Manufacturing, Tech-Transfer & Scale-Up

Ensure repeatable production and successful scale-up by standardizing transfer artifacts, control strategies and validation approaches for both sterile and non-sterile lines. We manage readiness assessments, pilot batches and validation activities to minimize first-run failures.

 

Key offerings

• Tech-transfer pack development and readiness assessments
   

• Process control strategy and critical-parameter definition
   

• IQ/OQ/PQ and method validation support for sterile and non-sterile lines
   

• Pilot batch troubleshooting and production stabilization
   

Typical deliverables

• Tech-transfer pack (process maps, SOPs, acceptance criteria)
   

• Validation protocols and master validation plan (MVP)
   

• Pilot batch reports with root-cause & corrective actions
   

• Production SOPs and operator training materials
   

Client impact / outcomes

• Higher first-pass batch success and shorter ramp-to-volume timelines

• Reduced variation and clearer control strategy for regulators and CMOs