New digital design and manufacturing techniques offer pharmaceutical manufacturers the possibility of a systems-based, digital approach to substantially streamline their design, development and manufacturing processes. The ADDoPT collaborative consortium has been working to explore how emerging process understanding and predictive models can be applied and embedded within industrial workflows to…
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Issue 3 2019
Zafar Iqbal sheds light on how Raman spectroscopy is used to detect and understand the amorphous phase in a range of solids, providing examples of his own laboratory applications.
Many bacterial species have been found to exist in a viable but non-culturable state. Jeanne Moldenhauer discusses this phenomenon and makes suggestions as to why we don’t often see an increase in viable cells when using viability-based methods.
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
Continuous innovation is key to the advancement of medical device technology. To allow for innovation, whilst also assuring safety and effectiveness, global standards are required. This article provides information for companies manufacturing medical devices on the benefits of holding ISO 13485 certification and how to get certified.
As 31 October draws closer, organisations across all sectors are putting contingency plans in place for whatever the impact of Brexit may be. However, for pharmaceutical organisations already operating in a heavily regulated, highly competitive landscape, the future looks a lot more uncertain than for most. Here, Neal Singh discusses…
The efficacy, safety and pharmacokinetic properties of a protein therapeutic substantially depend on the molecule having the right structure. This article reviews current methods used for obtaining higher order structure information of biotherapeutics.
The Supreme Court unanimously dismissed an appeal from the Court of Appeal in Actavis Group PTC EHF & Ors v ICOS Corporation & Anor, upholding its decision that a patent relating to the use of tadalafil in a 1 to 5mg dosage form is invalid for lack of inventive step.…
Effective drug serialisation and identification is essential for improving the safety of medicines and combatting counterfeits. The Falsified Medicines Directive’s new requirements promise to crack down on the impacts of unsafe drugs. Neil Piper discusses the human cost of falsified medicines and how companies need to increase traceability of individual…
Many researchers are keen to find analytical solutions that generate the chemical fingerprint of a sample at the molecular and cellular level. Overcoming these problems is made possible by label-free techniques such as Raman, SPRi or particle size analysis. This brief overview will identify the benefits of Raman spectroscopy.
Expert View: Eshmuno® CP-FT resin – developed for the flow-through removal of aggregates using frontal chromatography
Eshmuno® CP-FT cation exchange resin is specifically designed to provide efficient removal of monoclonal antibody (mAb) aggregates in the flow-through frontal chromatography mode of operation enabling loading capacities 10-times higher than traditional bind/elute CEX chromatography. It facilitates greater manufacturing flexibility and process intensification while reducing the overall cost for the…
It is a requirement of both US and EU regulations that pharmaceutical packaging operations demonstrate integrity. As technology-based solutions remain somewhat of an unknown quantity, this whitepaper tests the hypothesis that Sepha’s VisionScan test method is considered non destructive.
High-resolution measurements of particles are of great interest in many fields of application. Combining confocal Raman microscopy with particle analysis tools makes it possible to find, classify and identify particles almost entirely automatically.
Whether by ignorance of the latest best practices, or willful disregard for patient safety, the results of careless practice can often be fatal. The articles in this in-depth focus highlight how regulatory bodies are taking action to raise the industry’s game.