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• W2920659320 abstract "Information for Category 1 CME CreditCredit can now be obtained, free for a limited time, by reading the review articles in this issue. Please note the following instructions.Method of Physician Participation in Learning Process: The core material for these activities can be read in this issue of the Journal or online at the JACI Web site: www.jacionline.org. The accompanying tests may only be submitted online at www.jacionline.org. Fax or other copies will not be accepted.Date of Original Release: March 2019. Credit may be obtained for these courses until February 29, 2020.Copyright Statement: Copyright © 2019-2020. All rights reserved.Overall Purpose/Goal: To provide excellent reviews on key aspects of allergic disease to those who research, treat, or manage allergic disease.Target Audience: Physicians and researchers within the field of allergic disease.Accreditation/Provider Statements and Credit Designation: The American Academy of Allergy, Asthma & Immunology (AAAAI) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAAAI designates this journal-based CME activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.List of Design Committee Members: Vera Mahler, MD, Robert E. Esch, PhD, Jörg Kleine-Tebbe, MD, William Lavery, MD, PhD, Greg Plunkett, PhD, Stefan Vieths, PhD, and David I. Bernstein, MD (authors); Zuhair K. Ballas, MD (editor)Disclosure of Significant Relationships with Relevant CommercialCompanies/Organizations: V. Mahler reports personal fees (prior to current position) from ALK-Abelló, Bencard/ATL, HAL, Novartis/Leti and other support from Allergopharma, Germany, and DBV, France, outside the submitted work and grants, personal fees, and other support from Novartis, Germany, and nonfinancial support from the European Academy of Allergy and Clinical Immunology outside the submitted work. J. Kleine-Tebbe reports personal fees from Allergopharma, ALK-Abelló, Bencard/Allergy Therapeutics, Circassia, HAL, LETI, Lofarma, Merck (USA), and Stallergenes Greer for lecturing, conduct of studies or consultancy; personal fees from AllergenOnline (University of Nebraska), AstraZeneca, Dr. Pfleger, German Society of Allergology and Clinical Immunology, Glaxo, Novartis, Paraxel International, Sanofi, ThermoFisher for lecturing or consultancy; personal fees from Springer International and THIEME publishers outside the submitted work; and nonfinancial support from the American Academy of Allergy, Asthma & Immunology, European Academy of Allergy and Clinical Immunology, and WHO/IUIS Allergen Nomenclature Subcommittee. S. Vieths reports personal fees from Ärzteverband Deutscher Allergologen, the Swiss Society for Allergy and Immunology, Schattauer Allergologie Handbuch, Elsevier Nahrungsmittelallergien und Intoleranzen, Karger Food Allergy: Molecular Basis and Clinical Practice, and the American Academy of Asthma, Allergy & Immunology; nonfinancial support from the German Research Foundation, the European Directorate for the Quality of Medicines and Health Care, the European Academy of Allergy and Clinical Immunology, the German Chemical Society (GDCh), AKM Allergiekongress, the International Union of Immunological Societies; and personal fees from University Hospital Gießen/Marburg, the University of Bonn, and Pharmacon; and nonfinancial support from the Spanish Society for Allergy and Clinical Immunology (SEAIC) outside the submitted work. D. I. Bernstein reports grants and personal fees from ALK-Abelló and grants from Allergy Therapeutics, Merck, the American College of Allergy, and the American Academy of Allergy, Asthma & Immunology outside the submitted work. Z. K. Ballas (editor) disclosed no relevant financial relationships.Activity Objectives:1.To review the differences in allergen immunotherapy (manufacturing, regulatory requirements, and clinical administration) between the United States and Europe.2.To understand the differences between European and American immunotherapy products and practices, including unique products available in each setting.3.To describe the differing diagnostic and therapeutic approaches to allergen immunotherapy in Europe and the United States.Recognition of Commercial Support: This CME activity has not received external commercial support.List of CME Exam Authors: Ammara Ahmed, DO, Joan H. Dunlop, MD, Suzanne R. Kochis, MD, Jo Wilson, MD, and Robert A. Wood, MD.Disclosure of Significant Relationships with Relevant CommercialCompanies/Organizations: The exam authors disclosed no relevant financial relationships.Allergen immunotherapy (AIT) is thought to be clinically effective and safe in treating allergic rhinitis, asthma, and stinging insect allergy in Europe and North America. However, there are intercontinental differences in AIT therapeutic products in terms of their application and regulation. In North America unmodified standardized