Raman In-Depth Focus 2017
This In-Depth Focus looks at photobleaching profile of Raman peaks and surface-enhanced Raman spectroscopic sensing of glucose.
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Articles
What do we need from PAT?
Pharmaceutical manufacturing in the modern era is facing unprecedented demands, including in-depth scrutiny of production methodology, and inefficiencies in current practices with respect to waste, energy usage and time management. Coupling this with increased complexity in the manufacture of newer products and the decline of blockbuster drugs, results in an…
Surface-enhanced Raman spectroscopic sensing of glucose
The small normal Raman cross-section of glucose is a major challenge in its detection by surface enhanced Raman spectroscopy (SERS) for medical applications, such as blood glucose level monitoring of diabetic patients and evaluation of patients with other medical conditions, since glucose is a marker for many human diseases. Here…
Photobleaching profile of Raman peaks and fluorescence background
Laser-induced fluorescence is the most common source of interfering baseline signal encountered in Raman measurements. It shows itself as a slowly changing background in a spectrum. One of the challenges in the successful use of Raman spectroscopy is to extract Raman signatures from this, orders of magnitude stronger, broadband fluorescence…
The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies
QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. This article considers the issues involved.
Non-clinical dose formulation considerations
Designing appropriate non-clinical safety studies requires thoughtful, and sometimes experimental, consideration of the delivery methodology for the therapeutic. The choice of formulation affects drug release and absorption and has a direct impact on the pharmacokinetic profile and associated response of the model system. The formulation should be compatible with the…
Issue #6 2017 – Digital Version
This issue celebrates European Pharmaceutical Review's 21st birthday through 21 interviews with leading lights from across the pharmaceutical industry...
Developing a shared passion surrounded by great minds
As part of EPR’s Women in Pharma series, Andrea Miller, Head of Global R&D and Regulatory Affairs for Mylan, talks to Science Editor Dr Zara Kassam about the importance of being 'team smart', being open to new ideas and listening to other people’s perspectives and learning from them...
Meeting access challenges with adaptive trial designs
With access challenges even after successful but costly development programmes, the industry is under pressure to speed up the clinical development process and produce more for less. Adaptive trial designs, more collaborative working and data sharing could provide a solution in the area of cancer immunotherapy, says Jacqueline Karmel, principal…
Joining the dots at Janssen
As part of EPR’s Women in Pharma series, Catherine Owen, President of Infectious Disease and Vaccines at Johnson & Johnson, talks to Science Editor Dr Zara Kassam about keeping up with the competition, innovation and grasping the breadth of business...
Improving patient access, the UCB way
UCB’s ambition, according to its website, is to transform the lives of people living with severe diseases. The company’s Head of Global Clinical Development and Medical Affairs Stuart Dollow believes that making its clinical trial design more patient-centred and creating the right partnerships are key steps toward improving access to…
Modernising the supply chain using continuous manufacturing
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
Using quality as a lever for transformation
As part of EPR’s Women in Pharma series, Céline Schillinger, Head, Quality Innovation & Engagement at Sanofi Pasteur, talks to Science Editor Dr Zara Kassam about growing modern leadership skills, taking advantage of digital and social technologies and leveraging diversity in decision-making...
Regulatory, clinical and logistics challenges of Advanced Therapy Medicinal Products (ATMPs) in clinical research
Advanced Therapy Medicinal Products (ATMPs) are new therapeutics that require different procedures for clinical trials compared to traditional medicinal products. It is important to understand the nature and the manufacturing process of an ATMP for set-up and execution of the clinical development and later marketing of these therapies.
Balancing the efficacy and safety of preservatives in multidose products
The EMA recently introduced labelling requirements for some common excipients based on an in-depth assessment of their safety profiles, particularly in the paediatric population.1 This article considers their use in multidose products...
