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Issue 4 2016

 

Environmental Monitoring In-Depth Focus 2016

24 August 2016 | By European Pharmaceutical Review

In this Environmental Monitoring In-Depth Focus: Bacterial endotoxin contamination and testing limits in ophthalmics; The basics of environmental monitoring in aseptic units; Environmental Monitoring Roundtable...

Approaches in subcutaneous delivery of monoclonal antibodies

24 August 2016 | By , ,

Currently, subcutaneous delivery of therapeutic proteins is a fast-growing field, especially for such established modalities as monoclonal antibodies, which require large quantities of drug to be administrated. Different approaches, including high protein concentration, speciality formulations and drug delivery matrices, as well as devices enabling a more rapid administration of larger…

Current activities of the USP general chapters

24 August 2016 | By

From a microbiological perspective, pharmaceutical products fall into two categories – nonsterile and sterile. For both categories manufacturers must eliminate, or minimise, potential health risks to patients related to microorganisms and the toxins they produce, whilst maintaining product quality. Many contributing factors may affect the quality of a medicine or…

Application of LCMS in small-molecule drug development

24 August 2016 | By , ,

As a technology, mass spectrometry (MS) has evolved to the point where it is used throughout the drug development process. In particular, when MS is coupled with high-performance liquid chromatography (HPLC) it adds an orthogonal detection function for sample analysis and provides unique capabilities for pharmaceutical analysis, such as sensitivity,…

Characterising therapeutic antibodies and ADCs using mass spectrometry

24 August 2016 | By

Since the 1970s, the advent of biotechnology has resulted in the development and commercialisation of many therapeutic proteins, including antibodies and antibody fragments, for the treatment of human diseases. Examples include antibody treatments for autoimmune diseases (for example, adalimumab [Humira®] for rheumatoid arthritis), cancers (such as trastuzumab [Herceptin®] for breast…