Ensuring top-quality active agents

Chromatography column for purification – one of many steps in the purification process

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Ultra-pure proteins made by Roche Penzberg

Roche Penzberg is renowned for its deep expertise in protein production. Purification, quality control, and formulation of the sensitive protein active agents involve highly complex and specialised steps. To obtain market clearance for a therapeutic active agent, you need a purity level of 99.9%.

Successful isolation is half the battle

Chromatography is widely used to isolate proteins. Other separation techniques include filtration through a filter with a defined pore size, extraction of proteins using solvents, and electrophoresis (i.e., separation of a protein mixture inside an electric field).

What is chromatography?

Chromatography is a method for separating a mixture of substances into its ingredients. There are many different types of chromatography. What they all have in common is that the mixture of substances passes a stationary phase (e.g. silica gel beads) by means of a mobile phase (e.g. a solvent). If columnar glass vessels are used for this process (see picture), this is referred to as column chromatography.

From "cell soup" to pure active agent

A great number of work steps are required to isolate a therapeutic protein from the biological raw material. First, the cells containing the active agent must be disrupted. This is done using a so-called French press. Next, a multi-stage process is used to purify the active agent from the "cell soup".

Column chromatography – the standard procedure for protein purification

Column chromatography is widely used to purify proteins from a mixture of substances. It works as follows: Different substances pass through the chromatography column at different speeds based on their chemical and physical properties. These properties can be leveraged to separate mixtures of substances into different fractions. After the substances have passed through the column, they are collected in individual fractions. The fraction containing the respective protein is further separated in a multi-step process until an ultra-pure protein is produced.

What's the origin of the term "chromatography"?

The term "chromatography" has Greek roots: chroma is Greek for "colour" and graphein means "to write". The technique was developed by Russian botanist Michail S. Zwet. In 1901, he let an extract of green leaves pass through a column of sugar. Doing that, he noticed that the green leaf colourant (chlorophyll) was separated into green and yellow zones inside the column based on its colour components.

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Fotographer: Philipp Wente