and nonstandardized aqueous aeroallergen extracts are approved and used almost exclusively for subcutaneous immunotherapy, whereas more product options are available in Europe, including adsorbed allergens, chemically modified allergens, or both. Both liquid extracts and tablets are approved for sublingual immunotherapy in Europe. Nevertheless, within the European Union, there are major differences in AIT products approved and used in individual countries. There are major differences in the clinical approach to subcutaneous immunotherapy in polysensitized patients; in the United States mixed extracts containing multiple aeroallergens are used, whereas European allergists preferably administer separate injections of single allergen sources or homologous groups deemed to be clinically relevant. Moreover, the regulatory approach differs between the European Union and United States. In contrast to the United States, where common allergen standards exist based on biologic activity, no common standards exist in Europe. In terms of development of new investigational products, the United States has followed the European example for phase II and III studies; no formal US Food and Drug Administration guidance has been issued. Information for Category 1 CME CreditCredit can now be obtained, free for a limited time, by reading the review articles in this issue. Please note the following instructions.Method of Physician Participation in Learning Process: The core material for these activities can be read in this issue of the Journal or online at the JACI Web site: www.jacionline.org. The accompanying tests may only be submitted online at www.jacionline.org. Fax or other copies will not be accepted.Date of Original Release: March 2019. Credit may be obtained for these courses until February 29, 2020.Copyright Statement: Copyright © 2019-2020. All rights reserved.Overall Purpose/Goal: To provide excellent reviews on key aspects of allergic disease to those who research, treat, or manage allergic disease.Target Audience: Physicians and researchers within the field of allergic disease.Accreditation/Provider Statements and Credit Designation: The American Academy of Allergy, Asthma & Immunology (AAAAI) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAAAI designates this journal-based CME activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.List of Design Committee Members: Vera Mahler, MD, Robert E. Esch, PhD, Jörg Kleine-Tebbe, MD, William Lavery, MD, PhD, Greg Plunkett, PhD, Stefan Vieths, PhD, and David I. Bernstein, MD (authors); Zuhair K. Ballas, MD (editor)Disclosure of Significant Relationships with Relevant CommercialCompanies/Organizations: V. Mahler reports personal fees (prior to current position) from ALK-Abelló, Bencard/ATL, HAL, Novartis/Leti and other support from Allergopharma, Germany, and DBV, France, outside the submitted work and grants, personal fees, and other support from Novartis, Germany, and nonfinancial support from the European Academy of Allergy and Clinical Immunology outside the submitted work. J. Kleine-Tebbe reports personal fees from Allergopharma, ALK-Abelló, Bencard/Allergy Therapeutics, Circassia, HAL, LETI, Lofarma, Merck (USA), and Stallergenes Greer for lecturing, conduct of studies or consultancy; personal fees from AllergenOnline (University of Nebraska), AstraZeneca, Dr. Pfleger, German Society of Allergology and Clinical Immunology, Glaxo, Novartis, Paraxel International, Sanofi, ThermoFisher for lecturing or consultancy; personal fees from Springer International and THIEME publishers outside the submitted work; and nonfinancial support from the American Academy of Allergy, Asthma & Immunology, European Academy of Allergy and Clinical Immunology, and WHO/IUIS Allergen Nomenclature Subcommittee. S. Vieths reports personal fees from Ärzteverband Deutscher Allergologen, the Swiss Society for Allergy and Immunology, Schattauer Allergologie Handbuch, Elsevier Nahrungsmittelallergien und Intoleranzen, Karger Food Allergy: Molecular Basis and Clinical Practice, and the American Academy of Asthma, Allergy & Immunology; nonfinancial support from the German Research Foundation, the European Directorate for the Quality of Medicines and Health Care, the European Academy of Allergy and Clinical Immunology, the German Chemical Society (GDCh), AKM Allergiekongress, the International Union of Immunological Societies; and personal fees from University Hospital Gießen/Marburg, the University of Bonn, and Pharmacon; and nonfinancial support from the Spanish Society for Allergy and Clinical Immunology (SEAIC) outside the submitted work. D. I. Bernstein reports grants and personal fees from ALK-Abelló and grants from Allergy Therapeutics, Merck, the American College of Allergy, and the American Academy of Allergy, Asthma & Immunology outside the submitted work. Z. K. Ballas (editor) disclosed no relevant financial relationships.Activity