CMC Jumpstart™ provides representative scale-down data to understand product performance before clinical work begins.
The program has already supported LVV and AAV projects, helping two developers prepare for clinical work.
Today, we announced CMC Jumpstart™, a new program delivering early-stage assessments for gene of interest (GOI) candidates using viral vector platforms, with no long-term outsourcing contract commitments. The new service not only helps cell and gene developers make informed scientific and financial decisions but also provides an opportunity to evaluate AGC Biologics’ operations and ensure they align with a developer’s unique needs.
In an industry with limited resources, where every decision has immediate and long-term financial impacts, CMC Jumpstart™ provides an efficient solution for evaluating vector platform feasibility while offering valuable insight into the CDMO’s operational strengths. By offering a firsthand demonstration of AGC Biologics’ expertise, companies can assess how well the organization can meet their specific project requirements before committing to larger-scale work. Once the GOI is provided, AGC Biologics performs a representative scale-down run that provides essential Chemistry, Manufacturing, and Controls (CMC) data for a company’s top candidate.
The program includes an off-the-shelf packaging cell bank, packaging plasmids, and transfer plasmid backbone—all backed by in-house analytics and a fully qualified scale-down model. From this work, developer partners receive a dataset detailing their GOI candidates’ performance and the related feasibility of their viral vector platform before they invest in clinical work, along with materials derived from the study that are shipped to the developer. Furthermore, CMC Jumpstart™ is supported by AGC Biologics’ proven track record, spanning clinical and commercial production. This experience ensures that companies successfully navigate the clinical development phase and avoid potential manufacturing pitfalls that could delay commercialization. For companies whose GOI candidates are deemed viable, the program accelerates timelines by up to six months, completing necessary development and engineering runs for early-phase clinical work.
CMC Jumpstart™ leverages AGC Biologics' proprietary platform processes, including ProntoLVV™ and BravoAAV™ for both adherent- and suspension-based viral vector productions, providing flexible solutions tailored to various development needs. The program has already shown early success, helping multiple lentiviral vector and adeno-associated viral vector programs finalize GOI selection, conduct vector platform feasibility testing, and advance into clinical work. CMC Jumpstart™ was created at the AGC Biologics Center of Excellence for Cell and Gene Therapy in Milan.
“Cell and gene developers are faced with critical decisions early in a product’s lifecycle, and these choices can be detrimental if you do not have the right data on GOI performance and the platform feasibility,” said Luca Alberici, General Manager, AGC Biologics Milan Facility. “Through CMC Jumpstart™, we have built a new tool that helps companies with early-phase products understand any limitations in their platform that could directly impact cGMP manufacturing and even commercial viability. With this information, they can make strong, data-driven business decisions.”
For more information on CMC Jumpstart™, please visit https://www.agcbio.com/cmc-jumpstart-for-viral-vectors.
Visit www.agcbio.com to learn more about AGC Biologics and its global CDMO services.
