More in quality, microbiology and contamination control – Page 3
-
ArticleGuide to Testing 2024
In this Guide to Testing articles explore limit of detection requirements for microbial testing of short-shelf-life products and sustainable endotoxin testing.
-
ArticleEuropean Pharmaceutical Review Issue 2 2024
European Pharmaceutical Review Issue 2 includes articles on cell and gene therapy, from supply chain and manufacturing to microbial testing.
-
VideoWebinar: How Pfizer utilises Enzyme Indicator technology for bio-decontamination validation
Melanie Eggers is a Sterilisation Validation Project Support Engineer at Pfizer Belgium. In this webinar, she explains how Pfizer has adopted Enzyme Indicator (EI) technology for its VHP bio-decontamination procedures. She outlines the differences in EIs compared to more traditional Biological Indicators and the way in which Pfizer utilises the ...
-
ArticleMonitoring pharmaceuticals in the environment
Andreas Häner, an environmental risk assessor at Roche in Group Safety, Security, Health & Environmental protection (SHE), speaks to EPR about how the pharmaceutical industry monitors manufacturing emissions that can impact local environments.
-
ArticleEndotoxin testing: the international regulatory landscape
In this extract from EPR’s Pharma Horizon’s report, Evelyn Der, Lindsey Silva and Carmen Marín Delgado de Robles from Roche Group discuss the regulatory guidelines for bacterial endotoxin testing and the move towards adoption of recombinant methods.
-
ReportPharma Horizons: Environmental Monitoring
This report is dedicated to exploring some of the latest advances in pharmaceutical environmental monitoring, covering topics from contamination control and cleanroom validation through to emerging technologies for bacterial endotoxin testing.
-
ArticleLive biotherapeutic products: bridging innovations and challenges in manufacturing
In our third instalment of EPR's exclusive ‘Microbiome therapeutics: microscope to medicine’ series, Tue Hodal, Chief Technology Officer and Lorenz Rindisbacher, Chief Quality Officer, Bacthera, explore how live biotherapeutic products (LBPs) represent a transformative shift in medicine, highlighting their unique challenges and potential.
-
ReportPharma Horizons: Artificial Intelligence
EPR’s inaugural Pharma Horizons report explores the latest advances in artificial intelligence (AI) and machine learning (ML) for drug development, pharmaceutical manufacturing and quality control.
-
VideoVideo: Unveiling the science behind NGS
Virtual seminar presented by Christine Farrance, PhD, Senior Global Scientific Affairs Liaison of Microbial Solutions at Charles River designed to improve your understanding of how to leverage NGS to analyze the entire genome and mixed samples in a single, efficient test to identify, classify, and understand microbes in mixed and ...
-
ArticleYear in review: EPR’s top stories of 2023
EPR wraps up the year with a selection of top stories from 2023, highlighting key trends and topics such as environmental monitoring (EM), quality (QA/QC), manufacturing, regulation and clinical development.
-
ArticleNitrosamines analysis with LC/MS-MS
This ebook provides a comprehensive overview of nitrosamine analysis for the pharmaceutical industry.
-
ArticleGuide to Outsourcing 2023
In this Guide to Outsourcing, EPR explores trends in outsourcing of regulatory activities, Quotient Sciences discusses how to accelerate drug development and Associates of Cape Cod International looks at sustainable bacterial endotoxin testing.
-
ArticleQA/QC & Microbiology In-Depth Focus 2023
This microbiology in-depth focus, explores sterility and bioburden testing considerations for cell and gene therapies.
-
ArticleCPHI Barcelona 2023 - Event preview
CPHI Barcelona takes place in October 2023, covering a wide range of topics from next generation biomanufacturing and formulation to sustainability.
-
Video
Webinar: Advantages bringing early phase trials to North America
Watch Altasciences’ on-demand webinar to learn the key advantages and differences of conducting early phase clinical trials in North America.
-
ArticleThe benefits of mass spectrometry for expediting biologics to patients
A key element of development for new molecular format biological products is to leverage the appropriate analytical tools to enhance product and process understanding throughout the development lifecycle. Here, Ian Anderson, Mostafa Zarei and Qifeng Zhang at Lonza highlight the benefits of using mass spectrometry technologies to accelerate and de-risk ...
-
EventBarcelona Breakfast Briefing: how is Pharma 4.0 shaping manufacturing?
European Pharmaceutical Review will host an exclusive, free-to-attend, breakfast briefing during CPhI in Barcelona this October. The highly anticipated breakfast briefing is open to all CPhI attendees and European Pharmaceutical Review members and is free to attend.
-
ArticleUncovering new frontiers in microbiology and EM
In this Q&A, Laure Pomares Voisin, Quality Director, Catalent Biologics and Tony Cundell Principal Consultant, Microbiological Consulting, LLC discuss some of the key microbiology and environmental monitoring challenges and trends in pharmaceutical manufacturing today.
-
ArticleDeveloping an effective contamination control strategy
A key part of Annex 1, due to come into effect on 25 August 2023, is the development of a holistic contamination control strategy (CCS). In this article, EPR’s Caroline Peachey summarises an expert panel discussion, which explored common challenges in implementing a CCS and made several recommendations.
-
ArticleLeveraging PAT for environmental monitoring in light of Annex 1
The pharma industry’s adaptation to Industry 4.0 has been slow, due to the extensive regulatory requirements imposed on manufacturers. However, regulatory agencies are starting to embrace movement towards more rapid/automated systems, as illustrated in the revised EU GMP Annex 1, which entered into force in August. Here, Isabella Jul-Jørgensen from ...