Guide: Russian Serialization and How to Comply
The Chestny ZNAK is a national track & trace system created by the Center for Research in Perspective Technologies.
List view / Grid view
Whitepapers & App Notes
Whitepaper: EU GMP Draft Annex 1: Potential impact on cleaning and disinfection
CLEANING AND microbial contamination control are critical focus areas in the pharmaceutical and medical device industries.
Application note: Comprehensive cell culture profiling of iPS cells using LCMS Q-TOF – simultaneous analysis of SIM and Scan mode in a single run
In this work we report the metabolic analysis of cell cultures using a high-resolution accurate mass LCMS/MS Q-TOF platform to identify metabolite markers of genomics and phenotypic changes.
Whitepaper: Hydrogen peroxide: Is material compatibility a real challenge for this decontamination technology?
One of the most important challenges of the hydrogen peroxide technology has traditionally been the material compatibility.
Scientific poster: Time for science – Don’t let your time evaporate
Get some hints on how you can optimize the most time-demanding steps in your lab.
Brochure: Drug Development Services
Your Global Drug Development Organization For Analytical Laboratory Testing and Clinical Research.
Whitepaper: Know your ions – overcoming the limits of HPLC with ion chromatography
What’s the difference between High Performance Liquid Chromatography (HPLC) and Ion Chromatography (IC)? What are the capabilities and limitations of each technique? Knowing these differences can actually make a huge difference.
Whitepaper: A study of the peristaltic life and pumping performance of three TPE tubing products to assess their suitability for continuous bioprocessing
Drug manufacturers are increasingly adopting continuous bioprocessing to manufacture biologics as efficiently as possible. This is being driven by a need to reduce production costs and prices of pharmaceutical products. Furthermore, the FDA has stated its support for the implementation of continuous bioprocessing. A key consequence of continuous bioprocessing is…
Whitepaper: LIMS DIY: Is a Home-Grown or a Purchased LIMS Right For Your Laboratory?
Most laboratories today now have some form of LIMS to help manage their workflow. There are many types of LIMS, ranging in complexity from spreadsheets to intelligent programs that manage nearly every lab function.
Article: Data integrity – Metrohm software products make compliance easy
Data integrity requires data to be complete, consistent, and accurate throughout their complete lifecycle, providing full transparency and traceability. Industry guidelines such as ALCOA and ALCOA+ describe these requirements, which are used by the FDA, WHO, PIC/S and GAMP. All major Metrohm software products make compliance with the ALCOA and…
Application note: New Peak Detection Using the SCIEX OS Software 1.5 MAM Workflow
Liquid chromatography mass spectrometry (LC-MS) is a highly accurate and sensitive platform used in biopharmaceutical research and development.
Scientific poster: Common Laboratory Techniques in the Drug Discovery Workflow
The characterization of novel therapeutics involves many chemical processes.
Whitepaper: The Gap Between LIMS Capabilities and QC Microbiology Needs
LIMS requires a high degree of customization to meet QC Microbiology requirements. This means LIMS implementations often lock users into a functionality set that can’t accommodate technology advancements and regulatory changes without considerable investments, time, effort and money.
Application note: Calculating maximum allowable carryover (MAC) for cleaning validation
This application brief presents a framework for how to establish acceptance criteria limits using TOC to comply with FDA best practice guidance for the life cycle approach to cleaning validation.
Whitepaper: Pharmaceutical serialisation: the end of the beginning – moving beyond compliance
Confirming product authenticity, combating counterfeiting and preventing product diversion are key for compliance within the global supply chain. This whitepaper focuses on pharmaceutical serialisation and solutions to combat producers of counterfeit products.
