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Complimentary Webinar for ISPE Members and Non-Members

Innovations & Solutions
In Response to the Biopharmaceutical GMP

Capacity Crunch

Format:
GoToWebinar
Instructions to join will be emailed one day prior

Program Managers:
Emily (Nelson) Hess, Senior Director, Azzur Group
Nicki Lange, Director of Business Development, West Coast, G-CON Manufacturing Inc.
Stacy Pham, Project Manager, CAI

Speakers:

Daniel Dernbach, Vice President of Operations, Azzur Cleanrooms on Demand
Maik W. Jornitz, President and CEO, G-CON Manufacturing Inc.
George Wiker, CEO, CleanSpace, LLC.

Overview:

Biopharmaceutical manufacturing capacity was a highly desirable entity before COVID. Now we see the capacity shortage accelerating, which requires new approaches in the capacity build-out. Find out what innovations can alleviate the urgent needs.

About The Speakers and Their Companies

Daniel Dernbach is Vice President of Operations of Azzur Cleanrooms on Demand and has more than 25 years of experience in life science and healthcare, Dan brings comprehensive operational expertise to Azzur Cleanrooms on Demand’s Operations. Dan joined Azzur from Integrated DNA Technologies, Inc. in San Diego. There, he served as General Manager of West Coast Operations for 14 years after nearly a decade of progressive roles of increasing responsibility at the company’s Coralville, IA site. His focus was on the manufacturing of a variety of products serving the biotherapeutic and diagnostic markets. During that time, he oversaw all operations for two manufacturing sites, including manufacturing, facilities, logistics, engineering maintenance, and quality assurance. Dan holds a Bachelor of Science degree in biology and biochemistry from the University of Minnesota - Twin Cities.

In order to address the capacity crunch in the biopharma industry, Azzur Cleanrooms on Demand offers flexible manufacturing suites and support services. Utilizing modular cleanrooms and innovative design elements, Azzur’s facilities provide opportunities to accelerate early phase clinical manufacturing. Partner companies are able to focus on their manufacturing needs without the burden of facility ownership and operation. Multiple product lines can be manufactured simultaneously saving time and space. These facilities offer flexibility while still maintaining compliance.

Highlights Include:

  • Traditional approaches vs COD
  • Accelerated timeline examples for transitioning from R&D to clinical operations
  • Innovative design elements for multi-product facilities
  • Applicability and compliance aspects

Maik W. Jornitz is President and CEO of G-CON Manufacturing Inc. He is a technical expert with over 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. He has published 11 books, 18 book chapters and over 100 scientific papers. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces. He is a working member of Biophorum, ASTM, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. He recently has been recognized as one of the top ten global industry influencers. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland


New facility designs and systems are being introduced into the industry, ones that can be scaled, easily deployed and moved, if necessary. Prefabricated cleanroom units now replace so-called flexible modular structures, which did not show the necessary flexibility. These units are built off-site in a few weeks and moved into the shell building which is erected parallel to the manufacture of the cleanroom units. Such structures create flexibility, scalability, but moreover repurposability. Prefabricated systems also allow platform designs and possible integration of equipment to be drop shipped to the location needed within a cleanroom infrastructure.

George Wiker is CEO of CleanSpace, LLC. and has over 27 years of experience in the development of manufacturing facilities and operations. His particular focus is on process architecture (concept design), often leading the conceptual design for projects, analyzing and developing process flows, operational ergonomics, compliance drivers, as well as incorporating new industry trends. George has also managed and designed pharmbio projects of various types throughout the Americas, Europe and Asia. He has been part of many project teams from concept through construction and qualification, on small projects to projects over $350MM. He is also is a contributing author and lecturer, providing insight, trends, ideas and concepts to user groups and industry professionals.

As the use and implementation of modular systems become more mainstream in the development of life science projects, it is important to understand how to effectively implement and integrate these modular systems into projects. Traditional project execution methods must change and evolve, relying on key suppliers to integrate their product-driven solutions into the delivery process, and leverage these suppliers’ capabilities to reduce cost and time to fully deliver these projects, while increasing quality.

Items to be reviewed:

  • Modularity by design – Think Modular!
  • Modular methods of construction
  • Modular compared to stickframe
  • The benefits of modular

DETAILS

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