We support developers of recombinant proteins, antibodies, peptides, nucleic acids, and complex modalities with fast, high-confidence analytical data.
cGMP Compliant | 21 CFR Part 11 | FDA/EMA Ready
Our Analytical Capabilities
Mass Spectrometry
- Sequence confirmation
- Post-translational modification (PTM) identification and quantitation
- Modification ratios (e.g., conjugation, engineered variants)
High-Concentration and Biophysical Testing
- Analytical ultracentrifugation (AUC) for aggregation, self-association, and high-viscosity behavior
- AUC for % ternary complex formation
- Support for bsAbs, fusion proteins, nanobodies, and multi-chain complexes
Chromatography Solutions
- SEC, HILIC, IEC, RP, CE, LCMS
- Aggregate/fragment profiling
- Drug-to-antibody ratio (DAR) and molecular heterogeneity analysis
Stability and Developability
- Accelerated + real-time stability
- Light, oxidation, freeze/thaw stress
- Tracking PTM evolution over time
From Development to Release
Method Development, Qualification, Validation
Biologics manufacturing requires robust analytical methods. We create, implement, and clearly communicate these methods to our partners, providing comprehensive documentation and ongoing support.
GMP Release and Stability Testing
Today’s research, tomorrow’s therapy. BioAnalysis develops robust analytical methods for your research needs. When the time comes, we seamlessly transition to cGMP-compliant testing for regulatory submission and release testing.
Our Expertise
Comprehensive Testing
- Bespoke methods
- Cell lysate to commercial product
- Regular meetings with analysts
- Exceeding expectations
Quality Control
- Host cell protein (HCP) analysis
- Impurity profiling
- Critical quality attributes
- cGMP-compliant testing
Gene Therapy Expertise
- Viral capsid quantitation
- AAV VP1:VP2:VP3 ratio analysis
- Capsid protein modifications
- Empty/full capsid
Method Development
- Custom assay development
- Method qualification/validation
- Regulatory support
- Release testing
Why Choose BioAnalysis?
1. Scientific Excellence
Our team delivers rigorous methods and clear results.
2. Client Partnership
We work as an extension of your team, providing collaborative solutions tailored to your unique challenges.
3. Rapid Delivery
Efficient workflows and optimized processes ensure timely results without compromising scientific rigor.
4. Proven Track Record
Supporting numerous IND, BLA, and MAA applications with successful FDA/sponsor audits.
Modalities We Support
Antibodies (mAbs, bsAbs, nanobodies) | Conjugates (ADCs, AOCs, PDCs) | Fusion Proteins | mRNA-LNPs | Nucleic Acids (mRNA, oligos) | Peptides | PROTACs and Molecular Glues | Viral Vectors (AAVs, Adenos, Lenti)
By the Numbers
800+
Projects Completed (since 2021)
95%
On-Time Delivery (2024)
70+
Peer-Reviewed Publications
7,000+
Samples Analyzed
Breaking Through
Breaking through scientific barriers starts with breakthrough research. Explore how our published expertise delivers proven solutions for clients like you.
View all publications: bioanalysisllc.com/technical-hub
Ready to get started? Contact our team to discuss your analytical testing needs.