pharmaceutical & biotechnology

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UNITED STATES

Celgene to Open Biopharma Incubator in New Jersey

Celgene has unveiled plans to open the Thomas O. Daniel Research Incubator and Collaboration Center, offering entrepreneurs state-of-the-art lab space, resources and support to scientists and companies with potentially transformational approaches to accelerate medical discoveries and innovations. The facility houses 16,000 sq. ft. of shared and fully equipped lab facilities located on the Celgene Summit West Research campus in Summit, NJ, to create an environment that can help medical innovators accelerate discoveries that may lead to life-enhancing medicines for patients in need. The Incubator, set to open this year, is dedicated to Thomas O. Daniel, M.D., who served as executive vice president and president of research and early development at Celgene from 2006 to 2016.

“When it comes to the challenges we face in healthcare, the facts are clear and compelling that medical innovation is the solution, not the problem. That is why Celgene is excited to offer an innovative environment for promising scientists and start-up companies to cultivate their ideas and medical discoveries,” said Robert Hugin, executive chairman, Celgene. “Hosting the incubator at Celgene aligns with our mission to pursue bold science and provide potentially transformational treatments that will ultimately benefit patients, healthcare and society.”

“Celgene has always recognized the need to harness disruptive sciences that lead to the development of life-altering medicines,” said Thomas O. Daniel, M.D. “I am honored that the distributed research and development model that I helped establish in my tenure at Celgene will continue to thrive through Celgene’s incubator and the work of tomorrow’s medical innovators.”

The Incubator has the potential to bolster the entrepreneurial ecosystem in New Jersey, creating a global epicenter for biotechnology by seeding innovation in life sciences. New Jersey hosts a multitude of biopharmaceutical leaders that are committed to medical innovations, with strong manufacturing capabilities. The state is home to a majority of the world’s top 20 research-based biopharmaceutical companies and over 3,000 life sciences establishments. In addition, 13 teaching hospitals, five research universities and four medical schools are located in New Jersey. Based on this wealth of life sciences talent, the state is well-positioned to drive innovation and possibly cures for the 21st century.

“As a hub of medical innovation, New Jersey is a prime location to establish research facilities that will provide state-of-the-art resources to entrepreneurs, innovators and start-up companies hoping to enhance their research and discover scientific breakthroughs,” said Debbie Hart, founding president and chief executive officer of BioNJ. “We look forward to working with the Thomas O. Daniel Research Incubator and Collaboration Center to grow our economy in New Jersey and deliver new therapies to improve patients’ lives.”

“The HealthCare Institute of New Jersey (HINJ) congratulates Celgene on the launch of its incubator, which will enhance New Jersey’s expanding innovation ecosystem,” said Dean J. Paranicas, President and Chief Executive Officer of HINJ. “We look for this exciting initiative to create opportunities for new life sciences companies to develop novel treatments and cures that will benefit patients everywhere.”

New York Sketches Out $500M Plan to Build a Biotech Hub

New York City is doubling down on its long-discussed, never-realized dream of building a biotech hub to rival South San Francisco and Boston. The latest iteration of the dream comes backed by a $500 million financing package and a goal to quadruple the amount of R&D space in the city.

City officials sketched out the funding that is available as part of a request for proposals about how to increase the amount of life science space on the rental market.

The centerpiece of the plan is a $100 million investment by the city in a life science campus. Officials envisage the site serving as an institutional anchor for the New York biotech community while also providing a space for entrepreneurial training and R&D partnerships. Key details such as the location of the campus are yet to be nailed down.

Other facets of the plan are also light on specifics, but the city has a broad vision for how to address the bottlenecks that have constrained growth of the local biotech sector to date. Notably, the city is offering $300 million in tax incentives to encourage investment in commercial lab space. These tax breaks will carry the burden of addressing the long-standing shortage of space for biotech startups in New York City.

The focus of the spending reflects the city’s awareness of its own shortcomings.

“One area where we know that we are not the top is in the commercialization of the life sciences," James Patchett, CEO of the New York City Economic Development Corporation, told Forbes. “And, so, we believe that there's a moment in time, right now, where if we put our cards on the table we can be a leader in this field.”

Half of the remaining $100 million of the financing package is earmarked for investment in nonprofit research facilities. These investments are intended to help New York City’s existing institutions create spaces where their research can advance toward commercialization. In doing so, the city aims to build a bridge between academic researchers and the commercial lab space it hopes to bring online in the coming years.

The city has set itself hard targets against which to measure the success of its efforts, Forbes reports. Officials want to quadruple the amount of R&D space by 2026. Hitting that goal would result in New York City having 4 million square feet of lab space. The city also aims to boost NIH funding by 30%, quadruple annual investment in biotech and grow the number of commercial research jobs by 20%.

Cold Spring Harbor Laboratory Center for Therapeutics Research, New York

In October, Cold Spring Harbor Laboratory (CSHL) broke ground on its new Center for Therapeutics Research (CTR) facility in New York, US.

To be built with a $75m investment, the laboratory will support CSHL in research activities for developing novel therapeutics for genetic diseases.

The new research facility will generate 30 new scientific jobs upon completion in 2018. The project will generate 99 full-time positions in construction and 58 full-time-equivalent indirect jobs.

The CTR project will renovate the existing Demerec Laboratory, which was built in 1953. This laboratory is already home to four of the eight CSHL Nobel Prize winners.

Spread over a 26,000ft² area, the building will be equipped with state-of-the-art facilities and equipment.

The New York State is providing a $25m construction and equipment fund for the project, which will be used to modernize the Demerec Laboratory and house the CTR.

The funding is being provided under a state initiative, which aims to create a research corridor on Long Island.

The National Institute of Health is providing the remaining $50m needed to develop the project. This funding will cover recruitment, lab start-up costs, and CTR operations.

The CTR will establish partnerships with academic institutions such as Stony Brook University, the Brookhaven National Laboratory, and Northwell Health to carry out both lab-based and clinical research.

It will enable newly developed compounds to be refined by world-leading chemists to develop next-generation therapies. This research will form a basis for collaboration with private foundations and pharmaceutical companies, while advancing the development of new drugs.

In addition, the center will support ongoing research activities aimed to develop therapeutics for breast cancer, leukemia, autism, obesity, diabetes, and lung cancer. The primary goal of such research activities will include the development of advanced drug compounds targeting underlying biological pathways.

Development of the new facility will further, drive the local economy through the creation of additional jobs, spin-offs and new investment.

Cold Spring Harbor Laboratory is a private non-profit organization established in 1890. The research laboratory focuses on a range of programs in the areas cancer, neuroscience, plant biology, and quantitative biology.

The institute has more than 1,100 employees including scientists and technicians. It has an education arm, which conducts programs for high school students and teachers, as well as includes a publishing house and a graduate school.

Apart from the new CTR, the institute also operates the CSHL Cancer Center, which is a basic research facility conducting research on a broad range of cancers. Other facilities include Genome Research Center, Uplands Farm Field Research Center, the Banbury Center, and the Dolan DNA Learning Center.

Boehringer Ingelheim’s Fremont Manufacturing Facility Expansion, California

Boehringer Ingelheim has broken ground on a $217m expansion of its Fremont facility in California, US.

The facility manufactures monoclonal antibody therapies and other proteins based on mammalian cell culture technology in the areas of immunology, rheumatology, and oncology.

The expansion is expected to increase the facility’s manufacturing capacity by one-third upon completion by 2018. It will generate 300 new high-wage and highly-skilled jobs in the region.

The Fermont facility is located in the San Francisco Bay area, which is one of the world’s biggest biotechnology clusters.

Boehringer Ingelheim invests 20% of its net sales into research and development (R&D). Its latest investment in the Fremont facility will further strengthen the Bay area’s research activities and enable patients to access high-quality medicines.

The expansion project will add a 12,000l bioreactor and a 3,000l media feed tank to the Fremont facility. State-of-the-art equipment and gene expression biotechnology will be used to produce both biologics and biosimilars at the plant.

The products produced at the facility will be used for manufacturing other pharmaceutical products by various biopharmaceutical manufacturers.

Production of biologics and biosimilars will begin by growing cells for a specified period of time. The cells are then fermented in a large container and specific media is added to enable the cells to grow and secrete the desired protein or antibody.

The cells are purified using filters and resins, which remove various impurities including viruses, cell debris, and other undesirable elements. The purification process provides a product suitable for human use.

The State Treasurer’s Office has provided two tax credits worth $25.5m in total for the project.

The Fremont facility was acquired by Boehringer Ingelheim from Amgen in January 2011. Originally spanning 100,000ft², the facility has eventually been expanded to 300,000ft².

The design of the facility features extensive use of glass, which provides visibility into production suites and symbolizes open and transparent collaboration between the customer and the company.

The facility can produce multiple products simultaneously as each production line is a separate operation having its own purification facilities. It also includes development labs, QC labs and a good manufacturing practice (GMP) compliant pilot plant.

The plant is equipped with development-stage stainless steel bioreactors in 2l and 5l capacities and pilot-scale stainless steel bioreactors in 30l and 100l capacities. Single-use bioreactors in non-GMP and GMP scales are also available in 100l, 500l, and 1,000l capacities.

GMP-scale stainless steel bioreactors are available in 2,000l and 15,000l capacities. In addition, the facility is equipped with cell banking, cell culture, harvest, and purification facilities, column and membrane chromatography technologies and filtration technologies.

Boehringer Ingelheim’s Fremont facility provides services such as evaluation and optimization of cell culture processes and can also develop disposable cell cultures. Comparability and stability studies and GMP cell banking can also be carried out at the facility.

The plant is equipped with small-scale to commercial-scale production capabilities. Products in the clinical-stage or hundreds of kilograms a year of approved products can be produced at the plant.

The facility also has fill/finish, packaging and medical device assembly capabilities.

Fresenius Kabi’s Pharmaceutical Manufacturing Facility Expansion, Wilson, NC

German pharmaceutical firm Fresenius Kabi is expanding its pharmaceutical manufacturing facility in Wilson, North Carolina.

On completion, the facility is expected to increase its manufacturing capacity for generic drugs in ready-to-administer pre-filled syringes. Fresenius Kabi is investing more than $100m in the expansion.

Announced in November 2017, the expansion will create 445 new jobs in the region. It is Fresenius Kabi’s second project in North Carolina, following a previous announcement of plans to construct a new manufacturing facility in Wilson, which will produce products for hospitals and clinics across the US and Canada.

The Wilson facility is one of the country’s largest biotechnology centers. Its expansion will enable Fresenius Kabi to invest in the development of products and operations to meet growing demand. It will modernize the facility into a global center for prefilled syringe production.

The existing manufacturing facility employs more than 100 people in various roles. The expansion will increase the employee count to more than 500, adding jobs in various functions such as production specialists, engineers, scientists and managers.

“[The] expansion will enable Fresenius Kabi to invest in the development of products and operations to meet growing demand.”

Manufacturing contributes 22% to the economic output of North Carolina. The new project will enable North Carolina to retain its position in the manufacturing and life sciences sectors. It is estimated to boost the state’s economy by $853m.

The Economic Investment Committee of North Carolina state has approved a 12-year job development investment grant (JDIG) for the project. Fresenius Kabi will create 445 jobs over five years as part of the terms of the grant. The company will receive a reimbursement of $7.2m over 12 years as a benefit for the tax revenues generated by the new jobs it creates.

The North Carolina Department of Commerce and the Economic Development Partnership, the North Carolina General Assembly, the North Carolina Community College System, the North Carolina Biotechnology Center, Wilson County and the Wilson Economic Development Council collaborated with the state government to provide the grant.

Fresenius Kabi acquired the Wilson manufacturing plant from American medical technology company Becton Dickinson and Company (BD) in January 2016. The facility was part of BD’s Rx business.

Approved by the US Food and Drug Administration (FDA) in 2012, the facility is equipped with state-of-the-art manufacturing and packaging technologies. It develops various drugs in ready-to-administer pre-filled syringes.

Headquartered in Bad Homburg, Germany, Fresenius Kabi is a healthcare company involved in the development of medical devices, life-saving technologies and clinical nutrition products.

The US headquarters of the firm is situated at Lake Zurich, Illinois, and employs 1,500 people. The company operates manufacturing sites at Bensenville, Skokie, Lake Zurich and Melrose Park, IL. It has a total workforce of more than 3,000 in the US.

Fresenius Kabi also has production plants in New York, Pennsylvania, Puerto Rico and the Dominican Republic.

Cleanroom Class to Teach Proper Drug Manufacturing

When a patient leaves a doctor’s office with prescription in hand, he simply heads to the pharmacy, picks up a bottle of pills and swallows one down to begin treating what ails him.

It’s a simple process with which most are familiar. But rarely does the patient consider the behind-the-scenes work of multiple professionals that goes into creating that single prescription. The process is anything but simple.

The market for new, better medications is ever-expanding, and the rapid expansion of the industry has created a critical demand for skilled professionals (from equipment operators to advanced technical and quality assurance personnel) and additional infrastructure to support drug development and manufacturing. URI’s College of Pharmacy is helping fill that void with professionals trained in its state-of-the-art Good Manufacturing Practice (cGMP) Facility.

The URI College of Pharmacy is home to a state-of-the-art cleanroom used in drug manufacturing.

Located in the basement of Avedisian Hall, the 7,000 square-foot cleanroom has the purity and sterility of a hospital operating room, necessary for producing medications. A series of fans and an advanced filtration system constantly scrub the environment. The air pressure of each interconnected room and laboratory is lower than the next, ensuring air — and the contaminates it carries — is constantly flowing out.

“You have to design the room to protect the product so you can produce a clean drug with no contamination,” said Jim Vogel, director of the room and an adjunct professor in the College of Pharmacy. “There are very specific procedures that must be followed. If you miss even one step, things can go wrong. One of the biggest risks to a sterile product is the person working in the room.”

To combat such risks, the URI College of Pharmacy is training students and pharmacy professionals in the proper use and function of a drug manufacturing clean room. The College will offer BPS 426 in the spring semester, a course in the proper use and maintenance of a manufacturing cleanroom.

Students will learn about the various tools used in drug manufacturing, such as V blenders and fluid bed granulators, and the room’s engineered controls, including the fans and filtration system. They’ll also learn about their own critical role in maintaining the room’s sterility, which includes properly gowning, sterilizing themselves, and maintaining cleanliness inside the room, even to the point of using a small, personal fan directed up to prevent eyelashes from falling into their work.

“It’ll be both classroom and hands-on training so they can go and be functional in these places,” Vogel said. “They’re going to get in the room and learn actual clean room operation. We want people to be aware of the environmental risks and how to combat them to make a better drug.”

Avista Expands Drug Product cGMP Manufacturing at Colorado Site

Avista Pharma Solutions has completed extensive facility upgrades at its Longmont, Colorado site, expanding its drug product manufacturing footprint by approximately 20,000 square feet and allowing for the formulation and manufacture of new dosage forms. The expansion includes four new, state-of-the-art cGMP processing suites and all associated manufacturing support areas.

Avista Pharma’s drug product capabilities now include encapsulation; high-shear granulation; fluid-bed granulation, drying and Wurster coating; tablet compression; tablet coating; and packaging. In addition, Avista Pharma’s drug product operations team now supports the formulation and manufacture of the following dosage forms:

Immediate-release tablets and capsules

Enteric-release tablets

Modified-release, multi-particulate tablets and capsules

Hydrophilic and hydrophobic matrix extended-released tablets

Opiate tamper-resistant, modified-release tablets (using a surrogate drug)

Coated aqueous insoluble active ingredients

Complete with 24-hour environmental monitoring, the new manufacturing suites are designed and monitored to ISO 7 requirements. The expanded manufacturing support areas meet ISO 8 requirements and include a wash and prep area, as well as clean equipment storage. The facility will also include a new purified water system, walk-in stability storage chambers and a temperature-controlled warehouse containing refrigerated storage locations.

