The pharma industry changes slowly – it’s the inherent nature of the beast given tight regulations and the fact that drug development timelines can be well in excess of 10 years. In addition, pharma still depends on a tremendous amount of stainless steel infrastructure. Facilities can take years to plan, design and build – and sometimes, by the time they are ready to be used, they are already out of date. Pharma is well aware of the danger and is working hard to develop facilities that are not only fit for the present, but also a future that will demand higher quality at lower cost, as well as taking into account the uncertainty of competition from new therapeutic areas, such as cell and gene therapies.

The International Society for Pharmaceutical Engineering’s (ISPE) Facility of the Year Awards (FOYA) aim to bring the importance of facility design into the spotlight – and to showcase the successes so that the rest of the industry can learn from them. In September, the Overall Winner of the 2016 Facility of the Year Awards was announced: Genentech’s Cell Culture Biologics Drug Substance Plant 2 (CCP2) in Vacaville, California.

For the last three years, the judging committee has been led by Jim Breen from Johnson & Johnson Supply Chain, an organization in the Johnson & Johnson Family of Companies – where he has worked at for almost 20 years. Breen also currently holds the role of Treasurer on the ISPE Board of Directors. Here, he delves into the history of FOYA and what the 2016 awards tell us about the latest industry trends.

Tell us about the history of FOYA…

ISPE established FOYA more than 10 years ago and the goal is very simple: to recognize and celebrate great manufacturing facilities and the teams behind them. A good facility is essential for producing high quality medicines, but creating an effective facility is no easy task, particularly given the time and cost pressures on today’s industry. As well as recognizing stand-out facilities, FOYA promotes good facility design, methodology and technology to the wider pharmaceutical community, so that more companies and engineers can be inspired. At the moment, we don’t typically give out awards to R&D laboratories – our focus is on manufacturing or clinical plants, which closely aligns with ISPE.

The first FOYAs were awarded in 2005 (with the overall winner being Novo Nordisk’s manufacturing plant in Hillerød, Denmark), but specific categories were not introduced until 2007: Facility Integration; Project Execution; Equipment Innovation; and Process Innovation were the first categories. In later years, categories for Operational Excellence and Sustainability were introduced. The increase in the number of categories shows how the industry as a whole has changed over the last decade. For example, sustainability wasn’t such a hot topic 10 years ago, but a large number of companies today take this very seriously.

How are the awards judged?

We have judges from both small and large companies. Over the years, we’ve expanded the eligibility and requirements for the awards, and now we tend to receive anywhere from 20 to 50 applications every year. The judges review these and we all meet to debate them. It’s a very democratic process. Our judges have experience from all over the world and are very familiar with the latest trends. They know when companies try to stretch the truth – indeed, they are adept at spotting real innovation that can have an impact on the industry. Companies submit their entries for the categories that they want to win or feel are the best fit, but sometimes after reading the entries and doing our own research the judging panel may apply them in a different category. We also give out Honorable Mentions for companies that don’t necessarily meet the FOYA criteria, but have nevertheless achieved something impressive.

In terms of judging criteria, we are always looking for innovation, particularly that of a disruptive nature. Safety, however, is the most important consideration; the goal of the industry must always be to provide patients with products of the highest quality. If a project does not have a good safety record then we typically eliminate them from consideration. We also focus on the team. Running an effective facility is a team effort so we look at how the team participates in the whole project to make it a success.

Rising from the Ashes By Stephanie Sutton Genentech’s Cell Culture Biologics Drug Substance Plant 2 (CCP2) in Vacaville was originally conceived in 2004, but it was closed in 2010 – before it could produce a single product. At the time, it was expected that biosimilars would strongly undercut the innovative biologics market. With a very strong biomanufacturing footprint, Roche (which acquired Genentech in 2009) took the decision to close the site to avoid having excess capacity. However, the site was not sold but kept in a returnable site with the infrastructure intact – in case it was ever needed. Just three years later, Roche announced that the Vacaville facility would be reopened. Particularly in the US, biosimilars have had a slow start, and during the same time Genentech and Roche have seen rising demand for biologic oncology drugs – with their inventory reaching critically low levels. In September 2013, the decision was made to fast track the facility’s restart. Although the facility had been state of the art when first built, change can happen faster than expected in the pharma business landscape – the new facility needed to be brought in line with the latest GMP requirements, regulations and sustainability directives. In particular, the site needed improvements in environmental microbial control, manufacturing control and automation. Genentech had to bring in a number of contracting firms and people from the company’s other sites. In addition, the company also brought in patients to speak about their experience with cancer to remind workers about the end goal of the project. The plant reopened in January 2015 and uses some of the largest scale cell culture production equipment in the industry (8 x 25,000-L bioreactors; 1.8 m diameter chromatography columns; 7 clean-in-place skids for both upstream and downstream areas) – able to provide oncology products to more than 500,000 patients annually. As well as being the overall winner for FOYA, the company won the Process Innovation category.

What do the 2016 winners tell us about current industry trends?

Generally speaking, in today’s industry companies have to be flexible and adaptable because the industry is changing rapidly. In addition, it is crucial to be as cost effective as possible while still maintaining high quality standards. A lot of advances are being seen in the industry – not only in terms of new drugs and drug development technologies, but also in manufacturing methodologies; for example, there is a move to minimize the use of space-consuming cleanrooms, a move which reduces air conditioning, air changes and utility usages, and to use closed production instead.

