Tech Transfer: Let’s Take It from the Top

Why starting with a top-down approach to process definition and automation means better results at the bottom

By Bob Lenich, Life Science Business Director, and Bruce Greenwald, Platform Business Manager, Emerson Automation solutions

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Investments in life sciences research are driving a significant uptick in the pipeline of new drug substance compounds. Rapid development of these new compounds into products drives a company’s bottom line. But increasing global regulatory requirements coupled with competition from generics and biosimilars means that successful developments have less and less time as the exclusive offering — where pharmaceutical companies regain the bulk of the return on their development investment. Overcoming technology transfer challenges faced when moving product from lab to commercial manufacturing to the patient can help increase exclusivity time.

At the heart of making the research-to-production process more efficient and getting therapies to patients faster is a focus on improving technology transfer.

Because each stage of technology transfer is commonly handled independently with differing employees, processes, equipment, needs and locations, moving the product from one phase to the next can be cumbersome and inefficient.

To accelerate this pipeline and improve technology transfer effectiveness, four core conditions must be established:
• A corporate culture and associated operating environment that supports utilizing common drug manufacturing steps within and across pipeline phases
• Alignment of the standardized manufacturing and reporting steps to be used across each phase
• A clear pipeline management change control mechanism to pass the common manufacturing aspects to the next phase and to ensure that the current standards are used
• Clearly defined strategies for data collection, organization, comparison and analysis
Ideally, these four conditions will be addressed across all phases of a drug’s development process before the earliest stages of research and development take place.

Though all stages of the development process are essential to the creation of a new product, different departments tend to be siloed from one another and focused on their own unique needs. Research operates independently of development/clinical, which is entirely separate from commercial manufacturing. With no organizational incentive to connect the production operations of these groups, moving the drug’s manufacturing and packaging needs from one stage to the next becomes extremely inefficient.

Groups face significant complications with compatibility between recipe steps, utilized equipment, materials consumed and data collected during different phases. Key individuals involved in technology transfer must successfully hand over critical process parameters and quality attributes, equipment types and characteristics, all the recipe information (steps, sequence, materials, tests, etc.) and all the documented process understanding so that product development will progress successfully in later stages. Further complicating this process is that typically all the manufacturing technology to run production and capture data in each stage are different systems, designed by different manufacturers for different purposes, running the sequences differently and collecting data in different structures.

If there is a problem with the product during clinical trials or manufacturing, the problem must be traced through multiple systems with multiple interfaces, without impacting the varied development or production work in progress.

Organizations must provide meaningful cross-group incentives and identify clear owners of their product lifecycle management business process. Executive management must lead the development and implementation of this change to both confirm the priority and to resolve conflicts and roadblocks. People driving technology transfer must clearly understand both their own department’s needs as well as the needs of the next stage of development.

Some life sciences organizations have begun to approach technology solutions to this problem. Implementing individual systems geared toward department needs yet designed to work in other stages enables independent phases of the development structure to maintain and customize systems while still allowing for easy transfer, location and auditing across development. Integrated and scalable process control systems and manufacturing execution systems — such as Emerson’s DeltaV distributed control system (DCS) and Syncade manufacturing execution system (MES) — facilitate efficient sharing of manufacturing procedures and data across the development chain. By working with an automation vendor early to define control systems and strategies, organizations can significantly simplify cross-departmental transfer.

There are many benefits associated with utilizing standards for business processes and the associated technology supporting the execution of those business processes. Top examples include:
• Reduction of variation in work performance
• Reduction or elimination of errors and mistakes
• Improved, consistent quality
• Established scales and increased capacity for efficient task completion
• Visual management
• Seeing when processes are not operating normally
• Improved reporting, analytics and analysis practices

Establishing manufacturing standards across development stages presents challenges. How do you support the process flexibility and variability needed during development while also managing the enforced compliance required for commercial manufacturing? For example, maintaining common standards on recipes in each stage is critical to success. If critical process parameters require different names, sizing characteristics and testing methods between stages, the organization will waste valuable time and resources trying to reconcile this information to troubleshoot process problems and find a remedy. This problem gets compounded as all elements required to define a product manufacturing process (e.g. equipment, materials, recipe steps, etc.) are included.

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