We support your GMP project from the cell bank to the finished microbiological API

Pharma

Lactosan Pharma offers GMP/cGMP contract manufacturing of microbial drug products from cell bank to dried product. A clean room with a sterilisable freeze dryer, mill, mixer and product storage at 4°C and -20°C is available to process the product according to all requirements.

We offer you the best service

GMP-Services

We can support your GMP project from cell bank manufacture to lyophilized powder production. A GMP-compliant quality management system and a production facility designed according to GMP principles ensure product quality and meet the requirements of health authorities. From cell bank to dried product, the entire process is carried out according to GMP standards.

Cell banks according to GMP

A GMP-compliant master or working cell bank can be prepared from the appropriate lactic acid bacteria or bifidobacteria strain. These are tested for purity, identity and growth behaviour. The cell bank is stored at -80°C in glycerol stocks in qualified freezers.

Quality check GMP

Lactosan's pharma division offers quality at GMP level. GMP batches are rigorously tested in accordance with customer specifications and the requirements of AMBO and EMA regulations. This starts with raw materials from qualified suppliers, which are analysed and approved prior to use following a risk analysis.

In-process analysis includes process and batch quality control. A comprehensive final inspection of the powder produced in accordance with the specifications guarantees a 'flawless bulk product'.

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Our pharma technologies

Fermentation

Lactosan has three complete fermentation lines which are controlled by a process control system and can be fully sterilised.

Production

1 media tank
1000 litre fermentation main stage

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Separation

Fermentation is followed by a concentration step using a separator.

Production

1400 l/h separation

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Freeze drying

The aim of freeze-drying is to obtain a dried, very water-soluble product that retains the properties of the original product after the addition of water.