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Process Development |
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While there is a common belief that that cost pressures might dictate more generic processes that can be applied quickly as a viable route forward, we believe that the same pressure excites us to experiment on innovative approaches and alternative technologies, which can actually contribute to more productive and cost-effective manufacturing process. There are 2 aspects to process development:
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Process related aspects that include scalability, robustness and the 2 Cs- Consistency and Cleaning validation
Product related parameters like Purity and Yield |
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Both of these impact the economics of manufacturing a product without compromising on the quality requirements. |
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Scalability:
We understand that increasing cost pressures mean that scale-up doggedly remains a major stumbling block in bioprocess manufacturing. Because of the high risks of clinical failure, large-scale process trials are often done late when there is little time left for iteration. Therefore we pay keen attention to designing an easily and fully scalable process, especially when choosing technologies to be used in an unit operations. Scaled down model is not only important for process development but also for fine tuning and optimization of changes incorporated during establishing large scale manufacturing. Scalability properties are evaluated in great details even before preliminary feasibility stud ies are done. While downstream processes still pose to be the cost limiting factors, selection of an economically competitive process starts with a robust and stable high expression system.
While Inbiopro is investing in this platform, it is currently open to adopting any available high expression platform especially for the mammalian systems.
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Robustness:
Robustness of a scaled-down process is critical for acceptance of characterization and validation tests data to be adopted for large scale manufacturing. Designing worst case scenarios during contaminant clearance and spiking studies is an imperative feature inour process development activities.
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Consistency:
Consistency of process conditions are directly related to consistency of product quality. Therefore, it is important to generate extensive Failure Mode and Effect Analysis during process development. At Inbiopro FMEA is part of process development that selects critical parameters and examines the edge for failure. In our partnership model, FMEA is also an integral part of Process Transfer. Process transfers invariably involve changes- in equipments, raw material sources, water quality, personnel and even environmental conditions. Here our goal is to identify any changes between our in-house process and established process at final manufacturing site, however minimal trivial.This dictates educated additional characterization studies at a scaled-down model in the new site. |
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Cleaning Validation:
Cost of cleaning and its validation vs. Effectiveness of using disposable platforms and devices is the current predicament facing large scale biological manufacturers. Therefore, it is important for us to pay attention to the same choices in scaled-down models. We are constantly evaluating new developments in the disposable devices- from fermentors and filters to pre-packed chromatography columns at scaled down models for its feasibility and success at large scale. |
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Purity and Yield:
In therapeutic biologicals, there is no room for inconsistency in purity of the product. The challenge is in balancing the 2 key parameters in every step of a process. Even today every bioprocessing forum invariably culminates in the conclusion that that there will always be a reasonable compromise between cost, time, and yield, and achieving the maximum yield is currently impossible with the constraints we have in bioprocess technologies. Further, innovation in these technologies, directly dependent on the devices used, are usually in the hands of device manufacturers and not product and process development labs. This makes it important for us to work closely with key device manufacturers in optimizing any given process. Be it selection of fermentation media or charged depth filters or material of construction of chromatography base matrix, we extend our support and are involved in every step of scouting, assessment and its application in the process. |
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Our ultimate objective of any product development is to achieve maximum yield with required purity at lowest possible cost. |
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