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 110-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 hazardous, low-temperature and high-pressure reactions as well as continuous processing such as catalytic hydrogenations, alkylations, halogenations, Grignard and other metallorganic reactions.

Project/Product Managersare 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/product managers along project scale-up and life-cycle
• One-site concept to ensure high flexibility and fast decision making
• Experience from more than 3'300 projects, scale-up to multi-tons

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 9001:2015, 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)

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

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.

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 9001:2015, 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 February 2022.

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 inspection was completed in December 2022.