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Pharma Horizons: leading-edge formulation
This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.
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Articles
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.
The data challenges of research & development and collaboration
In the biopharmaceuticals industry today, only 13 percent of therapeutics that enter Phase 1 of clinical trials go on to launch1 – and the total journey from R&D to market can be anywhere between eight and 12 years.2
Expert View: Raman imaging and spectral database management for pharmaceutics
Sophisticated hardware and software offer speed and precision. Pharmaceutical development often involves samples in solution or on transparent substrates. For these applications, confocal Raman imaging using an inverted beam path is an especially versatile and powerful investigative method.
Expert View: What ADC evolution means for manufacturing
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…
Navigating roadblocks to clinical success: from molecule to clinic
For emerging biotech and small companies in early-stage clinical development, accessing the market as quickly as possible is of paramount importance. Biopharma executives must make important decisions at this stage that will impact the success of their commercial strategy. The key to success is making the right decisions at the…
Formulation, Development & Delivery In-Depth Focus 2018
In this supplement: Real-time PCR detection of Staphylococcus aureus in pharmaceutical products contaminated with mixed bacterial cultures, and an ICH Q3C(R5) elemental impurities update.
Biopharma, Processing & Development In-Depth Focus 2018
In this supplement: navigating roadblocks to clinical success, and the data challenges of R&D and collaboration.
Raman In-Depth Focus 2018
This In-Depth Focus covers drop-coating deposition Raman (DCDR) spectroscopy for metabolite profiling and recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines.
