More in quality, microbiology and contamination control – Page 2
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Content hubWebinar: Paradigm Shift in Analytical Development and QC
Pharmaceuticals, CMDO and testing laboratories need modern and efficient analytical procedures to handle complex drug analytics and evolving regulations for development and quality control. The Analytical Quality by Design framework and recent ICH guidelines emphasize the importance of robust and well-understood QC procedures while allowing flexibility when ...
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ArticleInvesting in the future of pharmaceutical microbiology QC
Troy Wright, Senior Vice President and Global Head of Quality at Abzena, shares an overview of current major challenges within pharmaceutical microbiology quality control, including the lack of staff knowledge in advanced technologies and how the sector’s importance can be overlooked, despite its key role in bringing safe, quality products ...
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ArticleEnvironmental Monitoring In-Depth Focus 2024
This in-depth focus features articles on environmental monitoring trends such as digitalised management of EM data, as well as endotoxin detection.
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ArticleGuide to Outsourcing 2024
In this Guide to Outsourcing article, Jessica Rayser, Associate Director Product Management, Accugenix®, explores how outsourcing microbial identification can benefit technicians and facilitate the most accurate identification possible.
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ArticleAdvancing environmental monitoring systems for CGT manufacturing
Gill Lewis, QP and Chief GMP Consultant, eXmoor Pharma. discusses the company's approach to environmental monitoring and the key challenges faced during integration at its Cell and Gene Therapy Centre in Bristol, a facility which received a GMP license from the MHRA in August.
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ArticleCPHI Milan 2024: everything you need to know
CPHI Milan takes place in October, covering a wide range of topics from packaging and drug delivery to integrated pharma.
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ArticleQuality from the start: designing a scalable AAV production platform
This Feature Partnership discusses AAVs and how manufacturers can overcome the key development challenges and create a scalable AAV production platform.
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ArticleEuropean Pharmaceutical Review Issue 4 2024
European Pharmaceutical Review Issue 4 includes articles on regulation, bioproduction, environmental monitoring, packaging and drug delivery.
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ReportPharma Horizons: Biologics
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments in pharmaceutical biologics for drug development, pharmaceutical manufacturing and quality control.
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ReportPharma Horizons: Formulation
European Pharmaceutical Review’s latest Pharma Horizons report provides insight on key developments within pharmaceutical drug formulation for drug development, pharmaceutical manufacturing and quality control.
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ArticleUncovering the potential of ADCs to target tumours
Antibody drug conjugates (ADCs) are set to play a pivotal role in the future of oncology, thanks to their potential to offer targeted treatments with a lower risk of side effects. Here, Mary Jane Hinrichs, Senior Vice President of Early Development at Ipsen, examines how ADCs could transform treatment options ...
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ArticleEndotoxin standards: reflection and recommendation
Dr Radhakrishna Tirumalai and Karen Zink McCullough reflect on the recent opportunity to update the user requirements document relating to reference endotoxin standards.
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ArticleQA/QC Microbiology In-Depth Focus 2024
This in-depth focus features articles on single temperature incubation, endotoxin standards and aseptic connections in pharmaceutical manufacturing.
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ArticleEuropean Pharmaceutical Review Issue 3 2024
European Pharmaceutical Review Issue 3 includes articles on microbiology, downstream bioprocessing and drug development. Register your details now to download this exclusive content.
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ArticleSFC-MS: advancements and applications in pharmaceutical quality control
Modern supercritical fluid chromatography systems coupled with mass spectrometry are empowering pharmaceutical QC laboratories. Here, analytical experts from the University of Liège discuss applications from impurity and nitrosamines detection to purity analysis.
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VideoWebinar: Overcoming contamination risks during biologicals production: Mycoplasma & virus testing
Listen to the discussion on contamination risks in biomanufacturing, featuring mycoplasma and virus testing per European Pharmacopoeia and USP standard.
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ReportPharma Horizons: Cell and Gene Therapy
This report is dedicated to exploring some of the latest innovations in the cell and gene therapy space, from development and quality control, through to manufacturing and clinical trials.
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ArticleICH Q14 – latest guideline on analytical procedure development
Here, Dave Elder delves into the newly issued ICH Q14 guidance on analytical procedure development, discussing its impact during commercial phases as well as clinical development.
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ArticleEffective data quality governance: challenging five common myths
It is a well-established expectation that regulatory processes will become increasingly data focused, which places a new urgency on data quality governance in the pharmaceutical industry. In this Q&A Steve Gens and Preeya Beczek present a pragmatic view of what is involved.
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ArticleUnder the microscope: Using recombinant reagents for BET
Veronika Wills, Associate Director, Global Technical Services at Associates of Cape Cod, Inc (ACC), discusses in-depth, motivations and strategies surrounding the use of recombinant reagents for bacterial endotoxin testing.