Among all of the important trends in life sciences industry such as modular plants, integrated modules, out-of-box smart factory, single-use equipment, PAT, and manufacturing execution systems (MES), IIOT has been receiving high interest including among pharmaceutical and biotech manufacturers.
It is our view that the same technology advancement that makes Industry 4.0 possible will lead to a revolution in technology transfer through drug development pipeline.
Industry 4.0 is based on the Internet of Things (IoT). The central concept is around cyber-robotic system, which is virtually a fully automated enterprise enabled by automation all the way from the physical process, to equipment and operations, and out to the supply chains.
These cyber-robotic systems would cover not only production but also design, services, and research, providing complementary capabilities to work with each other. Interfaces between ‘intelligence’ and physical component are ever better defined with smart instrument standards. Clouds are serving as a storage for the data behind the ‘intelligence’. The cyber-robotic system can eventually work with each other without human intervention, leading to the promise of Industry 4.0.
The pharmaceutical development process is extremely complicated represented by its multi-staged pipeline. Technology transfer through the drug development pipeline is essentially cooperation between different plants and different sites. It is understandable that technology transfer in Pharmaceutical Industry would first benefit from the technology advancement even before Industry 4.0 becomes a reality. This is especially true as contract manufacturing organizations (CMOs) are getting more and more popular in pharmaceutical business.
A new drug takes $2 billion in capital expenditures and 10 years on average, if it has the chance to go through the pipeline. Time-to-market is a top priority for drug manufacturers. A patented drug has only 17-20 years exclusivity before the generic competition enters the market. Also, the first generic drug would enjoy a much stronger market position than those that follow. A drug with either fast dis-proof or proof of concept would pose less financial uncertainty than a long drawn-out one under seemingly never-ending development.
The drug development pipeline gets thinner and thinner with the stages moving from discovery, to pre-clinical, to clinical manufacturing, and finally to commercial production as there is less than 10% chance for a drug to successfully move from one stage to the next one. The manufacturing scale and operation on the other side will increase by a factor of 10 from one stage to the next. While the data about the drug itself may be well received from one stage to the next, it is the rest of those outside the pipeline that need also to be standardized to achieve the improved performance of the pipeline.
The effectiveness of technology transfer through the pipeline will depend on the standardization of many of the technical specifications and data context through different layers of different stages in the drug development pipeline. Identifying these standards and populating them to the drug manufacturers are the key to make this happen. The standardization needs to address:
- the ability of managing processes through different scales
- the ability of managing the design space through different stages
- the separation of control strategy from execution (physical controller)
- the common inputs/outputs (I/O) to separate physical equipment from controllers
- the operation standard that separates procedural element from equipment element of a process, etc.
S95 is the industrial standard for enterprise automation that has a 5-level hierarchy, with level 0 at the bottom being the physical process and level 4 at the top being the business process. Level 2 is automation for equipment, sometimes called distributed control systems (DCS), and level 3 is automation for operation, sometimes also called manufacturing execution systems (MES).
Historically level 2 and level 4 were developed earlier than MES with no intention to be connected. It is now the moment that a holistic view on the entire drug development life cycle can be taken and it is the level 3 MES that binds all the pieces together and presents an opportunity for better managing the drug development pipeline.
The importance of such standardization becomes clear when drug development pipeline is placed in S95 view, which was first presented in the blog a couple of years ago. Common platform and consistent data structure, managing process through scales, separation of control strategy from controllers, common I/O for all equipment, management of critical process parameters and critical quality attributes will help make tech transfer faster, smoother, and less costly.
Emerson is a major supplier to the industry at both level 2 and level 3 in industrial automation. One recent innovation is the introduction of the DCS platform and S88 into lab and Research & Development with DeltaV Discovery and DeltaV PK controller. Bringing automation standards like S88 and S95 and introducing the DCS technology in the early development stage is particularly important for data management in R&D and is the first step towards a smoother, faster, and less costly technology transfers through drug development pipeline.
As highlighted in an earlier post, new approaches are also available for implementing design space into production through on-line multi-variate data analysis (MVDA) models to support process validation and continued process verification (CPV) during the tech transfer.
The same technology advancement that makes Industry 4.0 possible will naturally lead to the opportunity of having a better way to manage tech transfer throughout the drug development pipeline and site-to-site transfers. Current automation technology is advancing to this critical point. It is becoming possible to take this holistic view of what we do throughout a drug development pipeline. Significant benefits may be realized.
Benefits of such standardization will also be realized from significantly reduced validation by pre-validated objects and design now achievable with standardization. The savings on engineering and validation costs alone would justify such a strategy, not to mention the fact that the entire pipeline can be managed in fully functional data contexts. There will be no confusion or information loss during tech transfer. As a longstanding supplier to pharmaceutical and biotech manufacturers with years of automation project experience, Emerson can help you develop a solution-oriented design approach to your projects.
Learn more in the Life Sciences & Medical section of Emerson.com. You can also connect and interact with other pharmaceutical and biotech industry experts in the Life Sciences group in the Emerson Exchange 365 community.