“Expanding our drug product capabilities enables us to better serve our clients as a trusted, effective and innovative partner in all phases of the drug development lifecycle,” said Ken Domagalski, General Manager of the Longmont facility. “By offering optimized formulation and manufacturing of a wider range of dosage forms, we can now help make more life preserving medicines a reality.”

Juno Therapeutics Headquarters and R&D Facility, Washington

Juno Therapeutics has inaugurated a new research and development (R&D) facility with an investment of $232 million.

The biopharmaceutical company is engaged in developing innovative cellular immunotherapy drugs for the treatment of cancer.

Covering 90,000 ft², the new headquarters is located in a 375,000 ft² lab and office building situated at 400 Dexter Avenue North, South Lake Union, Seattle.

Juno filed an application with the US Securities and Exchange Commission to lease the top four floors of the 12-storey building for a period of seven years beginning February 2017. The agreement includes three five-year options, which allow Juno to lease three more floors covering an area of 71,000 ft².

The company will pay a base rent of $48 per square foot for the first year and will increase it by up to 2.5% a year.

Opened in September, the facility will allow researchers and scientists to collaborate on the R&D of immunotherapy treatments and will contribute to the long-term growth of the biotechnology sector in Seattle.

The state-of-the-art biotech facility features research laboratories and office spaces to accommodate the company’s researchers, scientists, technical professionals, and administrative staff, who were previously located at three separate sites.

The building features 269,700 ft² of laboratory and office space, a 13,800 ft² retail area on the first floor, and a 128,000 ft² carpark with 457 below-grade parking spaces. The third level is dedicated to a complete mechanical room to serve the needs of the occupants.

The building is constructed with steel frames, while the exterior comprises glass and masonry structures. Open space is provided towards south and rooftop deck.

Design work on the on Juno Therapeutics’ headquarters and R&D facility was completed in February 2015. A ground-breaking ceremony was held in June 2015 and construction was commenced in January 2016.

Salvaged site materials were used in the construction, helping to gain Leadership in Energy and Environmental Design (LEED) Gold environmental standard certification.

The life sciences building at 400 Dexter was designed by architect CollinsWoerman and is owned by Alexandria Real Estate Equities.

BNBuilders was contacted by Alexandria Real Estate Equities to carry out the construction. Costigan Integrated provided design and construction management, owner’s representation, and cost estimation services under a subcontract from Alexandria Real Estate Equities.

PSF Mechanical was selected as the design-build mechanical contractor for the building.

Juno Therapeutics awarded a contract worth $43 million to Skanska in October 2016 to complete the 155,000 ft², seven-floor tenant improvement works at the building.

Other contractors involved with the project are Weisman Design Group, Hart Crowser, and KPFF Consulting Engineers.

Established in 2013, Juno Therapeutics aims to develop new product candidates using its cell-based platform to treat a wide range of cancers and other human diseases.

With more than 500 employees, the company develops cancer immunotherapies using chimeric antigen receptor (CAR) and high-affinity T cell receptor (TCR) technologies to genetically engineer patient’s own immune cells to treat cancer.

The company is currently developing multiple cell-based product candidates for the treatment of B-cell malignancies, solid tumors, and myeloma.

SSM Health Saint Louis University Hospital and Ambulatory Care Center, St. Louis, Mo.

Cost: $550 million

Size: 800,000 sq. ft.

Project team: The Lawrence Group and HGA (architects), Alberici (construction), IMEG (engineering)

A new academic medical center in St. Louis is under construction as SSM Health Saint Louis University Hospital and SLUCare Physician Group break ground on the new facilities.

The new SSM Health Saint Louis University Hospital and ambulatory care center features more than 800,000 sq. ft. of space, 316 private patient rooms, an expanded Level I trauma center and emergency department, larger intensive care units, expanded patient parking, green space and areas for future campus expansion.

Employees of SSM Health Saint Louis University Hospital and SLUCare Physician Group celebrated with a brief ceremony and commemorated the day as they viewed current progress on the “big dig,” enjoyed a specially created cake that is an architectural model of the new campus and were able to take a virtual tour of the new facility.

“Breaking ground on the new SLU Hospital is not only an important step for the city of St. Louis, it’s also important for the patients who come here from all over the region,” says Kate Becker, SSM Health Saint Louis University Hospital president.

The new SSM Health Saint Louis University Hospital campus will be located on 15 acres adjacent to the current facility off Grand Boulevard between Rutger and Lasalle streets. The project is expected to total more than 2.2 million workforce construction hours and a peak workforce team of more than 600.

"Saint Louis University, SLUCare Physician Group and SSM Health St. Louis built upon their expanded partnership by collaborating closely in planning the new facilities," said Robert M. Heaney, M.D., SLUCare Physician Group CEO. "As a result, our new hospital will provide patients with the best possible healing environment, our students and trainees with an enhanced educational experience and our scientists with expanded medical research opportunities."

The new hospital will continue to focus on high-acuity patients, cardiovascular care, oncology, stroke, transplant and trauma.

The project is part of a commitment made by former SSM Health President/CEO William P. Thompson on the first day the organization assumed ownership of the hospital, Sept. 1, 2015. He announced an ambitious five-year plan to construct a new hospital and ambulatory care center that incorporates national best practices in patient-centered design while delivering an improved patient experience.

Completion date: September 2020

Robert M. & Joyce S. Graham Science Center, Snow College, Ephraim, Utah

Cost: $16,999,601

Size: 60,756 gross sq. ft. (gross building); 32,425 sq. ft. (net (assignable) building); 20,512 sq. ft. (laboratory and laboratory support)

Project team: Research Facilities Design (RFD) (laboratory planner); VCBO Architecture (architect)

The Robert M. & Joyce S. Graham Science Center at Snow College features laboratory and laboratory support space in a three-story building for the Departments of Biology, Chemistry, Physics, Geology, Engineering & Computer Science. The facility includes laboratories for Geology Teaching, Anatomy Teaching, Engineering Bustem, Majors Testing Teaching, General Biology Teaching, General Chemistry Teaching, Organic Chemistry Teaching, Physics Teaching and Chemistry Research.

Completion date: 2017

Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, N.Y.

Cost: $375 million

Size: 628,000 sq. ft.

Project team: HOK

Sixty-four years after moving to the University at Buffalo’s South Campus, the Jacobs School of Medicine and Biomedical Sciences has returned to downtown Buffalo. The massive building officially opened at 955 Main St., just steps from where it was located from 1893 to 1953.

The building was the first to receive NYSUNY 2020 Challenge Grant funding through NYSUNY 2020, legislation that was signed into law by Gov. Andrew M. Cuomo in 2011. The initiative has spurred economic growth across the state and strengthened the academic programs of New York’s public universities and colleges. The mission of the NYSUNY 2020 program is to elevate SUNY as a catalyst for regional economic development and affordable education.

The new building allows the Jacobs School to expand its class size by 25 percent, from 144 to 180 students, training many more doctors to address local and national physician shortages. This year, the Jacobs School admitted its first class of 180 students; by 2021, the school’s enrollment will reach 720 students.

That expansion, in turn, boosts UB’s ability to recruit and retain world-class faculty with medical expertise in specialties that the region sorely lacks so that Western New Yorkers do not have to leave town for specialty care.

The move of the Jacobs School to the Buffalo Niagara Medical Campus bolsters the city’s biomedical sector as a catalyst for regional economic development. Medical innovations will result from increased synergies with the clinical and research partners on the medical campus, in turn, creating new medical technologies and spinoff businesses.

Deliberately positioned as a “gateway” to the medical campus, the building features a pedestrian walkway from Allen Street and the vibrant Allentown neighborhood to Washington Street.

The building’s sustainable features include bicycles available to rent in the walkway and the NFTA Metro station, which is located under the building, a first for Buffalo, so that the public can readily access the medical campus from the Allen/Medical Campus station.

A 32-foot tall, two story light tower at the Main and High streets entrance functions as the building’s signature feature, a beacon, often lit in UB blue, but which can beam virtually any color, which architects intended as emblematic of the school’s return to its downtown roots. Just upstairs, on the second floor, in a more concrete nod to the historic past of the Jacobs School, hangs a pair of lanterns. Originally gaslights, they illuminated the High Street medical school lobby from 1893 until 1953 when the medical school moved to the UB South Campus on Main Street. The lanterns were restored by Ewa Stachowiak, assistant professor in the Department of Pathology and Anatomical Sciences and Brian Koyn, in the UB health sciences fabrication department who used a 3-D printer to restore missing and decaying lantern pieces with exact replicas of the original metalwork.

Through its classrooms and open spaces called learning landscapes, the Jacobs School’s new building promotes collaborative interactions among faculty and students. Its huge, open seven-story, light-filled atrium, comprising more than 19,000 feet of glass, fosters collegiality and a strong sense of community.

A key educational attribute of the building is its emphasis on active learning classrooms, which contain triangular tables that are fully electronic so that any student, even in a class of 180, can not only contribute but also present data to the entire group with the touch of a button.

Small classroom and study spaces are available throughout the building, all with optimal technology connections. A casual café is located on the second floor but for full-service dining options, faculty, staff and students will be encouraged to patronize local businesses, a deliberate feature of the building.

State-of-the-art laboratory spaces on the building’s third, fourth and fifth floors, are modern and light-filled.

The sixth floor includes expanded facilities where students will hone their skills, from the Behling Simulation Center, where students will gain interprofessional training using life-like mannequins in realistic medical scenarios, to the Clinical Competency Center, where students will interact in scripted clinical scenarios using standardized patient volunteers.

Students, medical residents and professionals also will have access to the building’s surgical suites and robotics suites, where they will be trained in the newest surgical and robotics skills. In addition to the traditional gross anatomy training using cadavers, students will have access to visualizations of the cadavers, providing far more detailed anatomical information.

Completion date: December 2017

‘Healing Oasis’ Will Provide Healthcare Services to Veterans

A 95,000 sq. ft, three-story healthcare facility is currently under construction directly adjacent to the 101 Freeway overlooking a wooded park site in San Jose, Calif. The $40 million V.A. San Jose Community-Based Outpatient Clinic will provide veterans and their families with healthcare services.

The building is being designed as a “healing oasis” that is inspired by scenic views of the Santa Cruz Mountains. It will allow patients, families, and care providers to connect with the outdoors via a park and other outdoor recreational areas. “The concept is based on incorporating air, light and space so the design becomes a part of the healing process for patients,” says Hosam Habib, AIA, Lead Designer, Hoefer Wysocki, in a release.

The space will use a modular floor plan to separate patient and staff corridors, which reduces noise and activity levels and contributes to a better healing environment.

The first floor will include general registration, imaging, a lab and pharmacy, and a mental health outpatient clinic. The second floor will be designed for outpatient services including primary care, audiology and speech pathology, podiatry, optometry, and dermatology. The third floor will be dedicated to specialty services such as a women’s health clinic. An outdoor terrace will also be located on the third floor to provide a space for patients, their families, and clinic staff to relax. The campus will also feature a memorial park to honor and thank veterans for their service.

The clinic is under construction and scheduled for occupancy in first quarter 2018. The Building Team includes Smith and Boucher (MEP), BKF (CE), BDC (structural engineer), and Gates and Associates (landscape consultant).

Pfizer CentreOne Expands Fill-Finish Services to its Kalamazoo Facility

Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, announced that it has expanded its fill-finish services to its Kalamazoo, Michigan (United States), site.

Along with vial-filling of small molecules and biologics, the facility also provides vial-filling of sterile suspensions, expanding Pfizer CentreOne’s service portfolio.

“Kalamazoo was the obvious choice for expansion of our fill-finish services,” said Peter Stevenson, Pfizer CentreOne’s Vice President and General Manager.

“Our Kalamazoo colleagues have been doing contract manufacturing for over 40 years on the API side – it’s part of the culture; and this is also one of Pfizer’s premier sterile-injectables sites. It’s a natural fit.”

With more than 65 years of experience in injectables fill-finish, Kalamazoo currently supplies drugs to more than 100 countries around the globe.

The Kalamazoo facility has dedicated, onsite technical, manufacturing science, regulatory affairs and quality teams. Over the last five years, they’ve successfully transferred 37 customer and Pfizer compounds into the facility.

Among Kalamazoo’s extensive scientific resources are experts in API processes who know how to solve complex issues with active ingredients; and a team of commodities experts who trouble-shoot problems with stoppers, glass and excipients.

“Our biopharma partners will be in good hands at Kalamazoo,” stated Stevenson, “with a dedicated Pfizer CentreOne team by their side who deeply understand their needs, who can leverage a world of top-flight resources at the site on their behalf.”

Said Bob Betzig, Kalamazoo site head, who oversees all operations on the Kalamazoo campus, “We’re thrilled to expand our contract manufacturing services to include sterile injectables. We value our contract manufacturing partners and pride ourselves on producing difficult-to-make injectables. Our team is ready and waiting.”

Abzena Selects Sartorius

Abzena, the life sciences group providing services and technologies to enable the development and manufacture of biopharmaceutical products, has selected Sartorius Stedim Biotech as its preferred equipment supplier in the US

Abzena has selected Sartorius Stedim to equip its integrated CDMO facilities in Bristol, PA (development and GMP manufacture of antibody drug conjugates) and San Diego, CA (development and GMP manufacture of monoclonal antibodies and other recombinant proteins).

Sartorius Stedim will provide both facilities with end-to-end process solutions in single-use (SU) format.

It will equip Abzena’s San Diego process development lab with leading industry technologies such as Ambr250, enabling fast scale up to 500 l initially and later to the 2000 l scale single-use bioreactor for its center of excellence in clinical manufacturing.

John Burt, Abzena CEO, said: “In addition to having selected Sartorius’ industry leading single-use technologies for antibody and ADC production, the Abzena facilities will feature Umetrics process analytics software throughout the process ensuring that all the data captured throughout our clients’ molecule development is transformed into process knowledge ensuring that we can rapidly develop a robust and reliable process that can be easily scaled up to ensure a smooth technology transfer.”

Reinhard Vogt, Sartorius Executive VP said: “We are pleased to have been selected by Abzena, a prominent global CDMO with a comprehensive industry portfolio across a wide range of modalities to supply single-use solutions that enable process development, tech transfer and GMP manufacturing. We look forward to working together to best serve the US and international markets.”

EVIO Acquires Licensed California Cannabis Testing Laboratory

The life sciences company and provider of quality control testing and advisory services to the regulated cannabis industry, has completed the acquisition of 60% of C3 Labs

EVIO is a life sciences company focused on analyzing cannabis as a means for improving quality of life. The company provides analytical testing services, advisory services and performs product research in its accredited laboratory testing facilities.

The company’s EVIO Labs division operating coast-to-coast provides state-mandated ancillary services to ensure the safety and quality of the nation's cannabis supply.

EVIO has the option to purchase the remaining ownership of C3 Labs subject to terms.

Located in Berkeley, CA, C3 Labs has been serving the cannabis industry since 2015 and was one of the first cannabis-focused contract research organization (CRO) in the US.

C3 Labs was also granted its temporary testing license from the State of California and will operate under the brand EVIO Labs Berkeley effective of 1 January, 2018.

The Bureau of Cannabis Control has implemented emergency rules which require all cannabis harvested or manufactured after 1 January, 2018 to be tested by a licensed testing laboratory.

Testing rules will phase-in, with increased testing requirements both on 1 July, 2018 and 1 January, 2019.

“The addition of C3 Labs to the EVIO network is a tremendous milestone for EVIO Inc. C3 Labs generated over US$1 million in consulting revenues during the last two years, EVIO plans to continue offering these services along with traditional compliance testing. The 8,000 ft2 is already outfitted with the latest analytical testing equipment and will become our Northern California hub laboratory,” said William Waldrop EVIO CEO.

C3 Labs will serve licensed California cannabis businesses in accordance with the rules set down by the Bureau of Cannabis Control. The State has issued more than 400 temporary licenses from the 1,800 applications submitted, with most still pending review.

