SCALE UP AND TECH TRANSFER
Scaling a chemical process from lab to manufacturing plant is one of the most critical transitions in drug development. A robust tech transfer can mean the difference between a smooth commercial launch and costly delays or compliance failures. At Lupin Manufacturing Solutions (LMS), our Scale-up & Tech Transfer services ensure that processes developed in R&D translate seamlessly to GMP-compliant manufacturing — with reproducibility, safety, and regulatory readiness at the core.
OUR SCALE-UP & TECH TRANSFER SERVICES
Process Scale-up
- Transition from gram-scale to multi-kilogram and multi-ton manufacturing
- Comprehensive evaluation of heat transfer, mixing, mass transfer, and kinetics
- Use of reaction calorimetry, DSC, and PAT tools for safe, data-driven scaling
- Optimization of workup, crystallization, and isolation steps for plant reproducibility
Technology Transfer Packages
- Development of a technology transfer dossier with all critical process and control parameters
- Detailed documentation: SOPs, batch records, analytical methods, stability data
- Training and support for receiving site personnel
- Risk assessments and mitigation strategies for smooth handover
Pilot Plant & Kilo Lab Bridging
- Dedicated kilo-labs and pilot facilities to bridge development to commercial scale
- Early-stage engineering studies to validate scalability
- Trial runs to confirm reproducibility before full-scale launch
Cross-Site & Client-Site Transfers
- Experience transferring processes across Lupin’s global network and client facilities
- Protocol-driven transfers with clear acceptance criteria
- On-site technical support to ensure successful implementation
WHY LMS?
- Decades of proven success in scaling APIs from lab to commercial production
- Integration across value chain One partner from route scouting to commercial supply
- Regulatory trust Processes transferred under frameworks that meet global regulatory expectations
- Complex molecule expertise High-potency APIs, hormones, macrolides, and controlled substances successfully scaled
- Collaborative approach Transparent communication and client involvement at every milestone
FAQs
Can LMS handle cross-site transfers across different geographies?
How do you ensure reproducibility during scale-up?
Do you support validation at commercial scale?
Can you manage scale-up of HPAPIs or hormonal APIs?
How long does a typical scale-up and transfer take?
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