DOTTIKON's equipment includes
DOTTIKON EXCLUSIVE SYNTHESIS AG dedicates significant resources for rigorous R&D, routefinding and process development.
Overview of DOTTIKONs facilities
Experience in over 2'900 projects and capacity for more than 20 simultaneous projects.
DOTTIKON EXCLUSIVE SYNTHESIS AG offers small-scale production capabilities to quickly respond to the demand for smaller quantities and scale-up development needs (1 to 50 kg).
DOTTIKON's facilities are suited to the manufacturing of chemical intermediates and active pharmaceutical ingredients (APIs) in clinical trials, as well as for marketed small-volume APIs. The small-scale capabilities are equipped to handle high-potency products.
Experience in over 130 different chemical reactions enable DOTTIKON to deliver to new complex organic compounds within weeks instead of months.
A trend towards high-potent and therefore low-dosage drugs is a key challenge for suppliers of intermediate and active pharmaceutical ingredient.
DOTTIKON EXCLUSIVE SYNTHESIS AG meets this demand with three stand-alone, fully qualified cGMP pilot/small-scale plants, equipped to handle high-potency products. DOTTIKON has experience in over 130 different chemical reactions and can scale up over 80 reaction steps per year using its portfolio of core technologies , low-temperature, high-pressure, and continuous processing.
DOTTIKON ES' modular approach to tailor the equipment to specific needs enables these facilities to handle small- to medium-scale production on one hand, and process and technology transfer as well as scale-up to feed our large-scale multipurpose plants on the other hand.
DOTTIKON EXCLUSIVE SYNTHESIS AG has nine cGMP multipurpose and specialized multi-ton production plants including hazardous reactions, high-pressure (50 bar), low-temperature (−100°C), and continuous processing.
As part of DOTTIKON's full volume range manufacturing and scale-up services, versatile large-scale capabilities are offered for the production of up to several 100 tons per product and year, e.g.
Isolation and drying equipment is available on all scales and in different materials. All equipment is compliant with cGMP and other higher industry standards.
Isolation equipment for small-scale, pilot and large-scale plants
Drying equipment (cGMP)
The quality control unit of DOTTIKON EXCLUSIVE SYNTHESIS AG ensures compliance with cGMP guidelines using validated analytical methods on qualified instruments.
As part of DOTTIKON's quality management, the quality control unit is responsible for testing raw materials, intermediates and final products to ensure compliance with specifications. For each material an approved testing procedure is available which defines the different analytical methods, and their acceptance criteria. The tests are carried out according to cGMP standards on qualified instruments that were calibrated in defined intervals. Method validation is performed according to the actual ICH guidelines.
The quality control consists of four laboratory teams for HPLC, GC, spectroscopic methods and pharmacopoeia tests, and validation of analytical methods with 16 analysts overall. Specifications and raw data are maintained in a Laboratory Information and Management System (LIMS).
Main analytical methods are
Analytical techniques regarding Process Analytical Technology (PAT)
Analytical techniques for structure elucidation