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Enthusiastic Members Celebrate "Chapter of the Year" Win
by Janet Tice, GMP Piping, with photos by Peter Teague, Boston Scientific
This year, the Boston Area Chapter won the top award presented at the ISPE Annual Meeting in November, the coveted "North American/South American Affiliate Council Platinum Grand Award for Excellence and Innovation." The award recognizes the Chapter with the best overall activities, accomplishments and achievements in Chapter management, services to members and contributions to the community during 2009.
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Sometimes a single photo says it all! |
Board Member Marita King, Maritek, |
What better reason for a celebration to sing the Chapter's praises and thank the many volunteers who made this exciting win possible? And celebrate we did! The festivities included a live band providing background music, drinks and hors d'oeuvres, and a cake with icing proclaiming our win. And just in case anyone doubted the hard work and the impressive range of activities that cemented our win, the room was filled with posters describing the Chapter's many accomplishments for 2009.
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Mike Marino, Boston Scientific Corp, with Board |
Chapter Officers Sylvia Beaulieu, |
Attendees included Chapter Past Presidents and Advisory Board Members, many of whom are recognized leaders in the local life sciences community, who turned out in an impressive show of support for the Chapter and its mission. With the many posters acting as thought-provoking conversation starters, members were overheard discussing creative ideas for future Chapter activities and initiatives in addition to sharing the usual industry updates. If the energy in the room that evening was any indication, Chapter members are well on the way toward securing another win for the Chapter in 2010!
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Chapter Past Presidents |
Membership Committee Member Joyce Chiu, |
From Fort to Pharma: Members Tour the Bristol-Myers Squibb Large-Scale Cell Culture (LSCC) Facility at Devens
by Lee J. Ward, Rockwell Automation, with photos provided by Bristol-Myers SquibbThe setting? A mid-November afternoon in blustery Devens, Massachusetts, on the site of what was once part of the "Fort Devens" military base, now seeing new life in the form of Bristol-Myers Squibb's newest addition to their world wide manufacturing strategy. The occasion? The Bristol-Myers Squibb Large-Scale Cell Culture (LSCC) team played host to the Boston Area Chapter's educational program, "From Fort to Pharma," designed to showcase their approach to the site re-development and the challenges they met and overcame during the redevelopment process.
The program began in the late afternoon in order to accommodate the almost one hundred attendees (ISPE members only!) who were given a comprehensive tour of the LSCC building. Attendees were split into groups of ten and entry to the facility was staggered.
Along the route, members were taken through the logical stages of the manufacturing process at their associated locations in the building. At each location, a knowledgeable BMS staffer was on hand to describe the specific processes that take place there and answer members' in-depth questions about the operation at that point. Key to the architecture of the manufacturing building was the modular nature of the construction that is apparent in the layout of the building.
Upon returning to the cafeteria, we were met by our hosts: Chris Perley, Dave Schwabb, Geoff Attenborough, and Wayne McFarland. After hors d'oeuvres were served, the audience took to their seats and the program was introduced by Boston Area Chapter Educational Committee Member H. Steven Kennedy of Parsons.
Chris Perley, Vice President and General Manager of the LSCC site, began the program by describing Bristol-Myers Squibb as a $25 billion, "mid size" biopharm company with a goal. That goal, according to Chris, is "to become the next generation, best of bio, best of pharma company, globally." He sees the execution of that plan manifesting itself at the Devens facility. He then went on to describe how the facility fits into BMS's "String of Pearls" strategy whereby they grow as a corporation through the development of technology sourced from "emerging companies," while not ruling out growth through acquisition.
The Devens project represents a three-year, $750M investment made in order to realize the demands of two key products: Orencia, prescribed for the treatment of rheumatoid arthritis, and a product being developed to manage tissue rejection. Chris posed the question, "Why here?" In answer, he commented that the Massachusetts area is strong in available talent and strong in the area of technology, both key ingredients required to ensure the success of the facility and position the site for growth in the future.
Next up was Wayne McFarland, Director, Technical Services, who began a presentation illustrating the project from concept to completion, beginning with the site re-development. History would represent a major part of the initial challenge, since unexploded ordinance was uncovered during the excavation phase of the project. This was not unexpected, however, as it was understood that parts of the site had served as a live firing range during two World Wars. In light of this, safety was a key element in the planning and execution of the project and policies and procedures were put in place to manage the situation. As in all of BMS's projects, site safety is paramount, and for that reason, every person admitted to the Devens construction site was subject to UXO (Unexploded Ordinance) training in addition to the usual site safety training.
