Recovery modeling of tangential flow systems.
The demand for increased formulation concentrations for protein therapeutics puts a significant strain on already existing tangential flow filtration (TFF) systems that were constructed with lower protein concentration targets as part of their design criteria. TFF is commonly used to buffer exchange and concentrate the product to the appropriate drug substance concentration. Analyzing the ability of an existing TFF system to process under conditions outside its original design specifications can be challenging. In this analysis, we present a systematic approach to assess the operational limits of a TFF process with consideration of system performance parameters for changing process targets. In two new engineering diagrams, the recovery efficiency diagram and the operating space plot, all relevant operational constraints and parameters are related to allow rapid process fit evaluation. The engineering assessment of TFF systems presented in this article allows a rational review of system limitations during process fit evaluations of existing TFF systems. It also provides a rational basis for targeted system upgrades and setting system design specifications for the design of new systems if existing systems are found inadequate.
Purification Process Development, Amgen Inc., Mail Stop 30W-2-A, One Amgen Center Dr., Thousand Oaks, California 91320, USA. sumar@amgen.com
Suma
S
Rao
Eva
E
Gefroh
Oliver
O
Kaltenbrunner
D001709:Biotechnology / Q000379:methods*; D005374:Filtration / Q000379:methods*; D007700:Kinetics; D008962:Models, Theoretical; D004364:Pharmaceutical Preparations / Q000302:isolation & purification; D011506:Proteins / Q000302:isolation & purification; D013678:Technology, Pharmaceutical / Q000379:methods*
D004364:Pharmaceutical Preparations; D011506:Proteins