References

General References used throughout:

 

Cox, L, et al.  Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol.  2011 Mar;127(3):840.

 

Cox, L, et al.  Allergen immunotherapy: a practice parameter second update. J Allergy Clin Immunol.  2007;127(suppl):S25-85, IV

 

Li, JT, et al.  Allergen immunotherapy: a practice parameter.  Ann Allergy Asthma Immunol.  2003;90:1-40

 

Nelson, M. 2009.  Physician’s Instruction Guide for the Preparation of Allergen Extract. 

http://www.jcaai.org/file_depot/0-10000000/20000-30000/27387/folder/62846/Physician_Instruction_Guide.pdf

 

The Joint Council of Allergy & Immunology (JCAAI):

www.JCAAI.org

 

The American Academy of Allergy, Asthma & Immunology (AAAAI)

www.AAAAI.org

 

The American College of Allergy, Asthma and Immunology (ACAAI)

www.ACAAI.org

 

General Allergic Inflammation:

Galli, SJ et al (2008) The development of allergic inflammation.  Nature; 454: 445-454

 

Mechanisms of IT:

Larche, M., et al.  2006.  Immunological mechanisms of allergen-specific immunotherapy.  Nature Reviews Immunology Vol 6, Oct 2006, 761-771

 

 

Stability references

 

Overall:

Plunkett, G. 2008.  Stability of allergen extracts used in skin testing and immunotherapy.  Current Opinion in Otolaryngology & Head and Neck Surgery 2008, 16:285-291.

 

Dilution, temp, preservative:

Niemeijer, N. Effect of dilution, temperature, and preservatives on the long-term stability of standardized inhalant allergen extracts.  Ann Allergy Asthma Immunol 1996;76:535-40.

 

Mold extract differences based on preparation, stability with different diluents:

Hansen, M 1994.  Allergens in Aspergillus fumigatus: I. Characterization of two different allergen extracts and evaluation of their stability and the importance of carbohydrate for IgE binding.  Allergy 1994: 49: 235-241.

 

Mixing pollen with mold, cockroach, dust mite:

Kordash, T, et al, 1993.  Effect of mixing allergenic extracts containing Helminthosporium, D. farinae, and cockroach with perennial ryegrass.  Annals of Allergy, Vol 71, Sept. 1993.

 

Mixing fire ant with other extracts:

Rans, T. et al 2009.  Compatibility of imported fire ant whole body extract with cat, ragweed, Dermatophagoides pteronyssinus, and timothy grass allergens.  Ann Allergy Asthma Immunol. 2009;102:57-61.

 

Temp excursions and shipping data:

ALK Internal stability study (2004) validating current shipping methods in the hottest and coldest months (worst case). 

 

Moore, M., et al.  Effects of summer mailing on in vivo and in vitro relative potencies of standardized timothy grass extract.  Ann Allergy Asthma Immunol. 2010;104:147-151.

 

General Protein Stability

http://www.btc-bti.com/spbioapplications/proteinstability.htm

BT&C, Inc.  MAINTENANCE OF PROTEIN STABILITY 

Established in 1987, Biotechnology Training and Consulting (BT&C) originally focused on the training of pharmaceutical scientists in hands-on techniques in biotechnology.

 

Stability of Frozen Vials:

Lankow, R.  2004.  FAQ: Frozen Allergenic Extracts.  ALK Technical Memo.

 

FDA Statement on Alum Safety

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm187810.htm

 

ALK Abstracts about Stability (Internal R&D):

Plunkett 2007 AAAAI - Stability of Major Allergen Proteins in Extract Mixes Diluted in Human Serum Albumin (HSA), Normal Saline (NSP), or Glycerin (GLY)

 

Plunkett & Schell 2010 ACAAI - Stability of Allergen Extracts Diluted in Saline or Human Serum Albumin

 

Plunkett & Schell 2008 AAAAI - Stability of Allergenic Extracts in Multi-Test II® and Duotip-Test® II Skin Testing Wells

 

Plunkett & Schell 2010 AAAAI – Allergen Extract Stability Following Short Term Temperature Variations

 

Plunkett 2006 ACAAAI - Stability of Major Allergen Proteins in Dilutions of Extract Mixes

 

 

Painful injection from 50% glycerin

 

Van Metre et al 1996.  Pain and dermal reaction caused by injected glycerin in immunotherapy solutions.  J Allevgy Clin Immunol 1996;97:1033-9.

 

 

FDA Standardization

 

Morrow, KS, & Slater, JE.  Regulatory aspects of allergen vaccines in the US.  Clin Rev Allergy Immunol. 2001 Oct;21(2-3):141-52.

 

ALK Abstract about Dust Mite major allergen and variability not seen in AU:

Plunkett, G. et al.  AAAAI 2009.  Standardization and Characterization of US House Dust Mite Extracts

 

 

Major Allergen and Standardization

           

Van Rhee 2006 – Indoor allergens: relevance of major allergen measurements and standardization.  J Allergy Clin Immunol

 

Plunkett, G.  Major Allergens and Allergenic Extracts.  ALK Technical Memo, May 2008.

