Let's Discuss Your AAV Program Challenges
Whether you're planning your first IND submission, optimizing manufacturing costs, evaluating CDMOs, conducting technical due diligence, or facing unexpected manufacturing challenges, SMAT Consultants provides the specialized expertise you need to succeed.
With 30+ years of AAV-specific experience — from vector optimization delivering up to 100-fold potency improvements to facilities design from a CMC perspective—we deliver practical, implementable solutions.
Schedule a confidential consultation to discuss how SMAT Consultants can support your AAV gene therapy program. Initial conversations are no-obligation and designed to help you understand your options.
WHAT TO EXPECT
Our Consultation Process
You will work directly with Dr. Franz Gerner throughout the engagement—no junior consultants or account managers. Here's what to expect:
Step 1: Initial Consultation (30 minutes, no charge)
Discuss your program, challenges, and objectives
Assess fit and identify optimal technical approaches
Completely confidential — we sign NDAs as needed
No obligation whatsoever
Step 2: Proposal Development (if appropriate)
Detailed scope of work tailored to your specific needs
Clear pricing structure and engagement model options (see Types of Engagements below)
Expected timeline and deliverables (for project-based work)
Flexible terms to fit your budget and urgency
Step 3: Engagement Kickoff (if we proceed)
Flexible engagement structure tailored to your needs— from ad-hoc consulting to fractional CTO roles
Direct access to Dr. Gerner with rapid response to your needs
Hands-on technical support using industry-standard tools — not just recommendations
Practical, implementable solutions you can act on immediately
HOW WE CAN HELP
Common Client Needs
To help us prepare for our initial consultation, please review this checklist and identify which areas are most relevant to your program.
Download our Consultation Preparation Checklist
You can download the checklist to complete and email to us, or simply reference the areas below when you reach out
Manufacturing:
☐ Plasmid manufacturing and ITR stability optimization
☐ Process development and optimization
☐ Upstream process improvements
☐ Downstream purification and empty capsid separation
☐ Formulation and fill-finish development
☐ Scale-up strategy
☐ Manufacturing platform selection and optimization
Analytical:
☐ Method development
☐ Method validation
☐ Characterization strategy
☐ Empty/full capsid ratio measurements
☐ Potency assay development
☐ Impurity testing (host cell DNA, proteins, endotoxin, residual DNA)
☐ Stability testing protocols and studies
Vector Design & Optimization:
☐ Capsid selection and serotype optimization for target tissue/delivery route
☐ ITR design and optimization (ssAAV vs scAAV, TRS modifications)
☐ Promoter and expression cassette optimization for target cells
☐ Transgene design (codon optimization, stability, payload capacity)
☐ Regulatory strategy for novel vector modifications and comparability
Strategic:
☐ Manufacturing strategy
☐ Risk assessment and mitigation strategies
☐ Technology assessment
☐ CDMO selection and evaluation
Due Diligence:
☐ Pre-acquisition technical assessment of AAV programs
☐ Manufacturing feasibility and scalability analysis
☐ COGS modeling and cost reduction opportunities
☐ CMC risk identification and mitigation recommendations
☐ Competitive technology assessment and positioning
☐ Portfolio company CMC assessment and optimization
☐ Manufacturing timeline and capital requirement projections
Infrastructure:
☐ Facility design from CMC/manufacturing perspective
☐ Cleanroom layout and workflow optimization
☐ Equipment selection and vendor evaluation
☐ Material compatibility assessment (AAV-specific oxidizing agents)
☐ Utility systems design (WFI, clean steam, HVAC, power, gases)
☐ GMP compliance and cross-contamination control
☐ Fill-finish system selection (semi-automated vs. fully automated)
☐ Technology transfer and process fit assessment
Quality & Regulatory:
☐ IND/BLA preparation
☐ Regulatory strategy
☐ Quality systems implementation
☐ GMP compliance
☐ FDA response support
Other:
☐ Vendor evaluation and management
☐ Cold chain and stability strategy
☐ Cell line development
☐ Custom needs (please describe)
TYPES OF ENGAGEMENTS
We offer flexible engagement models to fit your needs:
Hourly Consulting
Focused expertise on specific questions
Pay only for time used
No long-term commitment
Ideal for: Specific technical questions, short-term projects, ad-hoc advice
Project-Based Consulting
Defined scope and deliverables
Fixed price or time-and-materials
Clear timeline and milestones
Ideal for: Technology assessments, CDMO selection, due diligence, method development
Retainer Arrangements
Ongoing support and availability
Predictable monthly cost
Priority access
Ideal for: Comprehensive program support, multi-phase projects, continuous strategic guidance
Interim Leadership / Part-Time CTO
Part-time role in your organization
Fill gaps while you build team
Hands-on leadership and execution
Ideal for: Early-stage companies, leadership transitions, rapid program acceleration
We'll recommend the best approach during our initial consultation based on your specific situation.
