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Technology Transfer

Specialized Expertise In Technology Transfer

Our facility holds current GMP manufacturing licenses and is authorized to supply cell and gene therapies to multiple PIC/S-compliant jurisdictions. We maintain alignment with evolving global regulatory expectations to ensure consistent compliance and patient safety.

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Specialized Expertise In Technology Transfer
Why Cell Therapies' Technology Transfer Works

Why Cell Therapies' Technology Transfer Works

Digital Twins & Augmented Reality Walk‑Throughs cut sponsor travel 80%
Core Technology Transfer Team: Process Development, Quality Assurance, Quality Control, Supply‑Chain, and Digitalization
Regulatory Harmonization: Common Technical Document (CTD) Module 3 author support, bridging regulators
Change‑Control Discipline lock Critical Quality Attributes (CQA) & maintain global comparability
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Six Gates to Go-Live

Our facility holds current GMP manufacturing licenses and is authorized to supply cell and gene therapies to multiple PIC/S-compliant jurisdictions. We maintain alignment with evolving global regulatory expectations to ensure consistent compliance and patient safety.

1

Feasibility

CQA gap map • Regulatory landscape • Draft TT plan
2

Knowledge Capture

Full process dossier • Bill of materials • Digital workflow mapping
3

Facility Fit & Risk Analysis

URS alignment • Failure Mode study • Equipment qualification path
4

Engineering & MFG Runs

Demo batch • Sampling plan • In‑line analytics tuning
5

Validation

PPQ / MPQ • Analytical verification • Stability protocol
6

Launch & Lifecycle

Batch 001 release • Continuous improvement dashboard
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