ALK Extract Manufacturing

Facilities

ALK Source Materials produces and stocks over 800 different allergens. Many products are available for immediate shipment worldwide. These materials are the source of proteins found in allergy immunotherapy treatments and diagnostics and analytical testing. Product categories include tree, grass and weed pollens, dust and storage mites, freeze dried foods, epithelial and environmental products. Our extensive line of products allows many customers to maintain ALK Source Materials as a single supplier which gives them the benefit of product quality consistency and convenience. ALK Source Materials is the largest U.S. supplier of house dust mite source materials.

 


Raw Material Sourcing


Allergen Harvesting


Quality Control


Pollen Collection

ALK’s facilities and processes are integrated with quality control to assure they are GMP compliant for allergenic source materials and are routinely inspected by the FDA. ALK Source Materials grows many plant species on nearly 1,000 acres of farmland, where conditions are ideal for plant growth and harvesting of high quality pollen. In addition to the farm operation, ALK Source Materials has laboratory operations where all products are processed and checked to assure the customer receives the best source materials available.

Experts take great care in nurturing the plants to ensure that they grow a healthy, sustainable crop. Working with agricultural products does not come with the same concerns any other farm would be faced with, including extreme weather conditions, pests, pathogens and parasites. Wind, rain and heat present unique challenges as the collectors try to gather as much materials they can, as quickly as they can. Despite these concerns, the scientists, agronomists, horticulturists and technicians at ALK have many years of experience developing contingency plans. By using multiple locations and multiple cultivars (sub-breeds) of allergens that pollinate at slightly different times, they go a long way to ensure that allergen extract production does not grind to a halt during weather disruptions. ALK also implements rotating fields to avoid cross-contamination.

 

Manufacturing Standards



ALK’s success in creating source materials lies in a completely different arena – the extensive testing, documentation, and quality control measures. All pollen batches undergo a number of tests and quality checks before being released for manufacturing. Most importantly, species identity determinations are made by ASM experts using taxonomic keys and herbarium specimens. Additionally, the pollen is examined under the microscope to further certify the collected batch for identity, purity, and integrity.
At ALK Source Materials, final manufacturing processes are aimed at producing a pure and easy to use product that meets or exceeds all quality expectations while maintaining competitive prices. This is accomplished through processes that have been developed and tested over time and through customer feedback.


Scientists also test material degradation which helps in determining the long term effects of the quality and stability of our finished extracts by subjecting the material to elevated temperatures and measuring any changes. Some of these measures include documentation management, field certification, release and review, batch records, a compliance program for internal and external audits, and a specification management program to ensure that the materials that come into the building are handled appropriately. ALK strives to continuously improve and set the standard for allergen extract materials processing on a global scale. We have an unprecedented level of excellence for products of the allergy industry, as our source materials are held to European standards for purity and potency .If these levels can’t be achieved, then the entire source material lot is discarded.


 

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