Emerging Technologies in Facilities of the Future
Continuous Bioprocessing Platform
Continuous processing is not new to the pharmaceutical industry. Today, the majority of major pharmaceutical companies at least consider continuous processes when developing new small-molecule entities. In contrast, the biopharmaceutical industry has been slow to adopt continuous platforms, particularly related to high volume processes. This reticence can be attributed to a number of reasons. The risk adverse nature of the industry, Regulatory uncertainties, the impacts of the shift from traditional batch processing, and the technical challenges, particularly regarding the development of analytical technologies that can enable at-line/on-line real time monitoring. However, focus on continuous bioprocessing is increasing. Over the past few years, the FDA has become more active in its support of continuous manufacturing, primarily because it recognizes that continuous processing has the potential to reduce drug development and commercialization times, which would obviously be a major benefit to both the industry and ultimately the patient.
An integrated continuous bioprocess involves connected unit operations, with minimal need for intermediate hold steps. Compared to batch processing, the overall process is more efficient, has a smaller physical footprint, with lower CAPEX and OPEX costs. The increased automation involved in continuous operations results in more consistent product quality through greater process control, minimal downtime, and minimization of human interventions, reducing the likelihood of operator error as well as improving operator safety. As continuous processes operate for longer periods (typically weeks compared with days), it means that larger product output can be realised from smaller equipment. Crucially, it also enables similar process platforms to be used in both development and manufacturing, thereby shortening time to market.
Master Planning the Future – The Need for Advancement
It can be argued that the pharmaceutical industry is changing at its fastest rate in decades. This is driven in part by the requirement to manufacture new process modalities, as well as the need to deliver new facilities in a quicker and more cost-effective manner. Furthermore, growing demand for more flexible, adaptable and sustainable facilities, together with the advancement of new processing and Pharma 4.0™ technologies such as digitization and robotics, requires that Site Master Planning needs to advance in order for manufacturing sites to fully accommodate and exploit the benefits these changes will bring.
The potential impact on sites will be significant. For example, transforming a drug substance production site with multiple production lines from traditional stainless technologies to single-use technologies will have large implications on aspects such as utility generation and distribution, logistics storage and movements, and both solid and liquid waste handling. Warehouse requirements may increase significantly to accommodate the storage of single use components. The management and disposal of single-use solids waste could become a considerable task, particularly when trying to meet ever demanding sustainability targets.
Adapting a flexible facility to a different process platform in a short time means that space needs to be provided for out-of-service equipment. The provision for the use of autonomous logistics vehicles has implications on aspects such as corridor widths, floor gradients and the provision of battery charging stations. It is predicted that production robots will have an increasing impact on FTE numbers, which will have a corresponding impact on demand for various spaces such as for car parking, office space, and lockers.
The increasing use of on-line and at-line testing is also having an impact on QC laboratory sizing, which may require significant less space in 20 years-time. Additionally, the awareness that an organization’s employees are one of its most important assets means that architects need create “Well Building Design,” which are great working environments that both attract and retain staff. Consequently, site leadership teams need to plan appropriately for potential site changes. One important aspect is to produce a Site Master Plan, which is a living document that is managed and regularly reviewed. This is important not only in defining current and future requirements, but with current digital and 3D tools, it makes it possible to display information and communicate within organizations to ensure that the leadership site vision is understood, shared and embraced.
During the 2022 ISPE Facilities of the Future Conference session “Emerging Technologies I, ” Jonathan Souquet, Global Head of Biotech Process Science for of MercK KGaA will explain how they have introduced a fully continuous bioprocessing platform into a new dedicated bioprocessing centre that facilitates end-to-end convergence of Discovery, CMC Innovation, Development, and Clinical and Commercial supply. The anticipation is that the company will reap significant benefits through improved quality and process performance, shorter time to market, flexible manufacturing capacity, and reduced cost-of-goods.
Additionally, Jessica Hays, Project Manager, Strategic Projects, Bayer, and Jordaan Kemp, Director of Architecture, PM Group, will share their expert insights on site master planning the future and how it should adjust to accommodate new process modalities, delivery methods, and Pharma 4.0™ technologies.
Register for the 2022 Facilities of the Future Conference to explore advancements in pharmaceutical technologies and see what pharmaceutical manufacturing facilities will look like in the future. Network and learn from industry leaders already planning and building “facilities of the future” as they share insights into new manufacturing challenges, technologies, and regulatory factors impacting the ability of today’s companies to stay competitive and cost-effective.
