High quality

A unique production approach

As a company whose products touch the lives and affect the well-being of people around the world, we are committed to maintaining the highest production standards.

Producing allergy immunotherapy products

There are several key steps to ensuring ALK's products meet the required quality standards.

Our commitment to maintaining the highest standards spans the entire manufacturing process, from the collection of raw materials, such as pollen, to the manufacture of finished allergy immunotherapy products.

Raw materials

Our products are derived from natural allergen sources such as grass pollen, which are harvested at one of our raw materials production facilities.

Purification

After primary purification and quality control, the raw material is subjected to secondary purification into an active pharmaceutical ingredient at production facilities in Denmark, France, Spain and the USA. Here, excipients are added as the final product is formulated as either, injection-based immunotherapy, sublingual drops, or tablets.

Quality control and assurance

Following quality control, the products enter the final stages of the production process – packaging, labelling and distribution. The entire production process is subject to continuous quality assurance in compliance with EU, US and Japanese standards for good manufacturing practice.

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ALK works continuously to ensure its production process is as efficient and safe as possible. As a consequence, SAP was implemented as ALK's new Enterprise Resource Planning (ERP) system in 2014.

From pollens to finished products

  • Raw materials
    Raw materials
    Natural allergens, such as grass pollen and house dust mites, are the main ingredients of our products. Every year the company grows, collects or harvests several tonnes of allergens.
  • API Production
    API Production
    Handling natural allergens requires thorough analysis, standardisation and quality control processes. This ensures that the biological variation that will always be present in a natural product does not affect the quality of the finished product. It also ensures that it is possible to reproduce the product at any time.
  • Formulation
    Finished production
    The active pharmaceutical ingredient is purified in our own production facilities. Subsequently, the active ingredient is formulated as injections, sublingual drops or sublingual tablets.
  • Distribution
    Packaging and distribution
    Following careful quality control, the finished products are labelled, packaged and distributed.
Raw materials Natural allergens, such as grass pollen and house dust mites, are the main ingredients of our products. Every year the company grows, collects or harvests several tonnes of allergens.
API Production Handling natural allergens requires thorough analysis, standardisation and quality control processes. This ensures that the biological variation that will always be present in a natural product does not affect the quality of the finished product. It also ensures that it is possible to reproduce the product at any time.
Finished production The active pharmaceutical ingredient is purified in our own production facilities. Subsequently, the active ingredient is formulated as injections, sublingual drops or sublingual tablets.
Packaging and distribution Following careful quality control, the finished products are labelled, packaged and distributed.
  • Raw materials
    Raw materials
    Natural allergens, such as grass pollen and house dust mites, are the main ingredients of our products. Every year the company grows, collects or harvests several tonnes of allergens.
  • API Production
    API Production
    Handling natural allergens requires thorough analysis, standardisation and quality control processes. This ensures that the biological variation that will always be present in a natural product does not affect the quality of the finished product. It also ensures that it is possible to reproduce the product at any time.
  • Formulation
    Finished production
    The active pharmaceutical ingredient is purified in our own production facilities. Subsequently, the active ingredient is formulated as injections, sublingual drops or sublingual tablets.
  • Distribution
    Packaging and distribution
    Following careful quality control, the finished products are labelled, packaged and distributed.
Last updated: 2016.11.14