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.

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

A formal medical diagnosis is especially important for children as one allergy can escalate into multiple allergies, and because allergic rhinitis can lead to asthma. An early diagnosis can enable preventative treatment to begin so that the impact of any allergy can be minimised.

A diagnosis is typically made based on symptoms, a physical examination and a series of questions. In some cases, an allergy specialist can identify what is causing the allergy just from a medical history and symptoms, and a simple confirmatory diagnostic test.

Testing by skin prick test or blood test

A skin prick test provokes an allergic reaction by introducing a tiny amount of allergen – the substance which doctors think you may be allergic to – to the skin using a needle. Where an allergy exists, the skin will react and something similar to a mosquito bite will appear where the allergen was applied.

A blood test can be used on its own, or to support the results of the skin prick test. The blood is tested for immunoglobulin E (IgE) antibodies, which are substances produced by the body when there is an allergic reaction. If high levels of IgE antibodies are found in the blood and related symptoms are also present, then this will help to confirm the diagnosis.

Allergic rhinitis impacts most areas of life, but the the most common impact is upon sleep, work and outdoor activities.

Considerable burden
Although allergic rhinitis is frequently considered to be a trivial disease, surveys repeatedly show that its burden is considerable.

In one study of patients in Europe, two out of three felt that house dust mite allergy was a ‘major handicap’. 

Sleep disturbance
One of the most important issues is sleep disturbance and its impact on school and work performance.

And, while many people with rhinitis may still go to work or school, their performance is often impaired as breathing difficulties drain their mental and physical energy.