Attending Cell & Gene Meeting on the Mesa in Phoenix, AZ (October 5-7)
Expert in AAV Gene Therapy CMC Strategy, Execution, and Senior Leadership
From Preclinical Strategy through Commercial Readiness
Three decades of AAV CMC experience and Chief Technology Officer leadership, supporting drug developers, manufacturers and CDMOs, as well as investors and strategic partners across North America, Europe, Asia-Pacific, and beyond with strategic guidance, process optimization, operations-focused facility evaluation and design input, and technical due diligence. Track record includes multiple IND submissions supported, up to 7-fold AAV yield improvement, 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 senior judgment and hands-on technical depth that complement lean in-house teams at every level.
How we support drug developers:
- IND-enabling through commercial readiness support
- Fractional Head of CMC or interim CTO for early-stage programs
- Vector design, manufacturability, and analytical strategy
- CDMO selection, evaluation, and oversight
- Technology transfer, analytical method transfer, and fit assessment
- Regulatory CMC strategy and FDA interactions
- IND/BLA CMC section preparation support
Process and Production Optimization for Manufacturers and CDMOs
Hands-on AAV manufacturing experience across multiple 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 improve process performance from development through GMP manufacturing.
Capabilities and results:
- Up to 7-fold AAV yield improvement
- 30-50% COGS reductions
- Cell line development and characterization
- Upstream: adherent and suspension HEK293 platforms, including transfection and helper virus–based production
- Downstream: chromatographic and ultracentrifugation-based purification
- Fill-finish: manual, semi-automated, and fully automated systems
- A broad range of AAV serotypes and engineered capsids, in both single-stranded and self-complementary (scAAV) formats
Technical Due Diligence for Investors and Strategic Partners
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.
How we support investors:
- 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
Multiple
Patents
in AAV Manufacturing
Up to
7x Yield
Improvements
Multiple
IND Submissions
Supported
Former CTO
at a
Gene Therapy Company
Technical
Due Diligence and
COGS Analysis
CMC Steering
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.