Efficient Technology Transfer and Scale-Up for Commercial Readiness
With our integrated approach, we make technology transfer processes smooth, efficient, and hassle-free.
By combining our development and technology services in one unified team, we ensure seamless transitions with a process-driven approach. Our experts follow ICH Q10 procedures for 1:1 transfers while actively seeking opportunities to optimize process efficiency, enhance consistency, and adapt to evolving regulatory standards.
Comprehensive Technology Transfer Solutions
We follow a robust tech transfer framework to mitigate risks and optimize for a smooth transitional process. Our solution is tailored on a case-by-case basis, based on the key aspects:
Process and Method Transfer – for consistency between R&D and manufacturing
Regulatory Documentation Support – assistance with associated technology transfer documents
Scale-Up and Optimization – for process efficiency for large-scale production
Regulatory Compliance – adherence to ICH technology transfer requirements
The Tech Transfer Process
The process begins with an assessment & scoping phase, where we evaluate technical and regulatory requirements to identify potential challenges and develop a comprehensive transfer strategy. We analyse potential gaps and failure modes, conduct a risk assessment, and identify and cover long lead time items.
This is followed up with a planning phase to build a preliminary schedule including critical milestones and resource requirements. We refine transfer protocols, assess the robustness of scaling processes and develop risk management plans. Knowledge transfer is a focus point to ensure that critical process and analytical knowledge is effectively communicated between teams, maintaining consistency and quality.
Once complete, we proceed with process validation in the execution phase. Manufacturing processes are tested and optimized to ensure reproducibility at scale while meeting regulatory standards, before finalizing regulatory filing & approval. All necessary technology transfer documents are prepared and submitted in compliance with global regulatory requirements.
Why Choose Aenova for Your Tech Transfer?
Accelerated successful technology transfers are one of our core strengths at Aenova. With deep expertise in the pharmaceutical industry, we guarantee a seamless transfer process by guiding you through every stage - from assessment and planning, to process validation and regulatory approval.
Backed by a global network of manufacturing sites, we offer flexible and scalable solutions tailored to meet your product’s unique needs, ensuring efficiency and consistency every step of the way.
We provide:
Digital infrastructure that fosters collaboration and transparency
Batch strategies that streamline engineering runs
Quality systems to ensure “right first time” delivery
By choosing to work with us, you gain access to industry-leading expertise, cutting-edge technology, and a commitment to quality. Whether you need support for complex formulations, biologics, or large-scale production, our proven methodology ensures a successful transfer, accelerating time to market while maintaining product integrity and regulatory compliance.
Additional Development & Technology Services
At Aenova, we provide a wide range of development and technology services for pharmaceutical companies.
Ready to partner with us for industry-leading technology transfer services that ensure seamless, efficient, and compliant transitions to commercial production?
Contact us today to speak with our team of experts for support and consultation.
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