Overview

BioAnalytix works with leading biotherapeutic companies in the development and application of advanced LC-MS based analytics and data analysis of complex biologics, from candidate selection through regulatory package development and BLA.

Our programs are oriented around our hybrid LC-MS and data analysis platforms for precisely characterizing complex biologics. In working together with innovator partners, our team generates customized analytic data packages and works as an integrated part of the development programs to provide scientific, technical and regulatory support for advancing, de-risking and accelerating all stages of biotherapeutic development, including candidate selection/optimization and detailed characterization of biotherapeutics for IND package development, comparability assessment, control strategy design and CMC filings through licensing application.

Talk with our team of Analytic PhD Experts

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Your Partner Through Development

Advanced Data and Results Correlation Packages

We work collaboratively with your team to design and deliver precise analytic data packages with results correlation to specific program decisions and regulatory packages through all stages of biotherapeutic drug development.

Customized Method Development

In addition to our pharma expertise for program design, our PhD scientists further apply the latest advances in LC-MS technology to ensure accurate structural characterization and quantification of complex biologics.

Integrated Regulatory Support

We leverage our team’s experience with specific analytics and data interpretation, along with our understanding of CMC and regulatory requirements to support your product development from IND through BLA submission and review.

 

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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Advanced Analytics from Development Through Market

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Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

Discovery

Preclinical

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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
Techniques

CQA Analytic Programs


  • Peptide Mapping/PTMs
  • Complex Disulfide Bonds
  • N-Glycans
  • O-Glycans
  • Glycation
  • Sequence Variants
  • Degradants
  • Formulation Development
  • Commercial Lot Analysis
CQA Analysis

Candidates and Platforms


  • mAbs, Proteins, Enzymes
  • Fusion Proteins
  • PEGylated Molecules
  • Conjugate/ADCs
  • Bispecifics
  • Complex Formulations
  • Gene Therapy Vector Analysis
  • Gene Therapy Expression
Candidates

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

Quality Systems

Full Data Integrity. Traceability. Trackability.

We pride ourselves in rigorous Quality Systems with LIMS-driven lab processes to ensure both precise analytics and also full data integrity in each project.

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Instrumentation

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Thermo Scientific™ Vanquish™ UHPLC System
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HD PA 800 Plus image
SCIEX PA 800 Plus Pharmaceutical Analysis System
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Thermo Scientific™ Q Exactive™ Plus Hybrid Quadrupole-Orbitrap™ Mass Spectrometer
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Orbitrap Fusion™ Lumos™ Tribrid™ Mass Spectrometer
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LEAP HDX Automation
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UV 1900 UV VIS double beam Spectrophotometer BioAnalytix
Shimadzu UV-1900 UV-VIS Double Beam Spectrophotometer
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Shimadzu High Performance Liquid Chromatograph
Shimadzu High Performance Liquid Chromatograph
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