Wayne went on to describe the vast 89-acre site as supporting five main buildings in the current "Phase 1" development. However, he added that the site had been laid out to accommodate two additional LSCCs in future phases. The LSCC as it stands today is a 200,000 sq/ft building comprised of four floors housing everything from air handling equipment to process vessels. The LSCC module was designed with gravity in mind and makes use of the height of the building to go from seeding, to reaction, to harvesting, to purification, to bulk product released for shipping.
Wayne next described the central utilities building. This 45,000 sq/ft facility is designed to provide all that the site requires in terms of chilled water, process steam, compressed air, and building management, and is sized with expansion in mind. In addition, there is a 38,000 sq/ft warehouse, a 5,000 sq/ft chemical storage building, and finally the 90,000 sq/ft lab/office building in which we found ourselves for this event. In addition to the buildings, a key essential is the processing of waste. To this end the site has its own large-capacity waste water treatment plant (or WWTP) to manage the waste water resulting from the process manufacturing.
Wayne stated that mindful of the sensitive nature of the bio process and the needs of the regulatory bodies, steps were taken to ensure quality and consistency. With that in mind, Wayne described the need for "high availability" as a primary design criterion and therefore adoption of an N+1 model for all critical equipment. This manifested itself in duality for boilers, chillers and compressors as well as various control systems throughout.
Geoff Attenborough, Program Director, Project Management, took the podium next, outlining the 17-month effort to realize manufacturing implementation. He described the elements of the process from lab culture, to media prep, to media feed, harvest and purification. He stated that in planning the desired outcome, a decision has to be made early on in the process whether to go modular or "stick-built." This forces the decision, as it is too late to follow a different design philosophy later in the process.
Once the design methodology has been decided upon, it is time to engage the A&E, fabrication engineers, process engineers and construction/project management team. In this particular project, the A&E was able to "3-D" model based on the given design information. This enabled BMS to gain an early appreciation of what the facility would look like and how it would fit together way before ground was even broken.
Bristol-Myers Squibb adopted a very "hands on" approach and was very involved in the design process. This ensured that the original vision of what the plant should be followed through to the fabrication and construction on site. Geoff went on to describe that once the design decisions had been made, all of the capital procurement was undertaken by the A&E and all of the OEM and vendor purchasing was completed by the A&E as well.
Key to the design for process manufacturing was the adoption of the ASTME 2500 standard that was applied to the entire facility. This was mapped out from beginning to end and tied in the check points along the way including FAT (Factory Acceptance Testing) and the commissioning process.
Geoff went on to explain that one of the main elements in choosing a design and manufacturing approach based on the employment of standards and modular design is up to a 75 percent reduction in engineering and a savings of up to 3 percent on every $100M of investment. Over a $750M project, this will have saved BMS almost $23M and helped manage cash flow. Geoff then addressed the pros and cons of the choice to go modular, again reiterating that an early decision is the only way to make this methodology pay, as the perceived "on cost" for choosing to go modular must outweigh the cost of a delayed product launch, the potential result of a decision to go with the stick-built approach. In other words, the modular approach facilitates schedule compression realizing manufacturing sooner in the cycle.
Dave Schwab, Director of Manufacturing, took over for the final part of the program and discussed how the employment of the E2500 standard helped them proceed with a "risk-based" approach and taught the team that constant evaluation was a critical part of the process. The planning around the method helped harmonize and rationalize the testing and performance expectations such that repetition could be avoided where appropriate in order to shorten the time to complete. This not only became the "modus operandi" at FAT, but extended to some of the complex software in use throughout the facility.
Throughout the entire project, attention has been paid to how the teams involved got to the end goal. In the process, BMS and its construction partners strived to make sure all involved were able to work in a safe and relatively clean environment. To that end, the construction manager, Parsons, received OSHA VPP Star status for having a comprehensive and effective safety and health management system, for achieving injury and illness rates below the national average and for demonstrating their ability to control workplace hazards. Since breaking ground in February 2007, there have been 2.6 million man-hours and 700 days without a lost-time accident. In addition to this achievement, BMS was also extremely sensitive to the impact the site would have on the environment. As such, the entire facility has been designed and constructed with LEED in mind, and BMS will be pursuing that accreditation in the very near future.
As the session drew to a close, the presenters invited questions from the audience, all of which were answered with a refreshing combination of enthusiasm and honesty which, in my experience, has been the pattern for the entire project.
