HOF freeze-thaw technology implementation for biologics bulk drug substance at Bristol-Myers Squibb (BMS)
July 14-18, 2019
Biologics drug substance is ideally stored and transported in a frozen state to minimize potential temperature related instabilities. Currently, BMS utilizes compressor-based freezers or liquid N2 (LN2) blast freezer units that achieve cooling by convection. These processes are relatively long (up to 3 days), and provide limited capacity (e.g., up to 8 containers per blast-freezer unit). With the projected improvements in Drug Substance (DS) process yields (for example, a product reaching up to 80 filled containers per batch), the existing blast freezers capacity could easily exceed full utilization. This level of throughput would lead to the freezing process unit operation becoming a cadence limiting step and resulting in increased hold times prior to freezing. This poster describes successful first time implementation of active plate HOF freezing and thawing technology for freezing and thawing a biologics bulk drug substance at DS and Drug Product (DP) manufacturing sites (Figure 1). The poster will describe various challenges identified and resolved before technology implementation in manufacturing. The HOF technology led to faster (up to 2 cycles per day, 10 containers per cycle per unit) and a more robust freezing process (consistent freezing of a wide variety of loads). Furthermore, the HOF technology has application for thawing DS at the DP sites. In this poster, we will also present our roll out plans for implementation of the active-plate as the platform BMS technology for freezing and thawing DS, across both internal network and external partners.
Please click Additional Files below to see the full abstract.
Manoj Sharma, Cody Simmons, and Itzcoatl Pla, "HOF freeze-thaw technology implementation for biologics bulk drug substance at Bristol-Myers Squibb (BMS)" in "Biochemical and Molecular Engineering XXI", Christina Chan, Michigan State University, USA Mattheos Koffas, RPI, USA Steffen Schaffer, Evonik Industries, Germany Rashmi Kshirsagar, Biogen, USA Eds, ECI Symposium Series, (2019). https://dc.engconfintl.org/biochem_xxi/60