PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Ipsen Announces New Headquarters for North America

Ipsen, a global biopharmaceutical group, announced it will establish its North American headquarters in Cambridge, Massachusetts. The announcement was made at the 2018 BIO International Convention in Boston with the Massachusetts Life Sciences Center (MLSC), an economic development investment agency dedicated to supporting the growth and development of the life sciences in Massachusetts.

Ipsen will create its third global headquarters by consolidating its U.S. business in Cambridge, the leading global biotech hub. Ipsen will co-locate its North America business with its Global External Innovation and Partnering, R&D and Manufacturing teams, as well as certain global Commercial roles, creating a fully integrated biopharmaceutical business in the US.

“We are entering into a new era of innovation and growth for Ipsen as a leading global biotech company. By bringing our headquarters to Cambridge, we will build a sustainable innovation engine to advance opportunities for our employees and our overall business,” said Richard Paulson, CEO of Ipsen North America. “The MLSC has been instrumental throughout this process, and we look forward to continuing to partner with them as we grow our footprint even further in Cambridge and ultimately address patient needs.”

Ipsen will capitalize on Cambridge’s biotech ecosystem to support its accelerated growth, raise its profile and visibility as an employer and partner of choice. Ipsen already has an established presence in Cambridge with two sites in Kendall Square: a manufacturing site located in One Kendall Square and the 650 East Kendall Street offices, which houses its Global External Innovation and Partnering, and Research & Development activities.

“Our administration is committed to supporting strategic investments in life sciences, research, and development and is pleased that Ipsen has chosen to expand its footprint by relocating its headquarters to here in the Commonwealth,” said Massachusetts Governor Charlie Baker. “Massachusetts continues to be a global leader in the life sciences industry and we welcome Ipsen's planned growth in employment and investment that will spur continued innovation, collaboration and economic growth.”

Ipsen’s U.S. headquarters, currently based in Basking Ridge, NJ, will transition to Cambridge over the next 12 months. Ipsen’s two additional global biotech hubs will remain in the United Kingdom and France. The organization will also maintain a core services center in Basking Ridge, NJ.

Emergent Initiates Expansion

Emergent BioSolutions has initiated a $50m multi-year expansion at the company’s Baltimore, MD-based fill/finish facility.

The expansion – expected to be completed in 2021 – will see the addition of a new isolator enclosed fill line.

Groninger & Co. will install the FlexPro 50 filler with isolator technology and an integrated Christ lyophilizer at the company's facility in Baltimore. The line will have the capability to fill vials, syringes, and cartridges.

Additionally, Emergent BioSolutions will be adding a second autoclave to increase its sterilization capacity and provide manufacturing redundancy.

The addition also will provide new cold storage space to support 2-8⁰c and -20⁰c requirements, new stability chambers, new media fill incubators, and additional warehousing and office space, according to the company.

An additional 60 new jobs are expected to be created in the next three years, according to the contract development and manufacturing organization (CDMO).

BJ Hull, vice president, general manager and site head at the Camden facility, said in a press release: “This $50 million investment further demonstrates our commitment to meeting and exceeding the expectations of our customers as well as to stimulating economic growth and creating jobs in Baltimore.”

The Connell and O’Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer Institute, Boston, Mass.

Size: 30,000 sq. ft.

Project team: Skanska (construction)

Dana-Farber Cancer Institute’s crucial Cell Manipulation Core Facility was renovated and relocated from its original location to a larger space on the Institute's campus, within the prestigious Longwood Medical area.

The new 30,000 sq. ft., cGMP-validated facility expanded the facility’s workspace areas and development capabilities, providing numerous state-of-the-art cleanroom labs and flexible space to support Dana-Farber’s renowned Cell Therapy Program, which develops new cell-based treatments for cancer patients and supports clinical research studies that evaluate the safety and efficacy of those treatments.

