BioAnalytix | Advanced Analytics for Improved Biologic Development

Accelerating Biologics Through Advanced Analytics

Sound Support for Your Programs at Every Stage

We offer well-orchestrated business workflows, advanced analysis of biologic drugs, expert understanding of complex biologic structures, and full data integrity. See examples of our data in this short video.

Your Partner from Discovery Through Market

Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

Discovery

Pre-clinical

Discovery – Pre-clinical

Biologic Candidate Evaluation, Optimization and Selection into IND

Phase I – III

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

Phase I

Phase II

Phase III

Phase I – III

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

Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Registration

Market

Registration – Market

Commercial-Stage Comparability Testing by Qualified Advanced Methods

Our Capabilities

Advanced LC-MS
MSn (HCD, CID, ETD)
HDX-MS
Native-MS
Intact Protein Analysis
HPLC Separations
Low-Concentration Profiling
CE, SEC, RP Biophysical

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

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

Our Lab in Cambridge, MA

Watch Our Video Tour

BioAnalytix is set up to take on complex biologics in our state-of-the-art lab with our leading expertise in biologics development, customized experimental design, integrated analytical capabilities, and industry-leading technology platforms. Take a look inside our lab in this short video.

Talk with Our Team

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

Key Analytic Questions and Development Strategies

Advanced Technology and Dedicated Team of PhD Experts

Data Analysis and Reporting

Data Packages Applied into Biologic Development and Regulatory Programs

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.

Advance. De-Risk. Accelerate.

Accelerating Biologics Through Advanced Analytics

Sound Support for Your Programs at Every Stage

Your Partner from Discovery Through Market

Discovery – Pre-clinical

Discovery

Pre-clinical

Discovery – Pre-clinical

Phase I – III

Phase I

Phase II

Phase III

Phase I – III

Registration – Market

Registration

Market

Registration – Market

Our Capabilities

Techniques

CQA Analytic Programs

Candidates and Platforms

Advanced LC-MS Based Project Areas

Our Lab in Cambridge, MA

Watch Our Video Tour

Talk with Our Team

Our Approach

Leading Biologic Programs and Pipelines

Key Analytic Questions and Development Strategies

Advanced Technology and Dedicated Team of PhD Experts

Data Analysis and Reporting

Data Packages Applied into Biologic Development and Regulatory Programs

Recommended Content from Our Biologics Hub

A Global Analytic Services Provider for the Biopharmaceutical Industry

Accelerating Biologics Through Advanced Analytics

Sound Support for Your Programs at Every Stage

Your Partner from Discovery Through Market

Discovery – Pre-clinical

Discovery

Pre-clinical

Discovery – Pre-clinical

Phase I – III

Phase I

Phase II

Phase III

Phase I – III

Registration – Market

Registration

Market

Registration – Market

Our Capabilities

Techniques

CQA Analytic Programs

Candidates and Platforms

Advanced LC-MS Based Project Areas

Our Lab in Cambridge, MA

Watch Our Video Tour

Talk with Our Team

Our Approach

Leading Biologic Programs and Pipelines

Key Analytic Questions and Development Strategies

Advanced Technology and Dedicated Team of PhD Experts

Data Analysis and Reporting

Data Packages Applied into Biologic Development and Regulatory Programs

Recommended Content from Our Biologics Hub

A Global Analytic Services Provider for the Biopharmaceutical Industry

Join Our Email List