Objectives:1.To review the differences in allergen immunotherapy (manufacturing, regulatory requirements, and clinical administration) between the United States and Europe.2.To understand the differences between European and American immunotherapy products and practices, including unique products available in each setting.3.To describe the differing diagnostic and therapeutic approaches to allergen immunotherapy in Europe and the United States.Recognition of Commercial Support: This CME activity has not received external commercial support.List of CME Exam Authors: Ammara Ahmed, DO, Joan H. Dunlop, MD, Suzanne R. Kochis, MD, Jo Wilson, MD, and Robert A. Wood, MD.Disclosure of Significant Relationships with Relevant CommercialCompanies/Organizations: The exam authors disclosed no relevant financial relationships.Allergen immunotherapy (AIT) is thought to be clinically effective and safe in treating allergic rhinitis, asthma, and stinging insect allergy in Europe and North America. However, there are intercontinental differences in AIT therapeutic products in terms of their application and regulation. In North America unmodified standardized and nonstandardized aqueous aeroallergen extracts are approved and used almost exclusively for subcutaneous immunotherapy, whereas more product options are available in Europe, including adsorbed allergens, chemically modified allergens, or both. Both liquid extracts and tablets are approved for sublingual immunotherapy in Europe. Nevertheless, within the European Union, there are major differences in AIT products approved and used in individual countries. There are major differences in the clinical approach to subcutaneous immunotherapy in polysensitized patients; in the United States mixed extracts containing multiple aeroallergens are used, whereas European allergists preferably administer separate injections of single allergen sources or homologous groups deemed to be clinically relevant. Moreover, the regulatory approach differs between the European Union and United States. In contrast to the United States, where common allergen standards exist based on biologic activity, no common standards exist in Europe. In terms of development of new investigational products, the United States has followed the European example for phase II and III studies; no formal US Food and Drug Administration guidance has been issued. Credit can now be obtained, free for a limited time, by reading the review articles in this issue. Please note the following instructions. Method of Physician Participation in Learning Process: The core material for these activities can be read in this issue of the Journal or online at the JACI Web site: www.jacionline.org. The accompanying tests may only be submitted online at www.jacionline.org. Fax or other copies will not be accepted. Date of Original Release: March 2019. Credit may be obtained for these courses until February 29, 2020. Copyright Statement: Copyright © 2019-2020. All rights reserved. Overall Purpose/Goal: To provide excellent reviews on key aspects of allergic disease to those who research, treat, or manage allergic disease. Target Audience: Physicians and researchers within the field of allergic disease. Accreditation/Provider Statements and Credit Designation: The American Academy of Allergy, Asthma & Immunology (AAAAI) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. The AAAAI designates this journal-based CME activity for a maximum of 1.00 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. List of Design Committee Members: Vera Mahler, MD, Robert E. Esch, PhD, Jörg Kleine-Tebbe, MD, William Lavery, MD, PhD, Greg Plunkett, PhD, Stefan Vieths, PhD, and David I. Bernstein, MD (authors); Zuhair K. Ballas, MD (editor) Disclosure of Significant Relationships with Relevant Commercial Companies/Organizations: V. Mahler reports personal fees (prior to current position) from ALK-Abelló, Bencard/ATL, HAL, Novartis/Leti and other support from Allergopharma, Germany, and DBV, France, outside the submitted work and grants, personal fees, and other support from Novartis, Germany, and nonfinancial support from the European Academy of Allergy and Clinical Immunology outside the submitted work. J. Kleine-Tebbe reports personal fees from Allergopharma, ALK-Abelló, Bencard/Allergy Therapeutics, Circassia, HAL, LETI, Lofarma, Merck (USA), and Stallergenes Greer for lecturing, conduct of studies or consultancy; personal fees from AllergenOnline (University of Nebraska), AstraZeneca, Dr. Pfleger, German Society of Allergology and Clinical Immunology, Glaxo, Novartis, Paraxel International, Sanofi, ThermoFisher for lecturing or consultancy; personal fees from Springer International and THIEME publishers outside the submitted work; and nonfinancial support from the American Academy of Allergy, Asthma & Immunology, European Academy of Allergy and Clinical Immunology, and WHO/IUIS Allergen