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Infographic: Simplified bacterial endotoxin testing
Endotoxin automation using microfluidics enables simpler, compliant processes for pharma QC, QA, validation and IT. BET assay setup is simplified and less LAL is required.
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QA/QC
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European Pharmaceutical Review Issue 3 2021
In this journal, features on the current regulatory positions on nitrosamine impurities, how investing in off-patent medicines can help drive innovation and why new regulations could lead to a biosimilar boom in the UK. Other articles include an exploration of the challenges in developing and delivering lipid nanoparticle mRNA-based vaccines,…
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Video: BET automation is easy and simple with microfluidics
Endotoxin automation doesn’t mean complex instrumentation and setup. See how microfluidics enables easy BET assay setup so QC labs achieve high throughput with less hands-on time.
news
New consortium to develop PAT for cell and gene therapies
The Cell and Gene Therapy Catapult’s new consortium aims to accelerate therapeutic development by developing process analytical technologies (PAT) for cell and gene therapy manufacturing.
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On-demand webinar: Celsis® for sterility – product spotlight
A rapid sterility test method that can be validated as quickly and confidently as it provides test results.
news
Janssen COVID-19 Vaccine – one regulator blocks use, another promotes it
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
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On-demand webinar: Contamination control strategy essentials
This webinar presents the fundamentals of a contamination control strategy including forms of contamination, as well as cleaning and disinfection.
webinar
Navigating the transition from IVDD to IVDR
9 June 2021 | By Tecan
This on-demand webinar brings three leaders in the field together to discuss the new regulations, responsibilities across the whole supply chain, documentation, the notified body application process and key timelines.
news
Novel microfluidic device could enhance crystalline drug safety
The continuous-flow microfluidic device allows scientists to assess crystalline API growth rates, shapes and structures to more quickly identify the best conditions for drug manufacturing.
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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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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.
whitepaper
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.
