Overview

DOTTIKON EXCLUSIVE SYNTHESIS AG offers full-scale chemical cGMP production, specialized in hazardous reactionslow-temperature and high-pressure chemistry as well as continuous processing.

DOTTIKON's equipment includes

  • Small-scale and pilot plant reactors with a total volume of 15 m³ ranging from 15 to 1'000 l in stainless steel, glass-lined, and Hastelloy (C22) with pressure filters and centrifuges for separation
  • Production equipment with a total volume of 300 m³ and a reactor range of 4'000 to 12'500 l in stainless steel, glass-lined, and Hastelloy (C22) as well as pressure filters and centrifuges
  • Dedicated equipment for explosives, low-temperature, and continuous processing
  • Drying capabilities including a vacuum tray dryer (520 l, Hastelloy), paddle dryers (1'000 to 6'000 l in stainless steel and Hastelloy), a double conus dryer (6'000 l, stainless steel), and state-of-the-art spherical dryers (1'000 to 3'000 l in Hastelloy C22)
  • Batch distillation capacity with up to 40 plates under vacuum conditions
  • Thin film evaporator

R&D and Process Development

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.


Small-scale

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.

 

The stand-alone facility is coordinated with our pilot plant and is operated by qualified staff dedicated specifically to the unit. The two small-scale plants operate according to cGMP guidelines.


Pilot

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.


Production

DOTTIKON EXCLUSIVE SYNTHESIS AG has nine cGMP multipurpose and specialized multi-ton production plants including hazardous reactionshigh-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 & Drying

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

  • Pressure filters (mobile and fix, clean rooms)
  • Centrifuges (clean rooms)
  • Clean rooms (Class100'000)
  • Dedicated filtration rooms
  • Containment (endless liners, DoverPac system)

 

Drying equipment (cGMP)

  • Vacuum tray dryer (520 l, Hastelloy)
  • Spherical dryer (0.1 m3, Hastelloy)
  • Paddle dryers (1 to 6 m3, stainless steel/Hastelloy)
  • Double conus dryer (6 m3, stainless steel)
  • Spherical dryers (1.5 to 3 m3, Hastelloy)

Quality Control

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

  • Liquid chromatography (HPLC)
  • Gas chromatography (GC)
  • Ion chromatography (IC)
  • Capillary electrophoresis
  • Thin layer chromatography (TLC)
  • IR- and NIR Spectroscopy
  • UV/VIS spectroscopy
  • High-resolution continuum source AAS
  • X-ray fluorescence (XRF)
  • Hazen (APHA color scale)
  • Titration (including Karl Fischer)
  • pH
  • Melting point
  • Loss on drying
  • Differential scanning calorimetry (DSC)
  • Other gravimetric and thermogravimetric methods
  • Total organic carbon (TOC)
  • Particle size (Malvern)
  • X-ray powder diffraction (XPD, service)
  • Specific pharmacopoeia tests

 

Analytical techniques regarding Process Analytical Technology (PAT)

  • Online FTIR
  • Lasentec/FBRM

 

Analytical techniques for structure elucidation

  • Nuclear magnetic resonance (1H-, 13C-NMR, 24-hour service)
  • Liquid chromatography with mass spectrometry detection (HPLC-MS)
  • Gas chromatography with mass spectrometry detection (GC-MS)