Experts Give "Sneak Peeks" into INTERPHEX 2013 Conference Presentations

The conference schedule at INTERPHEX 2013 covers a wide range of topics, including facility and process design, product development, and regulatory quality assurance. Pharmaceutical Technology interviewed some of the speakers to get a preview of their presentations. Access the podcasts using the links below.

Modularization
Modularization has been used by other industries for decades and, over the last few years, has been more accepted by the bio/pharmaceutical industry. Modularization is fast becoming an essential component of bio/pharmaceutical facility design. Use of modularization is growing because it meets industry needs for reduced cost, accelerated construction schedules, and quality construction. The need for offsite skilled labor to construct hygienic components in a controlled, quality location is increasing, notes Craig Sandstrom, director of process engineering at Fluor, driven in part by the growth of construction in locations such as Asia or South America where local trades aren’t as mature as in North America and Europe.

The concept of “standardization” in modularization is often misunderstood, comments Par Almhem, president of ModWave and Modular Partners. He explains that a process can be divided into discrete operations with defined inputs and outputs, and a variety of systems can then be made from these standard building blocks (i.e., modules). In the future, modules will be used more widely as a more efficient way of building anything, whether it is a physical building, a software system, or a bio/pharmaceutical process, predicts Almhem.

Sandra Leuken from Baxter Pharmaceuticals, Par Almhen from Modular Partners, Detlef Kehm from Grifols, and Craig Sandstrom from Fluor are part of a panel discussion, “Getting Excited about the Modular Experience” (1:30-3:00 pm Wednesday, April 24).  Par’s presentation is on “Advances in modularization: standardization, modular unit operations, and global deployment,” and Craig’s presentation is titled, “Modularization overview and implementation strategies.”

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Craig Sandstrom, FluorPar Almhem, Modular Partners

Single-use Systems in Traditional Stainless-Steel Facilities
Advantages of single-use systems are well known. These include reducing cleaning costs, floor space requirements, and classified-space requirements. One of the biggest advantages, says Jeff Odum, director of operations at IPS–Integrated Project Services, is flexibility, particularly related to process changes in early-stage development. He explains that there are several types of companies that can benefit from the flexibility of single-use systems. These include contract manufacturing organizations (CMOs), research-driven organizations doing high-level development work, and companies focused on pandemic response, all of which need to adapt to new technologies. Academic institutions can benefit from the lower capital requirements. “Any manufacturing organization should explore the potential advantages of this technology,” says Odum.

The IPS presentation, “Implementing Single-Use Biomanufacturing Systems into Traditional Stainless Steel-based Facilities,” will be held on Tuesday, April 23 from 2:45-3:45 pm.

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Jeff Odum, IPS

Process Development and Validation
The International Conference on Harmonisation (ICH) guidance for industry, Q8(R2) Pharmaceutical Development and FDA’s Guidance for Industry Process Validation: General Principles and Practices describe approaches for development and validation of pharmaceutical processes (1, 2). These concepts can also provide a scientific basis for the development and validation of cleaning processes, says Keith Bader, senior director of technology at Hyde Engineering + Consulting. Cleaning processes have traditionally been developed on full-scale manufacturing equipment using general industry information without real regard for the nature of actual residues and their removal. Validation of cleaning processes, likewise, has in the past relied only on monitoring critical process parameters, such as temperature and concentration of cleaning solution, and using a fixed cycle time rather than using forward-processing criteria to indicate when the cleaning process is complete. Moving forward, however, process analytical technology and better understanding of the cleaning process design space can improve decision making and result in more efficient cleaning, explains Bader.

Keith’s presentation, “Establishing a design space: cleaning process development and validation,” will be held on Tuesday, April 23, from 11:30 am to 12:30 pm.

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Keith Bader, Hyde Engineering + Consulting

Each company must implement its own continuous validation program (CVP) for its systems based on current FDA guidelines (2). Defining a CVP helps plan and prioritize validation projects and determine personnel requirements and budgets, notes Victor Hernandez, senior process validation engineer, project engineer III, in the Sustainable Engineering department at EMD Millipore in Jaffrey, New Hampshire.  Procedures and policies must be transferred from the corporate level to the division level and to specific sites, where they must be applied to specific manufacturing processes. In his case-study presentation, Hernandez describes how the EMD Millipore Jaffrey site helped bring Merck’s CVP in line with current trends and apply it to EMD Millipore Corporate division and to EMD Millipore separation and filtration device-system manufacturing processes at various sites, following Millipore’s acquisition by Merck KGaA.
 
Victor’s presentation, “Current continuous process validation program: following FDA current guidelines,” will be held on Wednesday, April 24 from 1:30-2:30 pm.

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Victor Hernandez, EMD Millipore

Quality by Design
A panel discussion moderated by Pharmaceutical Technology will examine the lessons learned, successes achieved, and ongoing challenges of implementing QbD in pharmaceutical manufacturing.  Dr. John Lepore, senior director of Chemical Process Development and Commercialization for Global Pharmaceutical Commercialization at Merck and Co., will provide expertise on application of design space and control strategies for API manufacturing. Dr. Chris Moreton of FinnBrit Consulting will share his expertise in how to incorporate excipients into the design space. Jonathon Thompson, senior manager of Compliance Services Consulting at Invensys Operations Management will use his experience to discuss challenges in adapting the manufacturing process from a control perspective, including the feasibility of real time release. Together, the panel will consider the benefits of adapting QbD and the challenges yet to be addressed.

The panel discussion, “Lessons Learned: Successes and Challenges in Implementing Quality by Design,” will be held on Wednesday, April 24, from 10:15-11:15 am.

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Panel discussion

References:

1. ICH, Q8(R2) Pharmaceutical Development, Step 4 version(2009).
2. FDA, Guidance for Industry, Process Validation: General Principles and Practices, CDER (January 2011).