Nomenclature Subcommittee. S. Vieths reports personal fees from Ärzteverband Deutscher Allergologen, the Swiss Society for Allergy and Immunology, Schattauer Allergologie Handbuch, Elsevier Nahrungsmittelallergien und Intoleranzen, Karger Food Allergy: Molecular Basis and Clinical Practice, and the American Academy of Asthma, Allergy & Immunology; nonfinancial support from the German Research Foundation, the European Directorate for the Quality of Medicines and Health Care, the European Academy of Allergy and Clinical Immunology, the German Chemical Society (GDCh), AKM Allergiekongress, the International Union of Immunological Societies; and personal fees from University Hospital Gießen/Marburg, the University of Bonn, and Pharmacon; and nonfinancial support from the Spanish Society for Allergy and Clinical Immunology (SEAIC) outside the submitted work. D. I. Bernstein reports grants and personal fees from ALK-Abelló and grants from Allergy Therapeutics, Merck, the American College of Allergy, and the American Academy of Allergy, Asthma & Immunology outside the submitted work. Z. K. Ballas (editor) disclosed no relevant financial relationships. Activity Objectives:1.To review the differences in allergen immunotherapy (manufacturing, regulatory requirements, and clinical administration) between the United States and Europe.2.To understand the differences between European and American immunotherapy products and practices, including unique products available in each setting.3.To describe the differing diagnostic and therapeutic approaches to allergen immunotherapy in Europe and the United States. Recognition of Commercial Support: This CME activity has not received external commercial support. List of CME Exam Authors: Ammara Ahmed, DO, Joan H. Dunlop, MD, Suzanne R. Kochis, MD, Jo Wilson, MD, and Robert A. Wood, MD. Disclosure of Significant Relationships with Relevant Commercial Companies/Organizations: The exam authors disclosed no relevant financial relationships. Allergen immunotherapy (AIT) with grass pollen was first introduced by Noon and Freeman more than 100 years ago and has been used in clinical practice both in Europe and North America during the last century.1Bousquet J. Lockey R. Malling H.J. Allergen immunotherapy: therapeutic vaccines for allergic diseases. A WHO position paper.J Allergy Clin Immunol. 1998; 102: 558-562Abstract Full Text Full Text PDF PubMed Scopus (754) Google Scholar Subsequently, subcutaneous immunotherapy (SCIT) has been increasingly practiced on both sides of the pond for treating patients with seasonal and perennial allergic rhinitis, IgE-dependent asthma, and anaphylaxis caused by Hymenoptera insect venom. Placebo-controlled studies performed in both Europe and the United States have supported both the efficacy and safety of a variety of AIT modalities (https://www.clinicaltrialsregister.eu and https://clinicaltrials.gov/).2Durham S.R. Penagos M. Sublingual or subcutaneous immunotherapy for allergic rhinitis?.J Allergy Clin Immunol. 2016; 137: 339-349Abstract Full Text Full Text PDF PubMed Scopus (108) Google Scholar, 3Abramson M.J. Puy R.M. Weiner J.M. Injection allergen immunotherapy for asthma.Cochrane Database Syst Rev. 2010; 8: CD001186PubMed Google Scholar Yet over the decades, routine clinical practices surrounding AIT used by allergists prescribing AIT in the United States and Europe have diverged substantially. For example, 2 key differences in AIT practice patterns have emerged. First, a limited number of therapeutic aeroallergen species are used, particularly in Central Europe (eg, a single tree, grass, and house dust mite species), versus allergen mixtures used in the United States, representing multiple species of pollens, mold spores, house dust mites and mammalian epidermal allergens. Second, ready-to-use, alum-precipitated, and/or further modified aeroallergens have been adapted into clinical practice in European countries versus the United States, where practitioners have nearly exclusively used aqueous standardized and nonstandardized aeroallergen extract products. Because of clear intercontinental differences in aeroallergen sources and formulations, it is challenging to directly compare clinical efficacy and safety data derived from placebo-controlled studies conducted in Europe and the United States. Although the US Food and Drug Administration (FDA) has defined the minimal detectable clinical effect by using a statistical approach, in the European Union (EU) statistical significance is the chosen primary end point, and a clinical justification of the relevance of the effect obtained in a pivotal clinical trial is requested. Moreover, it is difficult to judge the effectiveness of the different AIT approaches in Europe and the United States under real-life conditions. There is likely a substantial lack of familiarity among European allergists of AIT products and practices in the United States