Company to show production of multiple serotypes of recombinant adeno-associated viral (rAAV) vectors and rAAV production in suspension-adapted cell line AE1-BHK-S

Morphology of adherent AE1-BHK (A) and suspension AE1-BHK-S (B) cells at 40X magnification

Agathos Biologics, a genetic medicine biotechnology company, will present data at the 27th Annual Meeting of the American Society of Gene and Cell Therapy on its proprietary AE1-BHK cell line for rAAV production. The poster titled “AE1-BHK Novel Cell Line for rAAV Production of Multiple Serotypes for Gene Therapy Applications”, number 1539, will show data from the adherent AE1-BHK cell line and the poster titled “Establishment of Serum Free Suspension Adapted AE1-BHK-S Novel Cell Line for the Manufacturing of rAAV”, number 1540, will show data from the adaptation of the AE1-BHK cell line to suspension culture, referred to as AE1-BHK-S. These posters will be presented during the poster session “AAV Vectors – Product Development and Manufacturing and Approval Considerations” from 12:00 – 7:00 PM on Friday, May 10.

“We are excited to present data on our continued development of the AE1-BHK cell line,” said James Brown, CEO of Agathos Biologics. “These data show the potential of AE1-BHK as a research tool and biomanufacturing platform. We aim to provide researchers, manufacturers, healthcare providers, and patients, with alternatives for genetic medicine that enhance current approaches and avoid ethical issues. Earlier this year, we launched our custom rAAV production service and fulfilled our first order. We plan to expand our rAAV offerings to include off-the-shelf control and reporter vectors and rAAV reference standards.”

Agathos has submitted a patent application for the cell line and provisional patent applications for related technologies. “We are looking for partners and collaborators who will work with us to develop these products,” Brown added. “Working with those who share our vision of expanding access to these advanced treatments is the best way to make a positive impact on genetic medicine. We will be at booth 2384 at the ASGCT Annual Meeting May 7-11, 2024, in Baltimore, MD, and look forward to discussing our results with attendees.” For more information on the AE1-BHK cell line and to inquire about partnerships, please visit AE1-BHK cell line : Agathos Biologics.

Agathos records first sale of recombinant adeno-associated virus produced using AE1-BHK to collaborator Genovac; provides free access to AE1-BHK cell line

March 6, 2024 (Fargo, N.D.) Agathos Biologics, a leading biotechnology company in genetic medicine, announced today the launch of its recombinant adeno-associated virus (rAAV) production service using the company’s novel proprietary cell line, AE1-BHK. The company recorded its first sale of rAAV to Genovac, a contract research and manufacturing organization (CRO/CMO) that discovers, develops, and manufactures antibodies for therapeutic, diagnostic, and research market segments. Agathos produced rAAV with a transgene sequence provided by Genovac in AE1-BHK using transfection with three plasmids (triple transfection), a well-established process that has been used extensively with the HEK293 cell line.

The AE1-BHK cell line was developed by stable transfection of the BHK-21 (C-13) cell line (ATCC®, catalog number ATCC CCL-10™) with the adenoviral E1 gene. The ATCC trademark and trade name and any and all ATCC catalog numbers are trademarks of the American Type Culture Collection.

“The launch of our custom rAAV service and the first sale of rAAV made using our AE1-BHK cell line is a significant milestone for the company,” said James Brown, CEO and co-founder of Agathos Biologics. “To our knowledge, this is the first sale of rAAV produced using triple transfection in a cell line other than HEK293. For our custom services, we will assist clients in the design of a rAAV expression cassette that contains their gene of interest and produce the rAAV for research use both in vitro and in vivo.”

“In addition to our custom rAAV service, we are providing samples of AE1-BHK, a polyclonal line, free of charge,” added Brown. “Clients need only pay shipping and handling to receive these cells for internal research use at their institution or company. Our goal is to make our cells widely available and expand the options for genetic medicine research and development, especially for researchers looking for alternatives to HEK293.”

“Genovac is committed to continuously exploring the most efficient genetic payload systems to illicit immune responses from all animal species and strains,” said Brian Walters, CEO of Genovac.  “We look forward to using Agathos’ rAAV as part of our efforts to generate diverse antibody candidates in support of our clients’ research and development needs,” added Walters. “We will also be receiving samples of AE1-BHK for evaluation of its use in recombinant antibody and protein production.”

Agathos is working with multiple collaborators on various aspects of AE1-BHK development. “We continue to develop AE1-BHK as part of our efforts to improve biomanufacturing and avoid ethical issues regarding cell lines derived from aborted fetal tissue like HEK293,” added Brown. “Gene therapy is having a positive impact on addressing unmet medical needs and has only begun to realize its potential. We will engage with others in the industry who share our mission to expand access to these novel treatments through improved manufacturing materials and methods.” Agathos first presented data on AE1-BHK in a poster session at the ASGCT 2023 Annual Meeting (designated BHK-[wt E1] in the poster). The company has submitted patent applications for AE1-BHK and associated technologies. For more information on custom AAV and to request samples of AE1-BHK cells please visit agathos.bio/custom-aav/.

About Agathos

Agathos Biologics is a biotechnology company pursuing transformational science in biomanufacturing, biologic payload delivery, and cell and gene therapy. Discoveries in bioprocessing and genetic characterization and control have created an abundance of scientific possibilities that can help us all lead better lives. Our mission as the good science company is to create breakthrough products and services within a strong ethical and moral framework that benefit everyone. We believe in science that serves and have a relentless focus on serving our clients, employees, and society. For more information, please visit www.agathos.bio.

About Genovac

Genovac is a contract research and manufacturing organization offering advanced antibody discovery and production solutions. Its immunization technologies, combined with multiple single B cell screening technologies, including Bruker’s Beacon, enable success against the most challenging targets. Since its founding in 1999, Genovac has completed more than 3,700 projects, providing antibodies to clients in North America, Europe, Australia, and Asia that have been developed into clinical and commercial drugs.  In addition to its headquarters and labs in Fargo, North Dakota, Genovac operates a scientific and production facility in Freiburg, Germany.