Technology Transfer

Technology transfer entails transferring product and process knowledge between development and manufacturing from small-scale clinical trials to large-scale commercial production.
Jubilant Biosys offers reliable and efficient approach to transfer technology and our clients can leverage our proficiency, agility, and extensive capacities to seamlessly propel a product through all developmental and manufacturing phases. Our dedicated Tech Transfer team with strong technical expertise helps facilitate speed to market as we collaborate with our partners to ensure successful process transfers, anticipating equipment capabilities and ensuring Quality by Design principles.

Evaluation
- Review of technology for transfer
- Project scope defined
- Approval of scope of work
Establishing Technology Transfer Team
- Project kick off meeting
- Project plan/schedule
- Communication structure
- Timeline for document review
- Change control
- Quality agreement
Knowledge/Document Transfer
- Gap analysis
- Technical document review meeting
- Analytical method transfer
- Process demo batch
- Deviation analysis
- Quality agreement
- Stability studies
Process Transfer
- EHS assessment
- Logistics
- Operations
- Process hazard analysis
- Pre-startup safety review Training
- Process simulation batches
- Validation protocols
- Master batch records
Manufacturing Campaign
- Initial manufacturing campaign
- Process validation summary report
- Continuous improvement recommendations
Continuous Improvement
- Manufacturing data review
- Equipment / process optimization
- Process monitoring
- Deviation-root cause analysis
- Corrective/preventive actions

CDMO Tech Transfer Project Team

Jubilant Biosys has a group of experienced and qualified Project Managers to support & manage CDMO project from kick-off to close-out.

Experienced Project Manager as single point of contact for entire project life-cycle: team communication, schedule, scope, action, risk and issue escalation management.
Process & tech transfer chemists work on seamless hand-over from R&D familiarization & process optimization (what if studies) to plant scale-up.
Dynochem simulation for plant equipment mapping and unit operation scalability.
Analytical chemist for method development, validation & transfer to plant QC team.
EHS for OEB and PDE classification and HAZOP evaluation.
Plant engineer for equipment train set up & readiness.
QA/QC to ensure GMP documentation, analysis and release.
Supply Chain to ensure supply strategy and robustness.
Regulatory to support customer filing.