One Size Does Not Fit All: Strategies for Bringing Advanced Therapy Medicinal Products to Market

The number of advanced therapy medicinal products (ATMP) on the global market is fewer than expected despite the large number of academic projects, start-ups, and small and medium-sized enterprises (SMEs) involved in their development. The low level of commercialization of the advanced medicines covering gene and cell therapies and tissue-engineered products has been attributed to a variety of factors such as the complexity of the technologies, high development costs, low investment returns, and difficulties with manufacturing processes. This presentation will showcase two case studies which outline different strategies to bring these unique products/therapies to market.

Learning Objectives:

  • Strategies for bringing small volume products to market
  • To learn about challenges in complying with ATMPs GMP rules
  • Gain a high level understanding of the variations of processes and their impact on facility design and operation
DNA - Advanced Therapy Medicinal Products

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Meet the Speakers:

Massimiliano Passerini, MSCh
General Manager
Angelantoni Life Science Srl

Massimiliano Passerini, who holds an MS in Chemistry from the University of Perugia and is a licensed Professional Chemist, has spent 20+ years in the Pharmaceutical and Medical Device industry across North America, South East Asia, Europe, and the Middle East gradually expanding his duties from product management to full P&L responsibilities.

Since 2008 he spent 10 years in the US serving the pharmaceutical industry by introducing in FDA audited manufacturing sites cGMP-compliant equipment for sterilization and containment. In 2018 he took a GM role at the Life Science business unit of the Angelantoni group to boost the company performances in the Medical Device arena, in the plasma fractionation process handling/storage, and in the pharmaceutical industry by means of the cold storage technologies developed, including robotic cryo-storage solutions.


Erich H. Bozenhardt
Process Manager
IPS - Integrated Project Services

Erich Bozenhardt is a BioProcess SME and internationally recognized authority in the domains of cell and gene therapy and bioprocessing. In his current role at IPS, he has the opportunity to establish a leadership position with numerous traditional biopharmaceutical, cell therapy and gene therapy manufacturing organizations in the design, engineering, construction and operations of new and renovated plants.

With a strong background in operations, engineering technology and FDA, EU, CDC, ECBC, and WHO compliance, Mr. Bozenhardt has built operating capabilities in BSL-1, 2, and 3 facilities. A significant aspect of his success is the ability to work with his clients and speak the language of operations ranging from pre-clinical development, through clinical trials, and into commercial operations. This allows him to expose variations and options in approach and then guide the clients to the best solution for them that meets their needs, those of the regulatory bodies and ultimately their patient base.


Meet the Moderator:

Jason S. Collins, AIA
Director, Process Architecture
IPS

Jason Collins is a process architect who develops concepts of pharmaceutical facilities for various clients around the world. He focuses on Advanced Aseptic Facility Design and is well-known for his knowledge of barrier and isolation technology. He has conceptualized and led the final design and construction services for numerous cutting-edge biopharmaceutical facilities around the world. As Director of Process Architecture at IPS, Jason’s focus is on designing integrated facilities that support manufacturing and operational processes. His designs lead to world class facilities that not only produce product, but can be maintained and operated efficiently and safely. Jason is a registered architect and has a degree in Architecture from The Pennsylvania State University.