To address the critical need for accelerated decision-making and de-risked progression from discovery to Chemistry, Manufacturing, and Controls (CMC) in cell and gene therapy programs, ProBio Inc. has launched its new Viral Vector Packaging Test. This early-stage development offering provides biopharma innovators with essential data and technical confidence, strengthening ProBio's end-to-end capabilities in advanced therapies.

Advancing Cell and Gene Therapy Development

The Viral Vector Packaging Test is designed to support vector design, manufacturability, and scalability decisions at a critical inflection point in development. It supports multiple viral vector modalities, including lentiviral vectors (LVV) for in vivo and ex vivo CAR T applications, and AAV for gene therapy. By leveraging ProBio's proprietary packaging systems and platform processes, the test enables rapid comparative evaluation of packaging strategies with turnaround times as short as three to five weeks, depending on the program design. This offering is particularly suited for candidate selection, feasibility assessment, and sample generation for pharmacology studies.

Key Features of the Viral Vector Packaging Test

The new offering incorporates several features to ensure robust and reliable data:

• Consistent development-to-CMC continuity: Uses the same cell lines and packaging plasmids applied in later-stage manufacturing.
• Platform upstream and downstream processes: Generates representative material for accurate assessment.
• Comprehensive quality assessments: Includes physical titer, genome purity, endotoxin levels, and full/empty ratio where applicable.
• Design of Experiments (DoE)–based screening: Enables systematic optimization of plasmid ratios and packaging components for LVV of in vivo CAR-T.

Expert Insight

Huiyi Zhu, Global Line Manager for Viral Vector at ProBio Inc., emphasized the significance of this new offering, stating, "Early development choices have lasting impact on the success of cell and gene therapy programs. This new packaging test reflects our commitment to providing biopharma innovators with practical data, technical confidence, and a clear path forward, using the same systems they can later take into CMC and clinical development."