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Technology Transfer Designed for Cell & Gene Therapy Developers

Purpose-Built for Global Continuity and Regulatory Confidence

Minaris Advanced Therapies supports technology transfer as a structured, multidisciplinary process rooted in reproducibility, regulatory transparency and site interoperability. With GMP-certified infrastructure across North America, Europe and Asia, our global tech transfer model enables programs to move between geographies or from external CDMOs with minimal process disruption and ensures process consistency, comparability and a consistently controlled product profile.

Minaris Advanced Therapies applies a unified global methodology for process definition, batch documentation and analytical equivalency, ensuring your product’s Critical Quality Attributes (CQAs) remain preserved across sites, scales and regional regulatory requirements.

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Phase-Appropriate Tech Transfer Models for Cell & Gene Therapy Developers

Minaris Advanced Therapies supports both horizontal (site-to-site) and vertical (development-to-manufacturing) technology transfers. Our models are customized based on program maturity, available documentation and risk tolerance. Each package is reviewed by a cross-functional steering team and governed by a formal tech transfer plan, ensuring complete visibility and traceability throughout the lifecycle.

Typical tech transfer packages include:

Comprehensive process characterization and risk analysis

Detailed gap assessments between source and receiving sites

Equipment and consumable comparability evaluation

Analytical method bridging studies with validation or verification steps

Process optimization, feasibility, verification and engineering runs design and execution

Training and qualification of process and analytical associates

Specialized Capabilities
for Complex Modalities

Tech transfer for advanced therapy products, including autologous and allogeneic cell therapies, presents unique challenges that we are well-equipped to handle. For processes involving gene editing, cell expansion in closed bioreactors, or high-volume drug product fill, we provide technology-specific transfer support, including downstream platform harmonization.

Minaris Advanced Therapies addresses these through:

  • Facility design that accommodates patient-specific workflows and chain-of-identity safeguards
  • Logistics-aware process mapping to minimize vein-to-vein variability
  • Dedicated tech transfer scientists embedded in both MS&T and manufacturing groups to maintain cross-functional knowledge continuity
  • Regulatory-grade documentation and data integrity systems to satisfy EMA, FDA and PMDA expectations
  • Robust closed-system workflow for autologous and allogeneic processes
  • Comprehensive gene editing workflows from GMP CRISPR-Cas material handling and RNP workflows
to scalable electroporation processes and additional
gene editing process support
  • Single-use flexible bioreactor platforms:
Stirred-tank, Xuri, G-Rex, etc
  • Semi-automatic product filling systems for large numbers of cryo-vials or bags

An Integrated Tech Transfer Framework Across Facilities and Functions

Our platform-based approach aligns manufacturing technologies, facility layouts and quality systems to eliminate site-specific friction during tech transfer. Across our network, Minaris Advanced Therapies uses harmonized state-of-the-art equipment sets and more closed and automated system technologies. SOPs and electronic master batch records are mapped to specific unit operations. Assay platforms and acceptance criteria for release and in-process controls are also standardized.

This enables your process to be reproduced with high fidelity, whether the source material originates in early development or a validated commercial program. We also maintain local regulatory expertise to anticipate region-specific requirements and accelerate global submissions.

Enabling Commercial Readiness Through Transfer-In Programs

Minaris Advanced Therapies routinely accepts established processes from client to site, site to site and PD to GMP for clinical scale-up, late-phase development or commercial manufacturing. Our team is adept at reverse engineering partial or non-standard documentation and applying QbD principles to identify critical process parameters (CPPs) and their impact on final product quality. This flexibility allows sponsors to scale operations, access new markets, or mitigate supply risk through secondary site activation without requalifying the product.
Key offerings include:

  • Analytical transfer and cross-site assay equivalency validation
  • Compilation of CMC modules for BLA, MAA or NDA submissions
  • Cross-validation of raw materials and supply chain mapping
  • Integration of sponsor-specific digital systems (MES, LIMS, eBR) where required

Data-Driven Tech Transfer Monitoring and Lifecycle Control

All Minaris Advanced Therapies tech transfers are supported by digital readiness assessments and governed by structured risk registers. Key performance indicators, including batch success rate, deviation rate and analytical concordance, are tracked throughout engineering runs and commercial launch. Our lifecycle approach enables continuous improvement and cost-of-goods optimization after transfer, without requiring validation resets.

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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