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.

Bionova would love to hear from you.