Manufacturing in Manitoba

WINNIPEG FREE PRESS - THURSDAY, APRIL 19, 2018 3 PROTECTING AND ENHANCING LIVES EMERGENT BIOSOLUTIONS COMBATS GLOBAL HEALTH AND SAFETY THREATS Emergent BioSolutions is a complex business with one clear mission — to protect and enhance lives. The life sciences company has a unique focus on creating products to treat or safeguard global civilian and military populations from biological, chemical and infectious disease threats, from anthrax to the Zika virus. The 125,000-square-foot Winnipeg facility, located at Smartpark at the University of Manitoba's Fort Garry campus, specializes in making plasma-derived products called hyperimmunes, which can target threats such as botulism and complications from smallpox vaccination. The process relies on plasma donors who have been stimulated to have an immune response and develop antibodies to fight specific diseases. Plasma is collected and used to create therapeutics that can be administered to patients who are suffering from those diseases — typically the very young, elderly or immunocompromised individuals. "We're quite proud of the fact that we are developing and manufacturing products that really save lives," says Emergent BioSolutions Winnipeg vice-president and general manager Mark Lobe. "We're currently developing two hyperimmunes — one for influenza and the other for Zika." Theoretically, since vaccines exist to combat flu, plasma from donors who have flu shots every year could help to create a treatment to alleviate the severity of the sometimes fatal illness. Zika, a threat that first came to the public's attention during the 2016 Summer Olympics in Brazil, is a mosquito-borne virus that can cause severe birth defects. Since there is no vaccine for Zika, Emergent is working with organizations in the U.S. to collect plasma from donors who have been exposed to the virus naturally, and who have developed the ability to fight it. Founded in Lansing, Mich., in 1998 with one product — an anthrax vaccine — Emergent's aggressive mergers and acquisitions strategy has led to rapid growth. "Today, we have 13 global locations, including facilities in Winnipeg, Maryland, Michigan, Massachusetts and Mississippi and offices in Washington, D.C., Germany, the U.K. and Singapore," Lobe says. "We have eight products and about 1,300 employees, and within that footprint, our site is quite unique. The term I like to use is that we're cradle-to-grave. We have capabilities in all phases — research and development, tech-transfer, and commercial manufacturing of the product." The local facility, formerly Cangene, was founded in 1984 and acquired by Emergent in 2014. Since then, its talent pool has grown from about 250 to 350 employees — predominantly born-and-raised Manitobans from front-line manufacturing and support staff to research scientists. Capital investments of roughly $20 million over the next couple years have increased its manufacturing capacity, with new equipment and technologies to maintain and expand its product line. "The enhanced investment has been a real breath of fresh air for the Winnipeg site," Lobe says. "Leading to the acquisition, Emergent certainly saw the value of our technical expertise and niche products. We also strengthened and diversified the portfolio with our plasma- derived products, which complemented the company's existing vaccines, therapeutics, and medical devices." Becoming part of a bigger corporate family was another benefit, since the Winnipeg site is able to gain access to skilled employees at other sites. Sean Kirk, senior vice-president, Manufacturing Operations and Contract Development and Manufacturing Organization Business Unit head, based in Gaithersburg, MD., spent the first 15 months after the acquisition commuting from Maryland to Manitoba, spending weekdays at the Winnipeg facility getting acquainted with the company and the community. From his perspective, renewed investment in Winnipeg was "very much a no-brainer," he says. "It was really indicative of the confidence that we had in the capability of the people and the facility that had been demonstrated through decades of success." Along with plasma-derived products, the Winnipeg facility had a long history of delivering products for treating or protecting against prenatal and pediatric blood disorders, chickenpox, and Hepatitis B — products Emergent continues to contract manufacture for spinoff company Aptevo Therapeutics. Emergent has a strategic growth plan to achieve $1 billion in top-line revenue by 2020 in the public health-threat preparedness arena, and a goal to protect and enhance the lives of 50 million people by 2025. Following the acquisition 20 years ago of its Lansing, Mich., manufacturing facility, formerly owned by the Michigan Department of Public Health, Emergent invested in security