Whitepaper: Improved aseptic processes and monitoring to reduce FDA 483s
In recent years, the FDA response to companies with insufficient proof of control over their production has become more aggressive...
List view / Grid view
Whitepapers & App Notes
Application Note: The characterisation of polymorphs by thermal analysis
TGA-FTIR was used to characterize and distinguish between different polymorphs...
Whitepaper: Extractables and leachables testing – A risk based approach
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient...
Whitepaper: Data Integrity: Technical controls that demonstrate trust
Using Chromeleon 7 Chromatography Data System for enhanced data integrity...
Whitepaper: Downstream biopharmaceutical operations
The work presented here investigates the development and application of new bioprocess analytics in accordance with the aims of QbD...
Whitepaper: Nitrosamines: analysis for extractables and leachables
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex...
Whitepaper: Key to outsourcing method development and validation: A pragmatic approach
In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation...
Application note: Verification of pharmaceutical raw materials using the Spectrum Two N FT-NIR Spectrometer
In this application note, PerkinElmer describes how the Spectrum Two N™ FT-NIR spectrometer can be deployed using a workflow approach, suitable for a regulated environment, to overcome a range of different challenges in raw material identification...
Whitepaper: SWILE pick & decision dispense
The SWILE technology is the first fully automated true one-to-one gravimetric "pick & decision dispense" of compounds...
Whitepaper: Regulatory compliance in pharma – software requirements and solutions
In this whitepaper, Metrohm discuss the standardisation organisations put forward for analytical instruments requirements with a focus on software...
Application note: Raman Imaging: A powerful tool for the label-free characterisation of single cells and bacteria
With confocal Raman imaging the molecules of a sample can be chemically identified and their distribution can be imaged three-dimensionally...
Whitepaper: Raman-Based Nutrient Control in Bioprocessing Optimises 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...
Application note: Quantitative Analysis of Immunosuppressant Drugs in Serum Using a QSight 110 Triple Quadrupole Mass Spectrometer
This application note describes a sensitive, fast and accurate LC/MS/MS quantitation method utilising a QSight™ 110 Triple Quadrupole Mass Spectrometer for the simultaneous analysis of the immunosuppressant drugs tacrolimus, sirolimus and cyclosporine A in serum, using everolimus as an internal standard...
Application note: Advancing diagnostics and treatment with Raman imaging
With confocal Raman imaging the molecules of a sample can be chemically identified and their distribution can be imaged three-dimensionally...
Whitepaper: Development of an Efficient Manufacturing Process for Adenovirus
Large-scale downstream processing of viruses for clinical applications poses challenges different from those for many other biotherapeutics. These challenges mostly arise from the size and complexity of the virus...