The company applies technologies employed by the food product and pharmaceutical industries to ensure that growers and processors operate in a fully compliant and quality manner and helps clients maintain the highest level of safe and effective medicinal products.

Biomedical Sciences Partnership Building, Phoenix, Arizona

Cost: $99 million

Size: 245,000 sq. ft.

Project team: CO Architects (executive and design architect—includes master planning, programming, laboratory planning, architecture, and interior design); Ayers Saint Gross (associate architect); DPR Construction/Sundt Construction Inc., Joint Venture (contractor); AEI Engineers (MEP engineer); John A. Martin & Associates (structural engineer); Colwell Shelor (landscape architect); Dibble Engineering (civil engineer); Kaplan Gehring McCarroll Lighting (lighting designer); Jensen Hughes (fire protection/code consultant); Lerch Bates (loading/vertical transportation consultant); JBA Consulting Engineers (information technology/audiovisual technology); The Capital Projects Group (cost); Novus Environmental (acoustics/vibration); Atelier Ten (energy and environmental design); Bill Timmerman (photographer)

The tallest addition to the Phoenix Biomedical Campus—the 10-story Biomedical Sciences Partnership Building (BSPB) designed by Los Angeles-based CO Architects with Ayers Saint Gross of Tempe, Ariz.—allows University of Arizona research scientists to collaborate with local healthcare providers and private companies to find new medical cures and treatments. The laboratory complex was programmed, designed and constructed in only 27-months.

BSPB is located to the north of the Health Sciences Education Building—also designed by the same architect and contractor team—on the University of Arizona’s biomedical research campus in downtown Phoenix. Similar to the education building, the newer biosciences structure is clad in folded copper panels, but its exterior, through pronounced setbacks and projections, presents a different physical interpretation of the tall, cleft, desert rock formations. Cantilevered floors extending outward shade the lower levels, while windows limited to the north and south sides control daylight and conserve energy.

Open offices at the building’s north perimeter take advantage of daylight and views, and are visually connected to the labs currently supporting neurological, cardiovascular, cancer, genomic, and nano-bioscience research. Highly flexible lab support spaces were designed as “wet garages” and are arranged next to the windows on the south side. Mechanical equipment is housed on the windowless east and west ends, rather than on the rooftop, protecting the occupants from the intense Phoenix sun.

At the northwest corner of the building, researchers and industry representatives meet on laboratory floors to exchange ideas in glass-enclosed two-story spaces designed with meeting rooms, lounges, and kitchenettes. A sheltering entrance porch on the west side of the building faces the central campus green to form a sunshaded gathering space similar to an outside lobby. A linear gallery connects the lobby to the courtyard, and acts as a pre-function space for meetings of various sizes.

Completion date: February 2017

Sharp Clinical Services Completes First Phase of Facility

Sharp, part of UDG Healthcare, a specialist in contract packaging and clinical supply services, has completed the first phase in the development of its new USD $23 million state-of-the-art facility in Bethlehem, PA.

Sharp acquired the new Bethlehem facility for $14m in 2017 and has now completed a $2.5m relocation project, transferring the company’s clinical storage and distribution services from its Phoenixville site.

A second phase will see Sharp co-locate its fully integrated clinical services offering at the site when its packaging, manufacturing and analytical services move to the facility in late-2018, following a $6.4m refit.

The Bethlehem development offers 1.5m ft.3 of capacity on a 16-acre plot and will allow the company to increase pallet space for both cold and controlled-temperature storage by approximately 50%.

Frank Lis, President of Sharp Clinical Services, said: “The Bethlehem facility is a strategically important investment for Sharp. It will allow us to offer greater capacity, scalability and automation in response to growing demand for our services, as well as co-locating our clinical services at one facility.”

“This facility allows us to simultaneously support multiple large-scale phase III studies through to commercial launch.”

Investing in the Bethlehem site has created 1.5m ft.3 of new clinical services capacity in 2017 and is consistent with Sharp’s strategy of capacity expansion to support current clients and meet future demand.

Shire Seeks US FDA Approval to Make First Med at Covington

Shire plc has asked the US FDA for permission to make its first product at its facility in Covington, Georgia.

Ireland-domiciled Shire announced it had sought agency permission to produce Gammagard Liquid – a plasma-derived antibody product used to treat primary humoral immunodeficiency (PI) - last month.

Matt Walker, head of technical operations for Shire, said, “We are pleased to have filed the Georgia site and look forward to working with the FDA to seek approval for manufacturing in 2018.”

The firm also announced its intention to seek permission to make a second product this year.

Shire acquired the Covington facility when it bought Baxalta in 2016.

In a subsequent US Securities and Exchange Commission (SEC) filing, the firm stated the facility would support growth of its plasma-based treatments.

At present, Shire employs 900 people in Covington. However, the firm said it intends to “ramp up hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and a variety of support and facility roles.”

In addition, Shire said that its subsidiary BioLife Plasma Services would further expand its plasma collection network in Georgia and throughout the US.

SCA Pharmaceuticals’ New Manufacturing Facility, Windsor, Connecticut, US

SCA Pharmaceuticals officially opened a new manufacturing facility in Windsor, Connecticut, November 27, 2017.

The new plant will produce sterile admixtures and pre-filled syringes for healthcare facilities. It is expected to increase turnaround times for SCA, provide economies of production and improve customer experiences.

SCA is expected to add more than 360 new jobs by 2021 at the Windsor facility.

SCA chose Connecticut as the location for its new plant due to the availability of a world-class workforce.

In addition, the location is in close proximity to Bradley International Airport, which will enable the company to deliver products to customers quickly and easily. It will also enable SCA to serve its east coast clients.

SCA has developed the new 90,000ft² facility in a leased site located at 755 Rainbow Road, Windsor.

It includes a good laboratory practice (GLP) analytical chemistry lab, current good manufacturing practice (cGMP) cleanrooms, a high-capacity aseptic production suite, office spaces and quality control laboratories.

The state-of-the-art facility is also equipped with multiple ISO 5 Laminar Air Flow Hoods, which enable sterile compounding operations. A backup generator is installed to ensure continuous production in case of power failure.

Cleanrooms at the new facility are operated by professional compounding staff and certified pharmacy technicians, who have hands-on-experience in high-risk sterile compounding.

The quality control unit of the facility ensures quality and training compliance for all cleanroom personnel. It is also responsible for annual aseptic recertification and carrying out regular quality audits.

SCA provides a range of sterile admixture services including antibiotics and anti-infective medicines such as Vancomycin and cardiovascular medicines such as Adenosine, Ephedrine, Heparin, Isoproterenol and Phenylephrine.

Labor and delivery medications such as epidurals, ephedrine, lidocaine, magnesium and oxytocin are also supplied in addition to sedatives such as ketamine and midazolam. Pain management drugs such as bupivacaine, fentanyl, morphine and ropivacaine are also supplied, as well as electrolytes such as calcium gluconate and potassium.

A ready-to-use operating room and anesthesia syringes are available, which are bar-coded and tamper-proof.

In addition, SCA provides multiple varieties of standard and specialty containers including Hospira LifeCare bags and Viaflex bags, Smiths medical CADD cassettes, Coviden Monoject syringes and plungerless syringe barrels.

The Connecticut State Government supported the project by providing more than $8.5m through the Department of Economic and Community Development (DECD) for leasehold improvement and procurement of new equipment.

SCA received equity capital of more than $700m from Enhanced Healthcare Partners in October 2017 for the project.

Headquartered in Little Rock, Arkansas, SCA Pharmaceuticals was founded in 2010. It currently employs 210 team members at its Arkansas facility.

The company provides sterile pharmaceuticals to pharmacies in hospitals and surgery centers and is licensed by State Boards of Pharmacy in 50 states across the US. Its product portfolio includes patient-controlled analgesia (PCA), anesthesia syringes, epidurals, and intravenous (IV) admixtures.

All the sterile products of SCA undergo environmental monitoring and full endotoxin testing that adhere to USP <85> guidelines. Outsourcing of products with SCA helps its customers to reduce product wastage, drug shortages, and staffing costs.

MilliporeSigma Officially Opened Life Science Hub in Massachusetts

The $115m project was announced and began construction in July 2016. Located in Burlington, the new facility replaced MilliporeSigma’s existing location in Billerica, Massachusetts.

The new building will provide employees with a sustainable and collaborative working environment. All 850 employees of the Billerica facility have been relocated to the new campus, which is home to nearly 1,000 employees.

MilliporeSigma is the life sciences division of Merck.

The 280,000ft² Burlington campus is spread over five stories and includes office spaces with flexible workspaces, laboratories and a customer service and call center. Training, display, storage and instrument repair rooms are also available.

The facility is also Leadership in Energy and Environmental Design (LEED) certified and includes 70,000ft² of space for future expansion.

In addition, the building hosts Merck’s M Lab™ Collaboration Center, a 15,000ft² trademarked laboratory on the first floor. This shared laboratory allows customers to work alongside Merck scientists and engineers in a non-good manufacturing practice (GMP) environment to solve major bio-manufacturing challenges.

The center provides application and technology demonstrations, as well as optimization and scale-up of complex applications, development of optimized protocols and procedures, and troubleshooting unit operations. It also provides hands-on training, including formal bioprocess educational courses, webinars and instructional videos and troubleshooting guides.

Other M Lab™ centers are located in Brazil, China, France, India, Singapore and South Korea.

The Burlington project was approved by the City of Massachusetts under the MassWorks Infrastructure Program, which provides funding for projects that support economic development and job creation.

Merck’s project received a 15% exemption on property taxes for a period of 15 years.

MilliporeSigma is one of many biopharmaceutical companies setting up operations in Massachusetts and nearby areas. With the presence of Massachusetts Institute of Technology (MIT), Harvard University and other academic institutions, the region is known to be one of the top hubs in the world for biopharmaceutical research and development (R&D).

Biopharmaceutical companies such as Bayer and Bristol-Myers Squibb have also set up innovation centers and shared laboratories similar to the M Lab™ center in Massachusetts to accelerate their R&D activities.

Burlington-based The Gutierrez Company built the new life science campus.

Merck was founded as a family-owned business in 1668. Operating as MilliporeSigma in the US and Canada, the company’s life sciences division, includes 65 manufacturing sites worldwide.

The life sciences division provides products and services based on process solutions, research solutions and applied solutions. The combined portfolio includes more than 300,000 products.

Some of the process solutions provided by the division include single-use manufacturing, pharmaceutical raw materials and engineering and validation services. Research solutions include bioscience reagents, specialty chemicals and lab separation tools. Applied solutions include lab water systems, critical raw materials, analytical reagents and point-of-use devices

Athenex Hires German Engineering Firm to Build Manufacturing Facility

Athenex, a biopharmaceutical company, entered into an agreement with M+W, a German design, engineering, and construction company, for the design and construction of a new pharmaceutical manufacturing facility in Dunkirk, NY. The cost of the 320,000 sq. ft. facility is estimated between $205 million and $210 million.

According to a company filing with the US Securities and Exchange Commission (SEC), the cost of the facility will be paid in part by the State of New York. This follows a previously disclosed grant of up to $200 million that the state awarded to Athenex. The remaining amount will be paid by the company. The payments will be made over time, dependent on completion of certain milestones under the agreement. The New York State Empire State Development Corporation must approve any payment from the grant funds.

The construction of the manufacturing facility is part of a $1.62-billion investment that Athenex is making over 10 years to expand its Dunkirk site and its North American headquarters in Buffalo, NY, according to an announcement by Governor Andrew Cuomo in February 2016. In July 2017, Athenex obtained New York State and local tax incentives related to the new Dunkirk facility.

REST OF WORLD

Almac Expands Clinical and Commercial Drug Supplies Services

Almac Group has confirmed the successful completion of Health Products Regulatory Authority (HPRA) inspections of Almac Clinical Services Ireland and Almac Pharma Services Ireland at its European campus in Dundalk, Ireland.

Almac previously confirmed that it secured new premises in Dundalk, Ireland in January 2017 as part of its ongoing global expansion strategy, to meet client demand and to address any potential challenges that may arise due to Brexit.

Following these successful HPRA inspections, Almac Group look forward to being officially licensed to conduct QP batch certification and release for both clinical trial material and commercial drug product from its European campus in Dundalk.

Ensuring the Group meets current and future client needs in the EU marketplace, Almac unveiled plans for further investment at the campus including a new QC laboratory and packaging facility for commercial drug products and a dedicated 79,000 sq. ft. EU Distribution Centre for clinical trial supply. This investment will more than treble the GMP footprint at its European campus which is scheduled to be operationally ready by January 2019.

This £30 million investment complements the existing clinical supply and drug product development operations offered from its Global HQ site in Craigavon, NI, just 40 minutes by road from the new European campus.

The new European campus increases the group’s global footprint and provides an expanded presence within the EU for both clinical trial supplies and commercial drug product operations.

Over the last 18 months, Almac has invested significantly, with the expansion of operational capabilities and employee numbers in each of its key territories including U.S., Asia and the UK. This announcement is part of a wider global expansion strategy. It will be paralleled with further investment and plans to increase employee headcount in all these locations in the coming 18 months, including its Global HQ in Craigavon, UK.

“Achieving these successful HPRA inspections is a key milestone,” said Alan Armstrong, chief executive officer and chairman, Almac Group, said, “In addition, the announcement today of further expansion will ensure our current and future clients receive a seamless solution with access to the EU marketplace. Crucially, this will ensure an uninterrupted service provision through any uncertainty Brexit may bring, and for the future, keeping Almac as a global leader in the life sciences sector.”

New Aseptic Fill/Finish CMO Launches Operations

Wuxi Griffin is a new contract manufacturer in China with Western management style and quality standards.

Wuxi Griffin Pharmaceutical Co. Ltd. is a new China-based company that has begun operations as an international contract manufacturer of sterile fill/finish pharmaceuticals. It is a Western managed joint venture between Sweden and China. According to the company, the focus will be to provide sterile fill and finish manufacturing services that meet Western GMP standards.

When discussing biologics in the Chinese market, Torgny Lundgren, chief executive officer of Wuxi Griffin Pharmaceutical, says very few Western contract manufacturers have established their presence in the Chinese market, especially to Western quality standards.

“There has been a lack of know-how of how to implement Western manufacturing GMP standards in China and this gap is filled by the new plant in Wuxi, China,” he said. “At a time when several biologics are coming off patent, the opportunities to be seized are significant as these pharmaceuticals will become more accessible in areas where it was previously not considered.”

China is the second largest market for pharmaceuticals and with the highest growth rate, Western pharmaceutical companies are looking to China to expand.

Products manufactured in the new Wuxi facility include MAbs, vaccines, recombinant proteins as well as biosimilars and traditional small molecule drugs. RABS and isolator production technology is used. There is capacity for manufacturing of clinical trials materials for biologics—small and medium-sized batches—as well as commercial manufacturing.

“Complying with global GMP standards gives us an advantage as the requirements of Chinese customers wanting Western quality products are met,” said Mr. Lundgren. “We also assist Western pharmaceutical companies wanting accelerated access to the Chinese market.”

Hangzhou Just Biotherapeutics Opens R&D Center, GMP Manufacturing Facility

Hangzhou Just Biotherapeutics (HJB) held the grand opening ceremony for its R&D Center and Manufacturing Facility. Around 200 guests including business partners, investors and representatives from pharmaceutical companies were present to witness this historical moment.

"HJB has reached another important milestone,” said Jonathan Y. Zhao, Founder and CEO of HJB, during a speech at the opening ceremony. “This is a great step towards our mission of expanding global access to biotherapeutics. We will further leverage the 3rd-generation biologics platform to develop and manufacture high quality biologics for patients around the world."

Jonathan Y. Zhao, Jim Thomas and two other senior executives from Amgen co-founded Just Biotherapeutics in Seattle in 2015. Subsequently, its sister company, HJB, was established in China in August 2016. So far, both companies employ nearly 200 scientists and engineers.

