| ALK

Production

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

Emergency medicine

Anaphylaxis

Treatment of acute allergic reactions

If you are allergic, exposure to specific food or bee og wasp sting may trigger an acute allergic reaction
People suffering from food allergies or who have an untreated allergy to insect venoms may be at risk of anaphylaxis if exposed to the allergen by accident.

The recommended emergency treatment is an intra-muscular injection of adrenaline followed by an immediate call for medical assistance.

ALK has developed an adrenaline pen for the treatment of acute life-threatening allergic reactions. The pen is specifically designed to be easy to use for patients or relatives.

Anaphylaxis can be triggered by exposure to specific food, or a bee or wasp stings, and can lead to respiratory arrest if quick and effective emergency treatment is not given.

Emergency Medicine Text Image

Learn more about how we collect, extract and process venom from bees and wasps to create venom allergy treatments.

Watch the video
Last updated: 05.07.2019

Allergy vaccines

Allergy vaccines

Reprogramming the immune system

Our solution is founded on evidence-based products that gradually build up tolerance to allergens.
Allergy immunotherapy (AIT) treatments are classified as biologics, because they are produced from living cells rather than being synthesised by chemists.

ALK’s AIT products are derived from natural allergen sources such as grass pollen, tree pollen and house dust mites. 

They come in three different forms:

Injections
Subcutaneous allergy immunotherapy (SCIT) is allergy immunotherapy given as regular injections under the skin. The treatment is administered by a doctor.

Sublingual drops
Sublingual allergy immunotherapy (SLIT) drops are administered under the tongue. Patients administer the drops themselves at home, avoiding the need for regular visits to the doctor.

Tablets
SLIT-tablets are administered by the patient at home and are the best-documented AIT treatment. Tablets for house dust mite, grass, ragweed and Japanese cedar allergies are already available in many markets.
 

Allergy Vaccines Text Image
Allergy immunotherapy has come a long way since it was first discovered. Our latest, tablet-based treatments have been tested in multiple clinical trials involving more than 20,000 people and have the largest evidence-base of any form of AIT treatment.
Read more about evidence-based medicine
Last updated: 30.04.2020

Diagnostics

Know your condition

Diagnosing allergy

The first step in being able to optimally treat any allergy is getting a definitive diagnosis.
ALK manufactures allergen extracts for use in the diagnosis of specific allergies, for instance: in skin prick tests.

In conjunction with the patient’s medical history, a skin prick test can show whether a person has an allergy and, if so, which particular allergen is responsible for their symptoms.

The first step to optimally treating any allergy is a formal diagnosis.

This can be established by reviewing any relevant disease history and symptoms, and can be confirmed by allergy testing.

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.

Diagnostics Text Image
Last updated: 05.07.2019

Consumer healthcare

Consumer healthcare

Making life with allergy simple

By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage.
Allergy is rarely a life-threatening condition, but it can often be life changing. Our aim is to help you manage that change practically and positively.

Allergy is the most widespread chronic disease in the world and, while ALK is an established expert in the field, just 1% of people with allergy currently receive the allergy immunotherapy products that form the core of our portfolio. 

As a result, many in the other 99% may not be aware of the full range of treatment options available to them. Frequently, these people are undiagnosed, suffering in silence, or self-managing their condition with various over-the-counter products and medicines.

Those who eventually find their way to allergy immunotherapy often do so after many years of failed attempts to treat their allergy with other types of product.

Read more about klarify
ALK’s sister brand, klarify, offers services and products for early allergy intervention.
Read more about the allergy app
The klarify app helps users track and manage their pollen allergy. Launched in markets such as Germany, UK, Denmark and USA, it provides personalised allergy information including accurate pollen counts, forecasts for all pollen types – such as grass, weeds and trees – and the latest air quality readings.

Digital eco-system

Despite these frustrations, research shows that people with allergies are highly engaged in managing their condition, and take daily decisions to mitigate its effects.

ALK aims to connect with ‘the other 99%’ by building an ecosystem of information, services and products that complement the company’s core portfolio.

The goal is to connect and engage with allergy sufferers much earlier in their disease journey, using digital tools and e-commerce offerings that offer support, guidance and relief, and smoothing the path to allergy immunotherapy treatment for those who might benefit from it.

klara
Last updated: 16.12.2020

Burden of allergic disease

High costs

The consequences of allergic disease

Allergic rhinitis and allergic asthma are an important cause of loss of productivity

Unmet need for treatment

Severely-affected allergy sufferers experience many symptoms despite treatment with symptom-relieving medication. This unmet need for treatment has substantial socio-economic consequences.

Severely-affected allergy sufferers experience many symptoms despite treatment with symptom-relieving medication. This has substantial socio-economic consequences.

Allergy is a widespread disease, which is becoming increasingly common worldwide and has a tendency to get worse with time. Currently, more than 20% of the world’s population suffer from respiratory allergies.

Socio-economic impact
For most people with respiratory allergies, their condition significantly reduces their quality of life, affecting both work and leisure time. They can relieve their symptoms by trying to avoid allergen exposure, but restricting their lives in this way can have psychological and social consequences as well as a socio-economic impact.

According to a European survey of diagnosed allergy sufferers, around 80% of the respondents said that their condition considerably affects their daily activities.

The increasing prevalence of allergy also has major economic consequences for society through reduced working capacity and more sick leave.

Unmet medical need
A small proportion of people with respiratory allergy still have symptoms despite treatment with symptom-relieving medication. As a result, their quality of life is affected along with their effectiveness at work and elsewhere.

