Exclusive Synthesis

DOTTIKON EXCLUSIVE SYNTHESIS AG provides chemical custom manufacturing services to scale up from grams to multi-tons, including routefinding, process design, process development, small-scale and pilot production, manufacturing, qualification and validation services.

DOTTIKON provides its customers with exclusive custom manufacturing services. The research and development efforts are optimized to allow for flexible and fast responses to customers needs. The streamlined decision process, the ability to ramp up production quickly and the state-of-the-art plants and equipment operated by highly-trained employees allow DOTTIKON to achieve its customers ambitious targets. DOTTIKON seeks to further expand on this platform by continuously improving the quality and efficiency of the production process based on the experience of a close exclusive interaction with customers, with whom DOTTIKON establishes unique and long-term relationships.
 

DOTTIKON is specialized in hazardous reactions. A 100-year history in handling explosives in the past makes DOTTIKON one of the most experienced partners in the industry for critical exothermal reactions such as nitrations, oxidations and azide chemistry, to name only a few. DOTTIKON's core technologies include hazardouslow-temperature and high-pressure reactions as well as continuous processing such as catalytic hydrogenations, alkylations, halogenations, Grignard and other metallorganic reactions.

DOTTIKON ES Spherical Dryer

Project Management

DOTTIKON EXCLUSIVE SYNTHESIS AG bases its operations on well-established and proven project management processes that are consistent with a sound quality management system.

Project Managers R&D are entrusted with the technical lead of the projects, while Business Development Managers take care of all commercial matters. The Steering Committee that involves the CEO and Senior Management regularly monitors and controls the progress of each project in order to ensure seamless project execution and the fulfillment of challenging customer requirements and high quality standards. This project governance structure in combination with highly skilled and experienced specialists ensures the safe and reliable achievements of project objectives.

 

Characteristics and benefits of DOTTIKON's project management

  • Dedicated technical and commercial project managers along project scale-up and life-cycle
  • One-site concept to ensure high flexibility and fast decision making
  • Experience from more than 2'900 projects, scale-up to multi-tons
Project Management

Active Pharmaceutical Ingredients

DOTTIKON EXCLUSIVE SYNTHESIS AG has more than 40 years of experience in the production of active pharmaceutical ingredients (APIs). DOTTIKON is FDA and EMA approved. DOTTIKON's technology portfolio is built around APIs to enable scale-up, high-quality and cost-effective manufacturing under cGMP requirements from kilograms to multi-tons. The processes fulfill the ICH guidelines.

Experience and services

  • Several API launches or post-launch transfers on production scale per year
  • Preformulation and blending of APIs (e.g., nitrate esters)
  • Quality management system in compliance with safety, health and environment (SHE) standards, ISO 9001:2008, including cGMP according to ICH Q10 guidelines
  • Analytical method validation according to ICH Q2(R1)
  • Process validation according to ICH Q10
  • Submission and maintenance of Drug and Active Substance Master Files (DMF/ASMF)
  • Stability testing according to ICH guideline Q1A(R2)
Validation Master Plan

Performance Chemicals

DOTTIKON EXCLUSIVE SYNTHESIS AG develops and commercializes proprietary, high grade performance chemicals for a wide range of industrial applications in close partnership with its customers.

DOTTIKON Performance Chemicals platforms and selected applications:

 

Aromatic and Alicyclic Diamines for

  • Polymers and composite applications
  • High performance adhesives and resins

 

Bio-based Organosilanes for

  • Polymer interfaces and surface modifications
  • Reinforcement of polymer matrices
  • Inorganic filler-polymer matrix coupling

 

Phlegmatized Azides as precursors for

  • Crosslinking agents for polymer applications
  • Coupling agents for carbon fiber composites
Performance Chemicals

Containment

Different occupational exposure limits require different safety measures to handle actives, APIs, HAPIs, and high-potent APIs. DOTTIKON's experience ensures a safe handling of all processes involved.

To handle active substances, DOTTIKON has state-of-the-art containment concepts on all scales (e.g. closed charging/handling/discharging, full protection suit, monitoring, WIP/CIP cleaning, and cleaning validation). These concepts are applied by highly skilled and regularly trained staff.

Containment

Quality Management

cGMP and other higher industry quality standards are an integral part of the comprehensive quality system of DOTTIKON EXCLUSIVE SYNTHESIS AG's independent Quality Management department. 

