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AAV Gene Therapy Program & Process Development
Accelerate your AAV Gene Therapy program
Construct design through BLA
CMC for your Gene Therapy Product
Accelerating Commercialization from Ultra Rare to Broad Market Indications
Our team brings extensive experience with established serotypes (AAV2, AAV5, AAV8, AAV9) and next-generation novel capsids. We refine development strategies to maximize step yield, purification efficiency, and optimize empty/full capsid ratios, proactively solving critical CMC challenges that delay IND filings.
We provide specialized CMC roadmaps for products eligible for accelerated development pathways, including:
- Fast Track: Streamlining development for unmet medical needs.
- Breakthrough Therapy: Intensifying FDA guidance for substantial clinical improvements.
- RMAT: Navigating the specific hurdles of Regenerative Medicine Advanced Therapies.
AAV Gene Therapy Process Development Services
Specialized capabilities for adeno-associated virus development across all platforms and serotypes
From AAV construct design to clinical manufacturing, our consultants offer end-to-end bioprocessing expertise. We specialize in producer cell lines, triple plasmid transfection, and baculovirus production, seamlessly scaling your processes up to 500L bioreactors with robust scalable downstream purification strategies built in.
Module 3 AuthorshipA Phase-Appropriate CMC Approach
Cutting Out Excess & Risks at Every Stage
Fast-tracking drug development and optimizing patient safety, production efficiency, and supply reliability to accelerate market access for AAV gene therapies and biologics.
Begin with the Commercial End State in Mind
Construct design through toxicology lot production, IND authorship & AAV platform selection
Lay the Groundwork for Reliable Clinical Supply
Tech transfer, scale-up, CDMO selection & IND amendment support
Ensure Process Control & Submission Readiness
PPQ, BLA filing, process characterization & viral clearance studies
Maintain Compliance & Expand Your Market
Continuous process validation, lifecycle management & site tech transfer
AAV Manufacturing Expertise
Specialized Viral Vector Process Development
Our process development services are designed to accelerate market access by fast-tracking drug development while prioritizing patient safety, production efficiency, and supply reliability. We leverage platform-agnostic expertise across both human (HEK293) and insect (Sf9) cell lines, navigating diverse production modalities ranging from stable producer lines and plasmid transfection to viral infection systems like HSV and Baculovirus.
Our integrated approach encompasses comprehensive upstream optimization including media screening, serum-free adaptation, and transfection complexation and robust downstream purification using methodologies like CsCl gradient ultracentrifugation, affinity and ion exchange chromatography. To ensure a seamless transition to the clinic and beyond, we provide specialized formulation development for cryogenic storage.
AAV2
AAV5
AAV8
AAV9
AAVrh10
Novel Capsids
Triple Plasmid vs. HSV vs. Baculovirus Platforms
Comparative platform assessment, technology transfer packages, and manufacturing robustness evaluation for HEK293 and Sf9 cell-based systems
Upstream Bioreactor Scale-Up
Adherent to suspension adaptation, bioreactor optimization (wave, stirred-tank), MOI and infection timing studies, and cell viability management
Downstream Purification Strategy
Ultracentrifugation, iodixanol gradient, affinity chromatography (AAVX, AVB Sepharose), and ion-exchange polishing platform and custom approaches
Empty/Full Capsid Control & Optimization
Analytical ultracentrifugation (AUC), AEX chromatography strategies, and process modification to achieve target full capsid percentage specifications
IND CMC Module 3 Authorship
DS and DP process description, characterization, control strategy, and container closure system for gene therapy
Rational Design, Reliable Results
Emphasizing Process Design & Product Quality
Our core principles drive measurable outcomes for AAV gene therapy and biologics programs at every stage.
High Product Quality
Achieve superior quality attributes with our specialized viral vector downstream processing strategies. We optimize chromatography steps for AAV purification and design AAV manufacturing process characterization studies to minimize impurities
Timeline Acceleration
Expedite your timeline with expert viral vector scale-up strategy, from triple transfection optimization to AAV suspension cell culture.
Our approach accelerates gene therapy IND CMC section authoring and AAV packaging capacity optimization to get you to the clinic sooner.
Commercial Supply Reliability & Validation
Ensure consistent supply with our AAV platform approach covering development from vial thaw to viral vector fill-finish. We guide you through PPQ strategy and late-phase validation to secure commercial readiness.
Proven Technologies
We balance innovation in novel capsids with the stability of proven manufacturing platforms. De-risk your program by leveraging robust viral vector downstream processing technologies and production methods.
Regulatory Alignment
Deep knowledge of FDA and EMA gene therapy CMC expectations, ICH and current CBER guidance for viral vectors.
CDMO Partnership Support
End-to-end CDMO selection, RFP management, technical due diligence, and tech transfer oversight for AAV and biologics manufacturing.
Connect With Our Team Today
Advance Your Drug Program with Confidence
Start building reliable, high-quality drug development programs today.