Expert CMC Strategy for AAV Gene Therapy Programs
From Preclinical Strategy through Commercial Readiness
Three decades of AAV CMC experience and Chief Technology Officer leadership — supporting drug developers, manufacturers, and investors with strategic guidance, process optimization, and technical due diligence. Proven track record of successful IND submissions, 7-fold yield improvements, and senior CMC leadership for early-stage programs.
Accelerate Your AAV Program with Proven CMC Expertise
Strategic CMC Leadership for Drug Developers
Drawing on three decades of AAV CMC experience and Chief Technology Officer leadership at a gene therapy company, we partner with early-stage and scaling drug developers across the full spectrum of CMC needs — from working through data and troubleshooting alongside your team to setting program strategy and representing your CMC story to the FDA. Whether you need fractional CMC leadership, IND-enabling support, or technical guidance on a specific challenge, we bring the senior judgment startup teams typically lack in-house, with the technical depth to engage at every level.
How we support drug developers:
- IND enabling through commercial readiness support
- Fractional or interim Head of CMC for early-stage programs
- Vector design, manufacturability, and analytical strategy
- CDMO selection, evaluation, and oversight
- Technology and analytical method transfer, and fit assessment
- Regulatory CMC strategy and FDA interactions
- IND/BLA CMC section preparation
Proven Manufacturing Excellence and Process Optimization
Three decades of AAV manufacturing experience across all major AAV production platforms, delivering measurable improvements in yield, purity, and cost. We work with CDMOs and in-house manufacturing teams to solve complex production challenges, optimize existing processes, and exceed industry benchmarks from process development through GMP manufacturing.
Capabilities and results:
- 7-fold viral vector yield improvements
- 80%+ purity enhancements
- 30–50% COGS reductions
- Cell line development and characterization
- Upstream: adherent, suspension, and stable producer cell line platforms
- Downstream: chromatographic and ultracentrifugation-based purification
- Fill/finish: manual, semi-automated, and fully automated systems
- All AAV serotypes and engineered variants, including scAAV
Technical Due Diligence and Investment Insight
Investment decisions in gene therapy demand rigorous CMC assessment beyond the pitch deck. Drawing on company-wide CMC strategy experience as a Chief Technology Officer, we provide investors, private equity, and corporate development teams with technical evaluation that identifies manufacturing risks, validates COGS assumptions, and assesses platform feasibility before capital commitments — and supports portfolio companies through scaling, partnership, and exit decisions.
Capabilities and results:
- Pre-investment and pre-acquisition CMC due diligence
- Manufacturing platform and feasibility assessment
- COGS analysis and competitive benchmarking
- Technical risk identification and mitigation
- Portfolio company manufacturing strategy review
- Comparability and scalability evaluation
- M&A technical integration support
Trusted Expertise, Proven Results
30+
Years
in Gene Therapy CMC
3
Patents
in AAV Manufacturing
7x
Yield
Improvements
Multiple
Successful
IND Submissions
Former CTO
at a
Gene Therapy Company
Technical
Due Diligence and
COGS Analysis
CMC Committee
Member
at ASGCT
Ready to Accelerate Your AAV Program?
Whether you are preparing for IND submission, scaling your CMC capability without a full-time leader, optimizing manufacturing or analytical processes, or conducting technical due diligence, we provide the specialized AAV expertise you need to succeed.
Engage at the level that fits your program — from focused consulting to fractional CMC leadership.
Confidential consultations. Global availability.