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The CPhI Pharma Awards recognise the innovation and dedication of companies and individuals who are driving the pharmaceutical industry forward. The CPhI Pharma Awards celebrate the thinkers and creators driving the industry forward through their innovations, technologies and strategies.

Short Project Description

The modular facility was designed and manufactured by KeyPlants in Sweden, shipped to Kiel (Germany) for Tech Transfer, production trials and process validation and finally shipped to Indonesia for validation batches, commercial production and launch.

Having the new facility initially assembled, commissioned and qualified in Kiel, with the availability of technical experts and process specialists on hand was critical for the success of the Tech-Transfer.   

The newly formed production team from Indonesia travelled to Kiel for training, to take over and qualify the new modular units. This reduced the risk of knowledge transfer and simplified the Tech Transfer activities.

With KeyPlants’ off-site modular approach, the facility design and manufacturing could be conducted in parallel with search and preparations at the final site. This further reduced the timeline.

Innovation

This is a unique solution for rapid deployment of modular, movable facilities.

The novelty is the combination of two innovations:

• 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 construction: A complete building with clean rooms, process equipment, and utilities.

Features

This solution introduces an innovative Tech Transfer approach by performing the tech transfer activities at the sending unit, in this case Kiel, Germany, to its final destination in Indonesia. In so doing, we were able to derive benefit from the full expertise and knowledge of the people at the current manufacturing site.

– No loss of information, knowledge or experience because the tech-transfer occurs at the sending unit location

– 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

Problem-solving

When establishing facilities in new markets, there are challenges to ensuring identical duplication of manufacturing processes, equipment and ways of working, using conventional methods. Distance, local regulations and cultural aspects can be a challenge. Challenges with Tech Transfer often includes loss of information when transferring from distant sending unit to receiving unit.

Establishing new pharmaceutical manufacturing facilities is very time consuming using conventional construction methods.

In summary, the following issues are being addressed with modular, movable facilities:

• Ensuring the quality of a new facility right from the start
• Reducing time to market (to establish local production and launch of an approved product on a new market)
• Efficient Qualification
• Accurate and more comprehensive transfer of knowledge

Competitive Advantage

Competitive advantages compared to conventional methods:

• No need to wait for the final location to start construction
• Rapid deployment of manufacturing facilities
• Overcoming Tech Transfer challenges
• Predictable and competitive cost

KeyPlants has made a donation to the Swedish Childhood Cancer Fund. With the donation, the fund can come closer to their vision; to eradicate childhood cancer. Donations are used for research and training, advice and support, and information, the three missions of the Swedish Childhood Cancer Fund.

The Swedish Childhood Cancer Fund works to fight childhood cancer and ensures that affected children, teens and their families receive the care and the support they need.

Webinar September 23

3:00 PM – 4:00 PM CET

Learn more about what is required to establish new operations for vaccine production and gain understanding about facility design for vaccine manufacturing.

Sign up:   https://my.demio.com/ref/OXD3mTz0kSGzrn41h

Questions?   Please send an email to [email protected]

Welcome to join this free Webinar!

Agenda

3:00 PM – 3:30 PM

Road map to establish local vaccine manufacturing

Learn about the current vaccine industry landscape and what is required to establish new vaccine manufacturing capabilities. Gain understanding of what is needed in terms of know-how, competence and resources.

Kristopher Howard, Global Vaccine Consultant, NRL Enterprise Solutions

3:30 PM – 4:00 PM

Rapid deployment of vaccine facilities

Facility design for common vaccine manufacturing technologies will be discussed. How to establish a new plant with speed, flexibility and predictability. Consequences on facility design based on manufacturing technology.

Åsa Gaasvik, Senior Design Engineer, KeyPlants

KeyPlants has signed an agreement with one of the worlds’ largest pharmaceutical companies! We will support their organisation in building a modular vaccine facility for drug substance manufacturing and fill finish. The facility will be delivered already in early 2021 and be producing hundreds of millions of vaccine doses when operational. The facility will be designed and manufactured by KeyPlants’ in Sweden.

Webinar June 24

3:00 PM – 4:00 PM CET

Learn about new opportunities with digitalization in pharmaceutical manufacturing.

Sign up:   https://my.demio.com/ref/32Rdhk9vOYMVHIdO

Questions?   Please send an email to [email protected]

Welcome to join this free Webinar!

Agenda

3:00 PM – 3:30 PM

Next generation robotic filling technologies

Learn about the next generation of aseptic filling technologies by means of using robotics, eliminating of operator errors and benefiting of IoT services and solutions.

Marius Römer, Product Manager, Groninger

3:30 PM – 4:00 PM

AI driven value creation

How can pharmaceutical manufacturers work with AI and automation to improve efficiencies? Increase yield, reduce processing time and improve consistency are the key areas where AI and automation add value. Big data, machine learning, anomaly detection, and artificial intelligence are topics that will be discussed.

Lukas Vikander, Automation Engineer, KeyPlants