End-to-End Biologics Process Development — Designed for Speed, Quality, and Scalability
At VectorBlue Biosciences, we build tailored upstream and downstream processes to support plasmid DNA, mAbs, viral vectors, and novel proteins — from early development to GMP readiness.
Why Process Development at VectorBlue?
- Cross-platform expertise (microbial, CHO, HEK293)
- Phase-appropriate strategy aligned with ICH guidelines
- Scalable from bench to 1000L
- Seamless upstream-downstream-analytical integration
- Speed-to-IND and tech transfer readiness
Whether you’re starting from a concept or optimizing a legacy process, our team ensures your process is robust, reproducible, and ready to scale.
Upstream Process Development
Key Features:
- High-throughput clone/media screening
- Fed-batch, intensified, and perfusion optimization
- Seeding density, feeding strategies, DO/temp shift studies
- Microbial fermentation and mammalian cell culture
- Clarification and harvest strategy (depth filtration, TFF)
- Delivering high yields with minimal process variability
Downstream Process Development
Key Features:
- Resin screening (AEX, CEX, HIC, SEC, Protein A)
- Capture and polishing chromatography development
- Tangential Flow Filtration (TFF) and UF/DF optimization
- Protein refolding protocols (for inclusion bodies)
- Buffer screening and formulation studies
- Viral filtration or clearance studies (if applicable)
- Optimized for purity, recovery, and scalability
Process Characterization & Tech Transfer
- Design of Experiments (DoE) & multivariate modeling
- Critical Process Parameter (CPP) identification
- Process performance qualification (PPQ) support
- Control strategy establishment
- Tech transfer protocols (internal or external CDMOs)
- Comparability assessments and bridging studies
- Robust characterization reduces risk at scale-up and regulatory stages.
Data, Analytics, and Digital Integration
- Integration with analytical method development
- Batch data visualization (real-time and retrospective)
- Digital twin development
- Use of PAT for real-time monitoring
- AI/ML readiness for DoE datasets (optional)
Modalities Supported
- Plasmid DNA
- Monoclonal and Bispecific Antibodies
- Recombinant Proteins
- Lentiviral & Viral Vectors
- Peptides or fusion proteins (optional mention)
Partner with VectorBlue
“Let’s Co-Create a Scalable and Compliant Bioprocess"
- Dedicated project manager
- Real-time communication and transparency
- Phase-specific documentation (PDP, BMRs, CMC sections)
Ready to Advance Your Program?
Schedule a discovery call with our scientific team.
Detailed services are available now!
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Research Grade ( 2-4 weeks )
- Rapid Discovery or preclinical use
- Single Use or Reusable Systems
- Cost Effective & Flexible Process
High Quality Grade ( 5-6 weeks )
- Essential Starting Material
- mRNA production templates
- Advance Quality Testing
- Material traceability
GMB Grade ( 8-12 weeks )
- Critical for clinical application
- Approved Raw material
- Comprehensive Validation
- Release QP
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Testimonials
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Deepak
, Demo,
Our leadership brings decades of experience across biologics, viral vectors, plasmid development, and CDMO strategy.
Sumit
, Demo,
Our leadership brings decades of experience across biologics, viral vectors, plasmid development, and CDMO strategy.
Venus
, Demo,
Our leadership brings decades of experience across biologics, viral vectors, plasmid development, and CDMO strategy.
Shams
, Demo,
Our leadership brings decades of experience across biologics, viral vectors, plasmid development, and CDMO strategy.