Technology transfer: a golden opportunity

When it comes to technology transfer, people in the life sciences industry tend to think of the process from discovery to commercial manufacturing. We can think about the whole process from developing a new formula, scaling up the formula and getting it into production. In fact, technology transfer activities are involved throughout the product life cycle, including:

From r&d to clinical mass production

From clinical trials to mass production on a larger scale

From mass production to commercial production

Linking sites of individual production activities (API development, packaging, etc.)

Sign contracts with manufacturing enterprises on plant construction, production scale upgrade and product registration

We need to recognise that technology transfer does not happen overnight. If you take into account the various transfer activities throughout the product life cycle, including products that never make it to market, we need to conduct thousands of technology transfer activities. Companies spent more than $2 billion on technology transfer and research and development for each successful drug.

If the technology transfer activities themselves are taken into account, the total cost of each activity is $5 million to $40 million. The industry spends billions of dollars a year on these processes. Therefore, it is of great significance to evaluate how to solve the problem of cost, speed up the progress of technology transfer and improve its efficiency.

Figure 1: Timeline of technology transfer in the life sciences industry

A timeline of typical technology transfer activities (Figure 1) gives us a different perspective on their impact. The first half represents the process of bringing the drug to market, with 10 months being the average time required to scale up the formulation and reach the commercial volume production stage. This is a stage of great opportunity. If this process can be performed more efficiently, more time can be saved, and the drug can be brought to market faster and earlier within the patent term, and the longer it stays under patent protection.

Everything on the right side of the timeline is a recurring cycle that occurs when you carry out other technology transfer activities, such as internal technology transfer from other branches of the enterprise to sites around the world. If you can digitize these processes to make them more efficient and repeatable, you can save significant time and effort.

What are the obstacles?

Why do we still fall short? What's holding us back? What challenges do we need to overcome? One is processing and creating data.

For example, chemical, manufacturing and Control (CMC) processes adopt what are known as key quality attributes (CQA), and then we try to develop the processes and key process parameters needed to achieve these CQAs. However, CQA in the process development and process formulation cycle will eventually need to be recorded in your regulatory file. This information needs to be recorded in the validation batches and registration batches.

Teams working in related fields within the enterprise need this information to prove the effectiveness of the formula. After that, there are post-approval issues that need to be coordinated in terms of change management, inter-site management, and recipe development.

Often, these teams work together based on different information. The reason is that there is no universal database and no single system to store all the information needed to make a product. Ultimately, you may not be able to perform technology transfer, process validation, site to site comparisons, and many other critical operations in the most efficient manner due to the lack of trusted data for versioning uniformity.

Failure to integrate and coordinate related resources will affect the execution system of manufacturing products. Manufacturing execution systems (MES) and distributed control systems (DCS) require this information. We currently do this through manual processes, which are paper records, manual transfers, and purely manual labor.

Work closely

From another perspective, we need to define the packaging, processes, and products necessary to perform critical functions. Product labels, label content, product design, and package design are all key information, which are developed by different teams.

Figure 2: Transfer of life sciences technology

The black diamond icon in Figure 2 indicates data silos and disconnects between the team and the system. We need to establish a seamless digital data flow from upstream systems to manufacturing execution systems to ensure that data is transferred and transferred digitally. This can not only save some manual process, but also improve efficiency and shorten time to market.

The way we do this is by creating a digital thread that seamlessly links all the information from the exploration phase to commercial manufacturing. Each link can share data and other information. Along the way, we can also gain relevant knowledge:

Scientists responsible for product development pass information to ensure process engineers better understand the operations they are performing

With a historical record of the process, the manufacturing system understands the impact of changes on the process

The quality department has access to records and information about previous steps in the process, enabling it to make more informed decisions based on historical data

In this industry, we're always looking for ways to get drugs to market faster to benefit as many people as possible. Accelerating technology transfer is one way to achieve this goal. The approach is not only to save time by connecting data and digital resources, but also to increase enterprise intelligence, visibility and insight into the process. So, in addition to shortening time, you can expect to save money and effort.