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Milan facility provides lentiviral vector and autologous CD34+ cell-based drug products for clinical testing.
July 28, 2022
By: Kristin Brooks
Managing Editor, Contract Pharma
AGC Biologics, a global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), entered a new partnership with Altheia Science, a gene therapy company pioneering cell and gene therapy strategies to treat autoimmune diseases and cancer. Under the alliance, Altheia Science aims to advance 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.” AGC’s Milan facility has a strong development and manufacturing track record 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.”
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