and plant upgrades. When it began commercial production in 2001, it was the sole supplier of anthrax vaccine to the U.S. military. In the wake of the Sept. 11, 2001 terrorist attacks and the subsequent wave of anthrax-laced mail attacks, there was increased demand for the vaccine and a new focus on developing other countermeasures. The U.S. government created the Biomedical Advanced Research and Development Authority (BARDA), one of several agencies with which Emergent works. Other partner organizations that identify and respond to global health threats include the U.S National Institutes of Health, the U.S. Centers for Disease Control and Prevention and the U.S. Department of Defense. "We spend a lot of time monitoring that pulse of the world, and then responding effectively when asked to do so," Kirk says. "We've produced an Ebola therapy and a vaccine for a clinical trial. We're active in the Zika and pandemic influenza space and in a variety of other emerging infectious disease spaces I won't get into for confidentiality reasons, but suffice it to say we are operating in an area, successfully, where few other companies have been able to demonstrate a similar capability." Emergent's core client base consists of the U.S. government and military, as well as the Canadian government and armed forces, and it has similar relationships on the international stage. Along with plasma-derived products, including equine plasma-derived botulism therapeutics, the Winnipeg facility supports the manufacture of a medical device called Reactive Skin Decontamination Lotion, which is predominantly used by the military and is stockpiled with various governments to help decontaminate individuals exposed to chemical agents. Lobe says local staff are also working on developing a rapid-response mobile manufacturing unit that is envisioned to be used during outbreaks of Zika, MERS, Ebola or other diseases around the world. Antibody Therapeutics Business Unit senior vice- president Dr. Laura Saward is heading up this project. "The concept is to design a unit that could be deployed where the outbreak is and quickly manufacture a therapeutic to a wide number of pathogens in this mobile facility that can be used to protect people from the disease." Kirk says the mobile unit reflects Emergent's nimbleness and innovation as an organization. Likewise, its corporate social responsibility program is part of Emergent's DNA, as a company that has focused on helping people and local communities from Day 1. "That is really an extension of who we are as an organization. It's our ability to get involved to create a connection point — not only with our employees, but between our employees and the local communities so that people come to recognize that Emergent is very much a part of the fabric of the community the same way that our people are when they go home every day," he says. In Winnipeg, the company and its employees invest time and dollars in Winnipeg Harvest, the Children's Wish Foundation, the Military Family Resource Centre, Ronald McDonald House, Salvation Army, Siloam Mission, Habitat for Humanity and many other organizations. Every employee is given eight hours of paid time off to volunteer. Called eGIVE, or Give, Invest, Volunteer in Emergent communities, the program provides financial contributions which can be directed to an employee's charity of choice. "We like to train tomorrow's scientific leaders, improve our communities, advance global health and sustain our environment," Lobe says. And because so many of the company's products are stockpiled for or used by military personnel, much of the focus is on protecting 'those who protect us,' he adds. "Emergent does take it very seriously and I can tell you without a doubt the Winnipeg employees cherish it and it's made for a phenomenal work environment and culture." Participation in academic and business communities is also important to the company. Dr. Saward has formed several partnerships with the University of Manitoba, her alma mater, and is exploring research and development opportunities and other synergies with the University of Winnipeg and other academic institutions. Through his work as vice-chair of the Biosciences Association of Manitoba (BAM), which recently named Emergent BioSolutions Bioscience Company of the Year, Lobe is also raising the $2.5 billion industry's profile in business as well as government circles. ❙ Top left: Antibody Therapeutics Business Unit senior vice- president Dr. Laura Saward with Manufacturing Operations senior vice-president and Contract Development and Manufacturing Organization Business Unit head Sean Kirk. Top Right: Winnipeg vice-president and general manager Mark Lobe. Below: Daryl Dorge, QA analyst, reviews laboratory samples.

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