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AAV Supply Chain & Procurement

End-to-end gene therapy supply chain solutions
Raw material sourcing to commercial launch.
End-to-End Solutions

Gene Therapy Supply Chain Complexity

AAV gene therapy supply chains present unique challenges that demand specialized expertise. Limited sourcing options for viral vector manufacturing, extended lead times for specialty raw materials, stringent cold chain requirements, and patient-specific dosing complexities require proactive planning and risk mitigation strategies that pose unique challenge. Our team are experts in navigating the complexities of the ever changing landscape.

We partner with clients to accelerate supplier qualification, secure continuity of supply of long lead time affinity resins, select CDMOs that provide the technical fit with your AAV manufacturing process, and design resilient supply strategies. From academic tech transfer through commercial launch, we provide the supply chain expertise to ensure your gene therapy program maintains reliable material availability.

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Viral Vector-Specific Raw Material Sourcing

Specialized procurement capabilities for AAV gene therapy manufacturing materials

Viral vector-specific raw material sourcing including plasmids (Transgene, Rep/Cap, Ad Helper plasmid), media, chromatography resins (AAVX, AVB Sepharose, AEX/CEX resins and monolith technologies), and single use technologies. We manage the entire supplier qualification, quality agreement, and master service agreement negotiations.

🔗   Plasmid Manufacturing & Supply
🔗   Cell Banking
🔗   Recombinant HSV / Baculovirus System Sourcing
🔗   Cell Culture Media & Sera (animal-free)
🔗   Single-Use Technologies
🔗   Chromatography Resins and Monoliths
🔗   Fill-Finish and Cold Chain Managment
🔗   CDMO / CMO Selection & Qualification
🔗   Master Service and Quality Agreement
Proven Expertise

Our Core Viral Vector Supply Chain Services

Comprehensive procurement and supply chain management services built around the specific requirements of AAV gene therapy and viral vector manufacturing.

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Raw Material Planning & Risk Assessment

Bill of materials analysis, safety stock strategy, and AAV-specific critical material qualification

   Bill of Materials (BOM) risk assessment for viral vector manufacturing
   Safety stock assessment and recommendations for long-lead-time materials
   Plasmid GMP manufacturing vendor qualification and selection
   Chromatography resin Sourcing (AAVX, AVB Sepharose, Capto, Monoliths, etc.)
   Analytical testing material sourcing (References Standards)
   Business continuity including secondary sourcing
   Animal and TSE/BSE free sourcing strategy
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Drug Product Supply Planning

Demand forecasting, capacity planning, and supply chain maps for visibility

   Supply chain maps (end-to-end visibility and transparancy)
   Sales & Operations Planning (S&OP) process implementation
   Capacity planning
   End-to-end supply chain risk assessment
   End-to-end logistics to clinical sites
   Drug product packaging and labeling qualification
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Contract Manufacturer (CDMO) Selection for AAV

RFP management, technical due diligence, and CDMO qualification for viral vector manufacturing

   Request for Proposal (RFP) and recommendations to C-Suite
   Cost Modeling
   Category strategy management
   Safety Stock Management
   Vendor Qualification
   Inventory management in support of technical transfer for global market approval
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Product Storage & Biorepository Management

Cold chain strategy, warehouse management, and 3PL solutions for AAV gene therapy products

   Cryogenice (-80°C, liquid nitrogen) cold chain strategy
   inventory and biorepository management
   ERP implementation and warehousing support
   3rd Party Logistics (3PL) solutions and qualification
   Serialization and implementation
   Business and risk management continuity planning
Viral Vector Raw Material Risk Framework

Key Material Risk Categories for AAV Manufacturing

Understanding the supply risk profile of your critical starting materials is the foundation of a resilient viral vector supply chain strategy.

Raw MaterialDES Pharma Strategy
GMP PlasmidsEarly vendor qualification, dual-sourcing, rolling safety stock
Cell Culture MediaLot-to-lot qualification, safety stock, chemically defined alternatives
Chromatography ResinsLifetime studies, resin reuse qualification, alternative resin validation
Filtration and Buffer Exchange ConsumablesLeachables/extractables qualification, validated alternatives
Single-Use Bioprocess ComponentsIn-house generation capability assessment, MCB/WCB backup strategy
Excipients & Formulation ComponentsStandard compendial sourcing with CoA review and supplier qualification
Our Approach

Tailored Solutions, Immediate Impact

Three core principles that differentiate DES Pharma’s supply chain practice for gene therapy and biologics programs.

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Customized Process

We listen, discuss, and understand your program’s specific needs. Our industry knowledge and CDMO network accelerates delivery of a rapid, customized viral vector supply strategy from development to commercialization.

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Forward-Thinking Experts

Innovation is embedded in our DNA. Our team of high-performing professionals provides access to the right skills and industry relationships for your program’s specific supply chain needs.

Immediate Value

We create immediate value through robust process implementation, optimizing cost, quality, and supply reliability accelerating your clinical timeline and commercial launch milestones.

Connect With Our Team Today

Build a Resilient Viral Vector Supply Chain Today

Protect your AAV gene therapy program from supply disruptions and CDMO delays.