Lonza

Learn how advanced vector technology elevates protein expression performance through improved glutamine synthetase selection stringency combined with a high-strength gene promoter to control product expression.

When people talk about accelerating DNA-to-IND timelines, the conversation often focuses on individual activities making up the critical path. Faster cell line development. Faster process development. Faster formulation studies. But in my experience, one of the biggest determinants of successfully bringing a molecule through CMC is something much less visible: How effectively information moves between teams. Drug substance and drug product development are deeply interconnected. Formulation decisions can influence downstream processing (DSP). Formulation data such as solubility and Gibbs-Donnan effect can inform DSP development strategy. Material and data generated at one stage can enable critical workstreams at another. When these activities happen in silos, timelines become vulnerable to delays, rework and unnecessary risk. This becomes even more critical as biologics developers pursue increasingly complex modalities and presentations, where developability and formulation considerations can quickly influence the overall development path. The most successful accelerated programs I've seen are not defined by cutting corners. They are defined by creating alignment between scientific disciplines from the very beginning. When development teams can transfer knowledge, data and material seamlessly across functions, they can start activities earlier, make decisions with greater confidence and maintain momentum toward IND filling. In our recent Labiotech article, Megan Mason and I share how integrated drug substance and drug product development can help teams navigate the path to IND while balancing speed, quality and long-term success. Read the article at the link below and connect with us to discuss formulation strategy, developability and accelerating your path to IND. https://lnkd.in/eqtqY6YC

Before scaling up, put your in vivo LVV process through its paces. Explore how vector design choices can influence productivity, recovery, purity and potency — and how early process assessment can inform the path towards GMP manufacturing. Watch Lonza’s on-demand webinar.

Moving lentiviral vectors from ex vivo applications to direct in vivo use brings new demands for purity, potency and stability. What does that mean for your manufacturing process? Join Lonza’s Bingnan Gu to explore a feasibility-first approach to developing fit-for-purpose in vivo LVVs. Watch the webinar on demand.

Developing lentiviral vectors for in vivo use requires more than a manufacturing process. It requires a development strategy connecting feasibility, advanced analytics, scalability and CMC readiness. Learn how Lonza is helping developers move complex, targeted LVV concepts toward clinic-ready products.

As gene therapy programs advance, manufacturing requirements become more complex. Discover key considerations for scaling viral vector production, managing tech transfer, ensuring regulatory readiness, and securing commercial supply.