About Us
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About Us
Home /
About Us
Capitol Biologics is a new venture from BioFactura, a company founded in 2004 that excels at small-scale biologics development and manufacturing.
Capitol Biologics is a full service CDMO supporting the R&D and early phase clinical trial manufacturing needs of emerging biotech firms. Focus is on quality-driven biologic, protein, & monoclonal antibody drug development from cell line development to GMP manufacturing.
Extensive Analytical and Quality Control capabilities to assess CQAs, ensuring seamless product development from conception to clinical readiness.
Proven track record in biologics development & manufacturing
Cutting-edge single-use technology & scalable platforms
Deployment of next-gen Continuous Manufacturing Processes
Fit for Purpose: By our nature, we are problem solvers.
Our aim is to efficiently deliver what you need, when you need it.
Highly skilled staff in all areas required to develop and manufacture high quality and regulatory compliant biologics
Molecular Biology, Cell Line & Process Development, Formulation & Drug Product Development
Physicochemical & Biomolecular Analytics to Address CQAs following ICH & FDA Guidance
Single Use Fed-batch and Perfusion Process, Bulk Drug Substance Fill
Beginning to end planning and oversight for Phase 1 & 2 trials
Robust quality systems applied in a phase-appropriate approach. Quality and CMC incorporated for product development strategy, not just for compliance
cGDP & cGLP practices
Feasibility
Scientifically sound, data driven experimental design
Activities align with ICH, FDA, EMU & industry guidance
Equipment is maintained & fit for use
Analytical equipment may be qualified
Data undergoes technical review
Efficiency, flexibility, and cost-effectiveness
Oversight
Subject Matter Expert
Data summary regularly shared with client
Collaboration with client at every step
Goal
Strong scientific foundation
Deliverables translatable to Tier 2
Transparent communications with client
Flexible path to GMP / cGMP activities
Data used to support release / stability and included in regulatory submission
Data integrity to support regulatory submission
ALCOA, as appropriate
Oversight
Project Management
Scientific Director Leadership
Client review
Goal
Data supports preclinical & clinical studies & regulatory submissions
Process development and characterization
Formulation development Method development and qualification
Characterization of drug CQAs (structure, function, purity, safety, etc.)
Characterization of critical reagents
Comparability studies, as appropriate
A client’s success is Capitol Biologics success
Primary focus is scientific integrity at every step
Early implementation of quality activities
Highly skilled / trained personnel involved at all stages
