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Live Webinar April 28 at 3pm – 4pm CET

Learn about the benefits of process simulation and scheduling  tools for debottlenecking, capacity increase and design of biopharmaceutical facilities. Gain a better understanding of SuperPro Designer and SchedulePro through actual case studies.

Sign up: https://lnkd.in/ecRKMqh

Questions? Please send an email to [email protected]

Welcome to join this free Webinar!

Agenda

The role of process simulation and scheduling tools in the biopharmaceutical industries with emphasis on cycle time reduction, debottlenecking, utility system sizing and multi-product facility design.

Demetri Petrides, President, Intelligen, Inc.

Learn from KeyPlants experience and case studies about capital investment projects in the biomanufacturing industry. How to use scheduling tools:

• Facility design based on process modelling
• Identify existing bottlenecks to increase capacity
• Provide insights for capital investment decisions
• Validate feasibility of a developed design concept

Ted Witherow, Process Engineer, KeyPlants

The need for more capacity to produce vaccines has increased since the COVID-19 outbreak. Global manufacturing trends are changing, and trends started years ago are being accelerated. There is a market demand to establish new vaccine facilities with speed, flexibility and predictability. This will be discussed as well as consequences on facility design based on manufacturing technology.

KeyPlants will be participating at New Horizons in Biologics & Bioprocessing on December 17th. At the event, David Lindholm will be talking about rapid deployment of vaccine facilities.

This digital event is free of charge. Registration and conference programme at http://www.bioprocessing.se/arrangement/page.xhtml?arrangeSubpage=489

Join and listen to KeyPlants’ presentation if you’re interested in this topic. It is possible to register and listen to the recorded version of the presentation also after December 17, after registration.

David Lindholm, Head of Sales at KeyPlants will be presenting at Cleanzone digital conference on November 18th.

Topic

Rapid Deployment of Vaccine Facilities.

Event information

https://cleanzone.messefrankfurt.com/frankfurt/en.html

Program Nov 18th with KeyPlants speaker slot at 11 AM.
https://events.messefrankfurt.com/2020/cleanzone/en/cleanzone-2020—program/18-11-2020/Calendar

PRESS RELEASE ONE

ZICCUM takes lead on new pilot study of vaccine plant producing cost-effective thermostable vaccines at volume with KeyPlants as engineering partner 

Ziccum has produced a pilot study, including blueprints and costings, exploring the technical and financial viability of a Fill and Finish plant producing thermostable air-dried vaccines at volume. The plan, produced in collaboration with leading modular plant construction specialist KeyPlants AB, indicates significant financial benefits from formulating and packaging vaccines based on Ziccum’s LaminarPace ambient dry-formulation technology. Ziccum will now move forward and seek strategic partnerships for establishing a pilot plant for vaccine manufacturing.

One of Ziccum’s key strategic goals has always been the integration of its dry-formulation technology LaminarPace into large-scale vaccine manufacturing – as demonstrated by recent patent applications on key technical aspects of its technology. Ziccum CEO Göran Conradson: “We have long stated our commitment to integrating LaminarPace into an industrial GMP environment. The detailed project planning we have carried out with KeyPlants has clarified for us the enormous scale of the savings our technology offers over today’s standard lyophilization processes, and how achievable the concept is as well. With KeyPlants we have a partner with high expertise not only in pharmaceutical facility design and engineering, but also in vaccine production and aseptic processing solutions. The core and modular technology for these new facilities is already available, and the limitations of our present vaccine supply chain are clear. The need to increase global vaccine manufacturing volume and coverage, and to make it more affordable, is urgent. This is a historic opportunity.”

Ziccum AB’s air-drying technology transforms liquid vaccine solutions into thermostable dry powders. Unlike currently available commercial vaccines and vaccines in development, these dry powder vaccines can be stored and transported at ambient temperatures for extended periods. They require no Cold Chain and meet WHO CTC (Controlled Temperature Chain) requirements.

Ziccum has identified ‘Fill and Finish’ (F/F), the third and final stage of vaccine production, where medical vials are filled with vaccine solutions and packaged for distribution, as a key target area of vaccine production that would profit from Ziccum capabilities. The vast majority of today’s F/F plants formulate, store and pack vaccines as liquid or lyophilized (freeze-dried) solutions – both are complex, costly, energy-intensive processes compared to ambient air drying.

Together with KeyPlants AB, a global leader in agile modular solutions who have carried out more than 50 projects globally, including F/F vaccine facilities, Ziccum has now drawn up detailed blueprints for a 36 m x 27 m two-floor F/F plant that would be able to produce up to 30 million doses of dry-formulated vaccine a year at an estimated 65% lower OPEX cost and 50% lower CAPEX cost than today’s standard lyophilization F/F plants. The pilot study report is attracting interest from some leading vaccine industry peers.

David Lindholm, head of Sales at KeyPlants: “We currently see a strong demand for new vaccine facilities and we’re currently working on several vaccine projects for customers worldwide. At KeyPlants we’re proud to be a key partner to Ziccum and we see great benefits with their LAPA-technology. This technology will not only significantly reduce facility CAPEX- and OPEX-costs, but also increase vaccine access and safety through the removal of the cold chain distribution.”

Ziccum CEO Göran Conradson: “We have made great progress with our other two key strategy areas – growing our IP portfolio of dry-formulated vaccines for license, and increasing our collaborations with vaccine research and stakeholder groups – we absolutely intend to keep developing those. Now, with the scale of potential savings revealed by our pilot study, we are focusing on building new collaborations and strategic partnerships to unlock funding and investment and move ahead towards capturing this extraordinary opportunity.   

“Our roots are in dry-powder aerosol technology, bringing the benefits of dry-formulation to vaccines could benefit millions around the world. We all consume essential food and pharma products in dry form as standard every day – knowing it means they can be stored and transported to more people, more cost-effectively. So why can’t we do the same with vaccines? The fact is we can. Now is the time for realistic new solutions for vaccine distribution. As an industry, we need to look again at what’s possible.”

For more information about Ziccum, please contact:

Göran Conradson: CEO Ziccum AB
E-mail: [email protected]
Mobile: +46 709 61 55 99

About Ziccum

Ziccum AB (publ) develops new patented formulations of biological drugs where sensitivity to temperature differences, especially during transportation, currently limits medical and so commercial potential. The company’s patented technology, LaminarPace, develops dry powder formulations of drugs and vaccines that currently only exist in liquid form. By doing so Ziccum can increase the availability of drugs and vaccines in existing markets—and open up new ones.

For more information about KeyPlants, please contact:

David Lindholm: Head of Sales KeyPlants AB
E-mail: [email protected]
Mobile: +46 703 295 868

About KeyPlants

KeyPlants provides fast track process and facility solutions for the Life Science and Advanced Technology Industries. KeyPlants is a global leader in modular facility solutions, having executed more than 50 modular projects globally. Pharmaceutical manufacturers around the world benefit from their modular off-site construction. Headquartered in Stockholm, Sweden, KeyPlants also provide engineering solutions and execute conventional pharmaceutical facility projects in the Nordic countries. Capabilities include full in-house design and construction as well as Subject Matter Expertise in Biomanufacturing, Aseptic Filling, Containment and Manufacturing of APIs and Oral Solids.

This press release has jointly been submitted for publication by the company’s CEO’s at 08.00 (CET) on October 16, 2020.

About the awards

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