Technology Transfer,
MSAT & PPQ
Advancing robust, scalable processes through scientific depth and operational precision
Switch with confidence
Avoid extending underperforming CDMO contracts
Seamless transfers and MSAT expertise
Save transfer times and reduce risks
PPQ – Right First Time
Make PPQ predictable, not painful
“We design for transfer readiness and de-risk scale-up to deliver smooth, inspection-ready PPQ – without surprises.”
When transfers stall progress
- Processes slowed by unclear documentation
- Gaps in tech transfer plans creating costly delays
- Poor alignment between CDMO partners and teams
- High risk of deviations and failed PPQ
Fast, successful transfers
- Clear gap assessments and structured playbooks
- Direct collaboration on process intent and regulatory needs
- Smooth onboarding, even with incomplete data
- Faster path to GMP and PPQ compliance
Expertise that drives reliable scale-up
Integrated tech transfer, MSAT, and PPQ solutions that reduce risk, accelerate timelines, and ensure seamless GMP readiness
Seamless tech transfer
Structured playbooks and gap assessments enable smooth onboarding, even with incomplete data. This speeds GMP readiness, prevents rework, and provides clear ownership and predictable milestones.
Integrated MSAT
Our MSAT team aligns development, analytics, QA, and operations to protect process integrity. Early issue detection and harmonized methods reduce deviations, repeat batches, and material waste.
Predictable PPQ
Stepwise, regulator-aligned strategies make PPQ smooth and inspection-ready, avoiding costly deviations and delays while ensuring confident, audit-ready submissions
Mirrored capabilities across sites
Clinical and commercial mirrored sites provide consistent execution across phases, accelerating timelines, preventing rework, and ensuring quality for commercial readiness
Tech transfer, MSAT
& PPQ services
Protecting process integrity and accelerating GMP readiness
Tech Transfer, MSAT & PPQ Services
Services that de-risk
scale-up
- Internal and external tech transfers
- Process mapping and optimization
- Analytical method review and bridging
- On-scale engineering runs
- Regulatory support and documentation
- PPQ preparation and execution
- Full QA and RA integration
PPQ Services
Predictable, regulator-aligned validation
- CQA mapping
- DoE-driven optimization
- End-to-end process characterization
- Robust PPQ strategy, protocols, and execution
- Integrated QA and RA support
- Traceable documentation
Where dedication delivers capabilities
End-to-end drug substance and drug product solutions deliver “ready to fill” products faster, at lower cost, with greater efficiency
Process development & characterization
Scalable upstream and downstream processes built for robustness
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Analytical capabilities
Phase-appropriate, method-qualified testing for product quality and release
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GMP manufacturing
Flexible capacity and inspection-ready operations for biologics production
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Quality
Systems aligned with regulatory requirements, confirmed by successful inspections and focused on lifecycle aspects
Read morePartner with us
We combines the scale of an established CDMO with the agility of a focused partner, backed by proven end-to-end biologics expertise
Transparent. Clear. Reliable.
Where innovation
meets execution
- Whether you’re advancing a novel biologic or planning for commercial scale, Rezon Bio is ready to help you move forward with confidence
- Connect with our team to explore how our expertise, integrated solutions, and dedication can accelerate your success