- CMC Consulting for Biologics & Gene Therapy
Engineering Confidence from Lab to Launch
Specialized in AAV Gene Therapy
Proven expertise for critical drug development needs
IND through BLA
50+
200+
5
AAV
Gene Therapy Expertise
A Trusted Partner in Drug Development
Proven Solutions for Drug Development Success
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.
Fast, Precise, & Compliant
Personalized Support for Pharma Programs
Program & Process Development
AAV Expertise
Including AAV capsid development, producer cell line optimization, and viral vector manufacturing scale-up
Quality Control / Analytics
We develop robust analytical methods and leverage scientific expertise to ensure product quality, safety, and efficacy throughout every stage of development.
Gene Therapy Analytics
Specialized AAV characterization methods including empty/full capsid ratio, vector genome titer, and residual DNA testing
Supply Chain / Procurement
Customized, end-to-end supply chain strategies to ensure reliable, cost-effective drug product supply from development through commercialization.
Viral Vector Sourcing
Viral vector-specific raw material sourcing including cell lines, plasmids, media, and chromatography resins
Quality Assurance
Comprehensive QA services ensuring compliance and product integrity, including deviation and CAPA management, batch release, and audit support.
Gene Therapy Compliance
Gene therapy-specific compliance, auditing and qualifying GMP-grade plasmids, AAV production systems, and MCBs.
Gene Therapy & Viral Vector Expertise
Gene Therapy & Viral Vector Expertise
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.
Serotypes Supported
- AAV2
- AAV5
- AAV8
- AAV9
- Novel Capsids
Upstream & Capsid Yield Optimization
Adherent-to-suspension transitions, plasmid transfection to baculovirus platform support, empty/full ratio optimization
AAV Specific Assay Development
Vector genome and Capsid titer, protein expression, infectivity, functional potency, and process and product residual testing
CDMO Tech Transfer & Scale-Up
Vendor selection, CDMO quality agreements, and tech transfer packages
Regulatory Strategy (IND / BLA)
FDA and EMA-aligned CMC filings
Driving Results & Impact
Real Results at Every Stage
End-to-End Development Support
Expertise across the entire drug product lifecycle that helps you meet your milestones.
Efficient, Results-Oriented Approach
Focused on essential experiments and processes to accelerate development.
Robust Quality & Compliance
Ensuring product safety, integrity, and regulatory adherence at every stage.
200+
Built on Science
Consistent Quality, Safer Outcomes
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.
Minimize Risk
Strategic program design eliminates downstream failures
Streamline Operations
Efficient processes from IND through commercialization
Safeguard Patient Safety
Regulatory-aligned quality systems that protect patients
Connect With Our Team Today
Advance Your Drug Program with Confidence
Start building reliable, high-quality drug development programs today.