Formulation and Quality – Biomolecular
2019 PharmSci 360
Therapeutic proteins including hormones, peptides, fusion proteins, monoclonal antibody products, and biosimilars are formulated as sterile injectable liquids or lyophilized powders for reconstitution. The effects of formulation and storage conditions (-20C, 4C, 25C and 25C/60%RH) on a model protein lyophilized in a Lyostar3 lyophilizer were characterized using different techniques: dynamic light scattering (DLS), X-ray powder diffraction (XRPD), thermal and spectroscopic methods. The suitability of lyophilization process conditions were investigated using Optical Coherence Tomography Freeze-Drying Microscopy (OCT-FDM). The product quality attributes of the resulting lyophilized product manufactured using collapse temperature (Tc), a critical process control parameter, determined by OCT-FDM, revealed the presence of collapse and product shrinkage in some lyophilized protein formulations depending on the excipients used. Formulation components, lyophilization cycle, storage and excursion conditions are critical to ensure process efficiency and product quality.