cGMP Manufacturing

cGMP Manufacturing Network – A Flexible Manufacturing Approach

DowpharmaSM has established a novel cGMP Manufacturing Network that offers you a flexible, cost-effective approach to cGMP therapeutic production. This network provides:

  • Global access to cGMP EU/US compliant manufacturing capacity
  • A well-defined technology transfer process
  • Flexibility
  • Rapid response to increased commercial demand
  • Mitigated schedule risk
  • Competitive pricing
process
Step 1: Rapid strain and process development using Dowpharma’s advanced technologies.

Step 2: You can evaluate participating contract manufacturing organizations (CMOs) in Dowpharma’s global manufacturing network for the cGMP clinical and/or commercial-scale manufacture of their product. All participating CMOs will be EU/US compliant; Dowpharma will conduct quality audits. The variety of manufacturers in the network will provide you with a high degree of flexibility.

Step 3: Dowpharma assists you in the preparation of a standardized Request for Proposal (RFP).

Step 4: You issue the completed RFP to the network CMOs.

Step 4: Based on RFP responses, you contract with the preferred CMO and inform us which CMO you have chosen.

Step 5: Dowpharma transfers the technology to the CMO using a Six Sigma-designed technology transfer process.

For more information about Dowpharma’s cGMP Manufacturing Network, contact us.

Please see our Checklist for Working With a CMO (145KB PDF) and Considerations for Preparing an RFP When Outsourcing a Biopharmaceutical (412KB PDF).

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