- November 09, 2015
By Bill Lydon, Editor
The growing need in the biotechnology industry for many new products that serve smaller populations is driving manufacturers to consider highly flexible, modular facilities. The emerging ‚ÄúFactory of the Future‚Äù model is intended to address this new customized, small-batch product demand.
Perspectives from the 2014 Pharmaceutical Automation Roundtable
By Bill Lydon, Editor
Pharmaceutical automation leaders from around the world gathered for the annual Pharmaceutical Automation Roundtable (PAR) at Bristol Myers Squibb in Devens, Massachusetts to discuss a number of automation challenges facing their companies. While the content was specific to the pharmaceutical and biotech industries, these challenges are certainly applicable to all industry segments.
This article reviews the highlights of a presentation made about Automation and “Factory of the Future”, focusing on challenges in automating flexible biotech facilities.
What is “Factory of the Future?”
The presenter explored the notion of the “Factory of the Future.” Automation professionals typically think about the future in terms of technology and integrating systems that include ISA88 and ISA95 standards, MES, DCS, BAS, LIMS, PLC, and business enterprise systems. The pharmaceutical industry is quickly moving away from large block buster medications towards more personalized medicines. This trend requires much more flexible manufacturing facilities.
The presenter used the example of one flexible manufacturing facility - the Biogen Idec Flexible Volume Manufacturing (FVM) Facility that was the 2013 ISPE Facility of the Year award winner in the category Facility Integration. The manufacturing methods employed at Biogen provide for a flexible, multi-product environment, with less initial capital investment, reduced utility demands, and increased speed through the product pipeline as compared to traditional biotech manufacturing methods. More information on this award: http://www.ispe.org/foya-winners-2013.
The presenter quoted the ISPE International Leadership Forum on Global Positioning Strategy from May of 2012:
“The pharmaceutical and biotechnology industry is experiencing rapid, significant, and revolutionary change…These products are becoming more diverse with treatments targeted at patients with specific disease subtypes...The technologies needed to manufacture these new therapies are becoming more complex, requiring significant investment at a time when there is already overcapacity and excessive cost.”
There is a growing need in the biotechnology industry for many new products, serving smaller populations. These products are primarily based on sterile biotechnology processes and robust well-known unit operations, that will be high yielding and small batch volumes compared to past biotech products. The emerging “Factory of the Future” model is intended to address this environment.
Aspects of the factory of the future are envisioned as a “standardized” repeatable facility with a “Flexible Core.” Facility design, structural layout, and automation can be similar or identical in many facilities. This replication allows leveraging of standard designs, either from outsourced firms or across projects internally. The “Flexible Core” focuses on GMP (Good Manufacturing Practices) unit operations for late clinical or commercial launch. This flexible approach enables production of multiple products in small to medium batch volumes (2,000 liter and under) with modular, disposable, single use technologies. Mobile units can be moved in/out based on each product and production demands. This approach also enables rapid process development and startup of new processes.
Over the past 15 years, automation technology has changed and is moving towards enterprise level automation with DCS, process data collection, and historians. There has also been rapid growth of lower level automation including integrated HMI/PLC products, automation accessible to smaller scale operations, and OEM-supplied systems. Elements of both technology evolutions may be required to implement the Factory of the Future.
The presenter posed a key question, “Are automation industry strategy and pharmaceutical manufacturing changes moving to strategic alignment or are they diverging?” He discussed how the automation industry has evolved to server-based systems with centralized data. However, now the pharmaceutical industry strategy is moving towards small scale, single use (disposable), plug and play, mobile, and modular production.
Automation and the industry have some alignment with repeatability, modularization, and rapid commercialization. Automation ensures process repeatability with execution the same way, every time. Modularization, with a well-designed S88 platform allows easy replication for additional modules or for duplicating facilities. If clinical development and production is performed on standard industrial platforms, rapid commercialization can be accomplished. Applied correctly, these elements are actually a strong fit with the “Factory of the Future,” especially if the facility or manufacturing site is to be replicated.
Factory of the Future Impact on Automation Strategy
Focus on disposables will introduce new failure modes, particularly with more operator set-ups required. Disposables require different instrumentation and control devices. The same levels of accuracy and reliability may not yet be available with disposable instrumentation.
The focus on small scale means lab systems will enter the GMP production environment often characterized by proprietary control platforms which limit customization. Vendors and R&D personnel are not leveraged in the engineering specification process.
Batch Records and Regulatory Strategy
We see more frequent “non-GMP” development operations yet systems still must meet applicable regulations depending on their intended use. Plug and play is essential to achieve scalability and portability goals.
Development & Manufacturing Alignment
Highly flexible manufacturing requires standardization and close alignment between product development and manufacturing groups.
Modular equipment and controls changes validation strategy. Functional tests (qualification) may be reduced but other areas of validation will emerge (such as leachable/extractable studies).
These are comments from PAR group members during the Factory of the Future discussion.
The inherent limitation with the concept of modular flexible manufacturing is you cannot automate what is not yet defined.
Generally participants expressed that various levels of modularity is starting to be adopted at their companies for flexibility.
OEMs are migrating to modular controllers that are more cost effective than traditional DCS systems.
This is going to require automation engineers to potentially deal with multiple control and automation vendors.
Smart instruments are getting smarter with embedded intelligence and Ethernet communications.
Many existing highly flexible S88 implementations are often complex and difficult to use. They need to be easier to use.
About the PAR Meetings and this Article Series
Every year, I have the opportunity to attend the Pharmaceutical Automation Roundtable (PAR) meetings, as the only outside observer. The 2014 PAR meeting was hosted at Bristol-Myers Squibb Devons, MA location. Lead automation engineers from around the world attended this invitation-only, two-day event. This group of engineers has a wealth of practical knowledge and knowhow and is willing to share with other participants - truly learning from each other. The PAR meetings represent a very knowledgeable group of automation professionals gathered in one place at any one time to discuss automation issues. The participating companies included Amgen, Biogen, Idec, J&J, Eli Lilly, NNE, Novartis, Novo Nordisk, Pfizer, Sanofi-Aventis. The PAR meetings consist of various presentations given by PAR members on specific automation topics. Other members then provide comments about their experience, ideas, and challenges relating to the topics. This article series presents a summary of those conversations with each article highlighting one or more of the topics covered by the PAR meetings. Comments by specific PAR members are reported anonymously.
PAR was founded about 16 years ago by Dave Adler and John Krenzke, both with Eli Lilly and Company. At the time, the purpose of the roundtable was to provide a means of benchmarking and sharing best practices for automation groups among peer pharmaceutical companies. The group specifically does not discuss confidential or proprietary information, cost or price of products, price or other terms of supply contracts, plans to do business or not do business with specific suppliers, contractors, or other companies.
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