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.…
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Issue 6 2018
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.
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
2 January 2019 | By Charlotte De Bleye (University of Liege Belgium), Elodie Dumont (University of Liege Belgium), Eric Ziemons (University of Liege Belgium), Hermane Avohou (University of Liege Belgium), Laureen Coic (University of Liege Belgium), Philippe Hubert (University of Liege Belgium), Pierre-Yves Sacre (University of Liege Belgium), Riccardo Deidda (University of Liege Belgium), Roland Marini (University of Liege Belgium)
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…
22 December 2018 | By Dave Elder (JPAG Member and David P Elder Consultancy)
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…
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
19 December 2018 | By Kaiser Optical Systems
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
19 December 2018 | By Unjulie Bhanot
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
19 December 2018 | By Harald Fischer
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.
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…
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…
19 December 2018 | By European Pharmaceutical Review
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.
18 December 2018 | By European Pharmaceutical Review
In this supplement: navigating roadblocks to clinical success, and the data challenges of R&D and collaboration.