Simplifying Global Compliance
The Biopharmaceutical Facility of the Future - Webinar CD/Transcript
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The Biopharmaceutical Facility of the Future: To 2025 and Beyond
The biopharmaceutical facilities that we design, build and renovate today — while evolving to accommodate new process technology and multiple products — will bear little resemblance to facilities of the future. Drivers of transformation in the industry include:
- Global regulatory harmonization
- Return on investment
- Relocation/adaptation to areas with more favorable tax structures
- Speed of product introduction
- Scalability at a rapid pace, as needed
- The ability to repurpose a facility, process or equipment instantly
- Mergers, acquisitions, and divestiture
Manufacturers will continue to focus on large molecules, novel delivery systems, and continuous processing; they’ll use small batch sizes to accommodate both the requirements of lower risk for high-value and high-volume products, and more individualized medicines. Thus, the facilities, processes, and filling will be profoundly different, even as the packaging remains recognizable. The financial drivers mentioned above will force a revolution in the process area, and we’ll see developments such as:
- Fully contained and disposable process equipment
- Inert system with no exposure to any atmosphere
- Pod-based, autonomous facilities/rooms
- Robotic assembly/disassembly of processes
- Humans existing only in ISO 8 environments
- PAT- and sensor-based quality control and release
Herman and Erich Bozenhardt will explore the commercial factors which are driving the industry — and often not towards success. Second, they’ll discuss the establishment of a joint global regulatory agency. Based on the business aspects, they’ll define future process requirements and provide a view of how change is accelerating from evolution to revolution. Finally, with the processes designed, they’ll discuss what manufacturing plants will eventually become and how they’ll support compliant production.
You will get an inside-out view of a future plant’s design model: Process Core, Facility Design, Facility Operations, HVAC, Utilities, and Construction. This presentation will explore these critical aspects, expose you to technologies available today from a design and compliance perspective, and provide you with specific guidelines and direction on how you can use them right now.
Specifically you will learn:
- The process technologies driving the future of the business
- A glimpse of the minimalist, modular state that companies will evolve towards
- The future of compliance — a singular “bullet-proof” concept without contamination
- What you can do today to enhance your production and become part of the revolution
- Compliance officers
- Engineering and design controls teams
- Executive management
- Managers
- Manufacturing directors and supervisors
- Pharmaceutical and cGMP auditors
- QA/QC personnel
- Risk management specialists
- Strategic planning and business development staff
- Validation specialists, scientists, engineers
Meet Your Presenters
Herman Bozenhardt has 39 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies. Mr. Bozenhardt is also a recognized expert in the area of aseptic filling facilities and systems, with service to Novo Nordisk, DSM, Catalent, Organon Teknika, Bausch and Lomb, Alcon, J&J, Bristol Myers Squibb, and Janssen Pharmaceuticals, as well as operations positions within Pfizer. Mr. Bozenhardt has extensive experience in the manufacturing of therapeutic biologicals and vaccines via cell culture technology, human plasma derivation and egg-based technologies. Prior to being an executive consultant, Mr. Bozenhardt was an engineering executive with Life Sciences International, Foster Wheeler, Aker Kvaerner, and KBR. Mr. Bozenhardt has a BS in Chemical Engineering and MS in System Engineering from the Polytechnic Institute of Brooklyn (now Polytechnic Institute of NYU).
Erich Bozenhardt is the head of the process group of the IPS Engineers in Raleigh NC. Mr. Bozenhardt has 10 years of experience in the biotechnology and aseptic processing business. Mr. Bozenhardt has led several biological manufacturing projects including cell therapies, mammalian cell culture, and novel delivery systems. Mr. Bozenhardt has a BS Chemical Engineering and a MBA, both from the University of Delaware.