Transformative pressure affecting the industry
Drug manufacturing is dramatically challenged by increasing cost pressure and growing competition. Virtual Value Chain Orchestrators are appearing on the pharmaceutical market and highly precise diagnostic and therapeutic technologies are developing into personalized medical products. These transformative pressures directly affect the expectations and needs of bio-manufacturers and lead to three critical benchmarks:
- Greater capital effectiveness due to cost certainty from project start. Waiting until 30-50% of a project is designed to understand the capital demand is no longer acceptable.
- Higher velocity in project delivery. Speeding up the project delivery and reducing unproductive deployed capital is critical.
- Flexibility and adaptability of facilities and installed equipment as products go through clinical trials and global market forecasts become refined.
Plant design and realization responding to market and client demands
The field of medicine is moving away from conventional therapies and edging its way towards a new area, with a deeper understanding of illnesses, their effective prevention, and more precise treatment of patients. The rapidly changing pharmaceutical market and the swift improvements in production methods, both of which are based on improved scientific understanding, digitization, and technological advancements, call for production facilities that are designed for change and expansion.
To this end, Exyte has developed advanced solutions that employ standardized and modularized elements called ExyCell®, which are combined with standard cleanroom systems:
- A highly flexible and expandable model layout for the cell culture-based manufacturing of Biopharmaceutical APIs such as mAbs (monoclonal antibodies) on a medium scale (2000 L or a multiple thereof ).
- A customizable model layout to serve the rapidly emerging cell and gene therapy sector, i.e. a solution for Advanced Therapy Medicinal Products.
- A third model layout for the upstream and downstream production of vaccines and viral vectors based on adherent cell cultures (600 m2 or a multiple thereof).
All three solutions are infinitely configurable bio-manufacturing environments that provide all the benefits of standardization and use the developed process as a starting point, not trying to fit it into a modular “box.”
Our end-to-end solutions can be deployed globally and enable cost predictability, speed to market, and a high degree of flexibility for desired adjustments by the end user in the future. They reflect the characteristics of a drug lifecycle, mitigate associated risks, meet current GMP demands, and effectively protect the CAPEX (capital expenditure) and OPEX (operational expenditure) of the owner – flexible, smart production platforms for tomorrow’s medicine.
Main benefits of ExyCell® are:
- Late-stage CAPEX decisions
- Early and reliable cost estimates
- Significant reduction of deployed capital
- Design adaptable to process, scale, and GMP/BSL demands
- Transparent project execution
- Significant reduction of owner workload
- Single source delivery of integrated solutions
- Ergonomic, light-filled, and comfortable work areas
- Plant modifications are easily implemented at any stage even during plant operation
- Expansion to the plant is easily integrated with minimal impact
Adaptation of plant layouts to ExyCell®
Our modular technology easily adapts to any developed bio-manufacturing process. A block-flow diagram or a process URS (user requirement specification) may be a good starting point for a first layout proposal. This process is very straightforward and a standardized ExyCell design can be provided very quickly. Interactive workshops with our client team allow for further refinement to match the layout with the process needs and regulatory requirements. Preferably in a face-to-face workshop together with our Subject Matter Experts (SMEs).
The layout design for a greenfield plant can be built in a very straightforward way from proven and accepted templates for the different areas. In brownfield projects, we will take care to provide an optimal fit to your process needs within the boundary limits of the existing building. Third-party plant layouts are also easily converted to become compatible with the ExyCell® technology by using the configuration options which are inherent to our technology such as wall placement and application of spacer elements.
ExyCell® elements are fixed on a frame within the building. The system is compatible with free heights floor-to-beam as low as 4.25m. The cleanroom height could be as high as 5.5m with the PIFF (plenum integrated filter fan) and even higher with different HVAC solutions integrating a low-level air return duct.
Manufacturing of all major parts is done locally from our workshop in Shanghai. This way we can keep communication and transport distances short and supply quickly and flexibly. As a global company, we apply the same quality and technology standards worldwide from manufacturing sites in North America and Europe.
Planned launch of ExyCell®
What is the current status?
The ExyCell® concept is established on 7 types of cell (building blocks) than can be used to meet different production facility requirements. The design of these different cells is competed. The design and construction of a small-scale Cell & Gene Therapy (CGT) production unit is ongoing in close collaboration with our technology partner Miltenyi Biotec.
What is Exyte’s implementation plan to help clients adopt ExyCell modular systems?
a) Provision of model factories and typical layouts, all of which were fully pre-engineered together with our technology partners: Miltenyi for ATMPs, and Univercells for vaccines / viral vectors
b) Free SME consultancy on project related topics
c) Free layout design and technical meetings with our ExyCell® development team
d) Special rebates for early adopters
The first ExyCell® facility is under construction with completion in 2021. We are also designing ExyCell® facility concepts for thre clients in Europe, with a total cleanroom area of 3,500 m2. Furthermore, we leverage our long experience in the design and construction of pharmaceutical facilities and the modular realization of several biological manufacturing facilities by our company in China, which has received the FOYA Award in 2019. Moreover, Exyte has developed and realized several other modular facilities, e.g. the renowned Catapult Development and Manufacturing Centre for Cell and Gene Therapy in Stevenage, UK or, very recently, a large modular biomanufacturing plant for upstream and downstream processing in Lithuania. All these plants have been designed and constructed, shipped and installed to operational readiness. We consider ExyCell to be an evolutional development or a “next generation” of our existing modular concepts.