Advanced therapy medicinal product (ATMP) manufacturing promises cures to previously incurable illnesses, such as cardiovascular diseases, cancer and genetic disorders. The COVID-19 pandemic proved that the pharma industry could overcome barriers using digital technologies — a critical achievement. Manufacturers, however, often use such technology for specific projects, not for an entire facility.
This points to a critical shortcoming among many pharma manufacturers — the slow adoption of digital transformation (DX), when compared to other large industries. By adopting DX across all facilities, ATMP manufacturing can move with greater speed and efficiency, provided it is not applied in a piecemeal fashion.
Why DX is necessary
Digital transformation describes the adoption of digital technologies by a company. While it may include specific projects for converting existing analog or non-automated systems to newer digital platforms, DX initiatives go beyond the project level, affecting the entire organization.
Most ATMP facilities record detailed information on paper, which is problematic for a few reasons:
- Manual recording tends to be laborious and error-prone
- Storage is costly, uses space and needs to be organized for location
- QA processes can only be provided by specialists with access to the physical records
- Delays during the regulatory process are significantly increased
These factors create bottlenecks. When scaling up for productivity, manufacturers often encounter difficulties transitioning from early lab-based research to a sustainable commercial process. The ATMP manufacturing process is mostly open and operator-driven, as opposed to closed and automated processes often found in traditional facilities. Not only is this slower but it also poses risks for contamination. In addition, cell therapies come directly from donors, which limits the potential for the same expansion seen in protein-based drugs.
The flexibility enabled by employing DX principles can help overcome these problems. When a facility adapts quickly to evolving industry technologies, it can more easily manufacture new therapies or larger volumes of existing therapies.
There are many contributing factors to the industry’s slow adoption of DX. These include a lack of a clear vision and strategy for digitalization and limited access to skilled resources. Pharma must overcome the ‘silo mentality’ that often develops in each department and change the corporate mindset to open the industry through collaboration.
In some cases, companies are reluctant to be the first to use new technologies in a highly-regulated environment. However, there are four major reasons for pharma manufacturers to implement DX:
- Speed: The manufacturing chain needs speed to be competitive — speed to produce, speed to market, and speed to supply
- Quality: Facilities need to maintain safety and efficacy, increasing the cost of quality in R&D and manufacturing
- Value: Global needs and the expense of development demands more streamlined operations
- Agility: Flexibility is crucial to an industry with inconsistent demand and new products
First steps
There are multiple ways to achieve DX success, but they all fall under one of three key factors: assessing the current state of the operation; visualizing where the company will be after integrating technology; or developing a roadmap that can work within an organization’s constraints.
Organizations use process data to design, manage and enhance product processes. Regulators review this data as evidence that products are made under good manufacturing processes. DX ensures access to this data, delivering insights into the manufacturer’s process.
Ask yourself these questions:
- What are the problem areas in our facility that could benefit from DX?
- What is the outcome we seek to deliver?
- Is this the right technology at the right time to solve the right problem?
Using new digital technologies for novel advanced therapies can require a large amount of analysis to find a solution that the entire organization will buy into. The time required for this analysis can be compounded by the time required for deployment. A strategic roadmap to implement your DX vision is the first, most important step you can take.
