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Unique testing regimen could prevent nuclease contamination
Biannual routine testing in the laboratory reduces both the likelihood of nuclease contamination occurrence and its impact, a study suggests.
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Assays
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Application note: Equivalency of PCR-based rapid sterility testing and the compendial culture method
Sterility testing is a critical component of release testing for any cell therapy product since microbial contamination of cell therapy products can potentially kill recipients.
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New method could replace microbiology CFU assay
A new, more efficient colony counting method called the Geometric Viability Assay (GVA) could enable microbiologists to test potential new drugs such as antibiotics more quickly.
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Under the microscope: QC compliance and environmental isolates
In this Q&A Microbiologics’ Brianna DeWitt explores how to make QC with environmental isolates simple and reliable while conquering compliance with regulations and standards.
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Application note: Low Endotoxin Recovery case study
This case study discusses the Low Endotoxin Recovery (LER) phenomenon in the drug testing and mitigation approach using the ENDO-RS® kit and ENDOLISA® assay for detecting endotoxin interference
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EMA publishes updated Q&A for ICH M10
An updated Q&A document for ICH M10 'Bioanalytical Method Validation and Study Sample Analysis’ has been published by the European Medicines Agency (EMA).
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Whitepaper: Futurising the QC lab with automated endotoxin testing
Nicola Reid, Associate Director of Product Management, Microbial Solutions, Charles River looks at implementing robotic endotoxin testing for throughput optimisation and human error reduction.
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Could Astellas antibody be first-line treatment for gastric cancer?
Monoclonal antibody Zolbetuximab plus mFOLFOX6 achieved significant progression-free survival in a Phase III trial for advanced gastric and gastroesophageal junction cancers.
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Application note: Revolutionising cell culture with cryopreserved pre-plated cell monolayers
Introducing an alternative means for time intensive cell culture processing by using cryopreserved cell monolayers.
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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.
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Does terminal sterilisation affect the quality of ophthalmic APIs?
EPR summarises research into the impact of gamma irradiation and ethylene oxide sterilisation treatments on European Pharmacopoeial compliance of common ophthalmic APIs.
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Critical steps when validating an assay or analytical method for cell and gene therapy products
Dr Kiren Baines, Analytics Lead at eXmoor Pharma, details some of the critical steps when validating an assay or analytical method, including key considerations for developing an experimental plan aligned with ICH guidelines.
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Bioprocessing & Bioproduction In-Depth Focus 2021
In this in-depth focus, experts discuss how a future skills shortage may impact the biopharma industry and the key considerations when validating assays and analytical methods for ATMPs.
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Globally harmonised microbial identification services with Charles River Accugenix®
Discover how to improve your microbial identification process, reduce costs and protect your manufacturing process and brand reputation.
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Application note: The Monocyte Activation Assay: The benefits of an animal-free test to show pyrogen-free pharmaceutical products
Fever is something that most of us have experienced. However, when we use medicines or medical devices, we expect them to improve our health – not to cause a fever.
