Whitepaper: Detection of mycoplasma in biopharmaceuticals vaccines and gene cell therapies
Mycoplasma are a form of bacteria that are characterized by the absence of a cell wall surrounding the cell membrane.
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Whitepapers & App Notes
Application note: A CMC Development Decision Support Tool for Batch Genealogy Management
Successful completion of product development for active pharmaceutical ingredients (APIs) is a tremendously challenging task, in large part due to the amount of analytical data collected.
Whitepaper: Complex Generic APIs: A Primer
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
Whitepaper: Product characterisation: reveal your molecule earlier, faster and with accuracy
Partnering for product characterisation can streamline drug development and create efficiencies in moving from concept to clinic.
Application note: TOC for cleaning validation: swab recoveries of worst-case compounds (feasibility testing)
THE PARENTERAL Drug Association Technical Report No. 49 serves as a resource to help guide the development and evaluation of a cleaning validation programme.
Application note: Cost review of water for injection systems
Vapour-compression-based WFI production has a total cost of ownership that is less than or equivalent to that of a membrane-based system and significantly less than that of a typical multiple-effect-based system. The following whitepaper provides examples that illustrate system designs that are relatively basic, yet typically sufficient.
Application note: Non-targeted host cell protein monitoring in downstream process samples using micro Pillar Array Columns combined with mass spectrometry (μPACTM-MS)
This whitepaper reports on the use of μPAC™ in combination with MS for the characterisation of HCPs and their monitoring during downstream processing.
Whitepaper: Innovative analytical techniques for bioprocess investigation
WITH THE RISE of metabolites/molecules production using complete living cells or their components (bacteria, enzymes, chloroplasts, etc), which is also termed bioprocessing, it has become increasingly important to control the different production steps and analyse the different biological materials.
Application note: Biologic drug identification at fill and finish
Pharmaceutical and biotechnology manufacturers must ensure the quality of materials – from incoming raw material through finished product.
Application note: Identifying microparticles with Raman imaging
Microparticles can be found everywhere, from pigments in paint and titanium dioxide in sunscreen to microplastics in water.
Case Study: Controlled Nucleation: more than just a homogenization tool
Optimizing the freeze-drying pharmaceutical process.
Whitepaper: An Update for Pharmaceutical Stress Testing Enabled by Modern Informatics Technologies
Stress testing or forced degradation is well recognized as a fundamental part of the drug development process, specifically related to purity through control of stability.
Research Report: Industrial Transformation Challenging in Life Sciences
Industrial transformation is a very real phenomenon. Companies are going beyond standard practices to seek out step-change improvement in industrial operations, with several companies already reporting "dramatic results".
Application note: Determining the structure of impurities
Most, if not all pharmaceutical companies will have experienced a product, that has been on the market for a long time, to suddenly and unexpectedly trigger a signal for an unknown substance in the quality control (QC) laboratory approval process.
Scientific poster: How to Automate Water Content Determination in Pharmaceuticals
The water content of pharmaceuticals strongly influences their quality, shelf-life, and stability as well as the release of the active substances. The determination of water content is, therefore, vital in pharmaceutical analysis.
