Pre-Engineered Facility Design Platforms for
Biologics Manufacturing Facilities
KeyPlants’ pre-engineered design platforms for biologics manufacturing facilities and fill-finish operations have been developed to:
- Simplify construction
- Offer a fast-track solution to build capacity
- Ease future expansion
- Adapt to future requirements
These solutions to rapidly deploy drug substance and drug product manufacturing capabilities, include clean room space and technical areas, integrated with process equipment and clean utilities.
Our standardised, pre-engineered modular solutions can be configured and combined to provide a facility that can be rapidly designed, built, and deployed globally.
Contact us to see how we can organise, execute, and document your project from initiation to client takeover.
Modular Bio Solutions (MBS) for Drug Substance Facilities
Our pre-engineered modular platform for biomanufacturing facilities (MBS) is designed for rapid deployment globally. With minor changes to our Modular Bio Solutions™ pre-engineered design platform, it is possible to accommodate any biopharmaceutical process based on cell culture or bacterial fermentation. MBS is currently available for the following biomanufacturing processes:
- mRNA
- Therapeutic proteins
- Monoclonal antibodies
- Cell therapies
- Viral Vectors (vaccines and gene therapies)
- Microbial Vaccines
We have also developed solutions for filling biopharmaceuticals in several dosage forms, including vials (including lyophilisation), pre-filled syringes, cartridges and pre-sterilised glass and plastic solutions. We call these Modular Aseptic Solutions (MAS).
Contact us to see exactly how we can organise, execute, and document your project from initiation to client takeover.
Modular Aseptic Solutions (MAS) for Drug Product Facilities
Our pre-engineered modular design platform for aseptic processing facilities (MAS) for small volume parenterals (SVP) are designed for rapid deployment globally. They maximize production flexibility in two important ways:
- They shorten the Concept Design and Basic Design phases, resulting in a delivery time as short as 12 months, for a fully functional aseptic filling facility
- Their flexible concept allows for expansion and easy add-ons, with minimal interruption to existing operations
MAS are particularly suitable for dosing liquids in pre-sterilised, ready-to-use (RTU) containers. Combining RTU and modular execution results in an especially strong business case. Our drug product pre-engineered design platforms are available for:
- Liquid solutions or lyophilisation
- Vials, cartridges and/or pre-filled syringes
- RABS or Isolator Technology
Pods cut lead times to weeks
Our portable on-demand (pod) facilities dramatically reduces the time it takes to set up new production, speeding up the development of cutting-edge therapies, and increasing production flexibility. pods can be on site and ready for operation anywhere in the world, in just few weeks for a single pod, compared to a year or more to build a conventional facility from scratch. They also offer maximum flexibility in production. pods give manufacturers:
- Flexibility to start small-scale production immediately and then scale out
- The advantages of a fixed price and time schedule
- A turnkey, integrated approach instead of pieces of a facility/process engineering puzzle
- An end to the time and complexity of specification, bidding, procurement, and permitting
- Lower total cost of ownership (TCO)
Pods are the fastest way to start or expand production, which will result in innovative, cost-effective solutions, from clinical development to commercialisation, since the total cost of ownership will be reduced. pod facilities can be sized-up by adding pods, and are also a solution for the small-scale production of cell and gene therapies, for example.
FAQ
FAQ
What is a biologics manufacturing facility?
A biologics manufacturing facility is a specialized plant designed for the production of biologic drugs, such as monoclonal antibodies, cell therapies, and vaccines. These facilities require strict control over environmental conditions and are often built with modular cleanroom technologies.
A biologics manufacturing facility is a specialized plant designed for the production of biologic drugs, such as monoclonal antibodies, cell therapies, and vaccines. These facilities require strict control over environmental conditions and are often built with modular cleanroom technologies.
What are the benefits of using a modular solution for biologics manufacturing facilities?
Modular solutions allow for faster construction, cost efficiency, and easier scalability. KeyPlants’ pre-engineered platforms enable biologics manufacturing facilities to be deployed rapidly while maintaining regulatory compliance and operational flexibility.
Modular solutions allow for faster construction, cost efficiency, and easier scalability. KeyPlants’ pre-engineered platforms enable biologics manufacturing facilities to be deployed rapidly while maintaining regulatory compliance and operational flexibility.
Can modular biologics manufacturing facilities support mRNA and cell therapy production?
Yes, our modular platforms are designed to support a wide range of biomanufacturing processes, including mRNA, cell and gene therapies, monoclonal antibodies, and microbial vaccines.
Yes, our modular platforms are designed to support a wide range of biomanufacturing processes, including mRNA, cell and gene therapies, monoclonal antibodies, and microbial vaccines.
How quickly can a biologics manufacturing facility be deployed using KeyPlants’ platform?
With our standardized, pre-engineered designs, a fully functional biologics manufacturing facility can be delivered in as little as 12 months, significantly reducing traditional construction timelines.
With our standardized, pre-engineered designs, a fully functional biologics manufacturing facility can be delivered in as little as 12 months, significantly reducing traditional construction timelines.
Are KeyPlants’ biologics manufacturing facilities compliant with global regulatory standards?
Yes, all our modular biologics manufacturing facilities are designed to meet international GMP (Good Manufacturing Practice) standards and can be customized to align with specific regulatory requirements in your target markets.
Yes, all our modular biologics manufacturing facilities are designed to meet international GMP (Good Manufacturing Practice) standards and can be customized to align with specific regulatory requirements in your target markets.
Our projects
“Bringing Strategic Generics to new markets requires speed and skills. That’s why Stragen Pharma chose KeyPlants as our partner”
“80% of all conventional projects are delayed by more than four months."
“KeyPlants took responsibility from project start to implementation. A successful delivery, on time, with a tight schedule.”
