AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a Lentiviral vector (LVV) expansion to its AGCellerate program designed to deliver GMP material for clinical trials in an accelerated timeline. The AGCellerate LVV offering guarantees developers 1e11 total transduction units (TU) of LVV material in nine months.
“This next phase of AGCellerate is designed to make the lives of cell and gene developers easier, particularly developers of rare disease therapies, through our commitment to deliver guaranteed LVV titers in record time to positively impact patients and families,” said Luca Alberici, General Manager, AGC Biologics Milan. “AGC Biologics already has one commercially approved LVV in the market and successfully concluded the PPQ campaigns of five other LVV projects. By utilizing our proven platform process, AGCellerate for LVV supports developers seeking quality material on an accelerated timeline.”
The AGCellerate LVV offering is supported by AGC Biologics’ proprietary ProntoLVV™ Platform, which offers a standardized process for full-scale development and manufacturing of viral vectors. The platform is fully qualified by major regulatory authorities and was created by scientists with 30 years of experience from AGC's Cell and Gene Center of Excellence in Milan.
The ProntoLVV platform features end-to-end vector services, including off-the shelf plasmids; standardized production and purification protocols, ready-to-use, high-yield adhesion and suspension GMP cell lines, pre-qualified scale-down models, in-house analytics and fill and finish capabilities.
AGC’s AGCellerate program offers support for monoclonal antibodies (mAbs), LVV material, plasmid DNA (pDNA) and adeno-associated viral vectors (AAV). The company announced its AGCellerate mAb program in June and plans to unveil its AAV and pDNA programs in the near future.
To access more details about AGCellerate and learn how it can accelerate your projects into the clinic, visit www.agcbio.com/capabilities/agcellerate-dna-to-ind-drug-substance-cdmo-services.
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. 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. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.