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Application note: Workflow for high-throughput glycoprofiling of rituximab
Protocol for purification, reduction, and SEC-MS glycoform analysis of a therapeutic monoclonal antibody (mAb)
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QA/QC
podcasts
EPR Podcast Episode 16 – Evolving QC for Cell & Gene Therapy – Félix Montero Julian and Thomas Jones, bioMérieux
What’s new in the cell and gene therapy landscape? What is the role of quality control in efforts to scale up manufacturing of CGT products and alleviate talent constraints? Find out more in this podcast with bioMérieux…
whitepaper
Under the microscope: How AI can help minimise compliance risks
Dr Joe DiCapite, Vodori Director of Strategy, discusses why he believes a revolution in material review software is coming.
whitepaper
Application note: Analysis of voglibose by postcolumn derivatisation method
This application note introduces the analysis of voglibose tablets as described in the 17th Edition of Japanese Pharmacopoeia.
article
Pharma’s green mission: trends in bacterial endotoxin testing
Having recently conducted a project to implement more sustainable, reliable and efficient bacterial endotoxin testing across the global Roche corporation, those involved in the project discuss with EPR’s Hannah Balfour the key takeaways from their implementation and validation, as well as current trends in bacterial endotoxin testing.
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Make confident operational decisions by understanding your microflora
Are you leveraging all the information from your QC data? A secure, compliant and powerful data management tool is critical for maintaining a state of control.
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Your endotoxin experts
A new age of sustainability: discover how ACC’s PyroSmart NextGen® recombinant Cascade Reagent (rCR) enhances bacterial endotoxin testing (BET).
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An Annex 1 and Pharma 4.0 perspective on water quality
Pharma 4.0 is coming and is further driven by the recent update of the EU GMP Annex 1 regarding manufacturing of sterile medical products, setting new regulatory expectations in all manufacturing processes. Here, Isabella Jul-Jørgensen from the University of Denmark focuses on sterile water quality and how the new requirements…
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Microbiology In-Depth Focus 2022
Features in this in-depth focus review the advances in bacterial genome sequencing and its role in pharmaceutical microbiology, as well as key considerations for when implementing and validating recombinant Factor C (rFC) endotoxin testing. Plus, coverage of how proposed US pharmaceutical regulation could impact European companies, in-house lentiviral vector manufacturing…
news
Validating FTIR for rapid cleaning verification
Researchers simulated the effect of surface roughness on Fourier-transform infrared (FTIR) spectroscopy, developing guidance for validating the technique for rapid cleaning verification.
news
Nitrogen dioxide for sterilisation of protein-filled polymer-based syringes
Nitrogen dioxide (NO2) gas found not to ingress and cause protein degradation when sterilising polymer-based prefilled syringes (P-PFSs), according to study.
article
Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
news
HPLC-MS/MS for NDMA impurity determination in sartans
EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
news
Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
news
HPLC determination of common cold formulations
EPR highlights a high-performance liquid chromatography (HPLC) method which enables the detection of both chlorpheniramine maleate and ibuprofen in formulation.
