Formulation Development

The Analytics department also design and optimize the formulation of the final product so to achieve sound stability of drug products under various shipping and storage conditions. BIOLOGICAL PHARMA CENTER Bio’s formulation screen typically includes two steps: 

Step  1: Screen

Screenings are initially done in 96 well format, using turbidity, thermostability and aggregation as read out 

Thermo Stability by DSF

Turbidity by plate reader

Aggregation by light scattering

Step 2: Confirmation

Using viscosity, activity, and aggregation as readout. Samples may need to go through various conditions, such as concentrating (up to 200mg/ml), multiple freezes and thaws, longer-term storage, or continuous shaking

SEC

Viscosity by Visometer

MFI with BotI Autosampler

HIAC Particle Counter