Publications

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Designation

Clinical & Real-World Data

Pharmacokinetic Model Based Sensitivity Analysis to Lower Recruitment Burden for Young Children Requiring Intravenous Immunoglobulin G Replacement

Authors:Todd Dumas, Shahram Mehr, Rebecca Avila, Amy Doman, Kaitlin Kestenberg, Isaac Melamed

Published: CPT Pharmacometrics Syst Pharmacol. 2026;15:e70275

High-titer IVIG 10% (human)–slra reduces infections and hospitalizations over 6 to 12 months: A retrospective quality improvement study

Authors:Tan G, Azzi S, Sehmi K, Hostoffer R

Published: Clin Immunol. 2026;282:110633

Real-world retrospective cohort study evaluating the tolerability of immune globulin intravenous 10% (BIVIGAM^®)

Authors:Van Anglen L, Luu Q, Rosenbach K, Herrscher R

Published: Front Immunol. 2025;16:1687588

High-Titer IVIG 10% (Human)–slra Reduces Infections and Hospitalizations Over 6 to 12 Months

Authors:Tan G, Azzi S, Sehmi K, Hostoffer R

Poster presented at: ACAAI 2025 Annual Meeting; November 6-10, 2025; Orlando, FL.

All IG Products Are Not the Same!

Author:Siegel J

Published: Pharmacy Practice News, February 2024

Case Study: IgG deficient patient receiving immune globulin intravenous, human-slra 10% demonstrates improvement in quality of life

Authors:C Miller, B Prosser, D Blake, D Doyle

Poster presented at: Clinical Immunology Society 2024 Annual Meeting; May 1-4, 2024; Minneapolis, MN.

Retrospective Review of Real-World Evidence of Immune Globulin Intravenous (IVIG), Human-slra 10% in Patients with Primary Immunodeficiency with Recurrent Infections

Authors:Myers G, Huss J, McNeil D, Melton S, Anaya M, Simard MC

Poster presented at: Consortium of Independent Immunology Clinics Spring 2024 Meeting; April 13, 2023; Arlington, TX.

Immune Response to Respiratory Viruses and Respiratory Viral Infections in Susceptible Populations

Authors:Fragkou PC, Chemaly R, De Angelis G, Dimopoulou D, Menchinelli G, Skevaki C

Published: Front Med. 10:1330265.

Clinical Assessment of Safety, Pharmacokinetics, and Efficacy of Immune Globulin Intravenous 10% in Pediatric Patients

Authors:Melamed I, Walter J, Alpan O, Jhaveri D, Koterba A, Leiding J

Poster presented at: American College of Allergy, Asthma, and Immunology 2023 Annual Scientific Meeting; November 9-13, 2023; Anaheim, CA.

Immune Globulin Intravenous (Human) 10% Liquid is Safe and Efficacious in Pediatric Patients with Primary Immune Deficiency Disorders

Authors:Melamed I, Walter J, Alpan O, Jhaveri D, Koterba A, Leiding J

Poster presented at: IgNS 2023 National Conference; October 5-8, 2023; Denver, CO.

Case Report: ASCENIV Use in Three Young Children with Immune Abnormalities and Acute Respiratory Failure Secondary to RSV Infection

Authors:Bindernagel C, Sotoudeh S, Nguyen M, Wetzstein G, Sriaroon P, Walter J

Published: Front Immunol. 2023;14:1154448

Response to Asceniv Treatment in a Case Series of Patients with Antibody Deficiency and Related Infections Refractory to Conventional Immunoglobulin Replacement Therapy

Authors:Tambay A, Loop L, Siri D, Geng B

Poster presented at: Aspen 2023 Annual Allergy Conference; July 30 - August 3, 2023; Aspen, CO.

In-vivo and Human Evidence for Potential Efficacy of Therapeutic Polyclonal RSV Neutralizing Antibodies for Palivizumab-resistant RSV Infections

Authors:Ramirez KA, Mond J, Papenburg J, Boivin G, Gilbert BE, Falsey AR, Bagga B, DeVincenzo JP

Published: Virology. 2023; 586:115-121

Case Report of Real-World Use of human-slra 10% through Subcutaneous Infusion

Authors:Loop L, Geng B

Poster presented at: The European Academy of Allergy and Clinical Immunology (EAACI) Congress; June 9-11, 2023; Hamburg, Germany

Treatment Response to Unique Blend IVIG with High Titers to RSV and Common Respiratory Pathogens in Patients with Antibody Deficiency and Chronic Lung Disease

Authors:Loop L, Tambay A, Geng B

Poster presented at: The European Academy of Allergy and Clinical Immunology (EAACI) Congress; June 9-11, 2023; Hamburg, Germany

Reductions in Infections and Associated Complications in Nine Common Variable Immunodeficiency Patients Treated with Immune globulin intravenous, human-slra

Authors:Huss J, McNeil D, Melton S, Myers G

Published: Poster presented at: The Eastern Allergy Conference Annual Meeting; June 1-4, 2023; Palm Beach, FL

