Contract Manufacturing

At pK Chemicals we have established a significant number of long-term partnerships with global medico and pharmaceutical customers.

DSMA in a barrel

From laboratory to full-scale production

For more than 70 years we have been building a profound technical and chemical knowledge of the production of ingredients for the pharma industry, based upon contract manufacturing of well-established ingredients as well as supporting customers throughout the process of taking a new product from laboratory to full-scale production. We specialize within contract manufacturing of products based upon Dextrans, Dextran Derivatives or Starch.

We can assist with detailed plans for process optimization and scale-up for Active pharmaceutical ingredients (API´s) and intermediates as well as knowledge about regulatory approvals. We handle all the technical aspects of the start-up of chemical production, including quality control and assessment of relevant environmental and safety conditions. We have a strong network of partners who can assist with coordination and advice during the process.

Our Core Capabilities

pK Chemicals´ production site in Køge is a multi-purpose factory enabling the flexibility needed to satisfy demands for contract manufacturing and handling of all the following processes: Syntheses, purifications, separations, drying and grinding.

The size of our Haarlev plant allows us to offer designated isolated production areas for large production lines.

Both plants can handle new production - either installed with equipment provided by pK Chemicals or equipment fully owned by the customer.

  • We can produce mixtures with varying containment of solvents (IPA, ethanol, ethyl acetate, acetone, etc.)
  • We manufacture our own high-quality water (PW) from our own well
  • We have permission (MST) to handle large amounts of solvents and other chemicals, toxic as well as less harmful
  • We have control of our working environment (no accidents)
  • We can handle development, validation and upscaling from LAB-scale, pilot-scale and full-scale production
  • We have access to an external supply of automation and stainless steel equipment with short reaction time given the mix of competences among the owners of pK Chemicals
  • We have well-educated, flexible and reliable staff
  • Our customers have fast and direct access to the decision makers in our organization
  • Our high Good Manufacturing Practice (GMP) level is constantly measured through frequent audits from our customers and authorities
  • We are experienced in handling consignment stocks

Project Administration

Project Management of upscaling from laboratory to full-scale can be part of the contract between the customer and pK Chemicals. We offer support in all the following activities - either as full or partial support, according to your needs:

  • Project administration
  • Pilot-scale test, technical runs and GMP conformity run
  • Design and Installation full scale
  • Environmental approval from Danish authorities
  • Emission measurements and reports
  • Validation and qualification of analytical methods
  • Process and cleaning validation
  • Preparations for stability testing
  • Preparation and conducting of audit from the Danish Medicines Agency