Faster, easier and cheaper technology transfer: a new differentiator for pharma and biotech companies
In the pharma and biotech industry, the process of technology transfer plays a critical role in the journey from initial concept through to commercialization of a new medicine or product. Yet today’s processes are slow and costly – which is where digital technologies can be transformative.
Technology transfer refers to the transfer of all relevant knowledge about how a medicine or product should be produced, including the designs and ideas from the discovery laboratory to clinical phases, and from clinical phases to commercial manufacturing. This requires the rich skills, knowledge and talent of many different experts: experts in process technologies, in regulations and compliance, in quality, the supply chain, engineering, manufacturing, and so on.
Why is technology transfer so expensive and time consuming?
As well as having different functions and skillsets, all the experts involved in technology transfer use different strategies and systems for storing and sharing their knowledge. What’s more, operational technology for commercial manufacturing is not well integrated with business and digital applications (such as Enterprise Resource Planning systems for aligning the production process with the set-up of physical plants). This means that significant effort must be expended on managing and maintaining paper-based documentation and associated processes.
Today, the average technology transfer process takes around 20 months and involves around 30 cross-functional experts. It requires an average of two ‘tech batches’ (upscaled production for evaluation of technological capabilities) and three ‘validation batches’ (commercial scale batches to validate the manufacturing process and reach the Golden Batch as a reference for future production).
As well as the full-time expertise that is required (costing an average of $5 million), the average costs for each batch are $2.5 million (for the tech batch and the validation batch).
In a competitive market, these costs – and the negative impact on time-to-market – are increasingly difficult for companies to bear.
This digitalization of technology transfer could save pharma and biotech companies around $10-15 million for each product.
How we can transform technology transfer
Working with our innovation partner, Fluxa, Atos is pioneering the use of digital technologies to transform the technology transfer process to make it much faster, easier and more efficient. In conjunction with Fluxa’s Process & Knowledge ManagementTM (PKMTM) software, which manages process knowledge across the R&D to manufacturing continuum, Atos has developed a platform that incorporates automation, machine learning, AI and digital twins to implement the technology transfer process end-to-end. To better understand this, consider the following key milestones that are typical of how tech transfers are executed today:
- Data transfer: information extraction, which includes understanding how the previous owner was manufacturing the product. For example, for the clinical manufacturing expert, it’s important to see and understand exactly how the scientist was producing the few grammes of product in his/her laboratory. This may involve, for example, extracting content from Excel spreadsheets and PDFs created during drug discovery and the ‘brain dumps’ that scientists have collected as unstructured thoughts.
- Assessment of the fits and gaps: this step makes sense of all the transferred information, extracting the knowledge-relevant insights to better understand the small-scale production process, determine fits (process and technology) and gaps in comparison with existing plants’ capabilities. This result of this step is a blueprint of the scaled-up process, matched with the manufacturing facilities.
- Validation and qualification: the production process blueprint is then used to manufacture the verification and qualification batches. Here is where high costs have traditionally been incurred trying to reach the Golden Batch as a reference manufactured product.
Fluxa PKM supports the highly specialized knowledge transfer during steps 1 and 2 above. It has a powerful engine that can digitize this knowledge, and create an ‘insight-ready’ model to derive a manufacturing process. It then supports the scale-up of the process to take account of all production engineering elements such as stability and critical mass.
Once the scaled-up process is available, PKM automatically aligns it to the production plant’s assets, automatically highlighting process fit and gaps, and generates the process blueprint for step 3 – essentially enabling a ‘one-click’ tech transfer. Using this blueprint, a digital twin developed by Atos can then create a complete virtual replica of the manufacturing process. Using the digital twin, with its related dashboard, the engineering team can simulate the validation and qualification batches, with the ability to scale up and down, and make adjustments and corrections without using any physical facilities.
Major benefits for companies
Based on our work so far, this digitalization of technology transfer could save pharma and biotech companies around $10-15 million for each product, cut the verification and qualification processes and batches by 50%, reduce the average technology transfer process to as little as six months (instead of 20 months), and eliminate most of the pilot and engineering batches – as well as eliminate a large number of cycles of laboratory work related to those batches.
By integrating the solution with manufacturers’ other systems (for example Enterprise Resource Planning and MES), every organization and every function involved can directly steer quality in real time throughout the production process. Careful change management is required to ensure adoption of this new way of working along the journey from R&D to commercialization. We hope to be working with customers to deploy the solution and turn these significant benefits into reality for today’s pharmaceutical and biotech companies.