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Standardization and alignment of the drug development and manufacturing process allow high-performing companies to globally source and efficiently produce pharmaceutical and biopharmaceutical products.
ADVANCES in biotherapeutics are generating an increasing range of complex molecules that present unique and often complex purification challenges.
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.
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.
To ensure that USP/EP standards are met, TOC of highly purified water can be determined by internal purification-process monitoring.
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.
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources. They may be added intentionally in synthesis, or may be present as contaminants, (e.g., through interactions with processing equipment or by being present in components of the drug product) and are consequently detectable in the…
Biocidal products manufactured in or imported into the EU or European Economic Area must be authorised for compliance with the requirements of the EU Biocidal Products Regulation (BPR) and any relevant national legislation before being placed on the market.
HPLC is critical to the discovery, development and eventual commercialization of pharmaceutical products. HPLC is the benchmark analytical method in the pharmaceutical industry due to its ability to score such high marks in analytical validation characteristics; including accuracy, precision, limit of detection, specificity, linearity and range, and ruggedness.
Light Scattering of macromolecules in solution has seen increasing interest over the past decades from scientists studying polymers and proteins.
Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.
Generic screening to provide fast solutions for chiral method development, whether needed for routine analytical use, trace analysis, LC/MS or preparative LC, has become increasingly important.
In this paper the suitability of reagent water for LC-MS biomedical analyses will be evaluated and the role of water quality in achieving sensitive and reliable LC-MS analyses will be discussed.
Spray-dried lactose is widely used as a filler and binder in the pharmaceutical industry, but many adults are not able to digest lactose. Therefore, it is indispensable to provide alternatives to lactose-containing drugs in order to make them suitable for lactose intolerant patients.
Having a holistic data infrastructure in place can not only save time by providing key real-time information and money through readily-accessible, enterprise-wide intelligence, it can also ensure stress-free operations.
