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Specialized in AAV Gene Therapy
Proven expertise for critical drug development needs
IND through BLA
Gene Therapy Expertise
At DES Pharma (Dynamic Engineering Solutions), we specialize in product and analytical development. Our services encompass processes from pre-clinical drug development to clinical manufacturing and product commercialization.
Including AAV capsid development, producer cell line optimization, and viral vector manufacturing scale-up
We develop robust analytical methods and leverage scientific expertise to ensure product quality, safety, and efficacy throughout every stage of development.
Specialized AAV characterization methods including empty/full capsid ratio, vector genome titer, and residual DNA testing
Customized, end-to-end supply chain strategies to ensure reliable, cost-effective drug product supply from development through commercialization.
Viral vector-specific raw material sourcing including cell lines, plasmids, media, and chromatography resins
Comprehensive QA services ensuring compliance and product integrity, including deviation and CAPA management, batch release, and audit support.
Gene therapy-specific compliance, auditing and qualifying GMP-grade plasmids, AAV production systems, and MCBs.
Specialized AAV Development from Pre-Clinical Through Commercial Launch
At DES Pharma, we bring deep expertise in AAV gene therapy development across all serotypes and manufacturing platforms. Our team has hands-on experience with AAV2, AAV5, AAV8, AAV9, and novel capsid variants, supporting clients through critical development milestones from construct design through commercial manufacturing.
We understand the unique challenges of AAV development: optimizing empty/full capsid ratios, scaling from adherent to suspension cell culture, selecting appropriate purification strategies, and navigating complex regulatory requirements for gene therapies. Whether you’re developing producer cell lines, transitioning from triple plasmid transfection to baculovirus systems, or preparing for your first IND submission, our consultants provide the technical depth and regulatory insight to accelerate your program.
Our AAV-specific services span the entire development lifecycle, including viral vector characterization, potency assay development, CDMO tech transfer, and BLA preparation support. We help gene therapy companies avoid common pitfalls, reduce manufacturing variability, and build robust processes that meet FDA and EMA expectations.
Adherent-to-suspension transitions, plasmid transfection to baculovirus platform support, empty/full ratio optimization
Vector genome and Capsid titer, protein expression, infectivity, functional potency, and process and product residual testing
Vendor selection, CDMO quality agreements, and tech transfer packages
FDA and EMA-aligned CMC filings
Expertise across the entire drug product lifecycle that helps you meet your milestones.
Focused on essential experiments and processes to accelerate development.
Ensuring product safety, integrity, and regulatory adherence at every stage.
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Reliable product quality begins with a strategic, system-driven development process. Our team at DES Pharma applies a disciplined program design that minimizes risk, streamlines operations, and safeguards patient safety.
By embedding quality and compliance at the core of every stage, we deliver results you can trust.
Strategic program design eliminates downstream failures
Efficient processes from IND through commercialization
Regulatory-aligned quality systems that protect patients
Start building reliable, high-quality drug development programs today.