Formulation Development
Successful development of biologics formulations
Formulation Development
Successful development of biologics formulations
Bionova has extensive experience in the successful development of formulations for mAb, Fab, ADC, bispecific, enzyme and other complex biologics.
Experienced, High-Throughput Approach to Formulations Development
Our Formulation Development team uses their in-depth knowledge of the performance and interactivity of commonly used excipients and buffers to design a tailored approach for each molecule.
Our high-throughput platforms enable Bionova to perform large DOE’s to narrow candidates for more in-depth testing including thermal stability, solubility/aggregation and confirmation with forced degradation and accelerated stability studies.
Formulation Development services include:
- 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 characterization
- Container compatibility studies
Additionally, we routinely work with formulations experts from our clients to assist in developing, screening, troubleshooting and testing formulation-related issues.