To date many Life Science innovators have selected Syntagon for their GMP manufacturing. We offer both speed of delivery as well as capacity to address the most complex syntheses by combining reactor technology for modern synthesis with purification techniques such as preparative HPLC. In summary our GMP plant is perfectly adapted for supply of clinical trials material and low volume manufacturing (< 1MT per annum).
Preparative scale HPLC
In 2008 we had our first preparative HPLC system up and running. Today three such unit (Novasep and Varian) are operational. These are equipped with 15 cm diameter columns working up 1.5 L/min flow rates and up to 100 bar pressure. Purification of complex reaction mixtures, resolution of enantiomers and fractionation of natural products are examples of what we typically use these systems for. Normally, 1 kg per day can be purified, making these systems suitable for clinical supply and low volume manufacturing (<500 kg annually).
Our reactors range from 30 L up to 800 L (glass lined and stainless steel, 316L). Each reactor is equipped with a stand-alone Huber heating/cooling unit offering a temperature range between -50 C and +170 degrees. This means that we can handle a wide range of reaction types including low temperature chemistry such as BuLi type and high temperature rearrangements. Some reactors and filter dryers are equipped with split butterfly valve (PSL) charging technology allowing for contained charges / discharge.
Four categories of pharmaceutical ingredients are currently developed and manufactured at Syntagon:
A custom manufactured life science ingredient involving chemical reactions on 250 L scale followed by purification using preparative HPLC. The manufacturing process is fully validated and capable of producing up to 500 kg annually.
A custom manufactured life science ingredient involving preparative HPLC for fractionation of natural products containing sapponines.
By a combination of purification techniques including short path distillation a life science ingredient of uniquely high quality is obtained. The manufacturing process is validated. This product
We typically deliver 3-5 different clinical API’s each year including supporting documentation for regulatory filing (IMPD/IND CMC section 2S).
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Preparative HPLC systems
Phone: +46 8 554 422 50
SE-151 02 Södertälje
Visiting & Delivery address
SE-151 38 Södertälje
Phone: +371 67 490 881
Postal and Visiting address
Syntagon Baltic SIA
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