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KMS Pharma

03 — Technology Transfer Company

Pharmaceutical Technology Transfer Company.

KMS Pharma is a Pharmaceutical Technology Transfer Company helping development teams move products and processes from laboratory to commercial manufacturing with greater confidence. Our technology transfer services cover process scale-up, critical process parameter identification, process monitoring, exhibit batches and transfer documentation, with a focus on making the process repeatable at the receiving site. We work with pharmaceutical companies and CMOs to transfer practical process knowledge, define operating ranges and address potential scale-up challenges, supporting a smooth transition from development to manufacturing.

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 Company

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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 · ganesan@kmshc.com · +91 97898 75194V-23

KMS PharmaChennai