Additional state-of-the-art infrastructural upgrade include new air-handling and exhaust equipment and a bulk LN2 system to support cryogenic freezers, as well as a RO/DI water filtration system for the entire building. The renovation and relocation was completed without disrupting the hospital’s operations, using cutting-edge laser scanning technology that enabled the team to take billions of micro-measurements to streamline the construction process. The laser scanning process is 50 percent faster than traditional surveying methods, as well as less prone to human error, leading to time and cost savings while improving the quality of the delivered site.

Completion date: May 7, 2018

Aldevron GMP Plasmid Manufacturing Facility

In March 2018, Aldevron initiated the construction of a good manufacturing practice (GMP) compliant plasmid manufacturing facility in Fargo, North Dakota, US.

Scheduled for completion in the second half of 2018, the new facility is expected to be the world’s biggest plasmid DNA manufacturing facility.

Aldevron is a biotechnology company based in the US. It has made a $30m investment in the new facility, which is expected to double the company’s GMP manufacturing capacity and enable it to meet the growing demand for current good manufacturing practice (cGMP) products.

Aldevron’s new plasmid manufacturing facility will have a total floor space of 70,000ft², including 17,000ft² of modular cleanrooms, which will be used for cGMP production.

The facility will also include ISO 8 and ISO 7 processing suites for cell banking and fermentation, as well as an EU-compliant Grade A product dispensing zone. The fermentation scale of the facility will range from 10l to 300l single-use systems, with provision for expansion to 2,000l in the future.

The product-dispensing and cell-banking suites will feature single-pass airflow, and the production area will feature a unidirectional personnel flow and airlocks. The cleanroom systems at the facility will be designed to provide customers with high-quality manufacturing.

The facility will also be equipped with an emergency generator back-up power, automated alarms and environmental monitoring.

The new facility will provide high-quality plasmid DNA manufacturing services using single-use fermentation (SUF) technology, which minimizes the need for costly cleaning validations and reduces the time between GMP production runs.

The plant will produce a variety of plasmid DNA catalogue items, which will be used to carry out research in mammalian cells. It will produce research-grade plasmid DNA, GMP-Source™ plasmid DNA, and GMP plasmid DNA.

The research-grade plasmid DNA is used in research applications in small, mid-size, large and high-throughput production scales, while the GMP-Source™ plasmid DNA is used as a subsidiary or critical raw material for manufacturing protein and viral candidates used in clinical trials.

Aldevron provides a range of customized GMP plasmid DNA services ranging from early research to commercial supply.

US-based cleanroom expert AES Clean Technology was contracted to design and construct the new GMP plasmid manufacturing facility.

Headquartered in Fargo, North Dakota, Aldevron was initially established as a small laboratory in the North Dakota State University in 1998. It later expanded into a biotechnology firm specializing in the production of nucleic acids, proteins, plasmids, RNA, gene editing enzymes and antibodies.

Aldevron provides clients with critical raw materials and key components, which are used for a wide range of research, pre-clinical, clinical, diagnostic and commercial applications, including gene therapy, gene editing and immunotherapy programs.

The company’s client base spans from some of the largest pharmaceutical companies to small start-ups.

Its Fargo site spans seven acres and includes a 50,000ft² GMP facility.

Fresenius Kabi’s Pharmaceutical Manufacturing Facility Expansion

In August 2016, German pharmaceutical company Fresenius Kabi announced a proposal to expand its pharmaceutical manufacturing capabilities at the Melrose Park village site in Illinois, US.

The expanded facility will be used to produce generic sterile injectable pharmaceuticals for hospitals and clinics across the US.

Construction commenced in September 2017 and the facility is expected to be fully operational by 2026. The expansion will create new jobs for construction and highly skilled workers in Melrose Park.

The expansion will see the construction of new buildings at Fresenius Kabi’s existing 124,267ft² plant In Melrose Park, which was built in 2008 at 2020 N Ruby St.