and vice versa. The goals of this article are to compare differences between the United States and Europe in AIT practices related to:1.manufacturing and development of therapeutic aeroallergen products;2.regulatory requirements and clinical development of AIT products;3.diagnostic approaches used to identify and select specific aeroallergens for AIT;4.clinical administration of AIT, including build-up schedules and risk management; and5.unmet needs and controversies. There are currently 4 United States–licensed companies that manufacture and market allergen extracts in the United States for clinical use. Together, they manufacture hundreds of extracts derived from diverse allergen sources. Before the 1970s, it was common practice for practicing allergists to manufacture their own extracts using allergen source materials provided by regional suppliers. Today, more stringent regulatory requirements have essentially eliminated this activity from the allergists' clinic and allowed for standardization of 19 products (Table I).4Cox L. Nelson H. Lockey R. Calabria C. Chacko T. Finegold I. et al.Allergen immunotherapy: a practice parameter third update.J Allergy Clin Immunol. 2011; 127: S1-S55Abstract Full Text Full Text PDF PubMed Scopus (851) Google ScholarTable ISummary of available SCIT products in the United States, including types of commercial products, available products standardized by allergenic potency, methods of preparation, and administration and riskCommercial treatment allergen productsSpecific allergensStandardized allergen productsAllergen preparationCompounding and preparing dilution vialsAdministrationRisk of systemic reactions and anaphylaxisAqueous and glycerinated aeroallergen productsHomogeneous liquid products∗Extraction is similar across the industry by using Coca solution (physiologic saline, bicarbonate buffer, and phenol) with or without glycerin. Pollen extracts are manufactured similarly by each company and show the least variability.Used in all treated patientsPollens, molds, house dust mites, mammalian epithelia and feathers, whole-body insect and miscellaneous items (eg, kapok)Standardized and nonstandardized products are used together.†Most allergen extracts in the United States are nonstandardized (no standard of potency). Commercial products must pass sterility and safety compendium tests (USP) but not a potency test. Strength by weight per volume or sometimes the protein nitrogen unit is used for labeling.Short ragweed, cat hair/pelt products, 7 temperate grasses, 1 subtropical grass Bermuda, 2 house dust mites (D farinae and D pteronyssinus)Single- or multiple-allergen mixes prepared in patient-specific vials diluted in normal saline and 0.4% phenol with or without buffer or 0.03% human serum albuminMultiple- or single-allergen vials mixed in allergy clinics and vial dilutions by staff according to USP 797 compounding guidance‡Manufacturers provide some allergen mixes (see text).Slow or accelerated cluster build-up used to safely reach effective maintenance doses§See Table IX in Cox et al for effective maintenance aeroallergen doses.4Maintenance injections given every 2-4 wk for 3-5 ySystemic reactions in 0.1% of injectionsRare cases of fatal anaphylaxisAsthmatic patients at risk for fatalreactionsLyophilizedHymenoptera venom productsYellow jacket, white-faced and yellow hornets, honey bee, Polistes species (wasp)Venoms diluted in PBS with human serum albuminNAVenom build-up schedule achieves maintenance dose (100 μg per venom) by 9-15 wkUltrarush build-up protocols for select patientsWell tolerated but high risk of severeanaphylaxis in patientswith mastocytosisAlum-absorbed products (rarely used)Pollens, nonstandardizedGrass extracts available and not standardizedNoneDiluted in normal saline and 0.4% phenolSame as aqueousAlum products not mixed with aqueousSame as aqueousLow riskAllergoids, adjuvant or recombinant productsNANANANANANANA, Not applicable.∗ Extraction is similar across the industry by using Coca solution (physiologic saline, bicarbonate buffer, and phenol) with or without glycerin. Pollen extracts are manufactured similarly by each company and show the least variability.† Most allergen extracts in the United States are nonstandardized (no standard of potency). Commercial products must pass sterility and safety compendium tests (USP) but not a potency test. Strength by weight per volume or sometimes the protein nitrogen unit is used for labeling.‡ Manufacturers provide some allergen mixes (see text).§ See Table IX in Cox et al for effective maintenance aeroallergen doses.4Cox L. Nelson H. Lockey R. Calabria C. Chacko T. Finegold I. et al.Allergen immunotherapy: a practice parameter third update.J Allergy Clin Immunol. 