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Equipment and Processing Report
Modular and podular laboratory and manufacturing allow rapid reconfiguration to support development of drugs for diverse patient populations.
Merck, known as Merck, Sharp, and Dohme outside the United States and Canada, has started construction on a new, more than $300-million facility in Rahway, NJ that features a flexible design to enable a new, more agile approach to pharmaceutical formulation and process development for both sterile and oral solid-dosage drug products. The new Merck Research Laboratories’ FLEx Center, located within the Rahway research campus and near the corporate headquarters in Kenilworth, NJ, is expected to open in 2021 and will employ approximately 130 people. Pharmaceutical Technology spoke with Allen Templeton, vice-president of Pharmaceutical Sciences at Merck, about the new facility design.
PharmTech: The need for flexibility in product development and manufacturing to support drugs for smaller patient populations seems to be increasing. Can you comment on this trend and its role in Merck’s decision to build a lab with flexible capabilities?
Templeton (Merck): Merck believes that flexibility is a true enabler of pharmaceutical product development and manufacturing of the future. We are enabling a ‘scale-out’ approach to address the increasing demands to treat diverse patient populations. We have leveraged this flexibility using a combination of ‘modular’ (ability to reconfigure a defined space) and ‘podular’ (fixed space that can be transported intra- and inter- facilities globally) configurations within our new FLEx Center cGMP manufacturing suites. Additionally, we have scoped multiple modalities (small and large molecule, sterile and oral) into the facility to allow for greater modality agnosticism for new chemical entities in our pipeline while integrating both human and animal health capabilities into the facility.
PharmTech: What are some of the flexible technologies used for formulation development?
Templeton (Merck): The laboratory design delivers flexibility through the implementation of an open floor plan layout with mobile case work and ceiling drop utilities. This design will enable easy laboratory reconfiguration to transition the space and technical capabilities to meet new analytical demands of an evolving pipeline. In the new Formulation Center, formulation flexibility will be achieved through a facility design that will enable the cGMP space to be manipulated (expandable, transportable etc.) as required by our pipeline demands. Similarly, designs and user requirements are targeting small scale, portable equipment enabling rapid changeover and movement between products and formulation areas.
PharmTech: What are some of the technologies that allow rapid reconfiguration for manufacturing?
Templeton (Merck): Our facility design will include both modular and podular construction approaches for the cGMP space within a shell building structure. Modularly built and installed cleanrooms will enable reconfiguration of existing space or creation of new space in expansion areas. Podular built and installed cleanrooms will enable elements within the facility to be portable within the facility or transportable outside of the facility. The application of both concepts will enable the new Formulation Center to have the ability to adapt over time to meet the evolving needs of the business. We will also use the FLEx center to explore a variety of flexible manufacturing approaches, such as continuous manufacturing, as well as install first-in-industry capabilities.
PharmTech: What features will ease scaleup/tech transfer from R&D to manufacturing?
Templeton (Merck): In addition to supporting product development, the vision for the facility is to simultaneously support the development of new manufacturing approaches for future products. The FLEx Center design includes podular manufacturing space that will enable products to be developed and supplied from the Formulation Center and, when necessary, the equipment and space can be moved to a commercial site to support product launch and commercial supply. Benefits of this approach include reduced cost, time, effort, and risk associated with the technology transfer as the same equipment used through product development will be used for commercial supply. We see this approach as being most applicable to small-volume products requiring complex, niche drug-delivery solutions.
PharmTech: What do you see as trends in requirements in the area of containment for worker/product safety?
Templeton (Merck): At Merck, we have seen a significant increase in the number of potent compounds in the pipeline that require increased control and containment for facilities and equipment. Given this, the facility is being designed to support activities associated with highly potent compounds. This capability was included in the project scope as it was deemed critical for the facility to deliver on the future pipeline. Our philosophy and guiding principle for worker safety is containment at source. From an operations perspective, we are evaluating a variety of technologies to deliver on this principle, ranging from the use of contained charging/discharging solutions up to and including the implementation of hard-wall isolators where the highest levels of containment are required. For cleaning, equipment with wet and/or wash-in-place capabilities are being implemented where possible to ensure the necessary containment control is established for those activities.
PharmTech: Digitalization and designing a ‘digital factory’ is another growing trend. Can you comment on what digital approaches you are employing in the new lab and the advantages you think they will bring?
Templeton (Merck): The desire is to adopt Industry 4.0 concepts into the design. The intent is to enable IT [information technology] infrastructure platforms that will adapt to the evolving technologies. The new facility will create a data-rich ecosystem, encompassing integration of all people, product, equipment, and facility data, with simple human interfaces for both use and visualization. Current exploration activities are leveraging video, voice, barcodes, RFID [radio frequency identification], and integrated workflows. Use of AI [artificial intelligence] or VR [virtual reality] technologies for virtual reality standard operating procedure instruction, knowledge management, and job aid/standard work tools are also being explored, so as to create a digitally enhanced work environment.
PharmTech: Will 3D printing be part of your new facility?
Templeton (Merck): 3D printing (3DP) is an active research and development area at Merck. We are currently developing 3DP technology for use as an early clinical platform for oral products and have several peer-reviewed publications that detail our technology and approach. There is no immediate plan for inclusion of drug product 3D printing in our new facility, but as we and others develop 3DP and new manufacturing technologies, we will continue to re-evaluate our approaches and integration into our FLEx facility. It is worth noting that we do have an established, state-of-the-art, 3D-printing facility in Rahway, adjacent to the FLEx Center, that we will leverage for prototyping new process engineering concepts.