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Scale Down Models: An Indispensable Tool to Biopharmaceutical Process Development

Thought Leadership

As published in Pharma's Almanac Q2 2016

 

Several advances in scale-down models have made great contributions to accelerating biopharmaceutical process development. Therapeutic biologics have gained considerable momentum in the past three decades by delivering superior clinical performance to common disorders (e.g., rheumatoid arthritis) and disease areas for which traditional small- molecule drugs have proven ineffective. Due to their inherent structural complexity, biologics production is strictly scrutinized from early development stages by regulatory agencies. Both biopharmaceutical manufacturers and regulators heavily emphasize developing science-based, consistent and robust manufacturing process to ensure quality, safety and efficacy of final biological products.