Our work centers on applying proven intelligence in vector manufacturing and analytics to accelerate programs from discovery to IND. We support a range of modalities, from Advanced Therapeutics including AAV, lentiviral, and adenoviral vectors to Complex Biologics. This is accomplished by integrating scalable production with a coherent CMC strategy and phase-appropriate analytics.

A reliable supply of high-quality drug product is the starting point for any successful preclinical program. The scientific leadership at Franklin Biolabs brings a deep operational history to this challenge, having produced thousands of manufacturing batches for clients in more than 30 countries. We have established both adherent and suspension-based systems to support programs from early discovery through IND-enabling toxicology and clinical studies.

Aligning Manufacturing with Regulatory Intent

The quality of a drug product is only as good as the process used to manufacture it. Our process development services are designed to build scalable, reproducible manufacturing workflows that meet regulatory expectations. A deep understanding of process and biology is required to anticipate and mitigate potential liabilities, such as toxicities that can manifest in preclinical safety evaluations (PMID: 38327046). By characterizing product-specific behavior early, we establish a foundation for robust platform technologies.

This manufacturing strategy is directly linked to a clear Chemistry, Manufacturing, and Controls (CMC) roadmap. We provide the analytical framework and documentation needed to bridge the gap between discovery and IND readiness. This alignment of CMC, analytics, and preclinical development into a single path greatly accelerates typical 18-24 month timelines.