whitepaper
Whitepaper: Complete Automation System for Endotoxin Testing
Automating a Laboratory’s BET workstream using Lonza’s PyroTec® PRO Robotic Solution, WinKQCL® Software, and MODA® Software.
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news
Rapid pseudomonas aeruginosa detection method developed
Research suggests the rapid detection method “will enable the timely implementation of microbiological monitoring strategies for large batches of medications”.
article
Live 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.
news
Inlet air conveyor optimisation in a continuous tablet coater
An inlet conveyor with a linear diffuser inside a continuous tablet coater offers better air flow distribution for tablet drying, research by IMA Pharma suggests.
news
Preventing fungal contamination in pharmaceuticals
While fungal contamination detection in pharmaceutical manufacturing remains a challenge, preventive practices and policies must be followed, research states.
webinar
Enhancing biopharma workflows with the power of UV/Vis spectroscopy
8 March 2024 | By Thermo Fisher Scientific
Discover the valuable role ultraviolet-visible spectroscopy can play in quickly and accurately monitoring a drug as it moves through the research & development workflow and enabling quality and regulatory compliance through the manufacturing process.
news
Employing MALDI-TOF MS for microbial identification in sterile drug manufacturing
A study investigating microbial risks of the entire manufacturing process has identified MALDI-TOF MS as a promising first-line tool for pharmaceutical environmental monitoring.
whitepaper
Product hub: High fidelity process control with Bruker’s Fourier PAT
Bringing a wealth of structural information and direct quantification to the lab or plant, the Fourier PAT benchtop NMR reduces tedious calibrations and increases (bio)process understanding and control, hence further reducing risks and cost.
whitepaper
Application Note: Automated Set-Up of the PyroGene® rFC Assay
Automating the pipetting steps of the PyroGene® rFC Assay on the ASSIST PLUS helps to reduce the opportunity for pipetting errors and ensures robust reproducibility.
news
Medical device manufacturers must remain “vigilant” to ensure data integrity of premarket submissions
With the integrity of a greater number of third-party-generated data called into question, the US Food and Drug Administration (FDA) is unable to rely on the data to grant marketing authorisation, the agency asserts.
news
Nelson Labs facility expansion to benefit parenteral and ophthalmic drug product manufacturers
The new Pharmaceutical Center of Excellence from Nelson Labs offers state-of-the-art chemistry manufacturing and controls (CMC) analytical testing support.
webinar
Process analytical technology: applications and opportunities for pharma
15 February 2024 | By European Pharmaceutical Review, sponsored by Mettler Toledo, Bruker and 908Devices
During this virtual panel, industry experts will discuss the latest advances and applications of process analytical technology in the pharmaceutical sector.
webinar
Are outdated microbial identification methods risking your product safety and operational efficiency?
9 February 2024 | By Charles River Laboratories
Watch this webinar to unravel the complexities of microbial identification technologies and their pivotal role in fortifying contamination control strategies within the pharmaceutical industry.
webinar
Mastering Pharma 4.0 validation challenges with technology
2 February 2024 | By Kneat Solutions
In this webinar Kneat Solutions’ Director of Consulting, Marcus Ryan, discusses the best way forward in the evolving world of Pharma 4.0™, revealing how companies can overcome validation complexities with technology.
news
Revised ISO guideline highlights toxicological evaluation of extractables and leachables
Included in the revised ISO 10993-17 guideline are requirements for toxicological risk assessment of medical device constituents, such as extractables and leachables (E&L).
