ABL News

ABL Awarded Subcontract to Support Immunogenicity Testing of Gene-Therapy Products for Rare Diseases

  • April 26, 2024

Rockville, MD, United States, April 26, 2024 – Advanced BioScience Laboratories. Inc., (ABL), a global Contract Development and Manufacturing Organization (CDMO) for biotherapies, oncolytics and viral vector vaccines, today announces it has been awarded a Subcontract for “Bioanalytical Assay Development” by Leidos Biomedical Research, Inc., (Leidos Biomed), the operational and technical support Contractor to the Frederick National Laboratory for Cancer Research (FNLCR) to support NIH’s National Center for Advancing Translational Sciences (NCATS) PAVE-GT Program. The subcontract number is 23X036F.

“This Subcontract strengthens ABL’s existing relationship with Leidos Biomed. We look forward to working with Leidos Biomed in providing critical immunological tools to test and evaluation promising AAV-based gene therapy approaches, thereby, supporting the mission of the NCATS to advance the development of safe and effective treatments for rare and neglected diseases in the pediatric population”, said Peter Silvera, PhD, Principal Investigator, Innovation and Translation Department at ABL.

About the Rare Diseases:

Most rare diseases (50–75%) affect children, with many disorders having serious, multisystemic, chronic, and/or progressive clinical manifestations. Collectively rare diseases are one of the leading causes of death in children in both industrialized and developing countries. Rare diseases (also termed orphan diseases) were first defined in the Orphan Drug Act of 1983 in the United States (US). There are an estimated 7000–10,000 rare diseases with approximately 80% monogenic (“single gene”) disorders as well as other chromosomal abnormalities, cancers, infections, toxic exposures, and degenerative and acquired conditions. While the numbers of individuals affected by one disease is small, collectively individuals with rare diseases account for a significant portion of the population. To date, approved therapies exist for less than 5% of rare diseases, therefore this unmet need persists. ABL’s support services under this Subcontract will provide important immunological tools to advance promising rare disease therapies from laboratory to clinic.

 About ABL

ABL, Inc. is a global contract research and manufacturing organization dedicated to advancing therapeutics, vaccines and other biological products. It has extensive experience working with diverse organizations including industry, government and academic entities. ABL maintains GMP facilities meeting US regulatory standards, providing manufacturing capabilities for the development and production of virus-based oncolytic therapies, gene therapies and viral vaccines. Our services include bulk drug substance, live virus fill/finish, process and assay development. We also support clients’ preclinical and clinical sample processing and testing needs through our immunological laboratories. ABL is a part of the Institut Mérieux, a group of companies dedicated to developing translational science for better patient care globally.

Advanced BioScience Laboratories, Inc.

9800 Medical Center Drive, Building D

Rockville, MD 20850


Contact: Peter Silvera, Ph.D.

Phone: 301-816-5423