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.
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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.
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.
The following excerpt is the introduction from MECO’s whitepaper titled, A Cost Review of WFI Systems. You can download the full version of this whitepaper at MECO’s website.
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.
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.
Pharmaceutical and biotechnology manufacturers must ensure the quality of materials – from incoming raw material through finished product.
Microparticles can be found everywhere, from pigments in paint and titanium dioxide in sunscreen to microplastics in water.
Optimizing the freeze-drying pharmaceutical process.
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.
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".
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.
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.
The Chestny ZNAK is a national track & trace system created by the Center for Research in Perspective Technologies.