Technology Transfer Services
In Wheeler’s commitment to bridge the translational gap between discovery and early clinical CMC manufacturing, we take the transfer from the development labs to manufacturing very seriously. The technology transfer process is a critical step to ensure manufacturing success, whether it is Wheeler performing phase 1 CGMP drug substance manufacture, or whether we are supporting your process transfer to your manufacturing partner of choice. Wheeler’s team of industry experts are highly experienced in every step involved in tech transfers and offer a unique transfer package designed with all relevant stakeholders in mind.
Learn more about Wheeler Bio’s custom development services.
Tech Transfer Execution Leveraging Risk Assessment Reporting
The tech transfer team at Wheeler Bio includes experts from development, analytical, manufacturing sciences, and operations; all working together to ensure no details are missed on the path to manufacturing. As process development culminates, this cross-functional team uses a risk-based perspective to ensure a seamless transition to manufacturing, whether that is in the Wheeler clinical manufacturing suites, or whether that is at your manufacturing partner of choice.
The transfer package we create for our clients includes a detailed risk assessment that identifies and mitigates risks to the process execution in manufacturing. This approach is unique for phase 1 manufacture and it has paid dividends at Wheeler with our first manufacturing runs being very successful.
The tech transfer process also evaluates and provides the following elements that lead to successful manufacturing execution, testing, and release:
- Product specific requirements
- Process descriptions, process flow diagrams, and sampling plans
- Bulk DS container closure configuration
- Executed lab-scale run records
- Analytical methods and lab-scale run results
- Safety, facilities, and utilities requirements
- MCB, upstream, and downstream BOMs
You can rely on our technical teams to deliver industry leading tech transfer plans and packages to greatly increase your manufacturing success and ultimately deliver product to the clinic faster.