Following development at the laboratory scale, the cell culture and fermentation processes are scaled up and the operation conditions and target ranges are tested at the pilot scale. Process modifications are made as necessary to facilitate operation at the manufacturing scale before transfer to the cGMP facility.
Having chosen a purification strategy from the laboratory scale evaluation, the process is scaled up and run in the pilot plant. This allows Lonza to assess the process for its ability to meet the target specification for purity and product characteristics and to make modifications as necessary before transferring the process to manufacturing. The product made at this stage is often used for pre-clinical studies.
Scale-up scientists work closely with the development, manufacturing and quality specialists to document all product specific processes and transfer them to the manufacturing facility. This intimate interaction between teams continues throughout the project to ensure that during the early full-scale manufacturing batches, the process operates in a reliable and predictable manner. Template documentation systems permit rapid transfer of new processes into the cGMP system.
The scale-up group is also responsible for pilot studies on the process as part of the development program examining key parameters to ensure successful operation in the cGMP environment. In addition, small quantities of product are often produced for use in our customer’s toxicological program.
Located within the development facility, the pilot suite has airlift and stirred manufacturing scales (130 to 400 liters), as well as single-use bioreactors, with associated primary recovery and purification systems. |
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