whitepaper
Whitepaper: Optimising the efficiency of QC laboratory: The power of automation
Charles River launches Endosafe Nexus 200, emphasises the importance of automated endotoxin testing systems to improve the efficiency of QC labs.
List view / Grid view
Microbiology
webinar
Annex 1 2022: how does it align with Annex 1 2008?
21 December 2022 | By Particle Measuring Systems
Watch this webinar to learn about the commonalities between Annex 1 2022 and the 2008 version. Both have the same requirements, but 2022 has added better defining language. Get side by side comparisons.
whitepaper
Whitepaper: Single-use technologies in biosimilar development
ImaLINK™ manifold, which is designed to minimise the need for fittings, connections or assembly of all leak points, entrapment areas are eliminated.
whitepaper
Whitepaper: rFC adoption for bacterial endotoxin testing
What is driving the adoption of rFC for BET? Alternative methods are the obvious sustainable solution for efficient manufacturing.
whitepaper
Whitepaper: LIMS integration: overcoming the hurdle of microbial QC digitalization
Learn how automated microbial enumeration technologies can ensure seamless integration of LIMS, improving lab efficiency and data integrity.
news
Live from CPhI: ‘Gut microbiome therapy to be approved in the next two years’
The promise of microbiome-based therapeutics is rapidly progressing towards real world applications as treatment of recurrent Clostridium difficile using faecal microbiota transplant edges towards a BLA.
whitepaper
Case study: Reduce plate counting costs and delays
Learn how a US influenza vaccine manufacturer concerned with intermittent positive plate counts used rapid microbial monitoring to save time and money.
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…
article
Guide to Outsourcing & Testing
In this Guide to Outsourcing & Testing, EPR explores trends in the pharmaceutical outsourcing market. Plus, Charles River discusses solutions for tracking, trending and microbial identification and Associates of Cape Cod International showcases its endotoxin testing capabilities.
article
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.
article
Methods for strain comparison and differentiation of environmental isolates
Identification of environmental isolates is a regular requirement in pharmaceutical manufacturing, and strain differentiation can be valuable in a variety of circumstances. There have been huge advances in the technology available for sequencing bacterial genomes, which has fed through to the analyses that are available to pharmaceutical microbiologists. NCIMB’s Identification…
article
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…
article
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
Microbial identification market valued at $10.7 billion by 2032
Technological innovations like automation and real-time analysis, as well as industry collaboration are anticipated to become key tools in the global microbial identification systems market going forward.
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.
