Supporting complex technology transfers

In pharmaceutical manufacturing, technology transfers are challenging due to a combination of technical complexity, regulatory requirements, documentation, equipment considerations, risk assessment, quality control, cost considerations and more. 

As molecules and processes become more complex, pharmaceutical organisations must support transfers with an even greater number of process steps and more rigourous requirements. Many times, limited process information is available upon tech transfer, adding to the difficulty of this critical procedure. Successful tech transfers, particularly for those involving over a dozen steps, demand meticulous planning, thorough familiarisation, risk assessment expertise, and experience across a variety of chemical processes.

A key challenge associated with multi-step tech transfers is the sheer volume of these processes. A standard pharmaceutical manufacturing process often has just four or five steps. However, processes for certain complex molecules, such as those that must cross cell membranes to facilitate drug delivery, can have upwards of fifteen steps—with a multitude of in-process control requirements, raw materials and other elements. Each step in the production chain must be executed with high precision to ensure the final product’s quality, safety and efficacy.

To ensure ongoing safety and quality, tech transfers should include a rigourous risk assessment, particularly when limited hazard information is available. This includes identifying hazards associated with toxic materials, complex process steps, impurities and other factors, then implementing extensive control strategies to mitigate these risks.

In addition to assessing physical hazards, organisations should perform thorough scale-up risk assessments to ensure that the process is scalable and anticipate how it will behave on plant.

Tech transfers can be costly and time-consuming, particularly without the ability to directly engage with the previous process owner. But with heightened competition and an intensified focus on speed-to-market, pharmaceutical and biotechnology organisations operate on faster project timelines. Adhering to project timelines, especially with many different processes happening in tandem, requires a well-orchestrated project management approach, close attention to detail and effective cross-team communication and collaboration.

Sterling leverages deep expertise in technology transfer, complex chemistry and cross-site collaboration to support even the most intricate manufacturing processes with quality and agility.

We pair expertise supporting a broad range of chemistry requirements across the full molecule lifecycle with a pragmatic approach to tech transfer that sets customers up for success. With dedicated teams for analytical and chemistry development working together towards a common goal, we streamline tech transfer while accounting for each critical project detail and maximising scalability. We have experience handling projects with over a dozen development steps, twenty-plus rounds of scale-up, fifty-plus in-process control methods and dozens of new raw materials.

When a project is transferred into Sterling, we undergo an extensive familiarisation exercise to identify key project requirements. Our experienced team can support high-volume analytical testing for raw materials, in-process controls, finished product specifications and more, all while process development occurs simultaneously. Our thorough approach enables us to ensure we get things right the first time and meet specification once a project reaches the plant scale.

Furthermore, we maintain close relationships with raw material suppliers in order to ensure supply chain reliability for our customers.

With five global facilities that support a wide variety of specialisations, we seamlessly tap into cross-site expertise to support a range of project requirements for our customers. For example, our Dudley site has more than 50 years of expertise in hazardous chemistry, with a dedicated hazard evaluation team to assess and mitigate risks. If a project is transferred into our Ringaskiddy site for manufacture with limited hazard information, the team at Dudley can then perform extensive hazard testing and recommend appropriate engineering controls. This might include specialised containment measures, guidance around charging the process to mitigate exposure and more. In addition, the Cary, North Carolina facility specialises in early phase development, with the ability to aid in reference standard synthesis and qualification.

Specialised equipment across our global facilities enables us to support an even wider range of project requirements. For example, our Ringaskiddy site’s large-scale chromatography columns enable us to perform separation and purification for large volumes of material.

Complex tech transfers can be riddled with unexpected scientific challenges, particularly when limited information is available upon transfer. At Sterling, we are adept scientific problem solvers, quickly identifying issues through systematic analysis, proposing scientifically sound solutions and implementing corrective actions. We have experience efficiently redeveloping processes to align with the equipment we have available on-site, and we have successfully transferred projects based on kilo lab procedures and draft analytical methods. Our team continues to seek opportunities for improvement and optimisation each time a project scales to circumvent challenges and improve efficiency.