Implementing any procedures and/or technologies that help to reduce the time-to-market for a new drug can have a significant impact on profitability.
One area of possible improvement is technology transfer, which is the formalised process of moving the production of a drug from one phase to another.
This involves a series of knowledge transfers and ramping up established manufacturing processes and/or relevant analytical methods from development to commercial production.
Tech transfer is an important but challenging part of bringing a new drug to market quickly and successfully.
It is also a critical undertaking when transferring the manufacturing process from one facility to another, whether that’s outsourcing to a contract manufacturer or simply to a different facility around the world to meet market demand.
For years now, tech transfer has been one of the slowest parts of the treatment development pipeline. Although most life science companies have transitioned from paper records to digital documentation, critical information about treatment development and manufacture is still siloed in different systems.
Typically, different areas of research and development use their own proprietary software packages and databases that are, in turn, different from those used in manufacturing.
Moving data between these groups often means performing complex conversions or custom configurations that are both time-consuming and costly.
Tech transfer requires detailed analytical methods, manufacturing process descriptions and parameters — as well as critical quality attributes (CQAs) — to be passed to the next phase of development and manufacture.
But, this often-unstructured data tends to be contained within spreadsheets, Word documents and other disparate software. This makes the process very challenging, especially when an external contract organisation is involved.
A lot of the required information must be manually extracted and inputted into the new production systems. The process can take months or even years when performed manually, with significant time and effort being spent trying to reconcile different items and data structures.
There is also a much greater potential for error, which can subsequently be the cause of major delays.
Streamlined automated tech transfer
As pharmaceutical companies have transitioned to fully digital manufacturing processes, they have been able to utilise functionality within their manufacturing execution system (MES) to help simplify the transfer of recipes and manufacturing information between project phases and system environments.
This MES functionality has not only automated the transfer of product recipes, materials master information and configuration settings, but also enabled users to archive the associated order execution information.
Expanding on this is a technology transfer solution called process knowledge management (PKM) software, which provides the ability to collect, download and immediately provide all process steps, associated activities and important parameters, such as CQAs and materials.
This not only helps to speed up the process, but also to eradicate human error.
PKM software works by creating a continuum of process knowledge throughout the entire drug development cycle, from early stage research through to late-state commercial manufacturing.
The software provides a structured central repository for drug development information, recipes and manufacturing processes, which helps to prevent silos of data.
All necessary information is captured digitally and, by facilitating fast, intuitive access to this data, it makes the tech transfer much simpler and far quicker.
Some key elements of the software include internal calculation engines that manage the process parameters and calculations automatically, making information more intuitive and accessible.
Templates are used to drive standardisation and improve efficiency. Using these templates, development teams can push changes to multiple recipes at once, saving many hours of manual editing.
Importantly, PKM facilitates GMP compliance with a stringent change management audit trail and an embedded approval workflow with electronic signatures.
Standardisation not only makes it easier to move a treatment through each stage of the development lifecycle, regardless of scale-up or differing equipment needs, but also makes it easier to solve problems during and after manufacture.
If a new treatment has a problem after its release, knowledge management throughout the lifecycle provides easy access to the data needed to quickly solve that problem.
The most advanced PKM software offers easy integration with widely used distributed control systems (DCS) and MES.
In a few short steps, the PKM software seamlessly pushes sequences of operation and parameters down to these systems, ensuring that downstream teams know exactly what to purchase and how to manufacture drugs based on the pre-established link from recipes to the MES.
PKM can also connect with planning and execution systems, further eliminating manual integration.
Emerson has tested its PKM software with its DeltaV DCS and Syncade MES and found that, under the right circumstances, automating technology transfer in this way can help to reduce the time-to-market of a new treatment from 10 years to just 2.5 years.