Over the past two years, HJB has secured a total of USD 67 million in financing from Lilly Asia Ventures, ARCH Venture Partners, Temasek, Taikang, HEDA and other investors. HJB completed the 140,000 sq. ft. R&D Center and GMP Manufacturing Facility which will supply the global market with clinical and commercial product.

Eisai Ups Capacity in China

Eisai Co Ltd has completed construction of an oral solid dose form manufacturing facility in Suzhou, China.

The Japanese drug firm announced completion of the project, explaining the new facility has capacity to make three billion tablets a year. The site will be operational in the second half of the year.

Eisai has made medicines in Suzhou since 2014 when it set up a facility for the production of injectable Methycobal (mecobalamin), which is used to treat anemia and nerve damage.

The newly completed plant will make and package an oral solid dosage form version of Methycobal.

It will also produce the Alzheimer’s disease pill Aricept (donepezil) and the proton pump inhibitor Pariet (rabeprazole sodium) for the Chinese market.

Eisai’s existing facility will close after the new plant is operational.

The firm said, “Through the completion of the OSD production facility at the new Suzhou Plant, Eisai seeks to strengthen its in-house domestic production system in China and expand its stable supply chain.”

China business

Eisai generated revenue of ¥49.2bn ($7.5bn) in China in the fiscal year ended March 31, 2017, up 17% year-on-year.

Methycobal revenue fell 4% to ¥17.9bn. Aricept brought in ¥6.1bn, which is an increase of 11.1%.

University of Copenhagen’s New Research Building

C. F. Møller designed the building.

Maersk Tower is a new 459,452 sq. ft. (42,700-sm) research building designed and built as an extension of Panum, the University of Copenhagen’s Faculty of Health Sciences. The new building includes research and teaching facilities and a conference center with auditoriums and meeting rooms.

The tower rests on a low base that comprises all common facilities. The base is publicly accessible and appears open and in close dialogue with the surrounding environment thanks to its glass façade. The research functions and laboratories are located in the tower itself and are bound to each other in a loop that provides short distances between locations and improves the possibility of collaboration.

An open atrium and a spiral stairway visually and physically connects each of the building’s fifteen floors. A “Forskertorv” exists around the staircase and creates a natural meeting place and community room for the building’s users.

Maersk Tower’s exterior façade is divided into a grid structure of floor-high copper-plated shutters. The shutters act as a climate guard that moves and shields direct sunlight and overheating. The shutters also help to break down the tower’s large scale. Adding to the energy efficiency of the building, the laboratories capture waste energy and reuse it for other purposes.

Surrounding the tower is a publicly available urban campus park equipped with a “floating trail” that leads pedestrians and cyclists across part of Maersk Tower and creates a new connection between Nørre Allé and Blegdamsvej.

Hermes Pharma obtains GMP Certification from Russian Authorities

The successful inspection will allow Hermes Pharma to manufacture for the Russian market.

Hermes Pharma, specialist in user-friendly oral dosage forms, successfully completed the good manufacturing practices (GMP) inspection of its production facilities by Russian authorities.

The German plant in Wolfratshausen, as well as the production facility in Wolfsberg, Austria, are now both authorized to manufacture medicinal products for the Russian market. The certification covers the manufacturing of several dosage forms and products.

User-friendly dosage forms such as instant drinks, orally disintegrating granules, lozenges, effervescent and chewable tablets represent a rapidly growing opportunity in the pharmaceuticals market, especially for patients who find swallowing tablets difficult.

These dosage forms are also gaining traction in Russia as companies seek to better meet the needs of patients, while diversifying their product portfolio, strengthening their brands and extending product life-cycles.

More than 7000 tons of material is processed and two billion effervescent and chewable tablets, lozenges, instant drinks and orally disintegrating granules are manufactured annually in Hermes Pharma’s production plants.

All operations, such as weighing, blending, granulating, tableting and packaging, take place in highly-automated systems. Rigorous quality assurance and control ensure compliance with GMP, regulatory demands and client specifications.

Dr Thomas Hein, Senior P Commercial and Regulatory Affairs at Hermes Pharma, said: “For a contract development and manufacturing organization (CDMO) like Hermes Pharma, the successful inspection through the Russian authorities is extremely important.”

“It does not only reflect our long-standing commitment to producing high quality products under stringent GMP conditions. It also marks a significant milestone as we are now able to fully support our customers wishing to sell their medicinal products manufactured by us into the Russian market.”

Since 2011, Russian policy has favored local production in efforts to reduce reliance on pharmaceutical imports. Vladimir Putin’s ‘Pharma 2020’ policy pushes for as much 90% of drugs consumed in Russia to be made domestically by 2020.

Such policies have led multinationals to tap the market through collaborations with domestic drugmakers. Pfizer, for example, teamed with Russian pharma firm NovaMedica last May to build an aseptic manufacturing plant in. But increasingly foreign CMOs like Hermes are being approved to make products for the region due to increasing demand for pharmaceuticals.

Slovakian CMO Saneca Pharma said in December that under new requirements foreign facilities can make products for the Russian market so long as Russian regulators audit them once every three years, as well as whenever a customer makes a new product filing in Russia. Saneca received GMP approval from Russian regulators in May 2017 at its facility in Hlohovec, Slovakia.

With such regulations superseding strict protectionist policies, Hermes told us it has no plans to expand into Russia directly.

“As we currently mainly act as a CDMO which means we develop and manufacture for other pharma and healthcare companies and do not import any own brands, we do not see the need to invest in Russia at the moment but this may change in the future.”

Cellular Biomedicine Group Adopts GE Healthcare Technology

Cellular Biomedicine Group Inc. (CBMG) has selected GE Healthcare’s FlexFactory technology for its CAR-T therapy production facility in Shanghai, China.

CBMG announced it had asked GE to install the tech this week, explaining it selected the system in an effort to accelerate and improve the production of its portfolio of Chimeric Antigen Receptor (CAR) T-Cell therapies.

CBMG is the first CAR-T developer to adopt the technology, which is used by companies like Dr Reddy’s, BeiGene and JHL to make biologics.

CBMG CEO Tony Liu said, “This is a productivity revolution in the CAR-T space – this new generation of semi-automated and standardized CAR-T manufacturing capabilities created by GE Healthcare and CBMG may allow cell therapy to provide an optimal platform and opportunity for general oncology patients.

“This long-term collaboration with GE could help us utilize digital technology, semi-automation and analytics, in an effort to reduce overall costs, and deliver treatments to patients more efficiently,” Liu added.

GE Healthcare claims its modular FlexFactory technology can be set up in nine months, which is around half the time it takes to set up other biomanufacturing systems.

Under the agreement, GE will provide staff training and support through its collaboration with the Centre for Commercialization of Regenerative Medicine (CCRM).

CBMG said it expects the FlexFactory installation to be operational before the end of the year.

A GE Healthcare representative said, “Most of the cell processing equipment is developed and manufactured in the US and Europe, from where it will be shipped to China.”

She also said the firm is in talks with other CAR-T developers, explaining, "We have a number of ongoing discussions, but nothing that we can disclose at this point."

Abbvie expands Irish Site

AbbVie says it will expand its biomanufacturing site in Ballytivnan, Sligo to support its oncology pipeline.

AbbVie announced plans to expand its Ballytivnan site – located about 150km northwest of Dublin – adding sterile manufacturing technology to expand its oncology drug pipeline.

An AbbVie spokesperson did not divulge which candidates the expansion would support, but the firm’s oncology pipeline includes 22 candidates in the clinic including six in Phase III.

The investment will create around 100 technical and manufacturing jobs over the next three years.

The $139m (€113m) investment is the latest at the site, as producing more than 50 percent of AbbVie’s total Phase III pipeline products across a variety of therapeutic areas.

In 2014, the firm added 175 jobs through a €85m investment at the site for the production of its all-oral, interferon-free treatment for chronic hepatitis C, Mavyret (glecaprevir/pibrentasvir), approved in the US in August last year.

The pharma sector in Ireland has followed the industry’s shift to large molecule drugs in recent years, with a number of large pharma firms closing or upgrading traditional small molecule manufacturing facilities while simultaneously investing in newer technologies to support the manufacture of their biopharmaceutical pipeline.

Eli Lilly, Merck & Co. (known as MSD outside North America) and Janssen are among those which have recently pledged investment into their Irish bioproduction networks.

And this latest investment was deemed “great news” by Martin Shanahan, CEO of Irish business development organization IDA Ireland.

“The pharma sector is one of our fastest growing sectors and makes a huge contribution to the Irish economy in terms of jobs and manufacturing exports,” he said. “[AbbVie’s investment] builds on their more than 70-year commitment to Ireland and is a tremendous vote of confidence in the capability of the workforce in Sligo and the wider North West Region.”

UK to Offer Funding for New Medicine Manufacturing Centers

The UK Government is set to offer a new grant through the Industrial Strategy Challenge Fund (ISCF) to create new manufacturing facilities to accelerate drug development.

Announced by new Universities and Science Minister Sam Gyimah, the £70m funding will also be utilized for new medical projects such as use of virtual reality to aid in patient recovery and digital speech therapy for stroke and brain injuries.

The investment is expected to increase the number of job opportunities, bolster the National Health Service (NHS) and improve care for patients.

It forms part of the government’s upcoming UK Research and Innovation (UKRI) Research and Innovation Infrastructure Roadmap Programme, which will include development of scientific facilities, major equipment, scientific data, e-infrastructures and communications networks by 2019.

“This investment will not only support high-value, highly skilled jobs but will develop lifesaving treatments that could change lives across the UK.”

Gyimah said: “This investment will not only support high-value, highly skilled jobs but will develop lifesaving treatments that could change lives across the UK.

“Through our ambitious, modern Industrial Strategy we want to unlock the innovations that will help people live better, longer lives by developing the medicines of the future.

“We want to improve the way we make medicines and we are determined to capitalize on our research and innovation infrastructure, which is why today I am launching the start of the UKRI Research and Innovation Infrastructure Roadmap Programme.”

The minister is set to explore innovative technologies such as cartoon-like robots designed to improve learning and understanding in children with autism, and artificial intelligence (AI) facial-recognition research aiming to detect the onset of depression.

Biomedicum Research Laboratory, Karolinska Institute

Biomedicum is planned to be one of the largest experimental biomedical research laboratories in Europe.

Located in the eastern part of the Solna Campus in Karolinska university hospital, Sweden, the facility is being developed to host medical research activities and is expected to develop Stockholm Life as one of the world’s leading life science districts.

Construction was initiated by Akademiska Hus in June 2013 in partnership with Karolinska Institute. Akademiska Hus also invested Skr320m ($37.64m) for construction in June 2016.

The topping out ceremony of the building was held in April 2016, while completion is scheduled for 2018.

The Biomedicum research laboratory will consist of sections A, B, C, and D, which will be spread across 11 floors. The building will have a total floor space of 699,400 sq. ft. (65,000m²).

Each story of the building will have a height of 3.9m, while the labs will have a ceiling height of 2.7m.

The research facility will be directly connected to BioClinicum, a clinical research facility of Karolinska university hospital.

An atrium located on the third floor entrance will include common spaces including a reception and a café, as well as a number of dining areas and conference rooms.

The laboratory will accommodate up to 1,600 researchers and other personnel. It will include 26 laboratory spaces to accommodate between 55 and 60 persons. Each area will have a total floor space ranging between 8,600 sq. ft. (800m²) and 10,760 sq. ft. (1,000m²).

“The facility will have an open lab design, which will encourage group-based work.”

The facility will have an open lab design, which will encourage group-based work. These labs will enhance collaboration among researchers to share equipment, bench space, and support functions, including storage and services. It will also feature closed labs and specialized equipment to perform specific research. The laboratory spaces will have 2mm-thick plain rubber flooring.

The laboratory’s design will be in compliance with biosafety level two. It will include a cell culture room fitted with two biological safety cabinets. Sinks and handwashing units will be included in the anteroom, and compressed air and CO2 gas will be supplied to the labs.

Research activities at Biomedicum

The building will be used to carry out scientific activities of multiple disciplines and crossover research under one roof. It will be occupied by five departments of the Karolinska Institute, including cell and molecular biology, medical biochemistry, biophysics, microbiology, tumor and cell biology, neuroscience, physiology, and pharmacology.

The laboratory will reinforce clinical translation at national and international levels, and act as a reference center for undergraduate, doctoral, and post-doctoral studies.

The facility will further enhance the Karolinska Institutet as an international destination for health, medical education, and science.

Biomedicum research laboratory was designed by C.F. Møller Architects, while Nyréns Arkitektkontor provided the interior design.

Skanska was awarded the general construction contract worth Skr1.2bn ($189.2m) in October 2013.

Akademiska Hus aims to obtain the silver energy and environmental design certificate from the Sweden Green Building Council for the Biomedicum laboratory building.

The office spaces of the building will be ventilated using a ventilation terminal in the ceiling, and ventilation and cooling systems will also be controlled automatically. A high-efficiency particulate air (HEPA) filter will also be fitted to the ventilation to provide a clean environment.

The workstations in the building will be equipped with lighting presence detectors. Textile and metal solar blinds will be fitted to automatically control and maintain the interior climate, thereby increasing energy efficiency.

In addition, the building will feature a green sedum roof for rainwater management.

Mérieux Nutrisciences has entered the Colombian Market

Mérieux NutriSciences has acquired a majority stake in a Colombian microbiology and chemistry testing lab to strengthen its presence in South America.

The firm did not reveal the percentage of the stake or the investment amount.

Tecnimicro Laboratorio de Analisis provides microbiology and chemistry services to the food and pharmaceutical industries.

The company employs 150 people and operates three labs in Medellin, Bogota and Baranquilla covering a surface area of 1400 m2 (~15000 sq. ft.).

Clients include PepsiCo, Corona, Coca-Cola FEMSA, Colanta, Gerfor and Sodexo.

Carlos Saldarriaga, CEO of Tecnimicro Laboratorio de Analisis, said: “We share the common spirit of entrepreneurship, excellence and quality and I strongly believe that our partnership will allow Tecnimicro Laboratorio de Analisis to rapidly evolve in Colombia.”

Tecnimicro Laboratorio de Analisis will be transitioned into the Mérieux NutriSciences network and all the employees will join its 6,500 staff.

“Mérieux NutriSciences is already present in Chile and in Brazil, as well as in Mexico through our North America organization. Colombia is a highly strategic addition to our South American network that will enable us to better cover the continent,” said Eugenio Luporini, managing director South America.

Philippe Sans, president and CEO of Mérieux NutriSciences, said the investment is part of its strategy to expand in high growth potential markets.

“Moreover Tecnimicro's leading position in Colombia and competencies complement Mérieux NutriSciences' recognized capabilities and reinforce the company's growing South American footprint.”

WFS opens Pharma Facility in Copenhagen

Worldwide Flight Services (WFS), the world’s largest air cargo handler, is continuing to enhance its ability to handle pharmaceutical cargoes with the opening of a new temperature-controlled facility in Copenhagen

The investment is in support of WFS’ airline customers’ growing pharma volumes and WFS’ own IATA CEIV Pharma certification program in Denmark, which it expects to complete in early 2018.

The facility has the capacity to store up to 16 cargo units and offers separate temperature chambers offering both 2-8°C and 15-25°C environments.

Each lane in the building is also equipped with an electronic roller-bed system to expedite the handling of pharma shipments.

The WFS team in Denmark is also celebrating winning the cargo handling contract for Air India’s new three times weekly Boeing 787 passenger and cargo services linking the country’s capital city with Delhi.

Jimi Daniel Hansen, WFS’ General Manager Scandinavia, said: “We are delighted to be handling cargo carried onboard Air India’s new non-stop services between Denmark and India, which offers a direct trade link for exporters and importers in both countries. WFS is also progressing towards its IATA CEIV certification in Denmark with the opening of our new cooler facility to supports our customers’ premium cargo products for temperature-sensitive pharma shipments.”

