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The new advanced cleanroom facility at ChemCon is now operational!


With an investment of 6 million euros, ChemCon GmbH has expanded its production capacities with new laboratory spaces, including a larger cleanroom with ISO-8 classification. The cleanroom was recently inspected by the relevant authorities, approved for GMP production, and is already in use.

As of now, a cleanroom with large equipment and a novel air pressure cascade is in operation on the 4th floor of the BioTechPark Freiburg, where ChemCon has a significant portion of its production space. Air pressure cascade means that the highest pressure is in the airlocks and air from the cleanroom cannot escape outside. Additionally, there are new chemical research laboratories for polymers as well as for preparative and analytical research at ChemCon. The modern facility enables the highest quality standards in the production of pharmaceutical active ingredients or fine chemicals. It also creates better conditions for the staff: large, brighter rooms make the work much more pleasant. With exhaust systems based on the latest technical findings, the next level of sustainability is achieved. “The layout meets the latest fire protection requirements, and the technical facilities are state-of-the-art,” said Deputy Production Manager Burkhard Auchter. “Now, everything is on one floor – from research and development to production.”

 

The first projects are already underway: a campaign for trace elements at Full Pharma GMP level in the cleanroom, as well as new analytical and development projects in the production laboratory. By summer 2024, the cleanroom facility's capacities will reach the planned 100%. This increases ChemCon's total production capacities by 25%.

 

In recent years, ChemCon has invested more than 10 million euros in the development and modernization of its facilities. For example, in other analytical laboratories and also in new innovative equipment such as reactors and dryers for other cleanrooms and production laboratories were purchased and installed. Software for optimized documentation and automation of business processes was acquired and established.

 

ChemCon's expansion is a direct response to the increasing demand for polymers, particularly polyethyleneimines (PEI) and polyoxazolines (POx). These are becoming increasingly indispensable in the pharmaceutical sector, e.g., as transfection agents. With over 15 years of experience in the production of PEI and POx under Good Manufacturing Practice (GMP) conditions, we are proud to be among the few global contract development and manufacturing organizations (CDMOs) equipped for this task. We have the highest GMP quality standard and can offer GMP production in larger quantities than other manufacturers – in multi-kg scale. Our goal is to provide a consistent, high-quality supply of GMP-compliant polymers and inorganic salts alongside small molecules.

 

Through these expansions and investments in cutting-edge technology, ChemCon is actively shaping the future. With nearly 30 years of enhanced research and development activities for the manufacture of active pharmaceutical ingredients (APIs), we position ourselves at the forefront of the dynamic pharmaceutical sector, while underscoring our commitment to innovation, excellence and reliability in healthcare.

 

About us:

ChemCon is an owner-managed, medium-sized chemical service provider based in Freiburg i.Br., at the foot of the Black Forest. The 130-employee company is a contract manufacturer and analytical service provider for pharmaceutical active ingredients and fine chemicals. Comprehensive investments in modern technologies and safety, even beyond legal requirements, are an integral part of the company’s strategy.

ChemCon’s laboratories and cleanrooms are specially designed for the production of pharmaceutical active ingredients for clinical studies and substances for special applications. Examples include active ingredients for rare diseases, emergency or postoperative medicine, ophthalmology, oncology, as well as intravenous excipients, diagnostics, or dietary supplements.

New ChemCon cleanroom.

New ChemCon labs.

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