Franklin Biolabs is a full‑service contract research organization that provides end‑to‑end preclinical, CMC, and bioanalytical support for genetic medicines and biologics, including AAV vector production, GLP toxicology, pharmacology, and advanced analytical testing. By integrating vector manufacturing, consulting, and regulatory‑grade studies under one roof, it helps biotech and pharma developers generate IND‑enabling data and accelerate timelines from discovery to clinical submission.
Funding
Funding not disclosed
Founders
Product
Problem
Developing genetic medicines and biologics requires specialized preclinical studies, scalable vector manufacturing, and comprehensive bioanalytical testing, yet many programs lack integrated CRO partners that can deliver end‑to‑end support with regulatory‑grade quality and rapid timelines.
Solution
Franklin Biolabs operates as a full‑service contract research organization focused on genetic medicines and biologics. It provides integrated vector production (research‑scale, process development, and large‑scale AAV manufacturing), CMC consulting, and advanced analytical testing to ensure product quality. The company also offers preclinical and translational services—including GLP toxicology, pharmacology, pathology, and animal model development—to generate IND‑enabling data within 18–24 months. Bioanalytical capabilities cover immunogenicity, biodistribution, viral shedding, and biomarker assays, with both research and GLP‑compliant options. By combining these capabilities under one roof, Franklin Biolabs reduces hand‑offs, accelerates timelines, and supports seamless progression from discovery to clinical submission.
Target Audience
Primary customers are biotech and pharmaceutical companies, as well as academic research groups, developing AAV‑based gene therapies, RNA medicines, or other advanced biologics that require preclinical, CMC, and bioanalytical support.
Features
- Research‑grade and large‑scale AAV vector production using both suspension bioreactors and adherent fixed‑bed systems
- Process development and CMC consulting to optimize upstream/downstream steps and meet regulatory expectations
- GLGL‑compliant preclinical studies (toxicology, pharmacology, pathology) with on‑site Good Laboratory Practice facilities
- Integrated pathology platform offering histology, multiplex ISH, and digital slide imaging for both non‑GLP and GLP programs
- Bioanalytical services for immunogenicity, biodistribution, viral shedding, and biomarker quantification using ELISA, MSD, mass spectrometry, and qPCR
- Comprehensive analytical testing suite (NGS, particle characterization, titer, potency, residuals, safety assays) with custom assay development
- Dedicated animal‑care infrastructure supporting rodent and non‑human primate studies, including specialized administration routes and neurobehavioral assessments
- Global regulatory expertise with a 100 % IND approval success rate since 2019 and experience supporting >30 clinical candidates