Advanced Analytics from Development Through Market

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Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

Discovery

Pre-clinical

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Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

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Phase I – III

Analytic Data and Characterization Packages for Accelerating Phase I-III Programs through BLA

Phase I

Phase II

Phase III

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Phase I – III

Analytic Data and Characterization Packages for Accelerating Phase I-III Programs through BLA

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Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Registration

Market

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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

  • LC-MS Based Host Cell Protein Analysis
  • HDX-MS Higher-Order Structure Analysis and Binding Site Profiling
  • Precise Sequence, Sequence Variant and PTM Characterization
  • In Vivo Critical Quality Attribute Mapping of Biologics in PK Samples
  • Forced Degradation and Stability Analysis
  • Drug-Drug and Drug-Device Compatibility
  • Low-Level Impurity Characterization
  • Method Internalization/Development for Non-GMP Commercial Lot Testing
  • Formulation Strategy and Development
  • Gene Therapy Vector Characterization with HCP Analysis
  • Gene Therapy Expression Product Quantification and PTM Analysis
Advanced-LC-MA-Based-Project-Areas

Talk with Our Team

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Whether you are looking to learn more about our platforms or get a project started, contact our team today.

Our Approach

Leading Biologic Programs and Pipelines

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Key Analytic Questions and Development Strategies

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Advanced Technology and Dedicated Team of PhD Experts

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Data Analysis and Reporting

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Data Packages Applied into Biologic Development and Regulatory Programs

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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.

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