Earlier this month, Brussels became the first WFS cargo station in Europe to achieve IATA CEIV Pharma certification.

WFS is also working towards Good Distribution Practice (GDP) or IATA CEIV Pharma certifications at other major locations across its network, which also includes building new facilities in Paris and Milan.

In Brussels, WFS has installed two new dedicated pharma cells in its main warehouse offering 15-25°C and 2-8°C temperature-controlled environments.

EMA approves mAb Production at Samsung BioLogics Facility

Samsung BioLogics announced that it received approval from the European Medicines Agency (EMA) for the production of a monoclonal antibody (mAb) drug substance at its second facility in Songdo, Incheon, South Korea. This marks the first mAb that will be produced at the 152,000-L bioproduction facility, according to the company.

Details regarding the drug and the scale of production were not released.

This approval follows the facility’s October 2017 FDA approval for mAb manufacturing. Both EMA and FDA inspections occurred in July 2016.

According to the company, the facility has 10 bioreactors and is five times larger than its first Songdo facility, which has a capacity of 30,000 L. Most recently, the company’s third Songdo facility was completed in November 2017 with a 180,000-L capacity, bringing total company production capacity to 362,000 L.

SGS Adds GMP DNA Sequencing Capabilities at Glasgow Facility

SGS, a provider of bio/pharmaceutical, analytical, and bioanalytical solutions, has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors. The service is now available under good manufacturing practice (GMP) conditions to clients from December 2017.

Sanger sequencing is a method of DNA sequencing based on the selective incorporation of chain-terminating deoxynucleotides by DNA polymerase during in-vitro DNA replication. Applications include cell bank characterization, virus seed and plasmid identity testing, and genetic stability testing of cell banks. The new service is supported by an investment in ABI Life Technologies’ validated 3500xl DNA sequencing technology and will complement existing services for this testing, to provide comprehensive analysis and characterization solutions for clients involved in the production and manufacturing of biopharmaceutical products.

The Glasgow facility became part of SGS in 2012 following the acquisition of biopharmaceutical contract testing organization Vitrology Limited, which specializes in biosafety testing. An expansion of the facility in 2014 added an additional 5,380 sq. ft. (500 m²) of laboratory space.

SGS has 20 laboratories offering contract analytical and bioanalytical services across in North America, Europe, and Asia. The company delivers harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides Phase I–IV clinical trial management, and services encompassing data management and statistics, pharmacokinetic/pharmacodynamic modeling and simulation, pharmacovigilance, and regulatory consultancy.

Novo Nordisk expands Insulin Manufacturing Facility in India

Novo Nordisk and its partner, Torrent Pharmaceuticals, an Indian pharmaceutical company, have expanded an insulin manufacturing facility at Torrent’s site in Indrad, Gujarat, India, Torrent announced on Dec. 11, 2017.

The Indrad facility manufactures bulk drugs/active pharmaceutical ingredients (APIs) as well as solid-oral dosage and liquid dosage formulations. Since August 2005, a part of Torrent’s parenteral facility has been exclusively dedicated for the formulation and packaging of insulin for Novo Nordisk.

“With the expansion of the facility at Indrad, we reiterate our commitment to ensuring the provision of affordable, quality insulin for people with diabetes. At Novo Nordisk, we are committed to addressing the growing diabetes burden by working with likeminded stakeholders to change diabetes,” said Frederik Kier, senior vice president, Region AAMEO, Novo Nordisk, in a company press release.

Melvin D’souza, managing director, Novo Nordisk India, said in the press release: “The growth of diabetes in India is alarming and people with diabetes have a right to access affordable, quality medication. Through this partnership, we will continue to ensure the provision of cost-effective yet high-quality medication.”

Novo Nordisk and Torrent Pharmaceuticals have a 25-year partnership in India, which began in 1992 with the manufacture and launch of insulin in 40 IU vials. An integrated manufacturing and vial-packaging plant was inaugurated later in 2009.

Lilly to Grow its Biomanufacturing in 2018

Eli Lilly has projected an increased spend across its biomanufacturing network next year to support bulk production and fill/finish of monoclonal antibodies.

The US-headquartered Big Biopharma firm declared its 2018 guidance this week with incoming CFO Josh Smiley telling investors capital expenditure is expected to be roughly $1.2bn (€1bn) – a “modest increase over 2017” to support large molecule manufacturing.

Lilly spokesperson Tamara Ann Hull confirmed the figure, telling Biopharma-Reporter “the modest increase in capital expenditures from 2017 to 2018 is driven by projects to expand production both bulk and fill/finish capacity of monoclonal antibodies.”

For this year, Lilly estimated CAPEX of around $1bn, including $850m of investment in its US network announced by CEO Dave Ricks in March as part of a patriotic appeal to Congress to scrap tax paid by American companies on overseas income.

The firm also confirmed plans to build a three-story biomanufacturing facility at its site in Kinsale, Ireland in May adding 130 operations and technical support staff by 2020.

Media reports in February suggested the investment – the size of which has not been disclosed – had been put on hold ahead of proposed changes to US tax laws, though a Lilly spokesperson said that this was not the case.

The biomanufacturing network was also spared the axe in September when the firm unveiled a restructuring plan hoping to save around $500m a year through reduced fixed costs and the loss of 3,500 jobs – around 9% of Lilly’s global workforce.

Hull did not reveal which sites would benefit from the planned expenditure.

According to Lilly’s annual report, principal active ingredient manufacturing occurs at its own sites in US, Ireland, Puerto Rico, and the UK, with formulation, filling, assembling, delivery device manufacturing, and packaging taking place at a number of sites throughout the world. The firm did not differentiate between its small and large molecule network.

Merck Kgaa to Transfer Tech for Vaccine Manufacturing Site in Ghana

Merck KGaA says it will provide technology and training to a local team in Sub-Saharan Africa, to help establish a dedicated human vaccine manufacturing facility.

The German pharmaceutical firm signed a Memorandum of Understanding (MoU) with Ridge Management Solutions.

Under the agreement, Merck will provide its ‘know-how’, techniques and equipment for the plant – to be located in Accra, next to the University of Ghana.

“Merck is covering the project end to end…Starting with the feasibility study and basic design until tech transfer, validation and training the local team on the running of machines,” a Merck spokesperson said.

Within Merck’s Life Science branch, “we have all the knowledge and techniques needed for the project in Ghana,” the spokesperson added.

The MoU is the base for a contract, which will be signed after the feasibility study and basic design is finished.

Merck said it is ‘fostering its presence’ in Africa, where it has ties with Morocco, Algeria, Tunisia, Nigeria, Ghana, Ethiopia, Kenya, Angola, Mozambique and South Africa.

In 2015, the firm acquired Sigma Aldrich as part of a plan to increase drug sales in South Africa, Kenya, Angola, Mozambique and Algeria.

Central Institute for Translational Cancer Research (TranslaTUM), Technical University of Munich

The Central Institute for Translational Cancer Research (TranslaTUM) is a new interdisciplinary research building officially inaugurated at the Technical University of Munich in September 2017.

The building was developed by the Free Federal State of Bavaria with the support of the German Federal Ministry of Education and Research.

Developed at a cost of €60m ($71.64m), the facility received a €24m ($28.65m) contribution from the Federal Government of Germany.

The six-story, S-shaped TranslaTUM research building has a total floor space of 60,256 sq. ft. (5,600m²). It features an entrance hall with an open and curving staircase.

The facade of the building is arranged horizontally with a number of long, thin windows. It also includes white, grooved ceramic plates, which highlight the wave-shaped structure.

Public areas include a cafeteria, a seminar area, and an auditorium.

The building features 43,040 sq. ft. (4,000m²) research labs, which can accommodate up to 230 researchers.

Designed to carry out research in translational oncology, the facility is constructed adjacent to the Technical University of Munich’s (TUM) hospital Klinikum rechts der Isar to support rapid translation of novel knowledge and technology into patient care. It provides physicists, engineers, and physicians with a shared new laboratory for transdisciplinary research.

The facility’s staff will focus on tumor diseases of bone marrow and the digestive tract, exploring the process of recognizing and sending molecular signals in tumor cells. They will also study the impact of cancer cells on the immune system with the help of new imaging and analysis methods.

The facility will allow collaboration among different disciplines including biology, biomedicine, biochemistry, physics, engineering sciences, and doctors in clinics.

The facility includes a 7,532 sq. ft. (700m²) seminar and conference area, as well as an underground garage with 50 parking spaces.

The TranslaTUM research building has core facilities including imaging, preclinical research, and cell analysis. It also features state-of-the-art laboratory equipment in core facilities including a central sequencing unit, a microscopy unit, a histology lab, and a central bioinformatics unit.

The facility is equipped to offer a broad variety of imaging studies using established and validated methods such as good manufacturing practice (GMP) produced radiopharmaceuticals. The imaging infrastructure at the facility includes magnetic resonance (MR), multi-spectral optoacoustic tomography (MSOT), ultrasound (US), positron emission tomography (PET), single-photon emission computed tomography (SPECT), computed tomography (CT), and phase contrast-CT technology.

The laboratory at the facility is in compliance with S2-biolevel safety standards. A 7,532 sq. ft. (700m²) area is designed for animal holding, where mice and rats can be retained in sealed rooms. These comply with animal welfare and hygiene standards, and are equipped with high-efficiency particulate absolute (HEPA) and odor filters to stop the spread of incoming or outgoing particles.

Construction of the new research building began in 2014 and the first floor of the building was completed in July 2015. The topping out ceremony was held in November 2015.

Contractors involved with TranslaTUM doranth post architekten was awarded a contract to provide designs for laboratories, offices, the seminar area, the cafeteria, and underground parking in the research building.

CDMO Pfizer CentreOne Expands Contract Manufacturing To Nagoya, Japan

Pfizer CentreOne, a global contract manufacturing organization embedded within Pfizer, announced that it is now offering services in Nagoya, Japan.

The Nagoya site will provide in-country manufacture of highly potent oral solid dosage forms. It will also provide gateway services into Japan – inspection, packaging and testing – for highly potent oral solid drugs and sterile injectables made by Pfizer CentreOne outside the country.

“We’re pleased to add Pfizer’s Nagoya facility to our manufacturing footprint,” said Peter Stevenson, vice president of contract manufacturing, Pfizer CentreOne. “Pfizer has been manufacturing pharmaceuticals in Japan for 50 years. We deeply understand the exacting expectations of Japanese pharmacies and patients, along with the challenges they entail. That knowledge can help our biopharmaceutical partners attain a marketing edge, whether they manufacture their drug at our Nagoya site or bring it into Japan through our Japan gateway services.”

The Nagoya facility provides state-of-the-art cGMP manufacturing of highly potent oral solid drugs that require containment (to protect personnel from contact with hazardous materials) and segregation (to prevent cross-contamination of drugs in the plant).

The site manufactures:

Highly active compounds

Immunosuppresive drugs

Sensitizing agents

Controlled drugs

Dosage forms include high and multiple doses; combination products; multiple release and fixed dose.

Containment: Containment technologies at the Nagoya site span Occupational Exposure Band (OEB) one through five and Occupational Exposure Limit (OEL) down to 0.01 µg/m3. OEBs and OELs protect production personnel by categorizing the risk of the drugs they handle and setting limits to their exposure to these materials.

Inspection and packaging: Services include inspection of primary, secondary and tertiary packaging to assure drugs and their packaging are free of defects before leaving the facility; and custom packaging development to maximize functionality for the pharmacy, and appeal and user-friendliness for the user.

Japan gateway services – inspection, packaging and testing – are available for Pfizer CentreOne’s biopharmaceutical partners who seek to introduce their highly potent oral solid drug or sterile injectable into Japan from another Pfizer CentreOne site. Inspection and packaging services are the same as for drugs manufactured in the Nagoya facility. Additional services include cold-chain handling and, if required, in-market testing for release to the Japanese market.

About Pfizer CentreOne: A global CDMO embedded within Pfizer, Pfizer CentreOne focuses on custom API synthesis, sterile injectables fill-finish and highly potent oral solid dosage forms; and is a leading supplier of steroid and hormone APIs and intermediates. For more than 40 years, we’ve manufactured complex compounds for our biopharmaceutical partners, guiding their drugs safely from development through commercialization.

Sterile Services Department Opens At West Suffolk Hospital, UK

A new purpose-built premises has been built at West Suffolk Hospital to bring the cleaning and sterilizing of medical equipment on site

The new sterile services department (SSD) at West Suffolk Hospital is officially open and fully operational after moving from the Hospital Road site, where it has been based since 1971, to the new purpose-built premises.

The hospital’s SSD plays a vital role in cleaning and sterilizing medical and surgical equipment. It processes on average around 96,000 sets of equipment each year, serving West Suffolk Hospital’s wards, clinics and operating theatres, Newmarket Community Hospital and local Gps.

The new facility has increased capacity, with five washers compared to the previous four, a new trolley washer to replace a previously manual process, and larger capacity sterilizers equaling 28 ft³, compared to the old site’s 21 ft³.

Angela Logan, SSD manager at West Suffolk NHS Foundation Trust (WSFT), said: “With brand new equipment and improved efficiency due to its proximity to the main hospital theatres, the Trust and our team has been looking forward to the very real benefits the move will bring.

“We started moving over in October, and although the first few weeks of getting used to our new surroundings came with some challenges, staff have coped really well and now feel much more connected to the hospital.”

The department has also been allocated a specialist porter, who can be bleeped via a pager to deliver equipment quickly and efficiently across the site.

Craig Black, director of resources at WSFT, said: “With staff no longer influenced by delivery times and couriers, the service is much more efficient and can react to the demands of the busy hospital and external services. It is also easier for the department to build relationships and problem solve with the colleagues they have served from a distance for so many years, so we are so pleased to welcome the sterile services team into their new home.”

Since the move, the SSD has processed around 13,222 trays, and 10,188 supplementary items of equipment for West Suffolk Hospital and other local services.

EMA to Relocate to New HQ in Amsterdam in Wake of Brexit

Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.

The European Medicines Agency (EMA) announced on Nov. 20, 2017 that it will relocate to Amsterdam, the Netherlands, following a vote by the 27 European Union (EU) member states in favor of making the city the new headquarters for the agency in the wake of Brexit. EMA has been based in London, UK, since it was established in 1995 and currently employs nearly 900 staff members at its headquarters in Canary Wharf, London.

The agency has just over 16 months to prepare for the move, which is a consequence of the UK’s withdrawal from the EU, and will take up operations in Amsterdam by March 30, 2019 at the latest. The agency itself was not involved in the selection of the new location.

“We welcome [the] decision on the new location of EMA. Now that we finally know where our journey is taking us, we can take concrete actions for a successful move,” said EMA Executive Director Guido Rasi in the agency’s press release.

“Amsterdam ticks many of our boxes,” he continued in the release. “It offers excellent connectivity and a building that can be shaped according to our needs. I am very grateful that the member states took into account our requirements for business continuity and gave priority to the protection of public and animal health."

Internal surveys show that a majority of EMA staff would be willing to move with the agency to Amsterdam. “However, even in this case, our activities will be impacted and we need to plan for this now to avoid the creation of gaps in knowledge and expertise,” Rasi said in the press release.

Amsterdam was one of 19 offers to host EMA that were submitted by the EU member states at the end of July 2017. The decision on the new location follows an assessment of the bids by the European Commission and EMA.

To start off their collaboration, EMA and the Netherlands will establish a joint governance structure that will steer and oversee the relocation project. The agency intends to give stakeholders and the public full visibility of the relocation project, and in early December, it will make available a monitoring chart on its website to allow tracking of the progress made with the relocation.

Source: EMA

Meissner expands Aseptic Fill/Finish Range

Meissner Filtration Products has bolstered its automated filling offerings through the acquisition of PDC Aseptic Filling Systems.

The deal – financials of which have not been divulged – adds PDC’s range of sterile fill and finish products to Meissner’s filtration, single-use fluid handling and unit processing portfolio.

