Vector Ready

Complete CMC Platform for Next Generation Therapies

Connecting Preclinical Insight, CMC Strategy, and Manufacturing Readiness

Advancing complex therapies requires more than individual services. Vector Ready™ connects Franklin Biolabs’ preclinical, CMC, analytical, manufacturing, and regulatory capabilities to help sponsors make informed decisions, reduce development risk, and maintain momentum toward key milestones.

By aligning preclinical insights with CMC and manufacturing strategy from the beginning, Vector Ready™ helps create a clearer path from early development and IND-enabling studies through clinical and commercial manufacturing.

Scalable Development and Manufacturing Support

As therapeutic programs progress, Vector Ready™ will establish a scalable, coordinated development path without sponsors’ having to manage multiple disconnected providers. By aligning preclinical data, product characterization, manufacturing plans, and regulatory expectations early, we help clients identify risks sooner and transition efficiently into GMP manufacturing for clinical and commercial needs.

Our support includes:

  • Process and product development
  • Manufacturing strategy from research scale through commercial readiness
  • Process optimization and scale-up
  • Technology transfer planning and execution
  • Manufacturing partner selection and management

Access R&D and GMP Analytics Across the Product Lifecycle

Comprehensive and robust analytical data enables a successful CMC strategy. Vector Ready™ provides a full suite of analytical support for product characterization, assay development, GMP testing, regulatory submissions, and lifecycle management.

Our broad and coordinated capabilities include:

  • Product characterization and quality assessment
  • Method development, qualification, and validation
  • Release and stability testing
  • Potency assay development and optimization
  • Comparability studies and lifecycle management

The Vector Ready™ analytical platform provides strategic support to respond to the evolution of the product, generating critical data to support near-term milestones while remaining valuable for future regulatory and commercial needs.

Streamlined Manufacturing and Technology Transfer

Manufacturing decisions affect timelines, cost, and regulatory readiness. Through our preferred partner network, Vector Ready™ helps clients evaluate options, select best-fit production partners, manage technology transfers, coordinate analytical and process transfers, and support comparability planning. Centralized program oversight and a single commercial framework can reduce handoff risk, simplify execution, and provide one point of accountability across development stages.

Practical Regulatory and CMC Guidance

Vector Ready™ aligns scientific, analytical, manufacturing, and regulatory strategies from the start. Drawing on experience supporting INDs, BLAs, and commercial programs, Franklin Biolabs helps clients prepare for critical regulatory milestones with greater confidence.

Our support includes:

  • CMC strategy development
  • Regulatory readiness assessments
  • Control strategy and potency planning
  • IND-enabling support
  • Submission planning
  • Commercial readiness and lifecycle strategy

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.

Vector Ready™ helps innovative therapy developers move from early development toward the clinic with greater clarity, continuity, and confidence.

Contact us for expert guidance to support your next project.

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