Our expertise spans technology transfers and manufacturing scale-up, with a deep understanding of process science disciplines in biologics manufacturing, including quality control and cell bank management. We offer strategic consulting for agency interactions, support in CMO selection, regulatory document preparation, and in-plant assistance. Our team is skilled in manufacturing investigations, root cause analyses, manufacturing optimization, PPQ preparation and execution, microbial hold strategy assessments for process intermediates, chemical stability evaluations, comprehensive process data reviews, and thorough protocol and PPQ report assessments. Our comprehensive approach ensures quality, efficiency, and regulatory compliance in biologics manufacturing.