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03 — Technology Transfer

Knowledge that survives the move to scale.

Most of what a development laboratory knows is not written in the batch record. Technology transfer is the work of making that knowledge explicit: which parameters are critical, how wide their ranges are, what fails first and what to do about it. We plan the scale-up, monitor execution on the floor and hand over a process the receiving site can repeat.

OutcomePartners receive exhibit batches, defined process parameters and a transfer package their site can operate from.

Critical process parameters identified and ranged
CPP
Critical process parameters identified and ranged
Ways to engage, from transfer to supply
5
Ways to engage, from transfer to supply
Transfers between sites and contract manufacturers
CMO
Transfers between sites and contract manufacturers
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01

The transfer path

  1. 01Development labA formulation and process defined and documented at laboratory scale.
  2. 02Scale-upScale-up planned with the receiving site and its execution monitored.
  3. 03Process optimisationCritical process parameters identified and the design space established.
  4. 04Exhibit batchesExhibit batches manufactured, with troubleshooting on the floor as they run.
  5. 05ValidationSupport for commercial-scale process validation at the receiving site.
  6. 06Commercial executionA process ready for routine manufacture and launch.

02

Site-to-site transfer

For products that already exist, we review the transfer documentation, assess critical process parameters and risk, and move the product between sites or contract manufacturing organisations without relearning the process from scratch.

03

Track record

KMS has established commercial-scale validation for complex products and supported their successful launch.

04

Ways to engage

Transfer can be the whole engagement, or one stage of a longer programme.

  • Dossier development
  • Dossier compilation
  • Co-development with profit sharing
  • Technology transfer
  • Commercial supply
Next capability04 Regulatory Affairs

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Where does your programme stand?

Tell us the molecule, the dosage form and the market you are filing in. A programme lead will read it and reply with what we would do next.

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Business enquiries: vasanthi@kmshc.com · +91 97898 75194V-23

KMS PharmaChennai