At the same time, companies also need to be able to react to public situations, such as disease outbreaks or drug shortages. To this end, speed is becoming crucial. This year, the winner of the Equipment Innovation category was Pfizer, for its investment in modular manufacturing equipment (GEA’s ConsiGma 25 system and G-CON’s modular POD system). The technology is all about speed of deployment – and I found Pfizer’s move particularly interesting because the company can now use its equipment to relatively easily set up manufacturing in any country, without having a large footprint.

The two Honorable Mentions for 2016 are also fascinating. Greater Pharma Manufacturing’s new facility in Thailand was one winner and shows how companies in developing countries are seeking to catch up with western standards. Around 15 years ago, visitors from ISPE told companies in Thailand that they needed to bring their manufacturing up to a higher standard – and Greater Pharma Manufacturing’s facility is a direct response to this. The company has applied western standards to the design, build and operation of the facility. It is the first plant in Thailand to use closed processes from raw material to finished product.

The second Honorable Mention went to the University of Strathclyde in the UK for the development of its Technology & Innovation Centre. The project did not meet the criteria for an award because the center is designed to support partnerships rather than be used for commercial or clinical manufacturing, but it is a good example of an effective public-private partnership. These types of partnerships will be important for the future of the industry. And of course, the students working in the center may well become pharmaceutical professionals in the future.

Another company I’d like to highlight is Ethicon, which is part of the Johnson &Johnson Family of Companies, where I work. Ethicon won the 2016 FOYA (I did not take part in the voting of course) in the Sustainability category for reducing the environmental footprint of its facility in San Lorenzo (Puerto Rico). The site was first set up in 1988 for the manufacture of medical devices, and the new sustainability efforts have reduced energy consumption by 26 percent and water consumption by 9 percent. At the same time, the facility’s production volumes have increased by 11 percent compared with 2010. The reductions are in line with J&J’s Healthy Future 2020 sustainability initiative – 20 percent of plants have to be using renewable energy by 2020 and then 80 percent of plants by 2050. It’s not easy to make a plant more sustainable; water consumption can be particularly difficult to reduce. However, an increasing number of plants are paying attention to this important area. There are some plants in India that are looking to have zero water discharge in the future.

How has the industry reacted to the awards?

Recognition is a powerful motivator – teams love to see that their hard work is paying off. It takes a long time to establish a new facility or to improve an old one and it is energizing to know that you are on the right track. For me personally, it is always rewarding to see the reactions of the winning companies. I think it’s very important to recognize the achievements of the pharma industry and we widely publicize the award winners, which gives the teams a popularity boost. FOYA is not just about rewarding a company and its owners – a lot of the credit goes to the engineers and contractors. At the same time, publicizing the winners also allows other companies to learn from and be inspired by them.

As well as being able to give something back to the industry, I’m also very encouraged by the progress that the industry as a whole is making. I’m also constantly learning and then asking myself what I can do to make things better in my own role. I work globally, so it’s great to see who is doing what – and whether the Johnson & Johnson Family of Companies are at the forefront or needing to up its game!

2016 Winners Overall Winner & Process Innovation

Genentech; CCP2 Return to Service

Location: Vacaville, California, USA

Project: Fast track restart of a previously closed biologic facility Equipment Innovation

Pfizer; The Portable Continuous Miniature and Modular Collaboration

Location: Groton, Connecticut, USA

Project: Formation of a consortium (Pfizer, GEA and GCon Manufacturing) to design and build a portable, autonomous manufacturing environment for continuous oral solid dosage production Facility Integration

Takara Bio; Center for Gene and Cell Processing Construction Project

Location: Kusatsu, Shiga, Japan

Project: Construction of a facility that houses cell products, viral vectors and recombinant proteins Operational Excellence

Baxter BioPharma Solutions; Baxter Biopharma Solutions (BPS) Oncology Manufacturing Expansion

Location: Halle, Germany

Project: Adding additional capacity for parenteral oncology and other complex liquid and lyophilized products

Project Execution

Janssen Vaccines; ZEBOV in 81J

Location: Bern, Switzerland

Project: Fast-track refurbishment of a facility for Ebola vaccine production Sustainability

Ethicon; San Lorenzo Conservation Strategy

Location: San Lorenzo, Puerto Rico

Project: Roll out of a sustainability program resulting in a 26-percent energy reduction Honorable Mentions

Greater Pharma Manufacturing; Greater Pharma New Facility

Location: Bangkok, Thailand

Project: Application of western standards to the design and operation of a manufacturing facility in Thailand University of Strathclyde; Project Technology & Innovation Centre

Location: Glasgow, Scotland

Project: Creation of a nine-storey collaborative research and conference centre designed to bridge the gap between academia and industry West Pharmaceutical Services; Kinston, NC Ready-to-Sterilize (RS) Expansion

Location: Kinston, North Carolina, USA

Project: Upgrade of a facility that produces components; implementation of lean techniques

Do you have any predictions for next year’s awards?

Over the last few years of FOYA, I’ve noticed that a greater number of small companies are submitting entries, as well as government-private partnerships. I’m also seeing contract manufacturing organizations winning awards. Overall, these trends show that the industry is not just about “Big Pharma” anymore so I expect to see more variety in the projects we receive in the future. I’d say that about half of the awards go to small projects. At FOYA, we always like to highlight the fact that the awards are not based on the science or size of the project, but on the overall standards and execution.

For 2017, we are adding a new category: Facility of the Future, which will recognize facilities that are reacting to potential future trends. I’m excited to see how this category works out next year.

Find more details about the awards at: www.facilityoftheyear.org