Biologics Formulation Development

• Thermal ramp experiment is performed on the molecule in 14 platform buffers in order to establish optimal buffer conditions

• Extended thermal stability of up to four lead formulations from Stage 1​
• Freeze/thaw stability of up to four lead formulations from Stage 1​
• Agitation stress stability (optional)​
• Photostability (Light stress) stability (optional)

• Higher concentration study (e.g. if administration via SC injection is preferential to IV infusion)

• Theoretical injection forces are calculated by measuring the viscosity at a range of shear rates to mimic the motion of the drug through the syringe and needle

• The effects of being ejected from a syringe and needle at high shear rates can be tested by loading of the drug product into the specified syringe/needle system, followed by syringing out of the material​

• Assessment of the molecule as a lyophilized product can be performed, in which its stability to the freeze-drying as well as buffer optimization is investigated​
• This can occur either at this stage (e.g. for a mAb) or pre-tox/phase 1 studies (for an ADC)

• Compatibility of the formulated drug product with IV bag systems and typical clinical diluents such as saline (for intravenous administration)​
• Compatibility of the formulated drug product with syringe/needle systems, pre-filled syringes or cartridges (for subcutaneous or intra-ocular administration)​
• Determination of extractables and leachables from container/closure system

• Extended thermal stability of 21 iterations of the lead formulation from Stage 2, to cover a design space based upon manufacturing tolerances and limits​
• DoE interpretation of data determines the effects of each parameter change and can identify potential risks in excipient​ level/pH/DP conc. deviations during manufacturing

Extended thermal stability of the final formulation assessed in the final format i.e. pre-filled syringes, cartridges, plastic/glass vials, etc

Drug formulation development is the process of understanding how a drugs properties change as a result of how it is formulated – through combining different chemicals and substances to create a final pharmaceutical product. The formulation process is not just about creating a drug that works; it’s about ensuring the drug reaches those who need it most in a form that maximizes its therapeutic potential.

Formulation scientists consider the method of drug delivery, whether it’s oral, injectable, topical, or inhalable. Each form presents unique challenges and considerations.

Customization in drug formulation enhances patient compliance and comfort and is particularly significant in addressing the diverse needs in chronic diseases and specific health conditions. With the rise of personalized medicine, formulation must cater to specific patient needs. This involves developing formulations suitable for different age groups or patients with specific health conditions.

Drug formulation has broad implications for the pharmaceutical industry including:

• Enhances drug stability and shelf-life
• Broadens patient reach and ensures compliance
• Optimizes therapeutic outcomes
• Reduces costs and time to market
• Drives innovation in medicine