Formulation Development
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.
Knowledgeable approach of formulation development for biologics
Getting formulation right from the start of early development can mitigate risk for your biotherapeutic development and help save valuable time.
Our team, bolstered by our experience over more than 800 different biomolecules projects, is able to offer the most appropriate formulation for your specific biologics (mAbs, proteins) according to the route of administration (oral, injectable..). We have an in-depth knowledge of the performance and interactivity of commonly-used excipients and buffers, and are able to design a tailored approach for each biomolecule.
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.
Analytical 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.
Custom ELISA
We are experts in the development and manufacturing of custom immunoassays based on your requirements.
Webinar
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.
Seeking for a formulation expert for your next biotherapeutic candidate?
Connect with our team and we will get back to you shortly.
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