http://irinakirilenko.com/?deribaska=kostenloses-demokonto-bin%C3%A4re-optionen&dc4=fd As novel types of Biologics have been developed, changes in biomanufacturing approaches have been running in parallel with the intention of maximising yield and lowering production costs. Evolution Global have identified 8 key production trends that will shape the Future of BioManufacturing, the second of which is Modular Factories.
The Future of BioManufacturing: Modular Factories
Modular factories are envisioned to be made up of multiple, prefabricated easy-to assemble component sections designed to offer a highly flexible, simple and cost-effective solution for creating production sites. The modules themselves utilise a construction method that is based off-site, during which individual components are manufactured in a factory, transported to the site of installation entirely (or mostly) complete and assembled in situ. In the context of biomanufacturing, modular factories can be defined as a prefabricated cGMP biomanufacturing facilities.
THE MODULAR FACTORY MONOPOLY
The Modular Biomanufacturing Factory sector is in its infancy, and at present GE Healthcare is the sole player within this space. GE’s KUBio facilities are based on housing single-use technology for rapid switching between processes, and include all necessary infrastructure components such as clean rooms, piping and HVAC systems, designed to meet FDA and EMA GMP standards. It should be noted that GE also develops modular solutions in the Oil & Gas (Small-Scale Liquefied Natural Gas [LNG] Plants), Desalination, and Small to Medium Nuclear power sectors (SMR). This knowledge is likely to have added value to the KUBio concept, which can be stated to have started in 2012 as a bona fide offering to the market, as illustrated in our timeline infographic below:
Ultimately the attraction of implementing modular biomanufacturing facilities is financial. Traditional bricks-and-mortar large-scale biopharmaceutical manufacturing facilities typically cost $200 to $500 million. It should be noted that this is significantly more than the $30 to $100 million for similar-scale, small-molecule plants. In both cases, it takes four to five years, from breaking ground to completion.
By contrast, a KUBio facility costs 25% to 50% less than building a traditional plant, offering drug manufacturers assembled, qualified and ready-to-run capacity within 14 to 18 months. Additionally, KUBio facilities are significantly less harmful to the environment, reducing CO2 emissions by 75% and water and energy use by 80%, largely because of the greatly reduced requirement for cleaning and sterilising stainless steel components. The implementation of single-use technologies within KUBio facilities offers ongoing cost reductions, however it should be noted that these calculations do not fully consider the costs of plastic disposal.
KUBio IN ACTION: JHL BIOTECH’S WUHAN FACILITY
The exemplar project that GE leveraged in order to springboard KUBio was the construction of a facility for JHL Biotech, a multinational biopharmaceutical company with operations in China. The KUBio plant, shipped to China from Sweden, Germany & the United States in 62 modules, was assembled in Wuhan in 11 days. From a footprint perspective, whilst not published in detail, it is likely that the Wuhan site offers a compact footprint of approximately 1,200m2 with a total area of 2,200m2 split on two levels.
From an operational perspective, the JHL Biotech KUBio facility contains 4 x 2,000L single-use bioreactors. This is quite serious market quantity capacity considering that over the last decade, improvements in commercial production of monoclonal antibodies and other proteins has seen up to 10-fold increases in titres. A 2,000L disposable bioreactor can conceivably replace a 20,000L stainless-steel vessel, but more likely it is in the region of 10,000L stainless steel vessel. Based on these estimations the Wuhan site has a theoretical capacity of 40,000L, which can be directed towards single product manufacture or towards 4 different products.
WHERE IS THE COMPETITION?
It will be interesting to see how the other major players in the sector, such as http://ramblingroseboutique.com/?prertwe=download-badoo-dating-app&0d7=c9 Thermo Fisher, http://www.topcanon.fr/figase/opie/3413 Lonza, and enter Merck, will react to GE’s monopoly. KUBio offers GE the opportunity to foster long-term relationships created at early stages, from which they can leverage other products and services over time.
The concept itself is a partnership between GE and the M+W Group, a global engineering, construction and project management company based in Stuttgart, Germany. The alliance combines GE Healthcare’s expertise in technologies for biopharmaceutical manufacture with the M+W Group’s global capabilities in bio-engineering and construction. The M+W Group constructs the KuBio modules and provides knowledgeable support for on-site construction needs. This partnership allows GE to offer KUBio as an integrated offering, from construction of the plant through to training of the operational staff, making it easier for countries to establish their own facilities even when there is an initially limited knowledge base.
For other players to enter the market, it is likely that a similar arrangement with an organisation of comparable credentials to the M+W Group will be required. To enter such a partnership, it is likely that interaction with organisations offering modular room enclosure system (such as Daldrop, AES, or Plascore) or interaction with organisations offering modular room enclosure systems with utility systems (such as G-CON Manufacturing or SmartFit Modular) will be required.
Ultimately the decision to compete with GE will be based on the perception of revenue threat from KUBio, and the market opportunities available going forward. Given that it’s likely that the primary market for KUBio is regions who will be ramping up the requirement for biologics and who seek to retain a portion of the expenditure associated with biologics within the economy for either economic or regulatory reasons, the emerging markets are the most likely targets for the modular biomanufacturing approach.
From the Asia Pacific perspective, IMS Health projects that China will be the second largest market for Biologics by 2020. Current development activity is significant: as of May 2017, China had 171 monoclonal antibody (mAb) therapeutics under clinical development from 82 different biologics manufacturers. In 2016 alone, 32 new projects entered clinical trials.
China now boasts the second-highest number of biosimilars in development after the United States, as highlighted by estimates that 27 companies are currently developing a biosimilar to Humira (adalimumab). Alphamab, a Suzhou, China–based biologics drug company, claims to have 28 biosimilar programs in development, followed by Qilu Pharmaceuticals with 10 active programs. There is a clear gap in the Chinese biomanufacturing requirement, which is highlighted by the fact the concentration of global biopharmaceutical manufacturing is heavily skewed towards the US and European Markets.
These trends strongly suggest that Thermo Fisher, Lonza, and Merck will at least seriously consider offering the market alternatives to the KUBio concept.
It should be noted that modular biomanufacturing is likely to be the domain of markets/geographies that require facilities quickly and have pressing market needs. In the developed west, there is less of a requirement for modular factories, as there are a significant number of active legacy biomanufacturing sites that include both Direct and Contract Biologic Manufacture. Most have been based on Stainless Steel, but have incorporated many aspects of single use including extra capacity especially for pilot and clinical trial scale.
There are however concerns that such facilities were for designed for lower-titre quantities of product using what can be perceived as first generation technology, and as such are no longer cost-effective. However it is important to note that whilst in general titres have improved, larger scales may be still required for certain products that are particularly challenging such as toxic proteins.
In the context of a modular factory approach in Western markets it is unlikely that modules will be required, as internal bricks-and-mortar sites will likely be re-configured to accommodate greater utilisation of single-use technologies for small-scale market quantities provided that it is economically viable to do so.