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.

Talk with 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

Latest Publications

Analytical Artifacts in Characterization of Recombinant Monoclonal Antibody Therapeutics

Upcoming Events

The ASGCT Annual Meeting

Recent White Papers

Advanced Analytical Approaches for Accelerated Development of Gene Therapy Products

Featured Articles

Our Top 12 Methods to Characterize ADCs and Bispecific/Multispecific Therapeutics

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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Protagen Protein Services GmbH
Inselwiesenstraße 10
74076 Heilbronn, Germany

Otto-Hahn-Straße 15
44227 Dortmund, Germany

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BioAnalytix, Inc.
790 Memorial Drive
Cambridge, MA 02139

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