We Are A Global Analytic Services Provider for the Biopharmaceutical Industry

Providing leading scientific, strategic and regulatory support to advance, de-risk and accelerate all stages of development of complex biologics.

From clone through commercialization, our teams are positioned to provide superior quality to our clients.

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