein therapeutics by mammalian cells is the most widely used bioprocess because of its ability to properly produce and fold a recombinant protein...
Handbook: Thermal analysis in practice: collected applications
For quantitative results, the curves obtained from the measurement instrument have to be properly evaluated. Often, several different procedures are available for calculating numerical results from the curves...
Application Note: Raman monitoring of active coating composition
Pharmaceutical tablets are coated for a variety of reasons, such as to enhance the appearance, taste, chemical stability, or swallowability of the tablet or to create a particular release profile for the active pharmaceutical ingredient (API)...
