Advanced Analytics from Development Through Market
Discovery – Pre-clinical
Biologic Candidate Evaluation, Optimization and Selection into IND
Discovery
Pre-clinical
Discovery – Pre-clinical
Biologic Candidate Evaluation, Optimization and Selection into IND
Phase I – III
Analytic Data and Characterization Packages for Accelerating Phase I-III Programs through BLA
Phase I
Phase II
Phase III
Phase I – III
Analytic Data and Characterization Packages for Accelerating Phase I-III Programs through BLA
Registration – Market
Commercial-Stage Comparability Testing by Qualified Advanced Methods
Registration
Market
Registration – Market
Commercial-Stage Comparability Testing by Qualified Advanced Methods
Our Capabilities
Techniques
- Advanced LC-MS
- MSn (HCD, CID, ETD)
- HDX-MS
- Native-MS
- Intact Protein Analysis
- HPLC Separations
- Low-Concentration Profiling
- CE, SEC, RP Biophysical
CQA Analytic Programs
- Peptide Mapping/PTMs
- Complex Disulfide Bonds
- N-Glycans
- O-Glycans
- Glycation
- Sequence Variants
- Degradants
- Formulation Development
- Commercial Lot Analysis
Candidates and Platforms
- mAbs, Proteins, Enzymes
- Fusion Proteins
- PEGylated Molecules
- Conjugate/ADCs
- Bispecifics
- Complex Formulations
- Gene Therapy Vector Analysis
- Gene Therapy Expression
Advanced LC-MS Based Project Areas
Talk with Our Team
Our Approach
Leading Biologic Programs and Pipelines
Key Analytic Questions and Development Strategies
Advanced Technology and Dedicated Team of PhD Experts
Data Analysis and Reporting
Data Packages Applied into Biologic Development and Regulatory Programs
Recommended Content from Our Biologics Hub
A Global Analytic Services Provider for the Biopharmaceutical Industry
BioAnalytix is now part of Protagen Protein Services (PPS). Together we generate best-in-class pre-clinical and CMC analytical data packages and provide scientific, technical and regulatory support to advance, de-risk and accelerate all stages of biopharmaceutical development at the highest of quality from clone through commercialization.
Protagen Protein Services GmbH
Inselwiesenstraße 10
74076 Heilbronn, Germany
Otto-Hahn-Straße 15
44227 Dortmund, Germany
