Stallergenes Greer is committed to bringing AIT to the highest quality standards and to delivering state-of-the-art treatments to patients.
As biologic drugs, the manufacture of allergen products is inherently challenging and complex (source: Declerk PJ. Biologicals and biosimilars: a review of the science and its implications. GaBI J 2012;1:13-6).
Allergen extracts: derived from natural sources
Allergen sources contain allergenic proteins from pollens, house dust mites, venom, food, animal dander, etc. Stallergenes Greer produces a large portion of its source materials, which are cultivated at the company’s production sites in Amilly (France) and Lenoir, North Carolina (US).
Quality, safety and controls
Like other biologics, Stallergenes Greer’s allergens are derived from living systems.
Controlling the quality of allergen products is of prime importance to guarantee consistent optimal clinical benefits (source: Zimmer J, et al. Standardization and regulation of allergen products in the European Union. Curr Allergy Asthma Proc 2016;16(3):21).
To ensure batch-to-batch consistency, quality and purity of its products, Stallergenes Greer has established stringent controls regarding the source and nature of the starting materials, and applies a large number of process controls to ensure that target quality attributes are delivered.
Each batch of product is the combination of the product, documentation and controls.
AIT starts with a patient-centric approach
At Stallergenes Greer, our product design is based on a clear understanding of patient needs:
- patient exposure to a specific allergen
- patient sensitisation
- allergen clinical relevance.
Stallergenes Greer covers the value chain from allergen extraction to the production of unique treatments adapted to the individual needs of each patient, in sublingual and subcutaneous forms.
Our manufacturing facilities in France produce individual treatments that are delivered directly to patients. In the US, our bulk allergen extracts are delivered to medical practitioners who prepare the individual treatment for their patients.
Consistent biological potency through process standardisation
Stallergenes Greer ensures the consistent biological potency of its tablets, sublingual and subcutaneous products through standardised and validated quantitative analytical methods.
Driving operational excellence
We seek excellence in every part of our organisation. We aim for a lean operating model without compromising on quality. We draw on improved and sustainable production processes and procedures to consistently deliver the highest quality products to patients.
Our approach to manufacturing the highest quality products relies on continuous learning and improvements to ensure we are continually modernising our quality controls and improving our processes through investments in our facilities. Over the past few years, we have made continuous improvements to our manufacturing capabilities both in France and the US, in order to put in place a manufacturing and quality system that meets the highest product quality standards.
These improvements were supported by programmes designed to strengthen and reinforce our culture of quality and continuous improvement.
Stallergenes Greer's manufacturing facilities in Antony
Stallergenes Greer's manufacturing facilities in Amilly (pollen harvesting)
Stallergenes Greer's manufacturing facilities in Amilly (mites strain bank)
Stallergenes Greer's manufacturing facilities in Lenoir