Viral Vectors Process Development

Process Development for Viral Vectors

Whether starting from an existing process or an early-stage platform process, SK pharmteco designs and optimizes viral vector processes with manufacturability in mind. Our teams assess key risks early and implement development strategies that support efficient scale-up, technology transfer, and progression into CGMP manufacturing.

Process development is critical to achieving consistent, scalable viral vector production. SK pharmteco provides integrated upstream, downstream, and drug product development services, aligned with analytical and regulatory requirements. This approach enables reproducible processes, supports IND-enabling activities, and ensures readiness for clinical and commercial manufacturing.

Viral Vector Process Development Services

We develop and optimize manufacturing processes tailored to each viral vector and therapeutic application. With experience across multiple vector types and production systems, our teams know what it takes to scale processes while maintaining product quality and enabling an efficient transition into CGMP manufacturing. From early process design through scale-up and GMP readiness, development activities are aligned with manufacturing and analytical workflows to ensure continuity and reduce risk during technology transfer.

Upstream Development

Suspension and adherent production platforms for AAV, lentiviral, adenoviral, and emerging vectors
Integration with cell and viral banking to support process consistency
Process development, optimization, and characterization to improve yield and reproducibility
Plasmid design strategies to eliminate inefficient constructs and reduce early-stage risk

Downstream Development

Purification process development including filtration, chromatography, and ultracentrifugation
Optimization of recovery, purity, processing time, and scalability
Process characterization to support robust and reproducible manufacturing

Drug Product & Analytical Integration

Formulation development and optimization
Drug product process development and characterization
Stability, compatibility, and forced degradation studies
Alignment with analytical method development to support product quality and shelf-life

Technology Transfer from Process Development to CGMP Manufacturing

SK pharmteco ensures efficient transfer from development to manufacturing through early risk assessment and cross-functional alignment. Process development, MSAT, and manufacturing teams work together to maintain consistency between development conditions, equipment, and CGMP production, enabling scalable and reproducible processes.

IND-Enabling Development Support

SK pharmteco provides integrated support for preclinical and IND-enabling activities, combining process development, analytical capabilities, and early manufacturing. This approach produces representative material and data to support regulatory submissions and reduces comparability risk during scale-up.

This approach:

Generates development material suitable for proof-of-concept, toxicology, and biodistribution studies
Supports analytical method development, reference standards, and early stability programs
Uses equipment platforms and process conditions aligned with CGMP manufacturing to support efficient technology transfer and minimize changes during scale-up

Learn more about our world-class analytical capabilities

IND-Enabling Preclinical Development Services

SK pharmteco’s IND-enabling preclinical package delivers end-to-end support for preclinical gene therapy studies and includes access to a proprietary manufacturing cell line, streamlined process development services, and scalable preclinical vector manufacturing services, as well as regulatory support for INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) and pre-IND meetings.

This package:

Enables partners to generate high-quality material and data in months and positions them to move rapidly toward IND approval and CGMP clinical manufacturing
Supplies drug substance and drug product for proof-of-concept, toxicology, safety, and biodistribution studies, as well as method development, interim reference standards, development stability, and drug product development critical for IND packages
Employs similar processing techniques as would be used for full CGMP manufacturing, eliminating comparability risks associated with process changes

Additional analytical testing and regulatory services are available to prepare data briefing packages for INTERACT and pre-IND meetings. Upon completion of preclinical manufacturing, clients have full visibility into the data from execution, production, and purification — a critical data set for clinical program sponsors.

Learn more about our world-class analytical capabilities