“PDC brings innovative technology and equipment to Meissner which augments our current capacity in two primary areas, automated filling systems and unique tube sealing equipment,” a Meissner spokesperson said.

“Both are hugely synergistic with our existing portfolio as well as our organizational trajectory whereby we are widening the breadth of complete unit processing operations we offer to the marketplace.”

The firm will be wholly integrated into Meissner, the spokesperson added, though this will be done over a period of time to ensure a “truly seamless” experience for the two firms’ client base.

“We expect this acquisition to integrate very well with our existing pharma business but more important than how it supports our business, is what these additional process solutions offer our clients and how it supports their operations.”

We were also told the expansion of Meissner’s processing business has been driven by a number of drivers within the pharma industry.

“Risk mitigation is always a primary concern, however there are also some additional market dynamics that bear consideration.”

These include processing smaller fluid volumes as productivity per liter increases at the same time as targeted populations bases are in general becoming smaller, leading to demand for products which can streamline the aseptic handling of closed system aliquots, we were told.

Other factors driving demand for tools which enhance productivity include increased competition in the marketplace from biosimilars, the firm added.

Expansions in Cell Culture Facility Offerings

Recent investments show expansion activity in cell culture facilities.

The upstream cell culture sector has seen expansion activity recently as some contract biomanufacturers invest in their cell culture facilities. Major projects announced in the past year include Lonza’s new Ibex solutions that the company is building in Visp, Switzerland, to support multiple technologies, including monoclonal antibody (mAb) cell culture, and FUJIFILM Diosynth Biotechnologies’ new cell culture laboratories in Teesside, UK, among others.

Lonza is building Ibex, a complex of five modular buildings providing 1,076,000 sq. ft.

(100,000 m²) of surface area. Construction began in June 2017. The first two buildings are due to be finished and ready for outfitting by mid-2018 and expected to be fully operational by 2020. In addition to Ibex, Lonza has previously built and licensed mammalian facilities in the United States, United Kingdom, Spain, and Singapore.

Ibex solutions is a new biological development and manufacturing concept that couples flexibility in facility build-out with tailored business models leveraging the company’s expertise and service network in Visp, according to Marc Funk, COO, Lonza Pharma & Biotech.

“Ibex biomanufacturing comprises a modular, technology-independent development and manufacturing complex that is capable of supporting activities across multiple technologies, including mammalian, microbial, cellular, and bio-conjugate, from late drug discovery to manufacture,” Funk says.

The complex will be able to operate at capacities varying from single-use to large scale, depending on customer requirements, according to Funk.

In addition to infrastructure and know-how, Ibex offers flexible models to match and adapt to individual customers’ expectations and forecasts, according to Funk. The availability of a modular complex with pre-built shells means time-to-market can be reduced by 12 months or more, he asserts.

One of the two initially finished buildings at the new complex will be occupied by Sanofi, Funk says. This move is in line with a joint venture that Sanofi and Lonza entered into in February 2017. The two companies are jointly investing approximately CHF290 million (US$298 million), split equally between them, for the joint venture (2). The second of the two buildings will house a mix of customer-dedicated suites and have capacity for polysuites.

FUJIFILM cell culture laboratory expansion

In the third quarter of 2017, FUJIFILM Diosynth Biotechnologies, a biologics contract development and manufacturing organization (BioCDMO), opened 10,000 ft2 of newly built cell-culture process development laboratories in Wilton Centre, Teesside, UK. The laboratories were built through a JPY 1-billion (US$8.9-million) investment, part of a greater JPY 14-billion (US$125-million) expansion announced by the BioCDMO’s parent company, FUJIFILM Corporation, in April 2017.

The Wilton facility is located close to the company’s site in Billingham, UK, which allows for easy access to both facilities.

“There is great scientific talent in the Northeast of England which is a perfect synergy with the Process Development expertise that we have been developing over the past 25 years,” says Funk. “We are excited to be part of a growing industry and the part we play in growing our industry.”

Although the BioCDMO says it has intention to invest further in growing its process development capabilities, it has no concrete new investment plans at present.

The new laboratories are dedicated to supporting activities in the company’s Saturn mAb Platform, which is designed to enable rapid access to process development and manufacturing capacity.

“The foundation of FUJIFILM Diosynth’s Saturn mAb Platform was built on its 25+ years of analytical and process development and manufacturing experience. The platform has built-in best practices, from our Apollo expression system to the latest high throughput process development technologies for process development,” Funk says.

“The platform is adaptable to customer’s existing cell lines as well. Once the platform has been proven to work for a customer’s monoclonal antibody, FDB [FUJIFILM Diosynth Biotechnologies] de-risks the production as we will guarantee performance,” he adds.

“From a GMP [good manufacturing practice] perspective, the Saturn mAb Platform offers a dedicated high-capacity mAb-only manufacturing facility with a simplified off-the-shelf supply chain and batch documentation,” Funk explains.

In addition to the Wilton facility, FUJIFILM Corporation’s overall JPY 14-billion (US$125-million) investment includes an expansion in the US at its site in Texas. The company completed a JPY 10-billion (US$89-million) cGMP production facility in April 2017 for its FUJIFILM Diosynth Biotechnologies Texas (FDBT) unit.

This facility was built in part with funding from the Biomedical Advanced Research and Development Authority, an office of the US Department of Health and Human Services. FUJIFILM plans to invest an additional JPY 3 billion (US$27 million) to outfit the Texas facility with mammalian cell-culture bioreactors.

The FDBT facility is scheduled to start operation in 2018 and will be the manufacturing center of excellence for the Saturn mAb Platform. It will have an initial cell-culture capacity of 6000 L via three 2000-L bioreactors. The facility is designed to allow for future expansion that can accommodate up to 24,000 L of upstream capacity to meet clinical and commercial demands.

FDBT was acquired by FUJIFILM in 2014 through its FUJIFILM Diosynth Biotechnologies USA subsidiary and became a wholly owned subsidiary in March 2017.

In addition to Lonza and FUJIFILM, Sartorius Stedim Cellca, a part of Sartorius Stedim Biotech, also recently announced an investment in a new cell culture facility.

In September 2017, the company started construction on a new EUR 30-million (US$36-million) Cell Culture Technology Center in Eselberg, Germany, which is scheduled to be completed by the end of 2019. The location of the new facility places it in the northwestern scientific hub headquartered in Ulm, Germany.

The company has thus far been operating in a rented building in Laupheim, Germany. The new facility will approximately double the company’s space, and the new location will provide closer proximity to universities and research institutes in Ulm’s Science Park, according to the company.

The company purchased the property, which spans more than 64,560 sq. ft. (6000 m2), at Science Park III in Eselberg in November 2016. The Cell Culture Technology Center can be expanded by a further 5000 m2 as needed, according to the company.

Sartorius Stedim Cellca, which develops cell lines and protein production processes, licenses technologies for the production of proteins, and offers cell culture media, currently employs around 90 people. The company intends to expand its workforce to more than 120 people over the medium term.

Further investment in cell culture capabilities includes pharma major Novartis. In August 2016, Jacobs Engineering Group, a provider of technical, professional, and construction services, was awarded a $100-million contract to expand Novartis’ biotechnology center in Huningue, France. The expansion project is scheduled to be completed by 2020 and adds cell-culture bioreactors to the site.

Jacobs is providing engineering, procurement, and construction management services and will increase the site’s production capacity by 70%.

In addition, it will create a second line of purification that allows for multiple drugs to be manufactured simultaneously. At 35,000 m2, Novartis’ Huningue site houses one of the largest production facilities for mAbs produced from mammalian cells.

Another expansion move involves Sumitomo Dainippon Pharma, an Osaka, Japan-based pharmaceutical company, which boosted its cell-culture production capabilities.

In April 2017, the company formed a deal with Hitachi, a Japanese business solutions provider, to supply automated cell mass-culture equipment for regenerative medicine using human induced pluripotent stem (iPS) cells.

The equipment supplied supports Sumitomo’s research into making practical use of dopaminergic neural progenitor cells. The equipment consists of single-use consumables, such as bottles, tubes, and cell culture dishes.

The iPS cells can be cultured and differentiated efficiently because they can be manufactured in large amounts automatically and be observed under closed sterile environment, according to Hitachi.

In addition to supplying the equipment, Hitachi has formed a joint research deal with Sumitomo to evaluate the validity of processing methods that will be adjusted for practical use of the automated cell culture equipment.

The companies aim to use the equipment for the clinical treatment of patients with Parkinson’s disease with human iPS cells. iPS cells have the ability to be developed into different types of tissues and organs and can be potentially used as regenerative medicine to repair wounded cells.

Sartorius Cell Culture Technology Center, Germany

Sartorius Stedim Cella broke ground on a new laboratory and office facility at the Science Park III, Ulm, Germany.

Sartorius Stedim Cellca is developing the Cell Culture Technology Center (CCTC) in Science Park III in Germany, with an estimated investment of €30m ($35.2m).

Sartorius Stedim Cellca is a subsidiary of Sartorius Stedim Biotech that has established innovative cell line development technology Cellca CHO Expression Platform.

The company held the groundbreaking ceremony for the facility in September 2017 to mark the start of construction. The new facility is expected to be completed by the end of 2019.

Science Park III is accessible through different transportation routes as it lies between Stuttgart and Munich.

Moving operations to this new facility will make it easier and more convenient for international customers to visit the company. The relocation will also place the CCTC closer to universities and research institutes that are in the vicinity of Ulm city.

The new center is being built on 64,560 sq. ft. (6,000m²) of land bought by Sartorius in November 2016.

The company is currently operating from a rented building in Laupheim with 90 employees. Rapid growth in business has necessitated a bigger space for the growing employee base and production facilities.

The new facility will include a laboratory and office space and will double Sartorius’ total space.

Sartorius Stedim Cellca devised a unique cell line development technology platform for protein production of biopharmaceuticals in Chinese hamster ovary (CHO) cells.

The platform helps provide stable cell lines with simple feed-batch processes for the biopharmaceutical industry. It consists of an expression vector, a host cell line, a CHO media system, and an upstream process design.

The Cellca CHO expression platform helps generate cell cultures from the DNA stage to the RCB stage within four months. It has developed 3g/L protein titers in 12-14 day standard feed-batch process.

The processes can be transferred and scaled-up to 1,000l range bioreactors using the platform, and more than 40 projects have successfully been completed.

Headquartered in France, Sartorius Stedim Biotech is an international supplier of products and services to the pharmaceutical industry.

The company serves as a total solution provider. Its portfolio covers various aspects of biopharmaceutical manufacturing.

The firm employed 4,700 staff members and generated €1.05bn ($1.1bn) in revenue in 2016.

Cellca was acquired by Sartorius Stedim Biotech Group in 2015 to become Sartorius Stedim Cellca. The new entity develops cell lines and protein production processes, as well as licenses technologies for protein production and offers media to develop cell culture.

The proteins are produced using living cells under controlled conditions and are used as the basis for the development and manufacture of medications.

Sartorius plans to expand its workforce by employing more than 120 employees in the future.

Science Research and Innovation Facility, University of Windsor

The University of Windsor is building a new science research and innovation facility (SRIF) at its campus in Ontario, Canada.

Located near Essex Hall and the Jackman Dramatic Art Centre, the new facility will be used to carry out research on various areas including cancer and nano materials.

The university is investing $30.3m in the development of the research facility. Construction is ongoing and is expected to be completed by April 2018.

The SRIF is expected to benefit the Ontario region by generating new jobs, fostering innovation, and driving economic growth.

The SRIF will be a three-story building with a built up area of 46,000ft². It will feature classrooms, state-of-the-art laboratory equipment, teaching labs, and wet and dry lab spaces.

The design of the facility is based on an open-lab concept with all the spaces being completely transparent and made of glass, which also allows for entry of natural light.

The entrance of the facility will include an atrium with a lounge interconnecting all three floors.

The interior space is designed to create a collaborative environment for both university staff, as well as graduate and undergraduate students. It is also adaptable and can be altered according to changing needs of the users.

The facility will be energy-efficient and will meet Leadership in Energy and Environmental Design (LEED) standards for environmental sustainability.

The project was announced in January 2017 and site work commenced in February. The topping off ceremony was held in November 2017.

The project has received $14.95m in funding from the Government of Canada through the Post-Secondary Institutions Strategic Investment Fund. The Provincial Government of Ontario is providing $2.56m towards construction, while the University of Windsor is contributing $12.8m.

The first floor of the facility will be dedicated to medical physics, including imaging and diagnostic technologies. It will house laboratories for X-ray diffraction, microscopy and instrumentation.

Currently located in the Department of Chemistry and Biochemistry, the nuclear magnetic resonance (NMR) facility will be moved to the first floor, while research on transitional health will be carried out on the second floor. This floor is designed to support advancement of cancer research.

The third floor will house the advanced materials research lab, which will carry out research on nano materials and biometrics.

Amico Design Build has been contracted to build the new facility, while Colliers Project Leaders is providing project management services.

Established in 1857, the University of Windsor currently 15,000 students studying a variety of undergraduate and graduate programs in the fields of law, business, engineering, education, nursing, human kinetics, and social work.

The university unveiled Phase I of its downtown campus in September 2015. Phase II is currently under construction and will help increase the university’s offerings.

Wasdell Group’s New Pharmaceutical Packaging Facility, Dundalk

Wasdell Group is building a new pharmaceutical packaging plant in Dundalk, Ireland.

Being developed at an estimated cost of €30m ($35.77m), the facility will be Wasdell’s first plant outside the UK.

The new packaging facility will enable Wasdell to serve customers in the European pharmaceutical industry. It will carry out drug testing, production of primary and secondary packaging, and distribution in Europe and international markets.

The project is backed by the Irish Government and is expected to generate 300 jobs. Operations are expected to commence by Q4 2018.

The new packaging facility is being built in the IDA Dundalk Science and Technology Park in Mullagharlin, Dundalk.

The location has various transport connections for product shipment, being within one hour’s journey from Dublin and Belfast via the motorway. In addition, it is around a 70 minute journey from the site to Belfast City and Belfast International airports. The site is also close to four deep water ports located within a one-hour drive. It is also well-connected by rail links to Dublin and Belfast.

The Irish plant is planned to be developed in phases with Phase I occupying 2.88 hectares. Wasdell holds land options to expand the site by another 2.68 hectares.

The site will house a 70,000ft² packaging plant, including 12 production suites. It will include quality control (QC) import testing facilities, state-of-the-art packaging technologies, and storage and distribution facilities.

It will also offer serialization technology and customized manufacturing solutions.

The Dundalk plant will initially produce blister pack and container-filling packaging formats. It will have the flexibility to offer alternative packaging types and dosage forms in the future.

The blister packaging offered by Wasdell includes polyvinyl chloride (PVC) / polyvinylidene chloride (PVDC), polyethylene terephthalate (PET), aclar, thermo-form, alu-alu (cold form), and pealable foil. Custom tooling and design is also offered under blister packaging services.

Wasdell offers a range of container-filling services for solid, liquid, and powder products. Filling of tablets, capsules, powders, and liquids in various containers is offered, along with labelling and label leaflets. Alternative packaging types available include strip packs, sachet filling, and packing.

The new plant will also offer 2D data matrix printing and carton serialization services to help pharmaceutical companies counter counterfeit and misbranded drugs. The technology applies 2D matrix barcodes on the product to ensure traceability.

Wasdell Group is a pharmaceutical services provider established in 1971 and based in England. It operates from Swindon, Burnley, and Newcastle, employing a total of 800 people.

The company offers technical, primary, and secondary packaging, manufacturing and distribution services to pharmaceutical and healthcare companies in Europe through its six divisions.

The Wasdell Packaging division offers primary and secondary packaging services, including manufacturing to support clinical trials and serialization to address counterfeit products.