In closing I would like to thank all of the many BMS representatives involved for offering the Boston Area Chapter membership a highly informative and extremely well-organized visit to their impressive facility and a unique, behind-the-scenes glimpse into the long process of planning and execution that brought the Devens site "from Fort to Pharma."
Combination Products and Convergence: Clinical Benefits, Regulatory Issues & Manufacturing Challenges™
by Paul L. Smock, Pfizer Global Manufacturing, Quality Operations with photos by Rami Mitri, Spectra Automation
On Tuesday, December 8, the Boston Area Chapter presented an educational program at the Royal Sonesta Hotel in Cambridge. Our presenter was Dr. Michael Drues, President of Vascular Sciences in Grafton and an Adjunct Professor of Medicine, Biomedical Engineering and Biotechnology at a number of universities including Northeastern. Dr. Drues brought his extensive experience in medical devices, drugs, biotechnology, biomedical engineering and medicine, as well as his experiences as a consultant to the FDA to bear in an educational and visionary presentation on combination products now and in the future.
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Meeting Manager Paul Smock introduced the |
After a brief introduction by Paul Smock, Past President and current Educational Program Committee member, Dr. Drues got the group immediately engaged in a brain teaser to get us to consider how we approach problem solving. His point was that we often focus on the wrong part of the problem and information about it, and then don't ask the right questions. He also indicated, as an example of this, clinical trials designs ending up being biased by asking the wrong questions. The idea of questioning everything was an excellent backdrop to some of his later examples of a not-so-science-fiction-like potential for combination products in the future.
We were next introduced to what is and what is not a combination product. Dr. Drues reviewed some examples of each, and included a discussion on pre-filled syringes, which are typically regulated as drugs or biologics but may be more properly classified as combination products. Basically combination products are combinations of two or more components from the drug, biologics and medical device areas (e.g. drug-device, biologic-device, drug-biologic, drug-biologic-device), but not combinations within an area (e.g. drug-drug).
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Attendees enjoyed a buffet dinner |
Next we reviewed the regulatory framework for combination products. This designation is only used in the US and prior to 1990 was applied on a case-by-case basis by FDA. There is now in place the Office of Combination Products (OCP), which doesn't regulate these products but establishes for each new application which center (CBER, CDER or CDRH) will have primary regulatory responsibility for the product. OCP also helps to manage the inter-center relationships, which are often somewhat challenging. The lead agency decision is currently based on the primary mode of action of the product, as proposed by the sponsor. As the combination products become more complex, this is rapidly becoming an outmoded concept! To help bring these concepts into sharper focus, several case studies of current products that are combination products, or should be considered as such, were presented. Included were the Mirena Intrauterine Contraceptive and a drug-biologic comprised of a monoclonal antibody with a bound cytotoxic drug. It was noted that not all combination products have a device component at all; and many older products that probably should be designated as such have not been and are not the focus of FDA's efforts.
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Chapter President Sylvia Beaulieu shared |
Next we looked at the world of stents, particularly drug-coated stents, and some of the controversy surrounding their use for cardiac disease along with angioplasty. This is where Dr. Drues began to circle back to the beginning of his talk on questioning everything and asking the right questions. His fundamental point was that stents, as manufactured and used today, are primarily trying to fix a "plumbing" problem, when the real problem is with biology, and not just with atherosclerosis. He challenged us to think biology first, then let the engineering follow for a future of second generation stents with multiple drugs attached. These could be used to treat the multiple underlying biology issues that address multiple biologic causes or outcomes; and to extend stent use to other diseases like cancer, diabetes, and Alzheimer's disease.
Lastly, Dr. Drues shared some visionary concepts on multiple combination products of the future - at the edge of science fiction but potentially in our grasp if we accept the challenge to think differently. These concepts included stents with multiple inner and outer layers comprised of different biologics, drugs and biomaterials that would be absorbed (and thus no longer in place) after their function was completed (unlike stainless steel stents), as well as bare stents that could have multiple different rings of drug-biologic combinations manufactured and placed on the stent by the treating physician - a real application of personalized medicine. Also presented was the idea of viewing tissue engineering as the quintessential combination product, regenerative organ replacements grown on-demand!
Throughout the talk there were many video vignettes presented that added greatly to our understanding and quotes from Socrates to Mark Twain to engage us, not just in the science and technology of this field but the philosophy as well. Mark Twain may have said it best with his famous, "It ain't what you don't know that gets you into trouble....it's what you know for sure that just ain't so."
Page last updated: 3 March 2010