High Concentration Formulation (HCF) Technology

Development of formulations for protein drugs requiring high dosing may become challenging for solubility limited proteins and for <1.5 mL allowable administration volume that requires >100 mg/mL protein concentrations. The optimization of formulation conditions for highly concentrated biologics necessitates stability evaluation at the required protein concentrations for administration. Traditional techniques either lack the dynamic range to measure protein stability over a wide range of concentrations, or the physical perturbation by itself induces protein aggregation.

Creative BioMart proprietary formulation technology using the combination of amino acids is effective in stabilizing proteins by inhibiting the aggregation as well as reducing viscosity. In developing a high concentration formulation of protein, we start with evaluating the existing formulation at higher concentrations. Depending on the protein and concentration sought, a new, more stabilizing formulation may be needed. By screening a series of different salts and excipients, varying concentrations of each, we develop HCF. The protein's stability is evaluated by multiple criteria, including aggregation, degradation, activity, concentration, and protein conformation.

Applications:

• Transforming Lyophilized Biologics into Ready-to Use Liquid Injections
• Transforming Intravenous Formulations to Subcutaneous Formulations
• Proprietary blends of amino acid stabilizers allow high protein concentration
• High throughput Screening (HTS) Research
• Feasibility Studies provide Quick Evaluation of the HCF (High Concentration Formulation) Technology

Creative BioMart has extensive experience in manufacturing proteins and characterization. Through a combination of powerful analytical techniques and deep understanding of protein structure and stability, we have been able to provide our clients with desired high-concentration formulations.