Powering the Future of CMC Bioanalytics with Intelligent Software
The Catalytic Platform integrates purpose-built bioinformatic pipelines with Al-powered workflows to streamline CMC characterization and regulatory submissions for complex biologic therapies
CMC Bioanalytics
GxP Compliant CMC Bioanalytics for All Stages of Product Development
The Catalytic Intelligence Platform integrates purpose-built bioinformatic pipelines with Al-powered workflows to streamline CMC characterization and regulatory submissions for complex biologic therapies.
No-code GXP Compliant Analysis and Reporting
1. Pre-processing & Quality Control
Analytics covering automated read trimming, read brimming, global alignment and local realignments
2. Variant Detection and Analysis
Comprehensive suite of bioinformatic pipelines covering detection of single nucleotide variants, short inDel variants, structural variants, large-scale InDels, and off-target edits for CRISPR, TALEN, ZFN, meganucleases, and custom endonucleases
3. Functional and Clinical Interpretation
Automated annotation pipelines that identify the functional impact of edits and genomic insertions on molecular and cellular processes and the clinical relevance of edits to safety and efficacy.
4. Automated Report Generation
Customizable Al Agents integrated with analytic and bioinformatic pipelines receive input data and draft written reports for regulatory submissions
5. CMC Analytics Hub
Rapidly access and integrate new capabilities from 500 analytics and pipelines in our Analytics Hub covering whole genome, whole exome, bulk RNA-seq, single cell RNA-seq, proteomics, metabalomics and flow cytometry workflows
Prevent Costly Regulatory Delays
Stay Ahead of Evolving Guidance
Intelligent Al agents monitor and analyze newly issued guidance documents and AdComm meetings to detect shifts in regulatory sentiment, helping partners stay ahead of emerging trends and potential changes.
Avoid IND Delays
With over 300 plug and play bioinformatic pipelines and analytic tools, you can rapidly add capabilities requested during INTERACT meetings without having to develop new solutions or outsource critical work.
Lift Clinical Holds
Adverse events are often unpredictable in early trials. Having access to a comprehensive library of analytic solutions and an experienced team at Catalytic enables you to promptly deliver the analysis regulators need to release holds.
Strengthen Release Criteria
Lockable analytic pipelines paired with detailed technical documentation, run-time metadata, version control, and full audit trails provide the transparency needed to support confident batch release, deviation management, and regulatory compliance.
