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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).
Delivering confident QA and QC in pharmaceutical manufacturing is of critical importance. This article discusses how the latest chromatography data systems are ensuring compliance with modern regulatory requirements.
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.
Duplex oligonucleotides (OGN) with lipid nanoparticles (LNPs) as delivery vehicles for different therapeutic indications are of great interest in pharma, exemplified by the recent approval of Onpattro from Alnylam Pharmaceuticals. Liquid chromatography is an essential analytical technique in the characterisation of LNPs containing OGNs. This brief review is intended to…
The articles in this in-depth focus discuss the importance of biosimilars and how liquid chromatography can be used to ensure the purity of lipid-based nanoparticles for drug delivery.
This in-depth focus highlights how liquid chromatography coupled to mass spectrometry (LC-MS) can be used to characterise proteins, what to do to improve regulatory compliance when using chromatography and the risks posed by underestimating bacterial contaminants in cleanrooms.
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?
Technetium-99m (99mTc) is a synthetic radioisotope that is used worldwide to produce radiopharmaceuticals that are mainly used for diagnostic purposes in nuclear medicines. The purity of the final radiopharmaceutical (99mTc-R) can be confirmed by applying chromatographic methods. This method is based on different rates of movement of substances in a…
In this in-depth focus are articles on consistent analytical techniques when changing laboratories and using chromatographic techniques to identify impurities in radiopharmaceuticals.
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.
This free poster compiles all basic chromatography principles needed to develop and run flash and prep HPLC methods.
The efficacy, safety and pharmacokinetic properties of a protein therapeutic substantially depend on the molecule having the right structure. This article reviews current methods used for obtaining higher order structure information of biotherapeutics.
Eshmuno® CP-FT cation exchange resin is specifically designed to provide efficient removal of monoclonal antibody (mAb) aggregates in the flow-through frontal chromatography mode of operation enabling loading capacities 10-times higher than traditional bind/elute CEX chromatography. It facilitates greater manufacturing flexibility and process intensification while reducing the overall cost for the…
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.
The elimination of product and process related impurities is essential to the safety and efficacy of biopharmaceuticals.
