this overview is a detailed roadmap how to transition to CM for OSD Drug Product:
- Get a good understanding of what CM is: landscape, cost/benefits, equipment, process, regulatory impact
- Assess how CM could solve your issues and increase your success - match with the SWOT of your own company
- Work out a strategy with High level investment plan and timeline, Identify pilot products and high level benefits
- Test feasibility for pilot products, potentially at vendor, innovation center or CMO
- Prepare deck to get buy-in from Sponsors, prepare well and focus on business aspects - not the technology
- Learn as much as you can from other users, vendors, academic researchers: participate in consortia, read publications, attend conferences
- In case of green light: prepare detailed Capital appropriation request, find up front internal alignment for all assumptions
- In case of approved capital: build a line with the future in mind - as well for R&D and for the Supply chain
- Start development with separate unit operations, lab equipment - and best in collaboration with academic institutions
- Develop Control strategy in parallel with equipment and process: this is an iterative exercise
- Potentially do further development with surrogate material, on external or rented equipment
- Have early conversations with the health authorities as soon as there is clarity on Control strategy
- Once Equipment is ready, finalize and finetune process development, control strategy, PAT and RTD models
- Validate, make stability batches and file - if possible with some RTR
- Train and transform your organization to fit a different manufacturing approach
- Prepare life cycle management work and data management
- Launch first product, collect additional data for trending and potential future model improvements
- Potentially file post launch change for longer runtime and additional RTR
If you do not have resources in house with CM experience, consultants can help you with each of these steps.
Martin Nsanta @ on
How do emerging early-stage startups transition to Continuous manufacturing?
Lawrence De Belder @ on
Hello Martin,
this overview is a detailed roadmap how to transition to CM for OSD Drug Product:
- Get a good understanding of what CM is: landscape, cost/benefits, equipment, process, regulatory impact
- Assess how CM could solve your issues and increase your success - match with the SWOT of your own company
- Work out a strategy with High level investment plan and timeline, Identify pilot products and high level benefits
- Test feasibility for pilot products, potentially at vendor, innovation center or CMO
- Prepare deck to get buy-in from Sponsors, prepare well and focus on business aspects - not the technology
- Learn as much as you can from other users, vendors, academic researchers: participate in consortia, read publications, attend conferences
- In case of green light: prepare detailed Capital appropriation request, find up front internal alignment for all assumptions
- In case of approved capital: build a line with the future in mind - as well for R&D and for the Supply chain
- Start development with separate unit operations, lab equipment - and best in collaboration with academic institutions
- Develop Control strategy in parallel with equipment and process: this is an iterative exercise
- Potentially do further development with surrogate material, on external or rented equipment
- Have early conversations with the health authorities as soon as there is clarity on Control strategy
- Once Equipment is ready, finalize and finetune process development, control strategy, PAT and RTD models
- Validate, make stability batches and file - if possible with some RTR
- Train and transform your organization to fit a different manufacturing approach
- Prepare life cycle management work and data management
- Launch first product, collect additional data for trending and potential future model improvements
- Potentially file post launch change for longer runtime and additional RTR
If you do not have resources in house with CM experience, consultants can help you with each of these steps.
Kind regards
Lawrence