
Introducing new technologies and methodologies into process development and manufacturing facilities should lead to improvements and efficiency gains in those facilities. The goals may vary for companies who could be at different stages of development, or who have diverse requirements for a range of therapeutic products in their pipeline.
However some goals will be similar to all companies independent of their size, product range or financial situation. Goals such as increasing protein expression, reducing cost of goods, and improving flexibility are all of interest. The ATF™ System offers many opportunities for achieving these goals, whether through extremely high cell density cultures and protein yields, or through rapid low shear cell harvesting and subsequent downstream simplification. But it is the combination of several improvements, some dramatic and some simple, that lead to a new paradigm in biologics manufacturing: a “factory of the future”. This factory can be seen as a small, multiproduct, flexible but highly productive and intensified biomanufacturing facility – and the costs simultaneously reduced. It could be for multi-tonne antibody production, removing the need for large (or even medium) sized steel tanks, or for diverse vaccine manufacture able to have production ramped up quickly in response to local demand.
In assessing the impact of a product such as Refine’s ATF System, the direct improvement in one unit operation, such as achieving a ten fold improvement in bioreactor yield, needs to be understood within the larger manufacturing environment to ensure the specific gain translates to a real achievable outcome at large commercial scale. An upstream success may cause a downstream bottleneck for example, and so Refine has extended the applications of the ATF System to enable capture the full benefits of process intensification.
Recognizing that there are different solutions to the same problem, and allowing flexibility in implementation can be important. Large scale perfusion is becoming mainstream, either for seed expansion and the n-1 step to allow higher inoculation densities or for the main production reactor itself. Concentrated Perfusion methods now allow 1g/L/day of protein to be routinely produced, meaning a single use 1000L bioreactor can produce 1kg per day – significantly more than many people expect. However, the continuous harvest produced is not always favored unless companies understand how to best utilize this higher productivity. Where a single concentrated harvest is preferred, a UF step allows a high cell concentration of over 100m cells/ml to produce a concentrated harvest of 20g/L and higher, depending on the cell specific productivity of the cell line.
Roll over each goal to show details.
| Goal | Process Development | Manufacturing | ||
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Reduce timelines in development
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Simplify and reduce development experimental space
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Increase number of manufacturing slots, with help from single use equipment
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Increase process efficiency (volumetric productivity, yield etc)
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Apply new process knowledge across product platforms to leverage maximum gain
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Reduce laboratory and factory floorspace for a given product output
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Achieve higher flexibility within a facility with minimal capital expenditure
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Feb
27
February 27 - February 29, 2012
4th Annual Disposable Solutions for Biomanufacturing
Brussels
Apr
02
April 02 - April 04, 2012
ISBioTech 2nd Annual Meeting
Virginia
Apr
11
April 11 - April 13, 2012
World Vaccine Congress 2012
Washington
Apr
18
April 18 - April 19, 2012
BioProcess International Europe 2012
Prague