Technology Transfer

Technology transfer of a drug substance is a multifaceted activity with inherent technical, regulatory, and quality risks that must be addressed to ensure a successful outcome. At Aragen, we specialize in technology transfer services that ensure smooth and efficient transitions of drug substance development across all phases—from early discovery to commercial-scale production. Our team combines deep expertise, advanced infrastructure, and a commitment to quality to facilitate the seamless transfer of processes, technologies, and knowledge throughout your project’s lifecycle.

We offer a proven and adaptable approach to technology transfer, whether for scale-up or transitioning to a different facility. Our experts meticulously assess the inherent complexity of your project, ensuring that our transfer scope and strategy are perfectly aligned with your specific needs. From small-scale development to large-scale commercial manufacturing, our goal is to ensure the efficiency and success of the transfer process at every phase.

Structured to support manufacturing operations in an FFS-based partnership model, we have access to a large-scale commercial cGMP production plant, a cGMP pilot plant, and cGMP kilo laboratories. This infrastructure ensures that we can deliver processes that meet both GMP and non-GMP requirements on time and with the appropriate quality, while minimizing risks and optimizing process scalability.

With a focus on reducing delays, maintaining product integrity, and meeting global regulatory standards, we guide your development through each critical transition, ensuring that your path to market is as smooth, efficient, and compliant as possible.

Our Approach to Technology Transfer

We employ a systematic, risk-based approach to technology transfer that ensures quality, compliance, and efficiency at every stage of the process. Our comprehensive approach includes:

• Initial Assessment & Feasibility Study: We begin with a detailed assessment of the current process, identify CPP’s and CQA’s during development, and create a customized technology transfer plan.
• Documentation & Knowledge Transfer: Ensuring thorough knowledge transfer is key. We work closely with your team to provide process documentation, standard operating procedures (SOPs), and other critical protocols.
• Process Validation & Scale-Up: Our team supports you through the critical steps of process validation, ensuring that scaling up is both technically sound and compliant with regulatory requirements.
• Regulatory Strategy & Compliance: We navigate complex global regulatory frameworks to ensure alignment with FDA, EMA, ICH, and other international standards.
• Ongoing Support & Monitoring: Technology transfer doesn’t end with the handover. We provide continuous support to monitor process performance, troubleshoot issues, and implement improvements.

Our Expertise

Our team consists of highly skilled scientists, engineers, and regulatory experts, all with decades of combined experience in drug substance development and technology transfer. We bring a deep understanding of process engineering, regulatory compliance, and industry best practices, ensuring that your technology transfer is both efficient and successful.

• Experienced Scientists & Engineers: Experts in chemistry, biology, process engineering, and quality assurance.
• Regulatory Affairs Experts: Knowledgeable in global regulatory requirements, ensuring smooth approvals at every stage.
• Project Managers: Dedicated to keeping your technology transfer on track, ensuring timelines and budgets are met.

Our Services

Early Phase

The early phase is critical for establishing the foundation of your drug substance development. We support technology transfer from the lab to pilot scale, ensuring a smooth transition for process development and optimization.

• Process Development & Optimization: We employ advanced techniques, including unit operations like distillation, filtration, and flow chemistry, to develop scalable, reproducible processes. Additionally, we utilize sophisticated tools such as Dynochem, Design Expert, and Visimix to model and optimize processes, ensuring efficiency and quality from the outset. These tools help us predict process behavior, identify optimization points, and fine-tune critical parameters to guarantee robustness and scalability in later phases.
• Non-GMP and GMP Options: We offer both non-GMP and GMP options for early-phase material production, ensuring flexibility based on your project’s needs.
• Preclinical and Clinical Supply Support: We help you transition from small-scale lab production to GMP (Good Manufacturing Practice) clinical material production for early-phase clinical trials.
• Technology Feasibility and Scale-Up: From laboratory experiments to pilot-scale batches, we ensure seamless scaling with minimal risk, supported by rigorous process optimization and scale-up strategies.
• Integrated CMC Services: Our early-phase services also include integration with biological/toxicological studies, formulation, and analytical development, ensuring all aspects of the process are aligned for successful scale-up.

As your product progresses to late-phase clinical trials, the focus shifts to scalability, process robustness, and compliance. Our late-phase technology transfer services ensure that your processes are optimized and ready for large-scale production.

• Process Optimization & Validation: Understanding appropriate process parameter sensitivities, set points, ranges, and in process controls is critical. We fine-tune and validate processes to ensure they meet the stringent requirements for Phase II and Phase III trials.
• Clinical Trial Materials (CTMs): We support the production of CTMs, ensuring on-time delivery and compliance with all regulatory requirements. To ensure that scale-up remains efficient, compliant, and consistent throughout the development, we continuously monitor real-time process conditions by utilizing advanced Process Analytical Technology (PAT) tools like Raman IR (Infrared Spectroscopy) and PVM (Process Visualisation Microscopy).
• Process Safety & Hazard Analysis: We incorporate advanced process safety technologies, such as DSC, Rc1e, and powder safety analysis, to identify and mitigate risks during scale-up.

As your product moves into the late-phase clinical trial stages, the emphasis transitions to ensuring that your manufacturing processes are both scalable and fully compliant with regulatory standards. Our technology transfer services provide the expertise needed to fine-tune and validate processes, ensuring seamless production scale-up while maintaining product quality and regulatory compliance.

As your product moves into commercialization, our focus is on ensuring large-scale production meets the required quality standards while maintaining cost-effectiveness and regulatory compliance.

• Tech Transfer to Commercial Manufacturing: We facilitate the transfer of processes from R&D or clinical manufacturing to full-scale commercial production.
• Process Robustness & Control: We ensure that manufacturing processes are optimized for large-scale, GMP-compliant production, while maintaining rigorous quality control.
• End-to-End Support: From pilot scale to commercial-scale manufacturing, we offer complete end-to-end support, ensuring your drug substance is delivered to market on time and within budget.
• Global Supply Chain Management: We support the establishment of robust, scalable supply chains for global distribution, ensuring traceability and transparency at every stage.

Our extensive infrastructure, including cGMP pilot plants and kilo laboratories, ensures that processes can be smoothly transferred to large-scale manufacturing. We use software tools like Cheetah and Visimix to simulate and optimize large-scale processes, ensuring they meet quality and safety standards.

Why Choose Us?

At Aragen, we aim to streamline the transfer process, ensuring your drug substance development progresses smoothly while meeting global regulatory standards, maintaining product quality, and reducing risks.

Our services provide you with:

• A Tailored Approach: Each phase of drug development requires different expertise. We customize our technology transfer strategy to meet the unique needs of early, late, and commercial-phase transitions.
• Expertise Across Phases: From process development to optimization, scale-up, and commercial manufacturing, we bring decades of experience to every project.
• Regulatory Compliance: Our team ensures that every aspect of the transfer process complies with global regulatory standards, including FDA, EMA, ICH, and others, ensuring smooth audits and approvals.
• Scalable Solutions: Whether you’re working on small-scale trials or large-scale commercial manufacturing, our solutions are flexible and scalable to suit the needs of each phase.