Franklin Biolabs Achieves CLIA Certification for AAV NAb Testing
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Chemistry, Manufacturing, and Controls (CMC) Consulting
End-to-end CMC solutions purpose-built to provide the manufacturing and analytical foundation preclinical teams need to advance to IND with confidence.
Purpose-Built CMC Solutions to Bridge the Gap Between Discovery and IND
Franklin Biolabs delivers end-to-end CMC solutions for genetic medicines and biologics, integrating CMC, analytics, and preclinical development into a streamlined path to IND. Leveraging expertise from thousands of programs, we help innovators reduce risk, accelerate development, and advance complex modalities with confidence.
Franklin Biolabs CMC Consulting Services Includes:
Build a clear, de risked path to first in human studies with an integrated CMC strategy that aligns development, analytics, and comparability plans, accelerating regulatory acceptance and reducing costly rework.
Create scalable, efficient, and compliant manufacturing processes that minimize variability, streamline tech transfer, and ensure your product is ready for every phase of development and commercialization.
Secure the right partners and maintain strong execution with expert guidance across vendor selection, tech transfer, and day to day oversight, so your program stays on track without operational bottlenecks.
Strengthen compliance and ensure uninterrupted supply with phase appropriate GMP systems, smart outsourcing strategies, and resilient supply chain design, including audits and batch record support.
Achieve consistent product quality and regulatory confidence through robust analytical methods, stability strategies, reference standards, and formulation approaches tailored to your molecule’s needs.
Submit with confidence. We craft and review high quality CMC content for IND, CTA, IMPD, NDA, and BLA filings, prepare briefing packages, and guide you through health authority interactions to avoid delays.
Identify and close critical gaps early with comprehensive evaluations of manufacturing, analytics, and quality systems, ensuring you’re fully prepared for first in human submissions.
Align CMC, toxicology, PK, and efficacy plans into a unified development roadmap that reduces risk, prevents misalignment, and keeps your program moving efficiently toward key milestones.
Access expert, fast turnaround support for Module 3 and quality documentation, including clear, defensible responses to regulatory questions that keep your submission timelines intact.
Add seasoned CMC leadership without increasing headcount. We embed directly into your team to manage CDMOs, drive execution, and provide strategic direction, ideal for organizations without dedicated internal resources to lead the program.
Meet Our Team
Kenneth Yancey, PhD
Senior Vice President, Head of Vector | CMC
Dr. Kenneth (Ken) Yancey is Franklin Biolabs Senior Vice President, Head of Vector | CMC, a position in which he is responsible for project management, strategy and operations for all CMC operations.
Previously, Ken worked at the Gene Therapy Program at the University of Pennsylvania since 2018 serving as Executive Director of process development and manufacturing. In his role as head of manufacturing, he oversaw the development of several dozen programs and had a 100% success rate in IND submissions which included six Investigational New Drug (IND) submissions.
Ken is also an author on nine scientific publications, is an inventor on five patents, and holds an MS degree in chemistry from Clarkson University and an MS and PhD in Bioengineering from Cornell University.
Ready to accelerate your CMC strategy?
Partner with Franklin Biolabs for integrated CMC solutions that accelerate development, reduce risk, and prepare your program for the next milestone.