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ICH opens consultation on Q3E drug impurities guideline on leachables
Draft publication is set to expand its frameworks for new medicinal products, including cell and gene therapies.
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ICH guidelines
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The key role of GMP analytical testing for drug products
Ensuring the quality, safety and efficacy of new pharmaceutical products is critical to bring them to market successfully. Here, Adragos Pharma’s Amalia Stroumpou, explains how the key to all three of these factors is rigorous good manufacturing practice (GMP) analytical testing.
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Driving QbD as a quality standard in drug development
To facilitate Quality by Design (QbD) in becoming a true standard approach for drug development, pharma should attend regulatory expectations and pursue innovative frameworks that guarantee high-quality levels, researchers urge.
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Rapid HPLC method could improve formulation QC studies
Researchers state the novel high-performance liquid chromatography with diode-array detection (HPLC-DAD) method can be utilised in routine quality control analysis of levofloxacin in pharmaceutical formulation and bioequivalence studies.
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Revised Annex 1 now effective
The much-anticipated Annex 1 revision is finally operational; manufacturers in the EU must be compliant with the GMP guideline updates when manufacturing sterile medicinal products.
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Establishing quality assurance in personalised preparations
A paper has highlighted a drug product quality assurance programme for personalised preparations, including application of a preventive or corrective measures (CAPA) system.
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The evolution of AAVs in cell and gene therapy
AAV development for cell and gene therapy in 2023 is being impacted by manufacturing and regulation challenges, however advancing technologies offer opportunity, according to leaders in the field.
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NITROSAMINES: Where now?
While determining active intakes and control strategies for short chain alkyl N-nitrosamines was relatively easy to establish, nitrosamine drug substance-related impurities continue to present challenges. Here, Dave Elder reflects on the three main instances of nitrosamine contamination in drug products.
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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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New developments in the pharmaceutical stress testing industry
A team of American scientists report on some recent developments in the realm of pharmaceutical stress testing, or forced degradation, practices relating to solid dosage forms, bringing some valuable clarity for drug developers.
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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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Future proofing risk assessment: preventing the next nitrosamine incident
The valsartan nitrosamine contamination issue was probably the most significant quality issue to hit the pharmaceutical industry in a decade. Here, Dave Elder outlines how agencies and manufacturers are dealing with the problem and indicates the knowledge gaps that might be concealing future complications.
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Less than lifetime limits for N-nitrosamine mutagenic impurities
Here, Dave Elder discusses the determination of less than lifetime (LTL) limits for highly potent N-nitrosamine compounds and how to ensure safety in dosing.
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O-glycan analysis of therapeutic proteins enabled by O-glycoprotease
Glycosylation of therapeutic proteins is important to biologic drug development and is a critical quality attribute that is monitored during manufacturing. Analysis of O-glycans is technically challenging compared to that of N-glycans. In this review, Xiaofeng Shi, Saulius Vainauskas and Christopher H Taron summarise current O-glycan analytical approaches, describe the…