The burden can be relieved
There are several ways to ease the burden of respiratory allergies:

• A significant number of people with allergy are undiagnosed, and the condition is often trivialised both by patients and doctors
• Although effective treatments exist, the disease is often not correctly managed
• An integrated management approach for patients with allergic rhinitis and asthma may both reduce medical treatment costs and improve symptom control

Burden of Allergic Disease Text Image
Allergic rhinitis can have a significant impact on students' exam results. A study has found pupils who are allergic to pollen can see their marks drop up to an entire grade if their condition strikes during exams.
Read more about allergy treatment
Last updated: 09.11.2016

Living with allergy

A modern condition

Impact on daily life

Almost 70% of people who are diagnosed with allergic rhinitis feel that the condition limits their way of life. Reprogramming their immune system to improve its tolerance of specific allergens can help.

Avoidance is difficult

If you suffer from house dust mite allergy it can be hard to escape its symptoms. House dust mites are present everywhere: at work, at home, and particularly in the bedroom. Even going outdoors may not help as, once your airways become inflamed, the symptoms can continue no matter where you go.
Read more about allergy treatment

Tired all the time

Allergy sufferers point to three areas that are affected in particular

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.

Living With The Allergy Text Image
The main difference between symptomatic and immunotherapy treatment is that immunotherapy reprogrammes the immune system, induces tolerance to specific allergens and alters the course of the disease.
Read more about house dust mites
Last updated: 09.11.2016

Pollen allergy

Airborne

Pollen allergy

Some allergens are almost impossible to avoid during the pollen season

Treatment is available

People often ignore their allergic symptoms or do not know enough about the available treatment options

It’s common to ignore allergy symptoms, especially if you do not know enough about the available treatment options. But, for many, pollen allergy can be more than just a minor inconvenience.

If left untreated, it can significantly affect quality of life and is a major risk factor in the development of asthma.

Depending on the severity of the symptoms, pollen allergy can cause poor sleep quality and daytime fatigue which can make it difficult for adults function at work,  or for children to perform well at school.

Particles in the air
Respiratory allergens are in the very air we breathe and house dust mite and grass pollen affect people all over the world.

But there are specific regional allergens too, including pollen from birch and related trees, ragweed pollen and Japanese cedar pollen.

Is it necessary to see a doctor?
If you have not been diagnosed with pollen allergy yet and you have symptoms that significantly impact your life, it is advised that you consult your doctor.

The doctor will probably ask about the history of your symptoms and arrange tests that can show if you have pollen allergy.

Kids Playing Football
The treatment options range from over-the-counter and prescription symptomatic medicines, to more long-term treatments like allergy immunotherapy.
Read more about allergy treatment
Last updated: 09.11.2016

House dust mite allergy

Global citizen

House dust mites live everywhere

The house dust mite is a tiny scavenger that thrives in homes all over the world

The invisible enemy

House dust mites are related to spiders and, like spiders, they have eight legs. They are found in 90% of homes, and they can colonise a brand new home within a year. House dust mites are the most important indoor allergen but, at just 0.2 mm in diameter, they are barely visible to most people.
Read more about allergy treatment
Blocked nose is common

Typical symptoms include blocked nose, especially at night and in the morning after exposure to the mites that live in our bedding. 

Year-round disease

People suffering from house dust mite allergy often feel tired and fatigued. They sleep restlessly and are often woken by breathing difficulties. Many also snore and experience a dry mouth and throat, or they wake up coughing.

Unlike pollen allergies, which are seasonal, house dust mites are present all year round, making them hard to avoid.

What is Allergy Promo Image 1
Respiratory allergens, especially those from house dust mites, can cause allergic asthma.
Read more about allergic asthma
Last updated: 09.11.2016

Treating allergy

Treating allergy

Treatment options for allergic rhinitis

There are two ways of treating allergic rhinitis. Both have been shown to relieve discomfort and allergy-related illness.

What are the treatment options?

Allergy immunotherapy treats the underlying cause of allergy and gives long-lasting improvement by reprogramming the immune system to better tolerate specific allergens.

There are two ways of treating allergic rhinitis. Both have been shown to provide relief and put an end to discomfort and feeling ill.

Symptomatic treatment
Symptomatic treatments are typically used to relieve the symptoms of allergic rhinitis but only work while the medicine is being taken. They have no long-term effect on the allergy itself.   This is because, while they reduce the symptoms of allergy, unlike immunotherapy, they do not induce allergen tolerance. 

Most symptomatic treatments are available over-the-counter (OTC), for example, in supermarkets or pharmacies, and include pharmaceutical medicines such as antihistamines, nasal steroids and decongestants.

Immunotherapy treatment
Immunotherapy treatment has a long-term effect which offers a sustained improvement in the patient’s condition, sometimes for several years following treatment. 

The main difference between symptomatic and immunotherapy treatment is that immunotherapy induces tolerance and so alters the natural course of the disease. There are immunotherapy treatments available for each of the most common respiratory allergens. 

Kids Playing Football
In determining which treatment option is the right one, the cause of the allergy, its severity and symptoms should be taken into account.
Read more about allergy immunotherapy
What is the difference
Allergy immunotherapy treats the underlying cause of allergy, and may provide both improvement of symptoms within a few months and long-lasting improvement. This is in contrast to the usual symptomatic medications that are prescribed, such as antihistamines and corticosteroids, which only temporarily relieve the allergy symptoms while the medication is being taken.
Read more about allergy immunotherapy
Last updated: 11.01.2018
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