Guide to Analytical Testing 2019
In this edition of our 'Guide to' series we look at analytical testing instruments from SUEZ.
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Articles
European Pharmaceutical Review Issue 1 2019
In this issue we look at the challenges of shipping temperature-controlled products, the potential use of blockchain for pharma, and using MALDI-TOF for identification of peptides in suspected illegal medicinal products. The edition also includes articles on aseptic containment, legal advice on licensing negotiations and an In-Depth Focus article from…
Key packaging trends for 2019
Consumer demands, a focus on sustainability and recycling, and political uncertainty in the UK are just a few challenges the packaging market had to overcome last year. Nikki Withers speaks to Ron Yakubison, Director of Pharmaceutical Packaging Operations at Merck Manufacturing and Sriman Banerjee, Head of Packaging at GSK, who…
Dr Penny Heaton, Bill & Melinda Gates MRI: ‘Lift while you climb’
As part of EPR’s Women in Pharma series, Dr Penny Heaton, Chief Executive Officer, Bill & Melinda Gates Medical Research Institute, talks to Science Editor Dr Zara Kassam about the need to disrupt global health product development by applying cutting-edge science and technology to combat age-old diseases in the world’s…
Rapid microbiological methods and the regulatory environment
Rapid microbiological methods (RMM) continue to gain acceptance within our industry and a number of companies have already realised significant gains in detection sensitivity, automation, throughput, time-to-result and return on investment (ROI) when they have replaced their classical methods with these alternative technologies.
Learning the unwritten rules and dynamics of power
As part of EPR’s Women in Pharma series, Nawal Ouzren, CEO of Sensorion, talks to Science Editor Dr Zara Kassam about the diversity in drug development, creating a new growth mindset and elevating conversations beyond obvious beliefs...
The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying
Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials.…
The future of precision medicine
As part of EPR’s Women in Pharma series, Ruth March, VP and Head of Precision Medicine and Genomics at AstraZeneca, talks to Science Editor Dr Zara Kassam about decreasing the clinical risk associated with solid tumour biopsy, balancing a scientific career with family life and taking advantage of company initiatives…
Clinically relevant dissolution specifications: selection and assessment
Setting specifications for new oral products can be challenging. Too lenient, and there is a risk of passing batches of inadequate quality; too stringent, and there is a risk of rejecting acceptable batches.
Drop-coating deposition Raman spectroscopy for metabolite profiling
There has been a lot of interest in enhancing the sensitivity of Raman spectroscopy due to the low efficiency of the Raman technique. A pre-concentration technique, drop-coating deposition Raman (DCDR), has been used in recent years to increase the utility of Raman spectroscopy by decreasing the detection limit for non-enhanced…
Recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines
Quality medicines are essential to any healthcare system and are the final goal of any pharmaceutical manufacturer. Unfortunately, as stated recently by the World Health Organization (WHO), one in 10 medical products circulating in low and middle-income countries is either substandard or falsified (SF products).1 Although the exact prevalence of…
Elemental impurities testing and specification limits – ICH Q3D
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…
Real-time PCR detection of S. aureus in pharmaceutical products
The contamination of pharmaceuticals by microorganisms represents a major threat to public health, not just in the USA and Europe, but all around the world. Pathogenic microorganisms cause morbidity and in some cases mortality when present in products.1,2 Spoilage due to microbial breakdown of formulations can affect potency and shelf…
Expert View: Beyond API monitoring: in‑line Raman spectroscopy for bioprocess monitoring and control
The FDA’s Quality by Design (QbD) initiative brought a paradigm shift to pharmaceutical manufacturing and leading manufacturers have realised improved processes after adopting QbD. Raman spectroscopy is an established Process Analytical Technology (PAT), enabling QbD and continuous approaches to pharmaceutical manufacturing.1
Application Notes & Whitepapers 2018
Keeping up with the latest developments in pharma.
