Smooth Technology Transfer
The material is good. Now for the scale up. (4)
Project Timeline: Five Months |
Case Studies
1, 2, 3, 4 |
Our client was a large biotech firm with a project moving into Phase I. A CMO had been selected to handle the API, but a problem arose -- a key intermediate could not be scaled-up. Cychem was able to work with a CRO with the know-how to develop an alternate route and also had the available capacity. The CRO worked closely with our client to modify the process. They then produced 2 X 1 kg batches of material using the modified process. The resulting material was produced in good yield and consistent quality. The client's needs for a quick turnaround were met because this was done in only 2 months time and they were able to attain the required kg quantities from the CRO.
In the meantime, the client's project team had a new demand to produce a much larger quantity of API, based on the clinical plan. This required 40 kg of the intermediate. In order for the CRO to provide this, they would have to make five batches, an expensive and time consuming process. The API manufacturer did not have this capacity. The alternative was to find a larger scale manufacturer (CMO) who had both the flexibility and capability to meet the project demands. We were able to do this, and quickly set up a meeting at the CRO in which Cychem and a team member from the CMO could witness the production of the intermediate. The team member from the CMO then went back to his lab, and confirmed that the procedure could be reproduced in their facility. Once this was done, they then were able to take the process quickly to their semi-works facility and produce the 40 kg. This process went smoothly and the client was very satisfied because we were able to get the responsive, necessary development capability from the CRO, plus the large scale batch capability provided by the CMO, with only a minimal delay for tech transfer.
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