Technical operations
Accelerating pharmaceutical development
To offer patients with allergies the best treatments and ensure that we stay at the forefront of AIT, we make specific efforts to optimise process development and formulation as well as continuously acquire increased knowledge of our molecules and processes.
Our teams work around the clock to make sure that patients and healthcare practitioners receive the highest quality diagnostic solutions and allergen immunotherapy treatments, on time, every time.
Products derived from living systems
Like other biologic drugs, Stallergenes Greer’s allergens are derived from living systems. Biologic drugs contain one or more active substances that are produced in a living system such as micro-organisms and plant or animal cells1. Biologics consist of large and complex molecules; their characterisation is challenging and involves highly advanced technologies. They target specific cells in the immune system.
A patient-centric approach
Because Stallergenes Greer’s allergen immunotherapy (AIT) treatments cater to the real needs of patients, product design begins with a clear understanding of patient profiles: to which specific allergen is a patient exposed, to which allergen(s) is a patient sensitised and is the allergen clinically relevant.
Quality, safety, controls at every stage
To provide patients with the benefits they need, controlling the quality of allergen products is of prime importance to guarantee both the safety and efficacy of allergy diagnosis, AIT and consistent optimal clinical benefits2.
Stallergenes Greer’s allergens are manufactured in a living system and their production is strongly process-dependent. To ensure batch-to-batch consistency, quality and purity of its products, Stallergenes Greer has established stringent controls of the source and nature of the source materials and applies hundreds of process controls to ensure that target quality attributes are delivered. Each batch of product is the combination of the product, documentation and controls.
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 which assure the uniformity and purity of the Group’s products and their activity.
Driving operational excellence
We seek excellence in every part of our organisation. Our approach to manufacturing 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.
Having the right product available is critical to ensuring patient’s needs. We rigorously manage our operations to ensure product availability by focusing on operational excellence and investing in state-of-the-art equipment, technology, and systems. Our manufacturing facilities in France produce individual treatments that are delivered directly to patients. In the U.S., our bulk allergen extracts are delivered to medical practitioners who prepare the individual treatment for their patients.
1. Biological product definitions www.fda.gov – 2. Zimmer J, et al. Standardization and regulation of allergen products in the European Union. Curr Allergy Asthma Proc 2016;16(3):21.