Case Study: Successful Transition to ASCENIV Therapy with Improved PROMs

Authors:Prosser B, Miller C

Poster presented at: CIS 2023 Annual Meeting; May 18-21, 2023; St Louis, MO

Case Study: Successful Transition to ASCENIV Therapy with Improved PROMs

Authors:Prosser B, Miller C, Walton T

Published: Clin Immunol. 2023;250(Supp):109445

ASCENIV™ utilization in a primary immunodeficiency patient with recurrent viral infections

Authors:Rosenbach KP, Greener BN, Rosenbach JT, Wetzstein GA

Published: Immunol Med. 2023;46(1):58-60

Treatment with intravenous immune globulin 10% in a real-world outpatient setting

Authors:Herrscher R, Rosenbach K, Luu Q, Kim-Romo D, Van Anglen L

Poster presented at: AAAAI 2023 Annual Meeting; February 24-27, 2023; San Antonio, TX

Real-world utilization of immune globulin intravenous 10% at physician office infusion centers

Authors:Herrscher R , Luu Q, Kim-Romo D, Van Anglen L

Poster presented at: ACAAI 2022 Annual Scientific Meeting; November 10-14, 2022; Louisville, KY

Real-world evaluation of immune globulin intravenous 10% in the treatment of primary immunodeficiency

Authors:Van Anglen L, Kim-Romo D

Poster presented at: IgNS 2022 11th National Conference; September 29-October 2, 2022; Washington, DC

Review of ASCENIV in Two Young Males with Immune Abnormalities and RSV-Induced Respiratory Failure: A Case Series

Authors:Bindernagel C, Sullivan S, Miranda MA, Timothy P, Wetzstein G, Sriaroon P, Walter J

Poster presented at: The Florida Allergy, Asthma & Immunology Society (FAAIS) 2022 Annual Meeting; July 15-17, 2022; Orlando, FL

ASCENIV™ reduces viral infections and associated comorbidities in a primary immunodeficiency patient

Authors:Rosenbach K, Greener B, Rosenbach J, Wetzstein G

Poster presented at: CIS 2022 Annual Meeting; March 31-April 3, 2022; Charlotte, NC

Use of ASCENIV™ in a young male with immune abnormalities and multiviral-induced respiratory failure

Authors:Bindernagel C, Sullivan S, Miranda MA, Timothy P, Wetzstein G, Sriaroon P, Walter, J

Poster presented at: AAAAI 2022 Annual Meeting; February 25-28, 2022; Phoenix, AZ

Clinical impact of concomitant use of a novel high-titer immune globulin in an adult with COVID-19 and severe acute respiratory distress syndrome (ARDS)

Authors:Wetzstein GA, Ismail M, Gruenglas J, Decker D, Mond J

Poster presented at: 2021 International Society for Influenza and Other Respiratory Virus Diseases—World Health Organization (ISIRV-WHO) Virtual Conference; October 19-21, 2021

Kinetics of post-vaccination seroprotection to S. pneumoniae for the immune-compromised and vaccine-naïve populations

Authors:Mond J, Scobie M, Tolman C, Gruenglas J, Martinez J

Poster presented at: IDWeek 2021 Virtual Conference; September 29-October 3, 2021

RI-002, an intravenous immunoglobulin containing high titer neutralizing antibody to RSV and other respiratory viruses for use in primary immunodeficiency disease and other immune compromised populations

Authors:Wasserman RL, Greener BN, Mond J

Published: Expert Rev Clin Immunol. 2017;13(12):1107-1119

Efficacy, safety, and pharmacokinetics of a new 10% liquid intravenous immunoglobulin containing high titer neutralizing antibody to RSV and other respiratory viruses in subjects with primary immunodeficiency disease

Authors:Wasserman RL, Lumry W, Harris J III, Levy R, Stein M, Forbes L, Cunningham-Rundles C, Melamed I, Kobayashi A, Du W, Kobayashi R

Phase 3 study published: J Clin Immunol. 2016;36(6):590-599

Analysis of specific antibody levels in PIDD patients enrolled in a pivotal trial with an IVIG containing high titer neutralizing antibody to RSV

Authors:Mond J, Orange J, Du W, Kobayashi A, Kobayashi R, Cunningham-Rundles C, Lumry W, Harris J III, Levy R, Stein M, Forbes L, Melamed I, Kestenberg K, Wasserman RL

Poster presented at: CIS 2015 Annual Meeting Immune Deficiency & Dysregulation North American Conference; April 9-12, 2015; Houston, TX

Preclinical Data

SG-001 Novel High Titer Streptococcus pneumoniae Immune Globulin Protects Against PN 3 and PN 19A, in Healthy and Immunocompromised Mouse Models

Authors:Laura Holler, Rebecca Avila, Kaitlin Kestenberg, Carley Armstrong, Adam Grossman

Poster Presented at: International Society of Pneumonia and Pneumococcal Diseases 2026; May 17-21, 2026, Copenhagen, Denmark.

