Expert technology transfer ensures a seamless transition from your program’s concept into clinical and commercial manufacturing.
The Right Steps at the Right Time
Collaborating with us ensures that your project moves smoothly through each development phase leading to GMP manufacturing, and we strive to instill assurance at each step by adopting a forward-thinking strategy to transfer your molecule and process technology into our facility. We leverage our proficiency, flexibility, and extensive capacities to seamlessly propel your product through all developmental and manufacturing phases.
Your Trusted Partner for a Seamless Tech Transfer
Our partnership begins by laying a solid groundwork. We collaborate closely with you to understand the intricacies of your project, objectives, and desired outcomes. Together, we formulate a comprehensive strategy that will drive your project through tech transfer.
Identifying potential gaps is vital. We conduct a meticulous technical assessment to identify any disparities between your project’s status and its future goals, ensuring no crucial detail is overlooked and that we’re ready to bridge any gaps that may arise during the tech transfer process.
Tanvex’s proficiency shines as we transfer your molecule and process into our facility. Our streamlined equipment between Process Development and GMP manufacturing enables us to perform small-scale process transfer to establish accurate upstream and downstream models that act as blueprints for scale up to GMP manufacture. Ensuring first time GMP run success.
With a blend of expertise, attention to detail and innovation, we turn plans into reality. Our Quality, Manufacturing Science and Operations teams work tirelessly to ensure that every intricate process and equipment detail aligns with the envisioned outcome and are captured in our batch record.
Engineering & GMP with Production
We’re not satisfied with just meeting standards; we exceed them. During the engineering run, our manufacturing team fine tunes any critical process parameters that could potentially impact product quality to ensure GMP manufacturing run success.
GMP Engineering & GMP with Production
Our collaboration comes to fruition as we embark on GMP runs. Your product will be manufactured under the highest quality standards and cGMP guidelines to ensure safety and efficacy for the patients.
Process Characterization for Phase III
As your project matures, we’re already looking towards the future. We will continuously gather critical process parameter data and engage in comprehensive process characterization as we propel your project into Phase III clinical trials with confidence.