Claudia Benati, Senior Scientific Director at Eurofins BioPharma Product Testing (Eurofins BPT) and Qualified person for Advanced Therapies (ATMPs), and Dr Anke McCartney, Global Key Account Manager, Eurofins BPT, discuss the challenges faced by the pharmaceutical industry in the field of analytical testing of COVID-19 vaccines in these unprecedented times…
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Liquid Chromatography - Mass Spectrometry (LC-MS)
Since their debut, the range of applications for which deep ultra-violet (DUV) handheld devices are used in the pharmaceutical setting continues to grow. For pharmaceutical or biopharmaceutical cleaning verification, there is a requirement for a versatile and adaptive analytical and imaging device to demonstrate and document cleaning cycles. Here, Krishnakumar…
The new general chapter (2.5.42) outlines three procedures for the analysis of N-nitrosamine impurities in active substances.
Pharmaceutical process development involves multi-disciplinary groups of chemists and analysts whose goal it is to create the API by the cheapest, most efficient route while ensuring product safety through effective impurity control measures.
Native liquid chromatography coupled to mass spectrometric analysis for the assessment of higher order structures of proteins
The accurate measurement of the molecular mass of proteins is an essential component of protein characterisation. In this article, Ioannis Papayannopoulos discusses the applications of native protein chromatography coupled to mass spectrometry to enable the characterisation of tertiary structures and non-covalent interactions.
This issue focuses on the regulatory challenges associated with increased ventilator demand during COVID-19, as well as articles investigating the use of LC-MS for protein characterisation, improving efficiency with continuous processing and the risks posed by cleanroom contaminants. Other features discuss the continual evolution of solid dosage forms and the…
Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
Liquid chromatography mass spectrometry (LC-MS) is a highly accurate and sensitive platform used in biopharmaceutical research and development.
Genotoxic impurities (GTI’s) are intermediate, reactive products or degradants formed during drug synthesis, formulation or storage.
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
Overview on how ionBench products can help LC/MS users with dedicated furniture for their instrumentation
Biopharma developers and manufacturers need to know their molecules and understand their manufacturing processes better than ever before. In this article, Mike Wilson discusses the benefits of mass analysis in biopharma and the current challenges of adopting new technologies.
Today’s biopharmaceutical developers need accurate and precise information at all stages of research and development in order to bring safe and effective therapies to patients. This in-depth focus features novel perspectives from industry experts that serve to illustrate which technologies and systems are benefitting this cause.
Application Note: Sensitive quantitation of the ADC ado-trastuzumab emtansine free cytotoxic drug DM1 in serum using MicroLC-MS
Antibody-drug conjugates (ADC’s) are targeted cancer therapeutics that deliver a cytotoxic agent, the payload, to the tumour.