news
Nitrogen dioxide for sterilisation of protein-filled polymer-based syringes
Nitrogen dioxide (NO2) gas found not to ingress and cause protein degradation when sterilising polymer-based prefilled syringes (P-PFSs), according to study.
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QA/QC
article
Economics and risks of FDA’s Quality management maturity rating programme
Ensuring that pharmaceutical manufacturers not only adhere to current good manufacturing processes but go beyond to embrace a culture of quality has far-reaching consequences for the industry, the health care community and consumers. A focus on quality across many sectors of the economy has demonstrated direct economic benefits accruing to…
news
HPLC-MS/MS for NDMA impurity determination in sartans
EPR summarises the development of a HPLC method for the detection, separation and quantification of N-nitrosodimethylamine (NDMA) in both olmesartan API and finished formulations.
news
Medicinal cannabis monograph proposed by US Pharmacopeia
A monograph outlining the analytical methods and acceptance criteria for cannabis chemotypes has been released for comment by USP’s Herbal Medicines Compendium.
news
HPLC determination of common cold formulations
EPR highlights a high-performance liquid chromatography (HPLC) method which enables the detection of both chlorpheniramine maleate and ibuprofen in formulation.
video
On-demand webinar: Effective contamination control strategy
Discover the significance of accurate microbial identifications in building an effective contamination control strategy to keep up with the latest regulatory requirements.
whitepaper
Guide: Rapid microbial detection methods
Plate counting falls short in reducing the risk of contamination during pharmaceutical production. Learn more about rapid microbiological methods.
webinar
Validation and implementation of a novel automated PCR technology for mycoplasma testing
22 September 2022 | By bioMérieux
This on-demand webinar presents the regulatory submission strategy for implementation and validation of a new PCR-based technology for mycoplasma testing of different products.
podcasts
EPR Podcast Episode 15 – Modernising microbiology – Sophie Bailes and Miriam Guest, AstraZeneca
How is the implementation of artificial intelligence, machine learning and virtual reality shaping the microbiology lab of the future? What do these innovations mean for personnel? Find out in this episode with AstraZeneca...
news
Green HPLC method enables antipsychotic determination
EPR highlights a green high performance liquid chromatography (HPLC) method that successfully determined four common antipsychotics in formulation.
webinar
Addressing analytical control challenges for different plasmid DNA products
16 September 2022 | By GenScript ProBio
Learn how to develop an analytical control strategy for different plasmid DNA product applications with GenScript ProBio, a global CDMO in cell and gene therapy industry.
whitepaper
Whitepaper: PAT leads the way in the adoption of continuous manufacturing processes
Martin Gadsby, CEO & Director at Optimal Industrial Technologies and Flavio Belvedere, Co-Founder of ABCS Srl, look at the benefits of PAT and the aspects to consider when deploying it.
news
Multi-angle light scattering: PAT for polysaccharide conjugate vaccines
EPR highlights the implementation of multi angle light scattering (MALS) as a process analytical technology (PAT) tool for the real-time monitoring of protein-polysaccharide conjugate fraction molar mass.
news
Evolving real-time dissolution prediction and product release
EPR highlights the development of a model to predict dissolution of sustained release formulations based on Raman process analytical technology (PAT) sensor data that could enable real-time release testing.
webinar
Pharmaceutical compliance audits: are you on top of regulations?
6 September 2022 | By MasterControl
Audits and inspections are always a stressful time for pharmaceutical companies. Watch this webinar to learn how to stay up to date on regulations and ensure audit readiness.
