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Infographic: How different endotoxin testing platforms work
From traditional LAL assays to cartridge-based systems, robotics and microfluidic BET automation, learn how different endotoxin testing systems work in this infographic.
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QA/QC
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The current limitations facing biosimilar products and manufacturers
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
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ebook: Important considerations for every bio-pharmaceutical microbiology QC lab
This ebook from Sartorius takes an in-depth look at how the quality control (QC) microbiology laboratory plays a critical role in control of the pharmaceutical manufacturing environment and product release.
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Application note: Resilient plastics in the Cold Chain
Pictorial that explains how Aramus TM single-layer fluoropolymer bag can withstand gamma irradiation and cold-chain temperatures down to -196°C.
webinar
Variable pathlength spectroscopy for dilution-free concentration measurement in GMP environments
27 May 2021 | By Repligen
Watch this on-demand webinar, where we reviewed VPT and how it can be used in various applications, from protein therapeutics to gene therapy.
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Technical bulletin: Nitrosamines: Questioning the current analytical approach
We look at the challenges posed in regards to nitrosamine testing methodologies and the way in which to move forward to ensure safer drug products.
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Article: Water activity of oral solid dosage products using FMS
This article describes water activity determination of OSD using Frequency Modulation Spectroscopy, with a non-destructive headspace gas analyser.
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Evolving your adverse event monitoring strategy for the post-COVID data influx
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
news
Novel Raman spectroscopy method enables ultra-sensitive detection
The new surface-enhanced Raman spectroscopy (SERS) method uses capillary suction to actively capture target molecules for detection.
whitepaper
Article: Replacing blue dye ingress with gas ingress CCI testing
This article describes headspace gas ingress as a CCI test method, which is increasingly being implemented to replace blue dye.
webinar
Quality assurance and data integrity from an auditors’ viewpoint
21 May 2021 | By Thermo Fisher Scientific
In this on-demand webinar, you will hear directly from industry auditors as they discuss the current regulatory framework for good manufacturing practice (GMP), including data integrity, validation and qualification for computerised systems in regulated laboratories.
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Article: Evaluating CCI of sterile vials using gas ingress
The article describes how CCI can be determined using Headspace gas ingress as a CCI test.
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News: Endotoxin automation is achieved with microfluidics for simple, compliant BET
Automated endotoxin testing is achieved in a compact platform, leveraging microfluidic liquid handling. QC labs simplify BET with easier, compliant assays using less LAL.
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Case study: New trends: reducing GWP impact on GMP freeze drying processes
How to turn an older refrigeration system in an existing freeze-dryer into a new environmentally friendly cooling system.
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Article: Effects of deep cold storage at -80°C on CCI
This article describes the effects of deep cold storage on the container closure integrity of sterile product vials.
