Beginning the Journey with a Development by Design Mindset

The Road to Manufacturing Commercially Viable Cell Therapies

Beginning the Journey with a Development by Design Mindset

Implementing DbD at the earliest stage.

Development by Design (DbD) is a commercial manufacturing strategy that includes consideration of quality, scalability, sustainability and cost of goods. Proactively developing and implementing a DbD strategy does not force a cell therapy developer to make a large investment early on in the process, but it does provide insight on the road ahead, to the benefit of all stakeholders.

Working through the four facets of DbD at an early stage can provide significant cost and time advantages as a cell therapy developer moves further along the clinical development process.

What’s in Chapter 1: Beginning the Journey with a Development by Design Mindset?

  • Product attributes and manufacturing design drivers of patient-specific cell therapies
  • Implementing a Development by Design strategy
  • Phase-appropriate quality consideration and achieving a commercial-ready quality state

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Chapter 2: Strategic Planning for Success

Patient-specific cell therapies (PSCTs) have made significant strides towards the goal of commercially viable manufacturing in recent years, yet many challenges remain.

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