 

ALK Abstract about Validating Internal Assays:

Plunkett, G. et al.  ACAAI 2002.  Validation of an ELISA for Determining Dust Mite

D. pteronyssinus (Dpt) Major Allergen Der p 1

 

Plunkett, G. et al.  AAAAI 2002.  Validation of an ELISA for Determining Cat Major Allergen Fel d 1

 

ALK Abstract about using internal assays to perform QC on unstandardized extracts:

Plunkett, G. et al.  AAAAI 2004.  Quality Control of Non-Standardized Allergenic Extracts: Major Allergen and IgE Binding of Birch, English Plantain and Olive Pollen

 

 

Regional Relevance of Allergens

 

White, J. & Bernstein, D.  Key pollen allergens in North America.  Ann Allergy Asthma Immunol. 2003;91:425– 435.

 

White, J., et al.  Lack of correlation between regional pollen counts and percutaneous reactivity to tree pollen extracts in patients with seasonal allergic rhinitis.  Ann Allergy Asthma Immunol. 2005;94:240-246.

 

Thommen’s postulates on allergenic importance:

Thompson A. In: Asthma and Hay fever in theory and practice. (Ed. By Coca, Walzer & Thommen) 1931; p.851, Thomas, Springfield, Illinois.

 

 

Cross-Reactivity

 

General:

Weber, R. 2007.  Cross-reactivity of pollen allergens: impact on

allergen immunotherapy.  Ann Allergy Asthma Immunol. 2007;99:203–212.

 

Radauer, C, & Breiteneder, H. 2007.  Evolutionary biology of plant food allergens.  J Allergy Clin Immunol. 2007 Sep;120(3):518-25.

 

Molecular Structure:

Aalberse, R. 2007.  Assessment of allergen cross-reactivity.  Clinical and Molecular Allergy 2007, 5:2

 

Aalberse, R., et al. 2001.  Cross-reactivity of IgE antibodies to allergens.  Allergy 2001: 56: 478–490.

 

Aalberse, R. 2000.  Structural biology of allergens.  J Allergy Clin Immunol 2000;106:228-38.)

 

Management of Anaphylaxis:

 

Lieberman P, Nicklas RA, Oppenheimer J, et al. The diagnosis and management

of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol 2010;126:477-80, e1-42.

 

 

Coring & Syringe Technique

 

Lankow, R.  2002.  Reducing Coring of Stoppers in Allergenic Extract Vials.  ALK Technical Memo.

 

 

Skin Testing

 

Overall:

Nelson, H.  Variables in allergy skin testing.  IMMUNOLOGY AND ALLERGY CLINICS OF NORTH AMERICA.  VOLUME 21 * NUMBER 2 MAY 2001

 

Lack of correlation with tests and clinical outcome (Venom):

Warrington, R. 2006.  Lack of Correlation between Severity of Clinical Symptoms, Skin Test Reactivity, and Radioallergosorbent Test Results in Venom-Allergic Patients.  Allergy, Asthma, and Clinical Immunology / Volume 2, Number 2, Summer 2006

 

Seasonal Histamine Response (ALK Abstract)

Young, J, et al, ACAAI 2011.  Seasonal Pattern Seen With Customer Complaints for Skin Test Non-Reactive Positive Control Histamine

 

Variable Histamine Skin Response at different concentrations, with different devices, under antihistamine inhibition (ALK Abstract)

(TBA) Plunkett, G, et al, AAAAI 2012.  Histamine Skin Prick Test (SPT) Titration Following Antihistamine Administration: Wheal Comparison of Histamine Strength Using Different Devices

 

Multi-test best skin testing device:

Nelson, H et al. 1998.  Evaluation of devices for skin prick testing.  J Allergy Clin Immunol. 1998;101:153-6

 

Dykewicz, M, et al 2011.  Comparison of the Multi-Test II and ComforTen allergy skin test devices.  Allergy Asthma Proc 32:1-5, 2011.

 

 

USP 797 References – Beyond Use Date, Pharmacy Compounding Rules

 

United States Pharmacopeial Convention 2008.  <797> Pharmaceutical Compounding—Sterile Preparations.  Pg. 16 – Allergen Extracts as CSPs. 

 

JCAAI USP 797 Update (June 11, 2008)

http://www.jcaai.org/file_depot/0-10000000/20000-30000/27387/folder/62846/08_06_11_USP_797_Update.doc

 

Letz, A., et al.  Monitoring bacteriostasis in allergen extract mixing: 10 years of culture data.  J Allergy Clin Immunol. 2009; 123: 1175-6

 

 

Allergen Information

 

AllFam: Database of Allergen Families:  http://www.meduniwien.ac.at/allergens/allfam/search.php

 

ALLERGEN NOMENCLATURE: International Union of Immunological Societies (IUIS) Allergen Nomenclature Sub-Committee:  www.allergen.org

 

ALLERGOME: The Platform for Allergen Knowledge:  www.allergome.org

 

PHADIA: ImmunoCAP Allergens:  http://www.phadia.com/nl/Allergenen/ImmunoCAP-Allergens/