Whitepaper: Manage Your Risk: Monitoring the Environment of Aseptic Processes
Risk assessment consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.
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Whitepapers & App Notes
Case study: Merck Leverages Data and Analytics to Support New Continuous Drug Manufacturing Processes
Over the past couple of years, the European Medicines Agency and US Food and Drug Administration have given approvals to a handful of pharmaceutical companies to manufacture drug products using continuous manufacturing processes.
Scientific poster: Chromatography essentials for performing perfect separations
This free poster compiles all basic chromatography principles needed to develop and run flash and prep HPLC methods.
Application note: Rapid Analysis of Genotoxic Nitrosamines by HPLC-MS/MS
Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
Whitepaper: Impact of the Claristep® Filtration System on recovery and adsorption of various therapeutic proteins at low sample volumes
Comparison of the Sartorius Claristep Filtration System with standard sample preparation using syringe filters.
Article: Tips & tricks: sensitivity gains in LC-MS
The prerequisite of any highly sensitive analysis via HPLC-MS (high performance liquid chromatography coupled to mass spectrometry) is the use of ultrapure solvents and reagents and careful handling of all associated materials, consumables, and systems.
Whitepaper: Stability testing blister packs inspected with Sepha’s VisionScan test method
It is a requirement of both US and EU regulations that pharmaceutical packaging operations demonstrate integrity. As technology-based solutions remain somewhat of an unknown quantity, this whitepaper tests the hypothesis that Sepha’s VisionScan test method is considered non destructive.
Journal article: Validation of Milliflex quantum for bioburden testing of pharmaceutical products
Pharmaceutical drug products must fulfill specified quality criteria regarding their microbial content in order to ensure patient safety. Drugs that are delivered into the body via injection, infusion, or implantation must be sterile (i.e., devoid of living microorganisms).
Whitepaper: Supelco preparative HPLC products for pharmaceutical development and production
There is an increasing need for purified materials in the development and production of pharmaceutical products. FDA and other regulatory agencies continue to require more stringent purity requirements on active pharmaceutical ingredients (API), including most recently chiral purity.
Whitepaper: Remediation requires transparency: A process for managing quality and compliance
Standardization and alignment of the drug development and manufacturing process allow high-performing companies to globally source and efficiently produce pharmaceutical and biopharmaceutical products.
Scientific poster: Advantage of antibody based selectivity in the purification of biologics
ADVANCES in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges.
Whitepaper: Monocyte activation test (MAT)
For pharmaceutical companies, patient safety has always been the priority. That’s why pyrogen detection has become a mandatory Quality Control test for release of any parenteral drug.
Scientific poster: High-throughput proteome analysis using 50 cm micro pillar array columns (μPAC™)
The practice of bottom-up proteomics relies to a large extent on the separation performance that can be achieved with state-of-the art nano LC-MS/MS equipment.
Whitepaper: USP 643: the wrong end of the stick
To ensure that USP/EP standards are met, TOC of highly purified water can be determined by internal purification-process monitoring.
Article: LC-UV-MS method development for antibody drug conjugates using a non-toxic ADC-mimic
Antibody-drug conjugates (ADC) represent a rapidly emerging class of biotherapeutic molecules, which harness the specificity of monoclonal antibodies (mAb) to selectively deliver highly potent cytotoxic drugs. Like all biotherapeutics they require significant analytical characterization.
