Topic #1: Breaking the Bottleneck…

Advances in upstream processing have increased protein yields per unit volume coming from bioreactors. Unfortunately, the capacity of bioprocessing operations designed years ago may struggle to accommodate the protein titers that can be produced today. Antibody expression levels now routinely exceed 1 g/L whereas levels of 100 mg/L were commonplace in the not so distant past. Successful efforts to maximize bioreactor titer levels have put significant pressure on downstream processes, shifting production bottlenecks from upstream to downstream unit operations.

Our experts describe how the latest advances in chromatography are helping to overcome production bottlenecks.

We’re all aware that higher and higher titers are coming from upstream processes – 1-5g/L is not uncommon and some processes can reach 10g/L.  Unfortunately, this increase in productivity isn’t counterbalanced by equivalent productivity improvements in chromatography processes.

Chromatography is a low throughput technique with limited flow rates.  If we have high volumes to process…

For more efficient, effective chromatographic purification of proteins, chromatographic materials providing higher selectivities towards individual target proteins are needed.  A lack of these materials results in the requirement for several chromatographic purification steps, increasing the costs associated with downstream processing. This problem is even worse if the purification of single protein species (protein isoforms) is necessary…

The current biomanufacturing process can be divided into templated processing and non-templated processing to address the question of bottlenecks.

For the templated processes such as mAb purification, bottlenecks are process scalability, process length and time, and flexible equipment utilization.  These bottlenecks are caused by increasing expression levels (titers) of target biopharmaceutical molecules…