The CDMO’s Milan facility provides lentiviral vector and autologous CD34+ cell-based drug products for clinical testing
SEATTLE, MILAN, July 28, 2022 (GLOBE NEWSWIRE) — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a new partnership with Altheia Science, a gene therapy company pioneering cell and gene therapy strategies to treat autoimmune diseases and cancer. Through this partnership, Altheia Science will advance its development of autoimmunity treatments, focused on modulating PD-L1 expression in patients’ hematopoietic stem and progenitor cells, into clinical testing.
AGC Biologics is performing drug product development at its Milan facility using lentiviral vector (LVV) and autologous CD34+ hematopoietic stem and progenitor cell systems. The cells will be transduced using a highly efficient ex vivo lentiviral material to encode the human PD-L1 DNA.
“The AGC Biologics Milan site has a long-standing expertise in successfully developing stem cell-based gene therapies, from clinical testing up to commercialization,” said Paolo Rizzardi, Chief Executive Officer of Altheia Science. “We believe this partnership is key in supporting our gene therapy programs and making these innovative therapies available to patients.”
The AGC Biologics Milan facility has one of the strongest development and manufacturing track records in the global cell and gene industry, working with virtually any cell type and lentiviral, retroviral and adeno‐associated viral vectors. The site has 25 years of expertise, including manufacturing three commercial products, and teams of scientists with significant development and regulatory experience. The site was the first ex-vivo cell and gene therapy site approved in Europe for GMP manufacturing of clinical and commercial supplies.
“We are pleased Altheia Science placed their trust in our cell therapy and viral vector services, and our Milan site, at this important stage in their product’s lifecycle,” notes JB Agnus, Chief Business Officer of AGC Biologics. “Our global Cell Therapy and Viral Vector services are powerful tools for partners creating life-changing treatments for patients. We pride ourselves on our ability to collaborate with cell and gene developers and work within their unique specifications and requirements.”
AGC Biologics’ cell therapy services and viral vector capabilities leverage the latest technology and processes, including proprietary platforms developed to address the evolving advanced therapies industry. To learn more about the company and its complete list of biologics and cell and gene services, visit www.agcbio.com.
About Altheia Science
Altheia Science has been founded by Prof. Alessandra Biffi, MD, and Prof. Paolo Fiorina, MD, Ph.D., together with the investment company AurorA-TT (www.aurora-tt.com). Altheia Science develops pioneering cell & gene therapy strategies to treat autoimmune diseases and cancer. To learn more, visit www.altheiascience.com.
About AGC Biologics
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan and we currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. To learn more, visit www.agcbio.com.