Recent improvements in facility construction have present cost-effective, flexible, biomanufacturing facility construction. As the challenges in biologics and vaccine manufacturing increase with fewer blockbuster drugs, emerging markets, patent expiration, shorter time-to-market, price pressures, and increased regulatory complexity, companies are turning to multi-product single-use facilities. The single-use and flexible factories provide many obvious advantages compare to traditional fixed, stainless steel based facilities. They help increase productivity, efficiency, reduce risk and cost, also enable faster deployment, accelerate product turnaround time, allow multi-product processing and flexibility in scaling. The single-use process platforms usually consist of several scalable unit operations modules, they can be customized and prequalified offsite to allow quick configuration of existing and new modules, therefore reduce engineering and installation efforts, ultimately allowing faster time-to-market of valuable biopharmaceutical products.
KUBio is a turnkey process and facility solution for cGMP mAb production that dramatically reduces time to market. KUBio creates biomanufacturing capacity by delivering a fully functional, cGMP ready-to-run facility in 14-18 months. The facility can be equipped with an integrated FlexFactory single-use manufacturing platform, or a hybrid processing platform.
Sartorius Stedim offers entire single-use process platforms (Process4Success®) as integrated solutions for biopharmaceutical plants, SSB FlexMoSys ™ is a flexible, modular, and fully integrated solutions. G-Con FlexMoSys™ modular cleanroom facility equipped with SSB single-use systems and standardized hardware.
Jet Solutions (an ILC Dover Company) provide flexible containment suite and rooms using either full flexible containment suites or a combination of rigid and flexible technology. Applications include Segregation of equipment or plant, Remote charging stations, Decontamination and safe-change areas, Temporary clean rooms, Safe storage areas
Merck Millipore Facility Design and Construction Service provide complete support to building agile and flexible biopharmaceutical factories such as modular cleanrooms, facility engineering and construction.
Biologics Modular (KeyPlants)
Biologics Modular designs and manufactures modular facilities (e.g., GMP modular cleanroom) to serve as bio-manufacturing suites, self-contained bio-repositories, and analytical labs to health science service providers, educational facilities and pharmaceutical manufacturers. DeployReady Platform provides the efficient and practical products, it delivers pre-validated, modular cleanroom facilities. Products include Modular Suites , Infectious Disease Facility (IDF) , Analytical Laboratories , Biorepositories
NNE Pharmaplan is an international company specialised in pharma engineering for highly GMP-regulated pharma industry. It delivers expert pharma engineering throughout the entire manufacturing and project lifecycle.
G-CON Manufacturing Inc. designs, produces and installs prefabricated, autonomous cleanroom PODs (G-CON PODS®). G-CON’s cleanroom POD portfolio encompasses a variety of different dimensions and purposes, from laboratory environments to personalized medicine and production process platforms. The POD cleanroom units are unique from traditional cleanroom structures due to the ease of scalability, mobility and the ability to repurpose the PODs once the production process reaches the end of its lifecycle.
Clean Air Products provides pharmaceutical clean room solutions such as Modular cleanrooms and equipment.
CleanZones, LLC designs and manufactures air filtration equipment and systems for the cleanroom industry from softwall, hardwall, semi-hardwall, to modular. Products including interfacing walls, panels, ceilings, doors and windows. Air showers, polypropylene filtered fume exhaust hoods, laboratory casework, work stations, fan filter units, wet process stations and a variety of other contamination control products.
- Biologics Production and Single-Use Technologies: Challenges, Trends and Techniques
- Integration of a Single-Use Platform Process within an Innovative Facility Design
- Efficient, Flexible Facilities for the 21st Century
- The Biomanufacturing Facility of the Future
- Single-Use Technology Enables Flexible Factories
- Holland Whitepaper: Keys to Successful Skid/Modular System Projects
- Facility of the Future: Next Generation Biomanufacturing Forum
- How to Build a Bio-manufacturing Facility for the Future: IT Infrastructure Integration
- Biomanufacturing Vision for the Future
- How Flexible Biomanufacturing Facilities of the Future Will Impact You
- Continuous Bioprocessing – The Biomanufacturing Model of the Future?
- Single-Use Technology and Modular Construction
- Flexible Manufacturing
- Defining Flexible Facilities: When is a flexible facility being flexible?
- Supplement: Single-Use Solutions for Modular Manufacturing
- Modular Manufacturing Platforms for Biologics
- An Introduction To Biopharmaceutical Facility Design & Layout
- FlexFactory™ Single-use Bioprocess Platform