The possibilities presented by real-world data to improve drug development processes could enhance regulatory and pricing decisions for new therapeutics.
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Under the microscope: A global perspective – Eurofins Professional Scientific Services Insourcing Solutions
In this interview, Beth DiPaolo, President and Global Head of Eurofins Professional Scientific Services (PSS) Insourcing Solutions, provides intelligence on their global service offerings.
The Joint Pharmaceutical Analysis Group (JPAG) held a stability meeting at the Royal Society of Chemistry’s headquarters in London earlier this year. Attended by 65 delegates, its focus was on developments in stability testing and evaluation. Here follows a summary of the presentations made at the meeting.
The Chinese pharmaceutical industry has been lagging behind in terms of drug development and bringing new products to the market. In this article, Megha Baruah discusses the changes the National Medical Products Administration (NMPA) of China is making to existing policies and informs on guidance documents that have been released…
Medicinal products typically cannot be manufactured without using excipients. Here, Dave Elder and Fabio Faïs discuss factors for excipient selection and the importance of defined allowable limits to ensure continued product safety.
The efficient handling of information and resources is key for achieving success within a commercial organisation. Against the backdrop of ICH Q10 – the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use – Christian Rack discusses five things you can implement right now to…
Biofluorescent particle detectors offer a fundamentally different way of enumerating microbes present in an environment, as compared to traditional growth-based methods. Here, the Process and Environmental Monitoring Methods (PEMM) group shares information about the technology and applications for real-time biofluorescent particle detection methods and how they help to address major…
Transforming a formulation into a successful solid dose product is a complex process that involves many considerations. Given the ever-growing demand for increased tablet quantities and the goal of reducing time to market, Rob Blanchard explains how the pressure is on manufacturers to find innovative processes to improve production efficiency.
In February this year the EU Falsified Medicines Directive (FMD) came into effect. Rich Quelch assesses this latest regulatory attempt to rid the supply chain of dangerous falsified products and reflects on the industry’s need to keep ahead of the game to future-protect itself.
We’re getting closer to something special with regard to how we manufacture biopharmaceuticals. Loe Cameron explores where the continuous bioprocessing journey could take us and what it might mean for medicine manufacturers worldwide.
Differential scanning calorimetry (DSC) has been one of the most widely used techniques to characterise the temperature stability of monoclonal antibodies (mAbs) and provide important information in formulation optimisation. However, despite its widespread use, not all the information contained in DSC data, especially denaturation kinetics, is routinely extracted. In this…
Dr Carsten Hopf and his team are using MALDI imaging in several applications, including drug metabolite and formulation distributions in tissues. This article investigates how this content-rich technique is enabling researchers to gain unique insights to facilitate faster and better drug discovery.
Mahfoozur Rahman and Sarwar Beg explain why we need to change tack from traditional formulation-driven development to a target-based approach in order to increase success with anticancer nanomedicine in the clinic.
All therapeutic developers and manufacturers are under intense pressure to improve efficiency and productivity and reduce costs, all while maintaining the highest quality standards.
Innovations in single-use process automation are driving single-use adoption into commercial biologics facilities. Here, Sartorius Stedim Biotech (SSB) shares its latest service offering.