Thermo Fisher Scientific expanded capacity at the North American site for sterile drug products in Greenville, NC and will now perform non-GMP work to support clinical phase programs. The new development laboratory features two Lyostar3 freeze dryers with SMART technology that are capable of decreasing the number of runs required for lyophilization cycle development. Fewer runs can translate into shorter development timelines and lower usage of precious API. The lab also includes significant bench space where various non-GMP studies are performed: formulation development, product contact compatibility studies, filtration studies, and clean-ability assessments. The new facility is part of Thermo Fisher’s overall investment in and expansion of steriles capabilities and capacity.
SOURCE: Thermo Fisher Scientific