Analytics
Comprehensive Bioanalytical Testing for Complex Biologics & Gene Therapies
At VectorBlue Biosciences, analytics is not an afterthought — it’s foundational. From plasmid DNA to monoclonal antibodies and viral vectors, our analytical services empower you with data-driven confidence throughout the product lifecycle from discovery to clinical and commercial release.
Whether you’re a fast-growing biotech or an established pharma partner, we deliver accurate, fast, and regulatory-aligned analytical solutions tailored to your molecule.
What We Do Best
Focused. Flexible. Regulatory-Aligned.
We provide both standalone and integrated analytical support to meet global regulatory expectations. Our capabilities are designed to answer the critical questions that define quality, safety, and efficacy — with speed and scientific depth.
Core Analytical Capabilities
Structural & Functional Characterization
- Protein sequence verification
- Amino acid modifications (PTMs)
- Higher-order structure (HOS)
- Aggregation & solubility analysis
Glycan & Charge Profiling
- Glycosylation mapping (G0F, G1F, G2F, afucosylation)
- Charge heterogeneity (icIEF, CEX)
Nucleic Acid Analysis
- DNA/RNA integrity testing
- Plasmid supercoiling & topology
- A260/280, endotoxin, residual RNase/Benzonase
- RNA quality, sequencing, and copy number validation
Impurity & Residuals Testing
- Host Cell DNA (HcDNA)
- Host Cell Protein (HCP)
- Residual enzymes (e.g., Benzonase, antibiotics)
Bioactivity & Potency Assays
- Cell-based potency testing
- SPR (Surface Plasmon Resonance)
- ELISA, Octet, GatorBio binding assays
- Reporter gene assays & neutralization assays
Serum/Plasma-Based Assays
- PK/PD analysis
- Immunogenicity testing
- Detection of circulating vectors/proteins
Electrophoresis & Chromatography
- CE-SDS, icIEF
- HPLC/UPLC methods
- Mass spectrometry-based profiling
- SEC, RP, and ion-exchange chromatography
Analytical Development & Method Transfer
Services include:
- Method development and optimization
- ICH Q2(R2) qualification & validation
- Compendial method verification
- Phase-appropriate qualification (non-GMP to GMP)
- Aligned with ICH Q2(R2), Q6B, Q14
Stability Testing Services
Shelf-Life & Degradation Profiling Aligned with ICH Guidelines
- Real-time and accelerated stability studies
- Forced degradation testing (oxidation, temperature, pH)
- Reference standard & critical material stability
- Ongoing program stability and post-approval updates
- Supports regulatory submissions (IND, IMPD, BLA, MAA)
Quality Control Built for Biologics
Our QC infrastructure supports:
- Identity, purity, safety, and potency testing
- GMP-compliant release testing for DS & DP
- Raw material and cell bank testing
- Vendor qualification for outsourced testing (if needed)
- Full batch record and CoA integration available
Analytical Services for Advanced Biologics
At VectorBlue Biosciences, analytics isn’t an afterthought — it’s a cornerstone of our process. We bring deep scientific expertise and regulatory insight to deliver comprehensive biopharmaceutical testing across every phase of your product’s journey — from early development to commercial release.
Whether you’re developing plasmid DNA, lentiviral vectors, or monoclonal antibodies (mAbs), our analytics team ensures your data is reliable, reproducible, and regulatory-ready.
End-to-End Analytical Solutions
Plasmid-based therapeutics
Cell and gene therapy vectors (e.g., Lentiviral, AAV)
Recombinant proteins, mAbs, peptides
Why Choose VectorBlue
Rapid Turnaround
Accelerate your timelines without compromising quality
100% On-Time Delivery Rate
Because every milestone matters
Scalable Infrastructure
From preclinical to commercial supply
Regulatory-Ready
Robust documentation and QA support
Client-Centric Approach
Transparent, flexible, and collaborative
Our Clients
We don’t just build softwares, we build your business.
Testimonials
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Deepak
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Venus
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Partner with VectorBlue
At VectorBlue Biosciences, you get more than just data — you gain:
- Regulatory-aligned documentation
- Scientific advisory for comparability & filing
- Full traceability from early R&D to commercial release
Blogs
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