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.
