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.
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
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
Advanced Analytics from Development Through Market
Discovery – Pre-clinical
Biologic Candidate Evaluation, Optimization and Selection into IND
Discovery
Preclinical
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 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
Instrumentation
