Method validation

New potency assays for anti-VEGF antibodies

Written by Dr. Janet Thode on . Posted in Method validation

Introduction and Background

The group of vascular endothelial growth factors (VEGF) plays a crucial role in the formation of new blood vessels (angiogenesis), since they stimulate the growth, i.e. the division and migration of endothelial cells, as the name already suggests. Since some tumor types can better supply themselves with nutrients via increased angiogenesis and thus grow faster, anti-VEGF antibodies represent significant cancer therapeutics. However, the various types of cancer are not the only indication; enhanced angiogenesis is also important in certain eye diseases.

Anti-VEGF antibodies or fragments include bevacizumab (Avastin®), ranibizumab (Lucentis®) or aflibercept (Eylea®) and an increasing number of biosimilars already on the market and in late-stage clinical trials, such as Mvasi®, Zirabev® or BevaciRel®.

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Journal Club: Validation of Raman spectroscopy for content determination in tablets

Written by Dr. Janet Thode on . Posted in Method validation

The various techniques of Raman spectroscopy find a wide range of applications in the different areas of the pharmaceutical industry, be it for the detection of counterfeits, as an in-process control (IPC) during the production of the active pharmaceutical ingredient, for content determinations, as an ID test for vaccines, for the simultaneous determination of several product quality attributes (PQAs) as part of a rapid release strategy, up to sterility tests, to name just a few examples [1-4].

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Risk assessments in method validation

Written by Dr. Janet Thode on . Posted in Method validation

Risk assessments are a good thing and can make life easier in the pharmaceutical environment. Everywhere it is said that this or that has to be or has been defined "risk-based"...

Hmm, all well and good, but where are the potential applications in the validation of analytical methods?

We’d like to make a deep dive into this question in today's blog post.

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Verification of a compendial method: Water Determination by Karl Fischer Titration

Written by Dr. Janet Thode on . Posted in Method validation

In lyophilizates of pharmaceutical drugs, the residual moisture content must be determined. It must be as low as possible in order to delay possible degradation reactions during storage and thus ensure the declared shelf life. Such a water determination can be performed applying the Karl Fischer titration. This titration method is a widely used procedure for quantitative water determination in a variety of samples and was developed by Karl Fischer in 1935. In the European Pharmacopoeia (Ph. Eur.), chapter 2.5.12 covers the volumetric (semi-micro) determination and chapter 2.5.32 covers the coulometric titration. The choice of method is primarily based on the amount of water present in the sample.

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Limit tests - (when) do they play a role?

Written by Dr. Janet Thode on . Posted in Method validation

Purity determinations are applied as part of the quality control of pharmaceuticals, their active pharmaceutical ingredients (and, if applicable, their excipients in case they are not yet obtained in compendial quality). This includes quantitative determinations, resulting in a definite statement of the quantity or concentration, as well as qualitative / semi-quantitative determinations with results allowing only conclusions to be drawn as to whether the impurity is present or not or whether it is below a certain limit value. Such determinations are also known as "limit tests". Some people will think back to a laboratory practical training in drug analysis during their studies with more or less enthusiasm when they hear the word "limit test"...

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