Tech Transfer

Tech Transfer

Navigating the transition from laboratory-scale processes to full-scale manufacturing can be a daunting task. At APC, we offer comprehensive Scale-up & Tech Transfer services designed to streamline this critical phase of pharmaceutical development.

Our approach is underpinned by the pursuit of a fundamental understanding (from engineering first-principles) of the critical process parameters (CPP’s) associated with the production of each medicine. Typically, this is done using scale-down experiments heavily complemented by Process Analytical Technology (PAT) and other tools and techniques which enable us to perform a “deep dive” into each process and understand and predict with confidence how each process will perform at different scales and in different reactor environments and what changes and tweaks are required to optimize performance at scale.

Our team of experienced engineers brings a wealth of knowledge and expertise to the scale-up process. Being located in Ireland (one of the world’s hubs for GMP pharmaceutical manufacturing) we are able to leverage the expertise of a wealth of talent with experience in different GMP manufacturing environments. This is true for small molecule manufacture (with a deep understanding of complex chemistries, crystallizations, filtration/drying etc.), and biologics manufacture (across upstream and downstream unit operations).

We prioritize “process portability”, ensuring that your processes can be seamlessly transferred across different manufacturing facilities without compromising product quality or efficiency. Leveraging data-rich experimentation and advanced modeling techniques, we develop scalable, portable processes that can perform consistently across various equipment sets.

Our goal is to achieve right-first-time manufacturing introductions, ensuring that your processes deliver the required product attributes consistently over the long run. Through our approach we mitigate potential challenges and facilitate smooth tech transfers of your medicine based on a fundamental understanding of the underlying process to manufacture it.

Throughout the scale-up and tech transfer process, we prioritize transparent collaboration, working closely with you and your partner network to understand your unique requirements and objectives. Our commitment to open communication and knowledge sharing ensures that your project stays on track and delivers results that exceed expectations.

This is all underpinned by our unique, first-in-class CMC digitalization platform, iAchieve, which tracks and curates data in real-time and provides visibility to every CMC decision made on your molecule’s journey, and more importantly, which experiment, data point or insight informed that decision. This streamlines the tech transfer process by eliminating the need to search through multiple systems or databases for critical information whilst at the same time ensuring that all decisions made during tech transfer are well-informed and supported by relevant data, reducing the likelihood of errors or misunderstandings. Furthermore, iAchieve facilitates you to quickly respond to regulatory inquiries or requests for information which help expedite the regulatory approval process by providing regulators with timely and accurate data.