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A biopharmaceutical client engaged BPE to assess the feasibility of refurbishing an existing underutilised pilot facility to accommodate a small scale GMP bio-manufacturing process. The study was required as a key component in an ongoing site capacity expansion project.
Key challenges related to a significant number of product streams at varying batch sizes and significant constraints on available space to house the new facilities. A number of technology options needed consideration to optimise the layout and design of the proposed facilities.
The feasibility study was executed through a series of interactive presentations/workshops to the client project team and client stakeholders.
The project problem statement was agreed, value drivers listed and options identified. Through subsequent presentation/workshops the options were rationalised and the scope defined against the project value drivers.
BPE and the client worked on a integrated basis to fully optimise material/personnel flows, technology selection/sizing and layout for the new facility. GMP classifications and regulatory requirements were rigorously applied. The study approach achieved complete client ‘buy-in’ and consensus for the next phase of the project, also being executed by BPE.