Biolab’s Research and Development Centre, Mississauga

Brazilian pharmaceutical firm Biolab Farmacêutica has opened a new research and development (R&D) center in Mississauga in the Greater Toronto Area (GTA) of Ontario, Canada.

Developed as part of a global expansion plan, the project will strengthen the work of the company’s São Paulo facility, which is located in Itapecerica da Serra, Brazil.

Constructed at a cost of C$56 million ($45 million), the new center is the first R&D facility built by the company outside Brazil. Construction commenced in August 2015 and the inauguration ceremony was held in October 2017.

Biolab collaborated with the Ontario Investment Office, City of Mississauga, Toronto Global and the Brazil-Canada Chamber of Commerce (BCCC) for the development of the R&D facility.

Biolab decided to build its new R&D facility in the GTA due to various available partnership opportunities.

Ontario’s life sciences industry also offered several advantages, including partnership opportunities with universities, laboratories and international research centers.

The new 13,988 sq. ft. (1,300 m²) R&D center in Canada will support the currently ongoing research activities of Biolab’s R&D center in Brazil.

Research and innovation activities will commence in 2018 after the facility is validated by Canadian authorities, including steps such as testing equipment, documentation creation and compliance with Health Canada standards.

The R&D center will initially employ a team of 20 scientists and pharmaceutical specialists, which is expected to increase to 60 researchers over the first year.

The new facility will carry out research for a wide range of products in Biolab’s pipeline. The exact number of products has not been finalized yet.

Biolab plans to initially focus on products with commercial potential in both Brazil and Canada.

The Ontario Government provided $2.8m for the new R&D facility through the Jobs and Prosperity Fund, which was created in 2013 to promote R&D activity and finance projects related to clinical trials and pharmaceutical research.

The fund helps reduce 15% in income tax for the beneficiary companies.

Established in 1997, Biolab develops healthcare solutions through the research, development and production of drugs in cardiology, gynecology, orthopedics, rheumatology, and pediatrics and dermatology sectors.

The company has more than 100 products in its portfolio and has filed 270 patent applications. It has the potential to generate 100 million units of drugs and cosmetic products a year.

Biolab employs 2,600 people at its Brazilian facility and operates a business development office in Miami, Florida. The company also has presence in international markets through the licensing of its products and collaborations with universities, and national and international research laboratories.

An estimated 50% of the revenue generated by the company is from its innovative medicines. Biolab invests 10% of the net revenue generated a year in research, development and innovation.

Biolab is already present in international markets through the licensing of its products. It plans to open a manufacturing facility in Canada by 2021.

The Francis Crick Institute, London

The Francis Crick Institute (previously known as the UK Centre for Medical Research and Innovation, or UKCMRI), is an interdisciplinary medical research center developed in London, UK.

It is located in Somers Town in the borough of Camden. The institute is the largest center for the research and development on biomedical sciences in Europe. The project was conceived in December 2007 and construction began in July 2011.

The research and innovation center was inaugurated by Queen and the Duke of Edinburgh in November 2016.

The institute has approximately 1,250 scientists from various disciplines worldwide and 250 other staff. The institute researches on interpreting the causes of heart diseases, stroke, cancers, infections and neurodegenerative diseases, as well as develop innovative solutions for their treatment. The center works with leading UK hospitals. Physicists, biologists, engineers, chemists, mathematicians and computer scientists will focus on rapidly turning the discoveries at laboratories into treatment developments.

The UKCMRI was renamed the Francis Crick Institute in May 2011, in the honor of the British neuroscientist, biophysicist and molecular biologist Francis Crick.

The institute is a world-class medical research facility. It is expected to improve lives and attract medical research innovation investments into the UK.

The Francis Crick Institute was set up by consortium partners, including University College London (UCL), the Medical Research Council, Cancer Research UK, the Wellcome Trust, Imperial College London and King’s College London. The consortium invested £650m into the project. The Francis Crick Institute is expected to require approximately £100m a year to remain operational.

The 15-storey Francis Crick Institute was built on a 3.6-acre site at Brill Place, in the Somers Town and St Pancras area. It is located beside the St. Pancras International Station and British Library in Central London.

The institute provides approximately 979,160 sq. ft. (91,000m²) of space for biomedical research and development. The facility is designed to exceed the biosafety level three standards.

It conducts research on cancer cells, various flu viruses, tuberculosis, malaria and HIV to develop vaccines.

The terracotta clad facility is designed to portray its significance in the prime historic location and also create favorable working conditions for the staff. The laboratories are housed in four quadrants of the building. A scaled transverse atrium provides views of the building interiors and allows flow of natural light. Its lowered roof design reduces the scale of the project and house cooling and heating units along with solar panels. A sequence of double height rooms connected by the transverse atria provides employees with meeting areas. Ground level is occupied with public elements.

The sustainable research center houses a two-story, 4,842 sq. ft. (450m²) healthy living center. The facility overlooking the Ossulston Street is dedicated to improving health and well-being of local inhabitants. It includes two training and meeting rooms, health-check rooms, sports and physical activity areas, a kitchen and a reception. The local residents, The Francis Crick Institute, Hopscotch, New Horizon Youth Centre, Training Link, Camden Council and Somers Town Community Centre run the facility.

The project includes a £1.7m allocation towards improvement of housing in the council through Camden’s Better Homes programme, a £3.8m on-site power plant, provision of apprentices during construction, funding on community safety, a teaching laboratory, public involvement in science programs, a 450-seat auditorium and exhibition space, improvements to community spaces, voluntary educational programs, a pedestrian and cycle access way, as well as aid for local businesses through the purchasing goods and services.

The striking building of the Francis Crick Institute has been designed by HOK in partnership with PLP Architecture. Local public consultation and views from the scientists, community groups and residents were considered for its design.

Laing O’Rourke was the main contractor and the contract value is about £350m. URS was the environmental engineer. Arup was the mechanical, electrical, public health engineer and was also responsible for project management. Adams Kara Taylor was the structural engineer and Turner and Townsend was the cost consultant.

The original design was opposed by the local community, who objected to the concept of such a massive center within a city that is facing land scarcity. Their opposition increased as the site was earlier rejected to accommodate public housing. Concerns over the building becoming a potential target for possible terrorist attacks were also raised. The scale of the building was subsequently reduced, following a number of design revisions.

United BioPharma selects GE Healthcare’s FlexFactory

United BioPharma (UBP) has selected GE Healthcare’s FlexFactory manufacturing platform for its new facility focusing on late-stage clinical and commercial production capacity of therapeutic monoclonal antibodies in Hsinchu Industrial Park, Taiwan.

With this added capacity, UBP will support local healthcare needs by bringing biopharmaceuticals to the Taiwanese and surrounding markets faster, while also opening global markets through the FlexFactory’s proven track record in meeting global regulations and quality standards.

The project received support from the Taiwanese Government to help improve access to biopharmaceuticals and boost the bioprocess market in the region. This is a key priority for the Taiwanese Government, which has introduced several policies to create a favorable environment for the development of the biotech, pharmaceutical, and medical devices industries in the country.

Including GE’s FlexFactory based on integrated single-use technologies, the new facility will be dedicated to late-stage clinical and commercial production capacity of biopharmaceuticals, especially monoclonal antibody UB-421, which will be used for HIV treatment. GE will also continue to work closely with UBP on the establishment of its contract development and manufacturing organization (CDMO) business.

Chairperson of UBP Dr. Chang Yi Wang said: “The completion of this state-of-the-art facility equipped with two of GE’s 2,000l single-use bioreactors and integrated manufacturing process is a much-anticipated achievement for UBP to enter into commercial-scale current good manufacturing practice (cGMP) production with international standards.

“It also resolves the manufacturing bottleneck for UBP’s rich pipeline. With the potential expansion to twelve 2,000l production lines within this eight-story building, UBP is and will continue to be the largest protein drug manufacturer in Taiwan in the foreseeable future.”

The head of Taiwan’s Industrial Development Bureau (IDB), Ministry of Economic Affairs (MOEA), said: “In order to improve the industry’s protein drug technology and commercialization capability, the MOEA will assist, through Industry Collaboration Programs, to bring in and transfer GE Healthcare’s process optimization and scale-up technology for monoclonal antibodies to United BioPharma (UBP).

“Through this, we will indirectly assist the establishment of UBP’s 2,000l x 2 biologics manufacturing plant. We expect that the successful operation of this plant will further enhance global competitiveness of Taiwan’s protein drug industry. We believe this will become the driving force for the growth of Taiwan’s biotechnology industry.”

General Manager of global commercial bioprocess at GE Healthcare Life Sciences Sven Henrichwark said: “UBP’s Flex Factory will help deliver increased capacity and support Taiwan’s growing pharmaceutical industry requirements more rapidly. Taiwan’s desire to boost its manufacturing capacity is an industry need we are hearing echoed across the globe.

“Local production capability is a crucial element in providing national healthcare systems with the vital medicines to address growing patient needs. We are excited to contribute to UBP’s development by delivering a robust and flexible biomanufacturing solution that includes final qualification and training.”

UBP’s partnership with GE started as a Fast Trak collaboration. GE Healthcare’s Fast Trak centers, with advanced laboratories, provided large-scale equipment and process-related support for UBP’s research and development (R&D) team members in developing new biopharmaceuticals. The collaboration under the Industrial Cooperation Programme helped manufacture clinical material and technology transferred the manufacturing process back to the UBP team in Taiwan with complete transparency, while their facility was being built.

About FlexFactory:

GE Healthcare’s FlexFactory is a centrally automated, flexible biomanufacturing platform. It allows manufacturers to quickly and easily establish biopharmaceutical manufacturing capacity within an existing building or as part of a new facility.

FlexFactory is designed to help manufacturers such as United BioPharma to rapidly respond to local healthcare needs and to support global customers in bringing lifesaving treatments to market more quickly, FlexFactory is primarily comprised of single-use technologies and associated process hardware and integrated with automation and control components for start-to-finish manufacturing of biopharmaceuticals.

GE’s Fast Trak Service Centers are specifically designed to help biopharmaceutical manufacturers increase their process productivity, reduce cost, and enable them to bring their products to market faster. The centers are equipped with the latest technologies for bioprocessing in an environment and at a scale that closely replicates the real-life industrial setting.

For more than 30 years, thousands of customers world-wide have been trained by GE’s experienced Fast Trak leadership teams, giving customers access to industry expertise encompassing process, analytical development, and process scale-up. Manufacture of drug substances for use in toxicology studies or Phase I and II clinical testing is also possible in the Fast Trak Center located in the US.

GE Healthcare has Fast Trak Service Centers in South Korea, the US, Sweden, India, and China, as well as satellite Fast Trak Centers in Turkey, Japan, and Singapore. More than 500 customers worldwide attend standard Fast Trak courses every year, with training available in local languages. In addition, there are customized courses that are built upon request and tailored according to customer needs.

Founded in October 2013, UBP was spun-off from its parent company United Biomedical Asia to focus on its monoclonal antibody drugs business.

UBP has established a strategic partnership with Taiwan conglomerate Formosa Plastics Group and its Chang-Gung Memorial Hospital network. UBP possesses a comprehensive technology platform for antibody drug development and is focused on the R&D, manufacture, and global commercialization of innovative monoclonal antibodies and biosimilar antibodies with significant market potential.

Driven by innovation and execution, UBP strives to provide effective therapeutics to address unmet medical needs, improve human health and contribute to Taiwan’s economic development

Wuxi Griffin – A New Aseptic Fill Contract Manufacturer in China

The pharmaceutical contract manufacturer Wuxi Griffin Pharmaceutical is a new joint venture between Wuxi Fortune Pharmaceutical in China and SialoCarb, a private company based in Eslöv, Sweden that specializes in sterile filling and medical device validation and production.

The main focus of the western-managed joint venture is aseptic fill & finish of sterile pharmaceuticals.

Headed by CEO Torgny Lundgren, Wuxi Griffin Pharmaceutical's management says it has extensive knowledge in the pharmaceutical business with an average of 15 years of experience.

Of the new venture, Lundgren, said: “There has been a lack of knowhow of how to implement western manufacturing GMP standards in China and this gap is filled by the new plant in Wuxi, China."

China is the second largest market for pharmaceuticals and with the highest growth rate, Western pharmaceutical companies therefore need to be in China to expand.

Products manufactured in the new Wuxi facility include MAbs, vaccine, recombinant proteins as well as biosimilars and small molecule drugs (traditional).

RABS and Isolator production technology is used, and there is capacity for manufacturing of clinical trials for biologics (small and medium sized batches) as well as commercial manufacturing.

"Complying with global GMP gives us an advantage as the requirements of Chinese customers wanting Western quality products are met. We also assist Western pharmaceutical companies wanting accelerated access to the Chinese market," added Lundgren.

On Jan. 4, 2018, contract manufacturer Wuxi Griffin announced the completion of a new 27,450-sq. ft. aseptic fill/finish facility in Wuxi, China. The facility is equipped with three filling suits and uses restricted access barrier systems and isolator production technology.

According to the company, the facility is compliant with GMP standards and offers manufacturing services for monoclonal antibodies, vaccines, recombinant proteins, biosimilars, and small-molecule drugs. Small- and medium-sized batch clinical trial manufacturing and commercial manufacturing are also available.

Polish GMP Inspections at API Plant Finished With Positive Results

Polpharma has announced that the Main Pharmaceutical Inspectorate (MPI) have completed two inspections at its active pharmaceutical ingredients (API) plant in Poland.

Both inspections finished with positive results, and the inspectors will recommend the issue of good manufacturing practice (GMP) certificates for all the substances evaluated.

It was further acknowledged that the API Plant meets GMP requirements, and the certificate makes it possible to sell products worldwide.

This is the best confirmation that Polpharma delivers high-quality products.

Abzena consolidating UK and West Coast US Operations

Abzena Plc has begun consolidating its UK operations at a facility in Cambridge and leased a plant in San Diego, US to consolidate its West Coast production activities.

The UK-based announced it had leased a 30,000 square foot building at the Babraham Research Campus in Cambridge in the UK in 2015.

Now the firm announced it is relocating all its UK operations including the head office functions, biology and chemistry research services groups.

In the US, Abzena has leased a 50,000 foot facility at Lusk Boulevard, San Diego at which it plans to consolidate its regional operations.

The project will see Abzena relocate activities carried out at a leased laboratory in Torrey Pines, which it took on when it bought Pacific GMP in 2015.

The Lusk Boulevard facility houses cleanrooms that will accommodate 500L and 2,000L bioreactors operated by Abzena’s manufacturing division.

On January 4, the firm entered into a preferred biomanufacturing equipment supply and services agreement with Sartorius Stedim Biotech SA.

Under the deal, Sartorius will supply the bioprocess reactor equipment, process analytic software and to provide support for the design of the facility. The site is expected to be fully operation in early 2019.

Pharma Technology Headquarters, Nivelles, Belgium

Cost: €8 million (about $9.5 million)

Pharma Technology is moving its headquarters to a green field site half a mile from its current home in Nivelles, Belgium. At 60,000 sq. ft., the new state-of-the-art site is twice the size of Pharma Technology’s former facility and, among other attributes, will feature a large R&D center to build upon the company’s reputation for innovation in tablet dedusting, capsule polishing and OSD testing technology.

The new headquarters also doubles Pharma Technology’s manufacturing capacity, and significantly increases its stocking space. Modernized technology will boost production of high-end equipment with continuous quality control through all manufacturing and assembly stages, resulting in an e-FAT individual document per machine. A spacious, fully equipped demonstration lab accommodates customer tests, FATs and special projects with OEB 3 containment capacity.

Leading up to the move, Pharma Technology also has up-staffed, hiring over a dozen workers to bring its personnel count to approximately 75. A formal inauguration for the new plant is planned for March 2018.

Lonza Emphasizes New Track and Trace Capabilities at Scotland Facility

Lonza has joined contractors predicting high demand for services that comply with track and trace rules due to be introduced in the EU and US.

