At GTP Bioways we have the expertise to support the successful development of your formulation whatever the biomolecule – mAbs, recombinant proteins, and other complex biologics.
Our formulation development services
At GTP Bioways, we use Design of Experiment (DoE) principles to optimise the formulation of your molecule whilst mitigating risk. Our formulation development services can be initiated from the earliest stage of your project.
After identifying which excipients and conditions allow for maximum product stability, we test them in parallel through systematic, real-time accelerated studies.
- Factorial DOE for rapid effect screening under accelerated temperature conditions
- Biophysical Property Assessment [solubility, thermal stability, aggregation, DLS viscosity]
- Surface response design for critical factor level determination
- Storage temperature product stability correlation study for product shelf-life prediction
- Real-time long-term formulation stability
- Extensive supporting analytics for product characterisation
Our knowledgeable team can support your formulations experts in developing, screening, troubleshooting and testing formulation-related issues.
GTP Bioways provides a wide range of analytical services dedicated to your biotherapeutics
We have the expertise to support the development of your biotherapeutics with our cutting-edge analytical & formulation services.
We offer expert analytical services dedicated to process development and GMP manufacturing.
Host Cell Protein
We are experts in the detection and/or quantification of process-related contaminants including HCP.
We are experts in the development and manufacturing of custom immunoassays based on your requirements.
HCP Risk Management
Vincent Rivera, founder and director at GTP Immuno (part of GTP Bioways) is sharing his great experience regarding HCP (host cell proteins) and biocontaminants risk management.