Enabling Lyophilization Scale-Up From Formulation To Full Commercial Production

By Zak Yusoff, Pharmaceutical Freeze Drying Applications Manager, SP Scientific, USA

Biologic drugs have shown great promise in curing many life changing diseases, even some that were once thought incurable. However, due to the sensitive nature of  biological material it requires specialized development and manufacturing processes. Stabilization by lyophilization is attractive to retain the product’s biological activity, structural integrity and homogenous quality, all of which are crucial to the success of the product. This white paper describes the challenges associated with lyophilization of biologic drug products. Using a Quality by Design (QbD) approach with SP Scientific’s Line of Sight™ (LoS) suite of technologies that provide a data-rich environment, many of these challenges can be overcome. In particular, scaling-up of lyophilization from early development to full commercialization can be streamlined through the use of scalable technologies available within the LoS portfolio. Companies working on biologics need robust processes with proven data to deliver successful products.