The new chapter describes a method for bacterial endotoxins (BET) testing using recombinant factor C (rFC) instead of limulus amoebocyte lysate (LAL).
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The promise of virally vectored DNA and mRNA vaccines is tremendous in terms of vaccine safety and speed of response to new pathogens. This article explores why these approaches have attracted attention in light of the COVID-19 pandemic and why they are highly appropriate for rapid vaccine development and deployment.
Separate your science from the status quo, advanced solutions offering superior retention time stability, flexible integration and minimal maintenance.
Charged aerosol detection is a technique capable of measuring any non-volatile and many semi-volatile species in a pharmaceutical applications.
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
Researchers have used CRISPR-Cas to edit the genes of contaminating proteins in mammalian cells used to produce recombinant-protein drugs, which could reduce costs and strengthen quality.
Included in this in-depth focus are articles examining the importance of child-resistant medicinal packaging and analysing whether continuous processing is the future for pharma.
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…