Article: Why filter validation matters in dissolution testing
Syringe membrane filter selection/validation methods to assess analyte loss due to membrane filter adsorption in pharmaceutical quality control tests.
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Whitepapers & App Notes
Brochures: Extractables & leachables services
Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
Whitepaper: Drug shortages – why do they happen and how can we stop them?
This whitepaper from NSF looks at the key causes of drug shortages and what we can do to stop them.
Case study: How to maximise performance and productivity of existing pharmaceutical sterilisation lines?
New trends in automation and process control for sterilisation systems by integrating robotised loading and unloading technology.
Whitepaper: What our remediation projects are saying about the industry
31 January 2020 | By
Based on a study of the pharma industry’s remediation projects, this white paper from NSF looks at the key issues behind GMP non-conformance. It also includes questions to ask yourself when making changes to your processes and systems.
Guide: Chromapedia Volume 1: Detection Methods
When performing chromatography separation, it is essential to determine the precise point when a substance is eluted from the column or cartridge to achieve optimal fractionation.
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.
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.
