Production | ALK

A unique production approach

Production and quality standards

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.

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.

Production Text Image
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.

Our quality culture

The heart of everything we do.

Quality is key at a pharma company like ALK. It is our license to operate, a safety net for our patients and a necessity for our continued growth as a company.

Therefore, quality is also a strategic priority at ALK. We take our responsibility for patient safety and public health very seriously, and we will continue to increase our investments in time, money and energy into making sure that we can continue to deliver high, consistent quality products to the many people with allergy, who rely on our solutions.

At ALK, quality is built upon two pillars – our quality culture and our quality system.

Our quality culture

Higher quality is an important part of safeguarding ALK as a robust and compliant company with high quality products and service levels. Quality is an integrated part of everything that we do and always a core focus for all of us across the global organisation.

 

Our quality system

The quality system at ALK outlines and describes the management and continuous improvement of our business processes. It has the purpose of ensuring:

  • Patient safety, product quality and efficacy, compliance, data integrity and stakeholder expectations
  • That quality is built into our products, processes, services, and systems
  • Continuous improvement of our operations, processes, and products
prodcution_culture_image
  • Patient safety, product quality and efficacy, compliance, data integrity and stakeholder expectations
  • That quality is built into our products, processes, services, and systems
  • Continuous improvement of our operations, processes, and products

ALK’s quality commitment 

By maintaining a strong focus on quality, we uphold our resilient heritage at ALK as a pioneer committed to helping people living with allergy. We remain committed to:

  • Ensuring that all employees have the appropriate skills and are sufficiently trained and competent to perform their work assignments
  • Using a risk-based process approach to integrate quality into the development and production of our products and our complementary services
  • Centering our approach on quality and ethical principles with emphasis on patient engagement, science, and medical data. This to ensure that we deliver safe and efficacious products and valuable information to guide healthcare professionals and people living with allergy
  • Complying with regulatory and business requirements, to meet stakeholder expectations and maintain and continuously improve the ALK quality system.
Last updated: 05.07.2019