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X-ray imaging enables automated parenteral product particulate inspection
X-ray imaging was able to detect all common particulates in lyophilised drug product and provide information of the cake structure in a new study.
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Hannah Balfour (European Pharmaceutical Review)
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Pepsin key for fast and efficient AAV peptide analysis, finds study
Researchers have created a new workflow using pepsin to expedite the LC-MS analysis of adeno associated virus (AAV) capsid proteins for gene therapies.
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Stabiliser-free PLGA nanoparticle formulation shows promise for drug delivery
Scientists have developed a stabiliser-free, non-toxic poly(lactic-co-glycolic acid) (PLGA) nanoparticle formulation for use in drug and vaccine delivery.
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New mass spectrometry technique to detect low-level host cell proteins
Host cell protein-automated iterative mass spectrometry (HCP-AIMS) enables the robust, reproducible and high throughput analysis of host cell proteins, says study.
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Excipient knowledgebase to optimise the formulation and dosing of drugs
Researchers have compiled a repository of clinical and in vitro data for excipients to enable their potential to interact with drugs to be modelled.
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Why is there no standard MALDI-TOF MS procedure for bacterial identification?
Here, EPR summarises a review outlining how different sample preparation protocols, culture media and conditions affect MALDI-TOF MS identification of bacteria.
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FDA sets up Novel Excipient Review Pilot Program
Manufacturers can submit their novel excipients for FDA review under the voluntary Novel Excipient Review Pilot Program.
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Using mass spectrometry data to expedite drug discovery
A new algorithm uses mass spectrometry data and machine learning to predict whether a molecule has been discovered before, saving drug discovery time and cost.
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Do we need gloves? Cleanroom dressing processes may not, finds study
Research indicates, with robust handwashing protocols, there is no difference in cleanroom garment bacterial contamination with or without gloves in the dressing process.
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Is your microbial air sampler fit for purpose?
Here, EPR summarises Tim Eaton’s explanation of the importance of assessing biological collection efficiency when selecting an air sampler.
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Mass spectrometry for gene therapy vector analysis
Researchers show combining mass spectrometry and a gas-phase electrophoretic mobility molecular analyser improves detection of full and empty virus-like particles for gene therapies.
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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
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Biological safety cabinet safest place for parenteral product compounding, says study
Researchers recommend the biological safety cabinet be used whenever possible to compound parenteral products in a clinical setting.
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New radionuclides network to revolutionise nuclear medicine and molecular imaging
The European PRISMAP consortium will provide access to novel radioisotopes for medical research and promote the development of new radio-medicinal products.
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HIV treatment evolution: drug development to meet the modern needs of patients
In this article, European Pharmaceutical Review’s Hannah Balfour explores some of big pharma’s latest developments in HIV treatment, with commentary from ViiV Healthcare’s Head of Research and Development, Kimberly Smith.