OUR COMMITMENT TO YOU
Confidentiality
All discussions are strictly confidential. We sign NDAs before any detailed program discussion. Your competitive and proprietary information is protected.
No-Pressure Approach
Initial consultations are genuinely exploratory—we're here to help you understand your options, not to pressure you into engagement. If we're not the right fit, we'll tell you and may suggest alternatives.
Responsive Communication
You'll work directly with Dr. Franz Gerner, not a team of junior consultants. Expect prompt email responses and flexible scheduling for calls.
Practical, Actionable Advice
Our goal is solving problems, not writing reports that sit on shelves. We deliver practical, implementable solutions with clear action steps.
Transparent Pricing
No hidden fees or surprise charges. You'll know exactly what services cost before any engagement begins.
Objective Recommendations
When recommending CDMOs, vendors, or technologies, our advice is based purely on technical fit and your program needs—we receive no commissions or referral fees that could bias our recommendations.
FREQUENTLY ASKED QUESTIONS
Q: How quickly can you start supporting our program?
A: Often within 1-2 weeks of initial consultation, depending on scope. For urgent needs, we can sometimes begin even sooner.
Q: Do you work with early-stage companies with limited budgets?
A: Absolutely. We offer flexible pricing and engagement models. Many early-stage clients start with targeted con-sulting on critical questions, then expand as budgets allow.
Q: Can you sign our NDA?
A: Yes, we routinely sign client NDAs before detailed program discussions.
Q: Do you take equity in lieu of fees?
A: We consider equity arrangements for very early-stage companies where cash is extremely limited and there's strong strategic alignment.
Q: Do you work internationally?
A: Yes, we support clients globally. Most work can be done remotely, with travel for facility visits, audits, or critical meetings as needed.
Q: What industries do you serve?
A: Primarily biotechnology and pharmaceutical companies developing AAV gene therapies, plus CDMOs, investors, and service providers supporting gene therapy development.
Q: Do you have conflicts of interest policies?
A: Yes. We maintain strict separation between clients working on competitive programs and will discuss any poten-tial conflicts transparently during initial consultations.
Q: Do you provide honds-on technical work or just strategic advice?
A: Both. We deliver strategic guidance plus hands-on technical implementation including facility design from a CMC perspective, plasmid redesign using professional software, specific equipment and vendor recommendations, and analytical method development. Our goal is implementable solutions, not just reports.
Q: Can you help with facility and cleanroom design?
A: Yes. We provide facility design from a CMC/manufacturing perspective including cleanroom layout, equipment selection and placement, material compatibility for AAV-specific requirements (like oxidizing agents), utility systems (WFI, clean steam, HVAC), and GMP compliance integration.
Q: Do you work with plasmid manufacturers and design?
A: Yes. We assist with plasmid design optimization (ITR stability, bacterial strain selection), plasmid manufacturing strategy, and coordination with plasmid CDMOs. We can also redesign existing plasmids for improved stability and manufacturability.
Q: Can you help optimize our AAV vector design?
A: Absolutely. We provide vector design optimization including capsid selection, ITR modifications (ssAAV vs scAAV), promoter and expression cassette optimization, transgene codon optimization, and regulatory strategy for novel vector modifications.
Q: Can you work on-site at our facility or CDMO?
