Expert CMC Strategy for AAV Gene Therapy Programs
From IND to Commercial Scale
30+ years optimizing viral vector manufacturing, analytical methods, and regulatory strategies for biotech companies, CDMOs, and investors. Proven track record of 7-fold yield improvements, successful IND submissions, and manufacturing cost reductions.
Accelerate Your AAV Program with Battle-Tested Expertise
End-to-End AAV Manufacturing Excellence
More than three decades solving complex CMC challenges across the entire development lifecycle. From vector design optimization and cell line development through scalable GMP manufacturing and analytical development, we bring hands-on experience with all AAV serotypes, production platforms, and purification technologies.
Key capabilities:
- IND enabling through commercial readiness support
- 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
- Single-strand and self-complementary AAV (scAAV)
Proven Manufacturing Process Optimization
Demonstrated track record of dramatic improvements in yield, purity, and cost efficiency. Our systematic approach to upstream and downstream process development has consistently delivered results that exceed industry benchmarks.
Results delivered:
- 7-fold viral vector yield improvements
- 80%+ purity enhancements
- 30-50% COGS reductions
- Regulatory-compliant scalability from research to commercial
Strategic Business Partner
We understand that CMC success isn't just about science—it's about timelines, budgets, and business objectives. With experience as a Chief Technology Officer leading CMC strategy and execution, departmental budget management, and cross-functional coordination across R&D, clinical, and regulatory teams, we provide strategic guidance that aligns technical excellence with business realities.
Strategic services:
- Technical due diligence for investors and M&A
- CDMO selection, evaluation, and management
- Global supply chain optimization with customs compliance expertise
- Manufacturing cost analysis and optimization
- Risk assessment and mitigation strategies
Specialized Support for Every AAV Stakeholder
CMC Leadership for Gene Therapy Programs:
- Vector design and manufacturability assessment
- Process development and scale-up strategy
- Analytical method strategy
- Formulation development
- Compatibility studies
- IND/BLA preparation and regulatory submissions
- Technology transfer and CDMO management
Biotech & Pharma Companies
Contract Development & Manufacturing Organizations
Manufacturing Excellence and Client Support
- Process optimization and yield improvement
- Production platform and purification development
- Analytical development and troubleshooting
- Quality systems and GMP compliance
- Client technical support and problem solving
Investors & Private Equity
Technical Due Diligence and Portfolio Support
- Pre-acquisition CMC assessment
- Manufacturing feasibility evaluation
- COGS analysis and competitive positioning
- Technical risk identification
- Portfolio company manufacturing strategy review
Analytical Development and Quality Strategy
- Method development and validation
- Characterization strategy
- Comparability protocols
- Regulatory compliance support
- Multi-site coordination
Contract Research & Testing Organizations
Comprehensive Expertise Across the AAV Manufacturing Lifecycle
Vector Design & Optimization
- Capsid selection and engineering
- ITR design and verification (ssAAV vs. scAAV)
- Expression cassette optimization
- Manufacturability assessment
- Transgene and promoter optimization
- Serotype selection strategy
- Payload design and cloning
Analytical Development & QC
- Cell line development
- Upstream development
- Downstream purification
- Clarification and filtration
- Fill-finish and formulation
- Clinical Trial Material yield calculation
- Global supply chain and CTM logistics
Regulatory & Quality
Manufacturing Processes
- Testing strategy and sampling plan
- Empty/partial/full capsid characterization
- Potency and infectivity assays
- Impurity quantification
- Method validation
- Stability testing protocols
- Lot release and characterization strategy
- IND/BLA CMC sections
- Regulatory strategy
- GMP compliance
- FDA/EMA interactions
- Comparability assessments
- CMC gap analysis and remediation
- Quality systems design
Trusted Expertise, Proven Results
30+
Years
in Gene Therapy CMC
3
Patents
in AAV Manufacturing
7x
Yield
Improvements
Multiple
Successful
IND Submissions
80%+
Purity
Enhancements
25+
Scientists
Supervised and Mentored
CMC Committee
Member
at ASGCT
Ready to Accelerate Your AAV Program?
Whether you're preparing your first IND, optimizing manufacturing processes, selecting a CDMO, or conducting technical due diligence, we provide the specialized AAV expertise you need to succeed.
Confidential consultations. Global availability.