List view / Grid view

Articles

 

Key packaging trends for 2019

21 February 2019 | By

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…

The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying

18 January 2019 | By ,

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

16 January 2019 | By

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…

Recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines

2 January 2019 | By , , , , , , , ,

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

22 December 2018 | By

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

21 December 2018 | By , , , ,

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: What ADC evolution means for manufacturing

19 December 2018 | By ,

The evolution of antibody-drug conjugates (ADCs) is a spectacular example of how global research can sculpt a new technology. Years of molecular and cell biology, conjugation chemistry and immunology progress has enabled a cytotoxic agent paired with a tumour-specifi c antibody to become mainstream cancer therapy.1 Today, advances continue, explains…