Lead
Preclinical
IND
Phase I
Phase II
Phase III
BLA
Market
Since inception: BioAnalytix ● PPS has supported the development of over 400 biologics with >250 different clients.
What Does an Analytical Program with
BioAnalytix ● PPS Look Like?
Advanced Analytics
- Deep Characterization of Biologics via LC-MS/MS & Biophysical Analytics
- In Vivo CQA Analysis
- Cell and Gene Therapy—Vector and Expression Product Quantification and Characterization
- Developability and Forced Degradation
- Isoform and Low-Level Impurity Characterization
- HCP Manufacturing and Process Characterization via MS
- HDX-MS HOS and Epitope Mapping
Established Analytic Panels
- Method Qualification and Maintenance/Transfer for Long Term Product Sample Testing
- LC-MS + PhysChem Panels
- Biologics Lead Candidate Selection
- DP Formulation Optimization
- QC Stability-Indicating Method Development
- Biosimilar and Bridging Study Comparability Program Support
- Reference Standard Characterization
- Process Development Analytics
- Lot Release and Lot Characterization Program Support
GMP Analytics
- Full GMP Services and Method Panels from Discovery through IND and BLA
- ICH/GMP Method Validation Including
- Mass Spectrometry
- Biophysical /HOS
- Physicochemical
- QC / Compendial
- GMP Stability and Lot Release Testing
- OOS/OOT Investigations
- Analytical Applications for Clinical Hold Resolution
Post Market Monitoring
- Lot Testing Under Qualified and GMP Established Methods
- Long Term Stability Testing
- Forced Degradation Testing
- Adverse Event Analytical Support
Our Key Advantages
- Antibodies
- ADCs
- Multispecific mAb
- Gene Therapy Vectors
- Enzyme Replacement Complex Glycosylation
- Complex Disulfide Mapping
- PEGylated Products
- Peptide and Protein Conjugates
- Fc Fusion Proteins
- Vaccines
- Extensive Experience with Over 30 Biosimilar Products
- Supporting a Broad Range of Innovator Biologic Candidates
- Method Establishment and Comparability Analysis
- QC Lot Release and Stability Testing
- Three Quality Levels:
- GMP
- Quality Standard
- Scientific/R&D
- Data Integrity Ensured Through Quality Systems
- End-to-End Coverage of Project Life Cycle
- Developability
- Formulation Development
- Manufacturing and Process Development Analytics Characterization
- Method Development
- Qualification and Validation
- Stability Program Management
- Preclinical
- IND/CMC
- Clinical in vivo Analytics
- BLA/CMC
- Post Market Analytics
- Consultative and Collaborative Program Design
- Product-Specific Technical Approach and Method Customization
- Phase-Specific Fit-for-Purpose Program Scope and Deliverables
- Global Service–US and Europe based sites-Multiple Decade Experience
- High Proportion PhD and Scientific Staff
- Origins from Industry and Academic Thought Leaders
- Successful Pharma Client Base
- Co-Publications with Pharma