2011; 127: S1-S55Abstract Full Text Full Text PDF PubMed Scopus (851) Google Scholar Open table in a new tab NA, Not applicable. FDA-approved tablet products standardized for allergenic potency are listed in Table II. However, most commercially available allergen extracts are not standardized. Extracts manufactured in the United States have been primarily regulated based on extraction methods used rather than the methods used to collect or produce allergen source materials. For this reason, most manufacturers of US products use similar extraction methods across different allergen source materials, including those derived from pollens, foods, epithelia, fungi, mites, and insects.5Slater J.E. Esch R.E. Preparation and standardization of allergen extracts.in: Adkinson N.F. Bochner B.S. Burks W. Busse W.W. Holgate S.T. Lemanske Jr., R.F. Allergy: principles and practice. 8th ed. Mosby, Philadelphia2014: 470-481Google Scholar Allergen source materials are extracted in a slightly alkaline buffer, such as bicarbonate pH 8.4, to increase protein and allergen recovery.Table IISummary of commercially available products used for SLIT in the United States including FDA-approved sublingual allergen products, approved indications, advantages, and limitationsCommercial tablet productsFDA-approved indication for allergic rhinitisStandardized products (effective allergen dose)Level of evidence supporting efficacy in patients with allergic rhinitisAdvantagesLimitationsGrass, ragweed, house dust mite∗No asthma indication for house dust mites in the United States, as in Europe. tabletsSeasonal or perennialFive-grass (300 IR)Timothy grass (2800 BAU, 15 μg of Phl p 5)Ragweed (12 μg of Amb a 1)HDM (12 SQ units, 30 μg of major allergens, including equal amounts of D farinae and D pteronyssinus group 1 and group 2 allergens)HighConvenient self-dosing and low risk of anaphylaxisSafe treatment option for patients unwilling to receive SCITMinimal treatment duration (12-16 wk) required to achieve efficacyPersistent site application reactions, <5% of patients might require cessationCost barriers in some patients and low adherence ratesOff-label sublingual use of commercial glycerinated aqueous allergen productsNoneEffective dose not establishedLowConvenient self-dosingUnproved efficacy and safety with sublingual aqueous drops administered in the United StatesNo reimbursement∗ No asthma indication for house dust mites in the United States, as in Europe. Open table in a new tab Extraction is similar across the industry, using Coca solution (physiologic saline, bicarbonate buffer, and phenol) with or without glycerin. Pollen extracts are manufactured similarly by each company and show the least variability. Each company has its own source material departments, and therefore there can be some variability in purification of the pollen. The other categories have different manufacturing methods. Molds are extracted similarly but use different strains and growing conditions. Some foods are dialyzed. Epithelial extracts are concentrated through various methods, such as lyophilization, diafiltration, or acetone precipitation. Dust mites are grown on different media and use different purification techniques. Some manufacturers perform dialysis, ultrafiltration, or other purification steps, but this is not common. All allergen extracts must be sterile, and this is accomplished by passing the bulk extract through a sterilizing filter with a nominal pore size of 0.2 μm. In addition, all extracts marketed in multiple-dose vials must contain a preservative that is bacteriostatic and fungistatic. Most manufacturers use phenol at 0.2% to 0.5% with or without 50% glycerin. When extracts are prepared with glycerin concentrations of greater than 50%, phenol is not required. The utility of glycerin in extracts as a stabilizer has been well established, and for this reason, the expiratory dating of nonstandardized extracts is assigned according to FDA regulations 21 Code of Federal Regulations 610.53, which states that extracts should be stored in final containers with 50% or greater glycerin and stored at 2°C to 8°C. The dating period is up to a maximum of 6 years but no more than 3 years in manufacturer's storage and no more than 3 years after the product is shipped by the manufacturer. For extracts in final containers with less than 50% glycerin and for alum-precipitated extracts, the period is up to a maximum of 3 years but no more than 18 months in manufacturer's storage and no more than 18 months after the product is shipped by the manufacturer. Qualitative differences between manufacturers' products are based on differences used to collect or produce allergen source materials. These differences are minimal with pollen source materials because their collection methods are well established across manufacturers and independent coll" @default.
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• W2920659320 title "Understanding differences in allergen immunotherapy products and practices in North America and Europe" @default.
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