Molecular Approaches to Allergen Standardization

Self Cite

Allergy diagnostics is being transformed by the advent of in vitro IgE testing using purified allergen molecules, combined with multiplex technology and biosensors, to deliver discriminating, sensitive, and high-throughput molecular diagnostics at the point of care. Essential elements of IgE molecular diagnostics are purified natural or recombinant allergens with defined purity and IgE reactivity, planar or bead-based multiplex systems to enable IgE to multiple allergens to be measured simultaneously, and, most recently, nanotechnology-based biosensors that facilitate rapid reaction rates and delivery of test results via mobile devices. Molecular diagnostics relies on measurement of IgE to purified allergens, the “active ingredients” of allergenic extracts. Typically, this involves measuring IgE to multiple allergens which is facilitated by multiplex technology and biosensors. The technology differentiates between clinically significant cross-reactive allergens (which could not be deduced by conventional IgE assays using allergenic extracts) and provides better diagnostic outcomes. Purified allergens are manufactured under good laboratory practice and validated using protein chemistry, mass spectrometry, and IgE antibody binding. Recently, multiple allergens (from dog) were expressed as a single molecule with high diagnostic efficacy. Challenges faced by molecular allergy diagnostic companies include generation of large panels of purified allergens with known diagnostic efficacy, access to flexible and robust array or sensor technology, and, importantly, access to well-defined serum panels form allergic patients for product development and validation. Innovations in IgE molecular diagnostics are rapidly being brought to market and will strengthen allergy testing at the point of care.

Section: Next-generation Innovationsmentioning

confidence: 99%

Technological Innovations for High-Throughput Approaches to In Vitro Allergy Diagnosis

Chapman

Wuenschmann

King

et al. 2015

Self Cite

“…However, in the USA, the Food and Drug Administration (FDA) provides all the information needed for allergen standardization and the references. In an effort to unify the standardization of allergenic extracts in Europe, the project CREATE [33] tried to modify the European system of standardization from the measurement of total allergenic activity to the measurement of major allergen content [34]. The results have had only limited success until now because allergen extract continues to be characterized by biological potency, and the manufacturers continue using their own units.…”

Section: Standardization Of Allergenic Extractsmentioning

confidence: 99%

Control Process for Manufacturing and Standardization of Allergenic Molecules

Carnés¹,

Iraola²,

Gallego³

et al. 2015

It is widely accepted that the success of the allergen immunotherapy (AIT), beyond clinical parameters such as dose, dosage regimen, or compliance, depends on the quality and composition of the final products used in the vaccines. Allergenic vaccines are pharmaceutical preparations derived from the natural sources which contain the allergenic components responsible for allergic sensitization. The selection of the appropriate allergenic sources must be a requirement. They suffer a dramatic transformation during the manufacturing process which renders a biologically standardized final product. The inclusion of the appropriate control analyses in the manufacturing process has demonstrated to be an efficient method to guarantee the quality and homogeneity of the final product as well as being a very useful tool for saving time and money. In this context, in the last years, the Regulatory Agencies have released specific guidelines to guarantee the manufacturing of the most appropriate products for the treatment of patients.

“…First, major allergens sensitize most allergic patients to a particular pollen; second, and more importantly, diagnoses and specific therapies are standardized and adjusted in relation to the major allergens [30][31][32][33][34][35]. As a consequence in most cases, major allergen-based diagnosis will be enough to correctly diagnose and, thus, adequately select extracts to treat more than 90 % of allergic patients.…”

Section: Major Allergen Markers and Cross-reactivitymentioning

confidence: 99%

Challenges for Allergy Diagnosis in Regions with Complex Pollen Exposures

Barber

Díaz‐Perales

Villalba

et al. 2014

Over the past few decades, significant scientific progress has influenced clinical allergy practice. The biological standardization of extracts was followed by the massive identification and characterization of new allergens and their progressive use as diagnostic tools including allergen micro arrays that facilitate the simultaneous testing of more than 100 allergen components. Specific diagnosis is the basis of allergy practice and is always aiming to select the best therapeutic or avoidance intervention. As a consequence, redundant or irrelevant information might be adding unnecessary cost and complexity to daily clinical practice. A rational use of the different diagnostic alternatives would allow a significant improvement in the diagnosis and treatment of allergic patients, especially for those residing in complex pollen exposure areas.