DOTTIKON meets the high quality requirements of its customers thanks to the strict adherence to a quality system based on the process approach of ISO 9001:2008, which includes cGMP according to ICH Q7 as well as safety, health and environmental (SHE) protection.

 

DOTTIKON is authorized by Swissmedic (Swiss Agency for Therapeutic Products) to manufacture and sell active pharmaceutical ingredients (APIs) including liquid and solid dosage forms. It is subject to regular inspections by the Regional Medicines Inspectorate of North-Western Switzerland. The most recent audit was completed in April 2016.

 

The Quality Management system is based on a 3-level hierarchy

  1. Quality manual with a general overview and the perspectives of quality management
  2. Processes and general instructions for the main business processes
  3. Standard operating procedures with detailed description of each operational step

 

As part of the company's Quality Management, the Quality Control unit is responsible for testing raw materials, intermediates and final products to ensure compliance with specifications. The process analytics unit is responsible for in-process tests as well as release of cleaning results. The Quality Assurance unit monitors compliance with cGMP requirements such as review of batch records. Activities such as cleaning and process validation are performed by the responsible Quality Management project manager.

 

Active Substance Master Files (ASMF) or Drug Master Files (DMF) are prepared in the new eCTD format and are registered with the respective authorities worldwide

  • In Europe with the EMA (European Medicines Agency) in the 'centralized procedure' and with the several national authorities in the 'national procedure'
  • In USA with FDA as Drug Master File Type II
  • In Japan with PMDA (Pharmaceutical and Medical Devices Agency)
  • In several other countries such as Australia, New Zealand and Canada

 

DOTTIKON's most recent FDA audit was completed in September 2015.

Quality ManagementQuality ManagementQuality Management

Recycling & Waste Treatment

Recycling & waste treatment includes the recycling of solvents, thermal recovery, high-temperature incineration, and waste water treatment and purification.

DOTTIKON EXCLUSIVE SYNTHESIS AG operates the following distillation plants

  •  5 Distillation plants consisting of columns for batch operations for 17 to 40 plates
  • 2 Thin-layer evaporators

 

The high-temperature waste incinerator is one of the most modern incineration plants of the world. It was built to incinerate waste that cannot be treated in any other type of plant 

  • Incineration of 8'000 to 9'000 t per year
  • Plant operates 24 hours, at 7 days per week
  • Computer-assisted operation and control of all operation process parameters

 

Based on the quality management system according to ISO 9001:2008, DOTTIKON ensures that the safety, health and environmental requirements of authorities and customers are consistently met.

Recycling Facilities

Catalog Products

Broad process development experience and technological expertise enables DOTTIKON EXCLUSIVE SYNTHESIS AG to offer high-quality chemicals and intermediates, including 

  • Amines 
  • Anilines
  • Azaindoles
  • Benzimidazoles
  • Benzoic acid derivatives
  • Benzyl compounds
  • Boron building blocks
  • Chiral compounds
  • Cyclohexane derivatives
  • Cyclopropyl building blocks

  • Indazoles

  • Indoles
  • N-Heterocycles
  • Nitrate esters
  • Nitroaromatic compounds
  • O-Heterocycles
  • Phenols and anisoles
  • Pyridine building blocks

 

Fine Chemicals Catalog

cGMP Production Plant

Dottisol

High purity isosorbide dimethyl ether (CAS 5306-85-4)

Drug Master File type IV, "Letter of Access" available upon request

Solubility enhancer in

 

Cosmetics

  • Self-tanning 
  • Skin whitening
  • Skin cleaning
  • Anti-ageing

 

Pharma

  • Pharma grade
  • Accelerated penetration
  • Formulation and stability enhancer
  • Miscible with water

 

Agro

  • Among best-in-class leaf penetration promoters
  • High water retention rate
  • No phytotoxicity observed

 

Performance additive in

 

Various industries

  • Phase transfer reagent 
  • FDA and EU food regulations compliance
  • Water-based formulations
  • Improved adhesive properties

 

Isosorbide applications

 

Article on isosorbide as renewable platform for novel applications

Spec. Chem. Mag. 34, 24 (2014).

Scanning electron micrograph of Dottisol in water spray droplet on cuticular tomato leaf membrane