Contract Manufacturing

For decades we have manufactured products under cGMP conditions for customers on an exclusive and confidential basis. We focus on commercial-scale Active Pharmaceutical Ingredients (APIs) and advanced intermediates, most of which are synthetic small molecules. These custom chemical synthesis products benefit from synergies with our non-exclusive products, for example by using the same multi-purpose equipment and quality system.

Our customized services include:

  • Process development and risk evaluation
  • Process scale-up
  • Process validation
  • Development and validation of analytical methods
  • Sourcing/supplier qualification
  • Stability studies
  • Regulatory support including compilation of a Drug Master File (DMF)

We work with several Contract Research Organisations (CROs) to support process development and optimization at lab scale. When we outsource parts of the development work, our expertise and practical experience enable us to achieve useful results with efficient use of cost and time. We also work with partner companies for specialized needs, such as for in-depth Intellectual Property (IP) evaluation, flow technology, trace impurity characterization and process safety and material safety studies.

Our main strength is in cGMP products with volumes between 100 kg and 100 MT per year with up to 5 synthetic steps. We have experience in many types of processes, such as large scale cyanation and vacuum distillation.

We guarantee full confidentiality and can offer a quick scaling up from R&D to commercial scale as well as a long term relationship based on mutual trust.

Our plant provides diverse capabilities for APIs and intermediates:

  1. Reactor volumes up to 10,000 ltr
  2. Broad range of auxiliary equipment such as centrifuges
  3. Multi purpose pilot plant with reactors of 100 ltr to 1000 ltr
  4. Contained environments
  5. On-site R&D and QC support

We achieve cost-competitiveness in toll manufacturing by:

  1. Thinking ahead in process development at lab and pilot scale
  2. Limiting the number of steps and operations
  3. Avoiding hazardous and costly materials and solvents
  4. Optimizing the whole supply chain
  5. Outsourcing processes that do not fit well in our plant
  6. Fitting toll manufacturing into an efficient plant with limited overhead costs and high utilization

Because our organisation is small and agile, we are able to incorporate new products into our plant relatively quickly, without compromising on quality and HSE requirements. Our in-house expertise in organic and analytical chemistry, technology and engineering allows us to identify and evaluate risks for quality and for HSE in the development stage. In the same way we can effectively manage risks in commercial scale manufacturing.

Contract manufacturing cases

Sulfonated polymer for biotech company
Anticholinergic for middle sized pharma company
Semicarbazone for leading chemical company
Bio-based amide derivative