The Swiss life science ingredients supplier made the forecast after it completed the installation of serialization technology at its facility in Edinburgh, Scotland last month.

The technology includes a line capable of serializing and tamper-proofing liquid-filled hard-capsule (LFHC) cartons for aggregation on shipment pallets.

Lonza predicted customers would benefit from this investment, citing drug serialization rules soon to be introduced under the EU Falsified Medicines Directive (FMD) and US Drug Supply Chain Security Act (DSCSA) as a driver.

Jane Fraser, head of operations at the site, said, “It’s important for our customers to know that our Lonza Edinburgh facility is ahead of the curve and already fully compliant with the new regulatory requirements in the United States and EU to combat anti-counterfeiting.

"Our new serialization line and quality system – fully commissioned and qualified this year – are now being used to serialize our customers’ sales packs, well in advance of the serialization deadlines" she added.

Lonza joins fellow contractors like Recipharm and Almac, which have also built promotional campaigns emphasizing their compliance with serialization regulations – also known as track & trace – in the US, Europe and other markets.

Technology firms like GEA and Zenith Technologies have also expanded their serialization offerings, predicting that demand for compliant systems will also increase.

CureVac GMP IV Production Facility, Tubingen

CureVac is developing a new good manufacturing practice (GMP) compliant ribonucleic acid (RNA) production facility at its German headquarters in Tubingen.

Planned to manufacture 30 million doses of RNA-based therapeutics a year, production is scheduled to commence in 2018, while commissioning is expected to be completed in 2019.

The new facility will expand CureVac’s manufacturing capabilities and meet growing demands for clinical trials and product commercialization.

Construction of the GMP IV facility began in October 2017.

With a floor space of 94,688 sq. ft. (8,800m²), the new facility will be used to produce a wide range of RNA-based products including RNActive®, RNArt®, RNAntibody® and RNAdjuvant®. These products are approved for indications such as cancer, infectious diseases and other illnesses.

The plant will also have the potential for future expansions.

The RNA active ingredients made at the plant can be used to treat various diseases and infections. A patent-protected production process is standardized for all RNA constructs.

The plant is able to manufacture multiple products, smoothly switching from one production method to another in a few hours. The platform also eliminates the need to develop validation concepts for new products.

Production processes can be scaled according to different quantities ranging from small and customized batches to commercial-scale output.

The GMP-compliant plant will be used to produce vaccines in the event of a pandemic. Vaccines can be made quickly using a biotechnological in-vitro process that uses naturally occurring components as source materials.

The plant will also adhere to the PureMessenger® method of production, which ensures pure and consistently high RNA quality. It will be equipped to manufacture new RNA sequences in GMP quality within a few weeks. The production process also significantly minimizes the cost per dose.

CureVac’s proprietary technology uses mRNA as a data carrier to instruct the human body to produce proteins capable of fighting various diseases. The company’s technologies are used to develop cancer drugs, vaccines and molecular therapies.

Established in 2000, CureVac is a biopharmaceutical company, which was a spin-off from the University of Tϋbingen.

It is one of the first companies to have initiated clinical trials on mRNA-based drugs and has more than 17 years of experience in producing RNA molecules for various medical needs.

CureVac has been operating GMP-compliant RNA production plants GMP I and GMP II since 2006. It also recently completed GMP III, a third in-house suite for manufacturing RNA products.

Clariant broke Ground for its New Plant in India

Specialty chemical company Clariant broke ground for its new manufacturing and healthcare packaging plant in Tamil Nadu, India, on 20 January 2016.

The facility is located in the Kudikadu region of the SPICOT industrial complex in the Cuddalore district.

The ceremony was attended by Clariant’s regional president in India Deepak Parikh, executive committee member Christian Kohlpaintner, masterbatches business unit head Marco Cenisio, and health packaging sales head in India Ketan Premani.

The company invested approximately Sfr10 million ($9.85 million) through its wholly owned Indian subsidiary for the construction of the new packaging plant, which began operations in November 2017.

Clariant’s new plant is designed to support the manufacture of desiccant canisters and packets which are inserted into pharmaceutical packaging to control moisture levels and maintain the stability of medicine. It expands the company’s current manufacturing capacities and provides access to India’s pharmaceutical packaging segment.

The plant features state-of-the-art global healthcare manufacturing infrastructure that is compliant with all current good manufacturing practices (cGMP) and US Food and Drug Administration (FDA) standards.

The production area also meets Cleanroom Class 100,000 and is ISO 8, ISO 9001 and ISO 14001 certified. In addition, the facility is in the process of obtaining ISO 15378 certification.

The new plant will manufacture Clariant’s Sorb-it^®, Tri-Sorb^®, 2-in-1 Can^® and Getter Can^® sorbent canisters.

The new manufacturing and packaging plant will serve globally active, generic and branded pharmaceutical companies, as well as the Indian pharmaceutical market.

The facility will also enhance Clariant’s medical specialty business and provide end-to-end solutions to customers.

Clariant’s new greenfield plant in Cuddalore; ten production sites in Gujarat, Maharashtra, Madhya Pradesh and Tamil Nadu; and its regional innovation center in Mumbai are part of its growth strategy in India.

Clariant is a specialty chemicals manufacturing company based in Switzerland. It is one of the biggest producers of pigments, textiles and leather chemicals in India.

Clariant Healthcare Packaging is a member of Clariant’s Masterbatches business unit, which manufactures controlled atmosphere packaging solutions such as pharmaceutical desiccants, equilibrium sorbents, adsorbent polymers, oxygen scavengers and pharmaceutical closures and containers.

It employs both active and passive packaging technologies, and offers an array of standard components and complete systems. It manufactures and markets textiles, leather, paints, plastic, printing inks and agrochemical products.

Boehringer-Ingelheim to Make First Mab from New Shanghai Plant

tislelizumab will be the first commercial product to be made from Boehringer-Ingelheim’s site in Shanghai, and the first to be made by a foreign CMO in China.

Germany-headquartered contract manufacturing organization (CMO) Boehringer-Ingelheim announced it has entered into an agreement to commercially supply the anti-PD-1 antibody islelizumab for its Chinese partner BeiGene.

The monoclonal antibody will be the first to be made commercially from Boehringer’s mammalian cell culture facility in Pudong, Shanghai which opened its doors in May last year.

The site, built in collaboration with Zhangjiang Biotech & Pharmaceutical Base Development Company, is part of Boehringer’s strategy to “become a leader for contract development and manufacturing of monoclonal antibodies and recombinant proteins in China,” said Boehringer spokesperson Ralph Warsinsky.

This agreement marks the first biopharmaceutical made by a third-party manufacturer to enter into commercial supply in China, though Warsinsky said Boehringer has “already been manufacturing clinical trial supplies in Shanghai since 2015,”

Until recently, third-party manufacturers were not permitted to operate in China. A China State Council announcement in May 2016 allowed trial projects for Marketing Authorization Holders (MAH) to use a GMP-compliant CMO, effectively overwriting this rule.

According to Warsinsky, Boehringer, through its facility and partnerships, was a key player in helping to change the regulations.

“Establishing and expanding our biopharmaceutical manufacturing facility in Shanghai has been accomplished in close collaboration with local authorities and partners,” he said.

“We are delighted that our experiences with our contract manufacturing operating model and GMP standards are acknowledged by Chinese authorities. These have supported the development of the regulatory reform in China, in terms of shaping the regulations on Biologics outsourcing.”

Telstar completes Design, Manufacture and Validation of 13 Isolators for Ipsen Biopham

Telstar has completed design, manufacture and validation services of a complex suite of thirteen isolators.

Comprising seven production isolators and six quality control (QC) lab isolators, the complex achieves containment levels of 0.2ng/m³ (200 picograms). It is specially designed to provide both operator protection from accidental release of the high-potency recombinant proteins and product protection from external contamination.

Developed for IPSEN Biopharm, the isolator package is installed in a recently upgraded cleanroom facility located in the Wrexham manufacturing site.

The set of 13 isolators were designed with a once-through airflow regime and include safe change inlets and exhaust filters integrated within the cleanroom in a very restrictive area. They are also connected to a dedicated heating, ventilation and air conditioning (HVAC) system. This proved a technical challenge for the Telstar team, which worked closely with the building contractors on site to successfully achieve the requirements of the client.

The isolators shared many common design details favored by the client from Telstar’s previous contract with the client. These details included clamped visor frames to provide a more robust gullwing design to provide support to larger-than-normal dimensional visors, and panel filters with safe change housings to provide the necessary increased flow rate but also enable the filters to be safely changed in and out locally without risks of secondary exposure.

In addition, contained transfer ports were included to maintain the low-level occupational exposure limit during transfer of product and removal of liquid and solid waste from the isolators. The equipment has now been successfully commissioned and tested in accordance with the principles of good manufacturing practice (GMP) for pharmaceuticals as set out by the International Society for Pharmaceutical Engineering (ISPE) Baseline Guide for Commissioning and Qualification Volume 5.

The isolators are specifically designed to contain a liquid biotoxin (BSL -4), which has an occupational exposure limit (OEL) of 0.2ng/m³. The isolator mechanical design strength is designed to withstand pressures of -2,500Pa to 2,500Pa.

All the isolator units are designed for bio-decontamination using hydrogen peroxide and are connected to a common manifold fed from one vaporized hydrogen peroxide delivery system, which is interfaced with each isolator over a central programmable logic controller (PLC) communications system, enabling the isolators to be decontaminated individually, or if required together.

This is the second major project developed by Telstar for IPSEN Biopharm. The company previously designed and installed six bespoke bio isolators for a new laboratory area, which also reached the demanding containment level of 0.2ng/m³, (200 picograms), which is exceptionally challenging operator exposure level within the isolator manufacturing industry.

Celltrion to ramp up Biosimilar Program with New Production Plant

At the J.P. Morgan Healthcare Conference that took place this week in San Francisco, California, Republic of Korea-based biotech company Celltrion announced that it is preparing to build a new overseas production plant that will add to the strength of its biosimilar program.

The new plant, with a production capacity of 360,000 liters, is triple the capacity of what Celltrion had initially planned. This decision was made to “ensure stable supplies as well as leverage on economy of scale to further lower the prices of its biosimilar drugs,” said Celltrion’s CEO, Jung Jin Seo.

The company currently owns 2 other production plants that, when running at full capacity, are capable of 50,000 liters and 90,000 liters, respectively.

During Seo’s presentation, he compared Celltrion to major global pharmaceutical companies such as Amgen and Genentech. Currently, Celltrion has 2 biosimilars on the market: infliximab (marketed as Inflectra in the United States, and referenced on Remicade), and rituximab (marketed as Truxima in the European Union, referenced on Rituxan).

Celltrion is also in the process of carrying out clinical trials of adalimumab (based on AbbVie’s Humira) and bevacizumab (based on Genentech’s Avastin) biosimilars. In order to create a competitive edge, the company says that it plans to develop its adalimumab biosimilar as a high-concentrate formula which enables a smaller injection volume than is currently on the market.

For its bevacizumab biosimilar, the company expects to be the first on a global scale to bring a bevacizumab biosimilar to the market, kicking off sales with a “first-mover advantage,” said Seo. However, there some biosimilar developers are further along than Celltrion in their bevacizumab programs. In November 2017, Indian drug maker Biocon announced that it launched a bevacizumab biosimilar in India. In addition, Amgen’s biosimilar, Mvasi, received FDA approval last year, though it has not yet been marketed.

Also in Celltrion’s pipeline is a subcutaneous-administration version of infliximab, which is not yet available in the market, as well as cetuximab (referenced on Erbitux) to treat colorectal cancer, and palivizumab (referenced on Synagis), which has a major indication for respiratory diseases.

Looking to the future, Celltrion is interested in potentially investing in the medical device business; as Seo reports, Celltrion sees big opportunities in both telemedicine and the next-generation diagnostics market. In the years ahead, “the firm plans to make strategic investments in these businesses,” said Seo.

Eisai ups Capacity for Pills and Ppis in China

Eisai Co Ltd has completed construction of an oral solid dose form manufacturing facility in Suzhou, China.

The Japanese drug firm announced completion of the project, explaining the new facility has capacity to make three billion tablets a year. The site will be operational in the second half of the year.

Eisai has made medicines in Suzhou since 2014 when it set up a facility for the production of injectable Methycobal (mecobalamin), which is used to treat anemia and nerve damage.

The newly completed plant will make and package an oral solid dosage form version of Methycobal.

It will also produce the Alzheimer’s disease pill Aricept (donepezil) and the proton pump inhibitor Pariet (rabeprazole sodium) for the Chinese market.

Eisai’s existing facility will close after the new plant is operational.

The firm said, “Through the completion of the OSD production facility at the new Suzhou Plant, Eisai seeks to strengthen its in-house domestic production system in China and expand its stable

supply chain.”

Eisai generated revenue of ¥49.2bn ($7.5bn) in China in the fiscal year ended March 31, 2017, up 17% year-on-year.

Methycobal revenue fell 4% to ¥17.9bn. Aricept brought in ¥6.1bn, which is an increase of 11.1%.

Malaysian Entrepreneurs to build Sri Lanka's First Pharma Industrial Zone

Called Pharma Zone, the industrial area occupies 50 acres of land, and will facilitate local pharmaceutical manufacturers with sufficient land and infrastructure facilities

As per reports, The Sultan of Johor, Sultan Ibrahim Ibni Almarhum Sultan Iskandar has teamed up with entrepreneur Patrick Lim Soo Kit to build an industrial zone for pharmaceutical manufacturers in Sri Lanka with an investment of 100 million US dollar.

According to a press release, the State Pharmaceuticals Manufacturing Corporation of Sri Lanka (SPMC) and Pharma Zone (Pvt) entered into an agreement to build the first ever exclusive pharmaceutical manufacturing zone of Sri Lanka in the Welipenna area of the Kalutara district.

Pharma Zone, located on 50 acres is a Sri Lankan Board of Investment approved company whose principals are Sultan Ibrahim and Lim Soo Kit, a leading Malaysian entrepreneur.

Health Minister Rajitha Seneratne said Sri Lanka was giving incentives for local firms to produce drugs for the state health system, through a 15-year guaranteed buyback agreement and a cost plus 20 percent purchase price in an 'import substitution' strategy.

The industrial zone will lease land to prospective firms for a premium and annual rental. The zone will come with common infrastructure including effluent treatment and warehousing. The firms in the zone will partner with Sri Lanka's SPMC.

The SPMC will provide drug formulations and monitor quality, Lohitha Samarawickrema, President of the newly established National Chamber of Pharmaceutical Manufacturers of Sri Lanka said.

SPMC had signed memorandum of understanding with 25 companies to make drugs for the government's medical supplies division.

SPMC Chairman Dr Sayura Samarasundera said prospective investors who were attempting to set up pharma factories were turned away from several industrial zones operated by the Board of Investment except Kandy, due to lack of understanding about the nature of the business.

The pharma manufacturing zone through its common facilities including warehousing will help reduce costs, Samarasundera said. It costs about 2 million US dollars to set up a factory to make 1-1 billion tablets or capsules but the warehouse cost about 200 million rupees (about 1.5 million dollars). The common facilities in the zone will provide common infrastructure helping keep down costs, he added.

Patrick Lim Soo Kit said the zone will adhere to the 'very strict' environmental standards of Sri Lanka. “We are delighted to enter into this agreement with the government of Sri Lanka which has always enjoyed warm relations with Malaysia. It is the fervent wish of Sultan Ibrahim, that this venture not only brings commercial prosperity to Sri Lanka but benefits the people by way of reduced pricing as well as the ready availability of drugs,” Lim said in the statement.

“This is a 100% Malaysian investment and it underlines the high regard that the Sultan and the people of Johor for Sri Lanka,” he added.

SPMC chairman Dr. Sayura Samarasundara said that with the completion of the Pharma Zone, envisaged to be in operation within one year, the Country Sri Lanka’s dependency on imported drugs would soon become a thing of the past.

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