Continuous downstream processing of a monoclonal antibody using Periodic Counter Current Chromatography (PCC) and Straight Through Processing (STP)

There is an increased interest to perform process intensification in order to reduce costs and improve throughput in the development and production of monoclonal antibodies (MAbs). One solution to these demands can be to implement continuous or semi-continuous downstream processing. New emerging technologies such as periodic counter-current (PCC) chromatography and straight through processing (STP) are entering the market. Here, these two technologies were evaluated in a continuous three step chromatography MAb process. The capture step was performed with protein A media (resin) on a 3 column PCC chromatography system followed by two polishing steps which were connected in series with an in line conditioning step in between. The three step process was performed using MAb from fed-batch cell culture. Results will also be presented based on the purification of MAb from a perfusion cell culture using PCC setup for the capture step

Process intensification through integration of upstream perfusion cell culture with downstream continuous chromatography in monoclonal antibody production

Process intensification is gaining interest as a strategy to reduce production costs, while improving product quality and throughput in the manufacturing of biopharmaceuticals. For a competitive production process, continuous or semi-continuous upstream and downstream processing can be employed. Compared with a process performed in batch runs, continuous processing allows for increased capacity utilization and eliminates or minimized the need for intermediate hold-up steps. Here, we describe the integration of a high-performing upstream cell culture process with downstream purification utilizing new emerging technologies such as periodic counter-current (PCC) chromatography and straight-through processing (STP). A high-cell density perfusion process based on commercially available ActiCHO™ cell culture media was developed for a MAb-producing Chinese hamster ovary (CHO) cell line. Medium prototypes were evaluated in small scale using the single-use ReadyToProcess WAVE™ 25 bioreactor system. Medium optimization resulted in a final process with a cell-specific perfusion rate (CSPR) of less than 50 pL/cell/d. Process performance was verified at laboratory scale using single-use stirred-tank bioreactor systems. Productivity and product quality of the developed perfusion process were compared with a standard fed-batch process. MAb capture on MabSelect SuRe™ LX protein A chromatography medium (resin) was performed in a three-column PCC (3C PCC) setup. The capture step was followed by two polishing steps using Capto™ S ImpAct ion exchange and Capto adhere multimodal ion exchange media in serially connected columns in a STP setup. MAb purity and yield of the developed continuous processes were compared with traditional setups performed in batch runs. In this case study, we demonstrate the feasibility of integrated upstream and downstream MAb processing performed in a continuous manner. The developed process shows a performance equivalent to traditional processing performed in batch runs

Rättvis bedömning? Några gymnasieelevers uppfattningar om bedömning och betygsättning

Syftet med studien var att få inblick i hur arbetet med rättvis bedömning och betygsättning kan gestaltas i gymnasieskolan ur ett elevperspektiv. Fem elever från fyra gymnasieskolors studieförberedande program intervjuades. Resultatet visade för det första att tre olika bedömningsformer kan urskiljas: 1) Summativ bedömning; 2) Summativ bedömning med formativa inslag; 3) Formativ bedömning. För det andra sker för de flesta av eleverna ingen större involvering i bedömningsprocessen: eleverna blir bedömda. För det tredje anser de flesta av eleverna att den återkoppling de får av läraren är bristfällig och otillräcklig. De efterfrågar feedback av mer utförlig och konkret karaktär. För det fjärde efterfrågar eleverna en mer rättvis bedömning i linje med formativ bedömning. I den avslutande diskussionen relateras resultatet i relation till konsekvenser för lärandet samt kvalitativ/rättvis bedömning