Off-site manufacturing: A solution
To technology transfer challenges
Technology transfer is a key challenge whenever setting up new production, whether it’s scaling up from development for a commercial launch of a new product, increasing existing production by building a new facility or establishing local production to launch an approved product on a new market. Distance, local building regulations, regulatory product approval, and cultural aspects are among the hurdles.
By ensuring identical manufacturing processes, the need for costly and time-delaying clinical studies is avoided and the regulatory approval process can be reduced. Modular, movable facilities can add value. This can be a rapid, cost-effective, and low-risk solution for pharmaceutical companies looking to build identical production facilities across Europe, the US, and anywhere else in the world. Another example would be for companies looking to establish local production in developing countries with limited access to engineering- and process expertise.
Modular manufacturing is one way to ensure that your production process can be reproduced and regulatory changes can be eliminated. And with movable facilities, you can easily control the technology transfer process. For example, you can train operators for any location where the facility is to be placed close to current operations (or at KeyPlants’ workshop) vs performing all tech transfer activities at a distant location for a new market.
Also, KeyPlants has the expertise to carry out off-site fabrication and pre-qualification efficiently, with minimum site disruption through rapid deployment of modular, movable facilities.
- A compliant regulatory pathway: Limited differences between the existing and new facilities to ensure smooth regulatory approval.
- Movability: A complete manufacturing facility can be built in one location, further equipped, tested, and qualified in another location, and then moved again to a final site to begin production.
- Off-site manufacturing: A complete building with clean rooms, process equipment, and utilities.
- Work performed under workshop conditions according to agreed specifications.
By performing the tech transfer activities at the current manufacturing site, our customers are able to benefit from the full expertise and knowledge of their staff. This means no loss of information, knowledge, or experience because the tech transfer occurs at the sending unit location.
With KeyPlants’ off-site modular approach, the facility design and manufacturing can also be conducted in parallel with search, permitting, and preparations at the final site. This further reduces the timeline.
Modular manufacturing advantages include:
- Ensuring the quality of a new facility right from the start
- Reducing time to market (from development to commercial launch of new products, or to establish local production and launch of an approved product on a new market)
- Efficient Qualification
- Accurate and more comprehensive transfer of knowledge
- No need to wait for the final location to start construction
- Rapid deployment of GMP operations
- Overcoming Tech Transfer challenges
- Predictable and competitive cost
- Faster time to market.
- Cost and schedule predictability.
- Fewer site disturbances and increased safety.
- Less impact on daily business and site regulatory requirements (e.g., update of Site Master Plan).
- Flexibility of the facility – expandable and movable.
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1) KeyPlants designs and manages the project. We build the facility under workshop conditions according to agreed specifications and install process and utility equipment.
2) KeyPlants relocates the facility to the client’s center of excellence.
3) The client works on the facility to develop SOPs, optimize the process, and train operators.
4) The facility is shipped to its final destination.
Learn more about Modular Solutions
Expanding production? Launching a new product? The KeyPlants team has decades of proven, worldwide experience building modular, turnkey facilities for the world’s leading pharmaceutical and biotech companies. Our modular and POD agile design solutions meet the demanding requirements of today’s business needs in the production of therapeutics.
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