A: Yes. While most consulting can be done remotely, we provide on-site support for facility design reviews, equip-ment qualification, process troubleshooting, audits, and technology transfer activities when hands-on presence adds value.
Q: Do you review existing processes and provide optimization recommendations?
A: Absolutely. We frequently assess existing manufacturing processes, analytical methods, and facilities to identify optimization opportunities, troubleshoot issues, and recommend improvements for yield, quality, cost, or regulatory compliance.
Q: What's your experience with self-complementary AAV (scAAV)?
A: Extensive. We have deep expertise in scAAV design including ITR modifications, TRS deletions, D-sequence optimi-zation, packaging efficiency, and analytical method development specific to scAAV constructs.
Q: How can I prepare for our initial consultation?
A: Download our Consultation Preparation Checklist
WHY CLIENTS CHOOSE SMAT CONSULTANTS?
Unmatched AAV Expertise
30+ years focused specifically on AAV manufacturing and analytics. PhD in AAV vector optimization from groundbreaking research at Ludwig-Maximilians-University. Deep hands-on experience across all serotypes and production platforms, not just strategic advice.
Proven Results
Track record of delivering measurable improvements across multiple programs and companies:
7-fold yield improvements
80%+ purity enhancements
30-50% COGS reductions
Multiple successful regulatory submissions
These results come from systematic problem-solving and hands-on technical implementation, not just recommendations.
Full Lifecycle Experience
From early-stage vector design through IND enabling, clinical manufacturing, and commercial readiness strategies. This comprehensive perspective ensures early decisions support late-stage regulatory requirements and commercial viability— avoiding costly redesigns and delays.
Business & Technical Integration
Former CTO responsible for CMC strategy and execution, departmental budgets, cross-functional team coordination, and strategic vendor relationships. This executive experience means understanding not just the science, but also timelines, resource constraints, investor expectations, and business implications of technical decisions.
Industry Network
Extensive relationships across CDMOs, CROs, analytical service providers, reagent suppliers, and equipment vendors built over 30+ years. These connections help you identify qualified partners, negotiate favorable terms, and avoid problematic vendors—saving months of evaluation time.
Facility Design from CMC Perspective
Unlike typical consultants, we provide hands-on facility design including cleanroom layout, material compatibility for AAV-specific requirements (like oxidizing agents), utility systems (WFI, clean steam, HVAC), and GMP compliance integration—ensuring your facility supports your manufacturing process.
Vector Optimization Success
Demonstrated track record of up to 100-fold potency improvements through systematic vector design optimization including capsid selection, ITR modifications (ssAAV vs scAAV), promoter optimization, and transgene codon optimization.
Comprehensive AAV Platform Expertise
Experience across all AAV serotypes, production platforms (HEK293, Sf9, suspension, adherent), purification methods (affinity, ion exchange, ultracentrifugation), and analytical techniques. From plasmid design through drug product fill-finish and commercial readiness—we understand the complete AAV development pathway.
HOW TO REACH US
Ready to discuss your AAV Gene Therapy Needs?
To Get Started:
Download and complete our Consultation Preparation Checklist
Email the completed checklist to fgerner@smatconsultants.com
Contact Information:
Email: fgerner@smatconsultants.com
Connect on LinkedIn
Next Steps:
We will schedule a complimentary 30-minute consultation to discuss your program.
No obligation, completely confidential. See "What to Expect" above for our full process.
DON'T WAIT TO REACH OUT
Many clients contact us when they're already in crisis mode—manufacturing batches failing, regulatory deadlines looming, CDMOs underperforming. While we can help in these situations, it's always better (and more cost-effective) to engage early when we can prevent problems rather than fix them.
We work with clients globally, providing remote strategic support and on-site assistance for facility design, process troubleshooting, and technology transfer when hands-on presence adds value.
Common triggers that should prompt a consultation:
Planning IND submission in next 12 months
Manufacturing yields not meeting projections
Considering first CDMO engagement
Empty capsid specifications concerns
Facing unexpected regulatory questions
Evaluating acquisition or investment
Building internal manufacturing capabilities
Seeking specialized expertise for specific challenges