GTP Bioways
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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.

GTP Bioways CDMO - CMC Development

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.

Rely on our experienced team to develop a suitable formulation for your biomolecule

Our formulation team has years of experience formulating all kinds of biomolecules and will work closely with you to develop a formulation that meets your project needs.

Throughout thousands of projects, our team has acquired a deep expertise allowing them to tackle stability issues or aggregation difficulties while maximising product potential. 

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 CDMO - Bioconjugates Analytical Development

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.

Watch the Webinar