Treatment with novel RSV Ig RI-002 controls viral replication and reduces pulmonary damage in immunocompromised Sigmodon hispidus

Authors:Boukhvalova M, Blanco JCG, Falsey AR, Mond J

Published: Bone Marrow Transplant. 2016;51(1):119-126

Therapeutic immunoglobulin selected for high antibody titer to RSV also contains high antibody titers to other respiratory viruses

Authors:Orange JS, Du W, Falsey AR

Published: Front Immunol. 2015;6:431

IVIG Manufacturing Overview

Gloveless Robotic Isolator Technology: Mitigating Biopharma Industry's Implicit Biases on Contamination Control from an Early Adopter of Advanced Aseptic Technology

Authors:McCall J, Gruenglas J

Published: Sixth International Conference on PharmScience Research & Development; February 26-28, 2024; Boston, MA

Manufacturing process optimization of ADMA Biologics’ intravenous immunoglobulin products, BIVIGAM® and ASCENIV™

Authors:Wasserman RL, Garcia D, Greener BN, Kestenberg K, Pinkert A, Mond J, Grossman A

Published: Immunotherapy. 2019 Nov;11(16):1423-1433

Health Economics and Outcomes Research

Access to Intravenous Immune Globulin and Patient Compliance: Follow-up Results from an IVIG Support Program

Authors:Gruenglas J, Anaya M, Carneiro R

Poster presented at: National Home Infusion Association (NHIA) 2024; March 23-27, 2024; Austin, TX

Pharmacoeconomic analysis of a unique immune globulin containing a blend of high-titer RSV and normal source plasma compared with IVIG+palivizumab in a patient with SCID

Authors:Gruenglas J, Miller R, Wetzstein G, Carneiro R

Poster presented at: Fifth International Conference on PharmScience Research & Development; February 21-24, 2023; Las Vegas, NV

Patient support facilitates access to IVIG therapy: interim results of a hub health program

Authors:Gruenglas J, Carneiro R, Karalian A

Poster presented at: IgNS 2022 11th National Conference; September 29-October 2, 2022; Washington, DC

Pharmacoeconomic analysis comparing medical costs for prophylaxis of HIV and HBV infection in sexual assault patients

Authors:

Gruenglas J, Pantello D, Mond J

Published:

Virtual AMCP 2021 Conference; April 12-16, 2021

Health Policy

Acute Hepatitis B Infection: U.S. Policy and Guidelines

Authors:Henin S, Gruenglas J, Anaya M, Simard M-C

Published: In: Feitelson M, ed. Hepatitis B Virus – Pathogenesis and Therapeutic Approaches. IntechOpen; 2024;. doi: 10.5772/intechopen.1005754

Ethical assessment of post-exposure prophylaxis

Authors:Gruenglas J, Mond J

Published: The Journal of Healthcare Ethics and Administration. 2021 Aug 12; 29:37

Medical Survey Research

Respiratory viral infections continue to be an unresolved problem in the care of immunocompromised transplant patients

Authors:Wetzstein G, Decker D, Mond J

Poster presented at: National Comprehensive Cancer Network 2021 Virtual Annual Conference; March 18-20, 2021

Respiratory viral infections continue to be a growing problem in the care of hematopoietic cell transplanted patients

Authors:Wetzstein G, Decker D, Mond J

Poster presented at: The 2021 Transplantation and Cellular Therapy Meetings Digital Experience; February 8-12, 2021

Respiratory syncytial virus infections continue to be a growing problem in the care of immunocompromised patients receiving transplants

Authors:Wetzstein G, Decker D, Mond J

Poster presented at: International Society for Influenza and Other Respiratory Virus Diseases "RSV Webinar Series"; February 2021

Compassionate Use

Treatment of RSV lower respiratory tract infection in two immunocompromised children with polyclonal immunoglobulin containing standardized levels of neutralizing anti-RSV antibodies

Authors:Levy ER, Madigan T, Binnicker MJ, Mond J, Huskins WC

Poster presented at: IDWeek; October 5, 2019; Washington, DC

Compassionate use experience with high-titer respiratory syncytical virus (RSV) immunoglobulin in RSV-infected immunocompromised persons

Authors:Falsey AR, Koval C, DeVincenzo JP, Walsh EE

Published: Transpl Infect Dis. 2017;19(2):10.1111/tid.12657

Generative AI

Optimizing Biopharmaceutical Manufacturing with AI: A Case Study on ADMAlytics™ - Powered by tgcmcube

Author:Soumyopriyo Saha, Senior Director, Life Science – AI and Analytics, TCG Digital

If you would like to receive a full-text copy of any of the content listed below, email ma@admabio.com.

To expedite your request, please include the title of the content, your first and last name, healthcare designation (MD, NP, etc.) and business address.

Clinical & Real-World Data

Preclinical Data

IVIG Manufacturing Overview

Health Economics and Outcomes Research

Health Policy

Medical Survey Research

Compassionate Use

Generative AI

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