The site is located in a general industrial area in the outskirts of Chicago, five miles away from the O`Hare International Airport. It employs approximately 700 people.

The plant currently produces a wide range of generic injectable medicines for the treatment of critically and chronically ill patients.

Fresenius Kabi will add four new buildings to the site, with a total floor space of 130,000ft². The facility will include space for highly automated manufacturing, offices, warehousing of materials, and utilities.

The expansion is expected to support the production of injectable drugs used for anesthesia, pain management, cancer treatment and eliminating infections. The project will be completed to meet the latest regulatory and quality requirements.

The new facility will be equipped with a state-of-the-art urban manufacturing campus, including fully-automated aseptic filling lines and sophisticated isolator technology, as well as expanded freeze capabilities and formulation areas. It will also include a dedicated warehouse for raw materials and components, alongside an administration building with a conference center, laboratories, office spaces and a cafeteria.

The multi-stage, multi-year project is expected to be completed in ten years, with an estimated investment of $250m.

Fresenius Kabi is expected to receive $15m in tax-increment financing subsidies from Melrose Park village if it spends at least $80m on the expansion. The company is also expected to obtain subsidies for water usage, while Cook County will offer a 12-year property tax reduction.

Fresenius Kabi will also receive state tax credits for the expansion from the Illinois Department of Commerce and Economic Opportunity.

The new facility at the Melrose Park site was designed by CRB.

Gilbane Building Company was awarded the general construction contract for the new facility.

Headquartered in Germany, Fresenius Kabi is a global healthcare company engaged in the development of medicines and technologies for infusion, transfusion and clinical nutrition.

Fresenius Kabi’s US headquarters is located at Lake Zurich, Illinois. The company’s pharmaceutical manufacturing centers are located at Bensenville, Skokie, Lake Zurich, and Melrose Park in Illinois. It also has manufacturing sites in New York, North Carolina and Pennsylvania.

The company’s US manufacturing sites mainly focus on the development of pharmaceuticals, but also manufacture medical devices and clinical nutrition products. Fresenius Kabi has a total workforce of approximately 2,500 people across the country.

CDMO Tedor Pharma Investment

The newly-formed investment firm DORA Ventures has recapitalized Tedor Pharma, which recently completed a multi-million-dollar expansion of its manufacturing capabilities.

Tedor Pharma is a contract development and manufacturing company (CDMO) founded in 2001.

The company announced the closing of the recapitalization and reorganization of its business funded by investments from DORA Ventures, which is owned and controlled by Laura Iorio, chairwoman of Tedor Pharma, and Doug Drysdale, president and CEO of Tedor Pharma.

"The recapitalization was undertaken to give Tedor a strong operating runway," Drysdale said. "The next steps for Tedor are to leverage the capital investments made over the past two years to expand production capacity."

The Cumberland, RI-based CDMO recently completed a multi-million-dollar expansion of its large-scale manufacturing capabilities. The investment included the installation of new multi-purpose cGMP manufacturing suites.

"We are already seeing an increase in volumes and projects from existing customers and our business development efforts continue to create new opportunities," Drysdale said.

Bronze Award: Large-Scale Science Center Project

A conscientious Building Team takes steps to minimize the impact of this large-scale science center project in a historic neighborhood.

Located in the heart of the third-largest suburb of Chicago—and one of its most prominent cities—North Central College has been an anchor and dedicated community member in Naperville for more than 155 years. The 3,000-student, 65-acre campus is surrounded by historic residential neighborhoods, just blocks from the quaint downtown.

The school’s newest addition, the 124,000 sq. ft. Wentz Science Center, sits on the edge of campus and was designed to engage the surrounding neighborhoods, as well as students and faculty. Public areas and flexible spaces—including a sandwich shop and events space—were incorporated into the facility to draw in the general public.

To address concerns over the size and scale of the science building, the project team worked closely with community leaders to optimize the design and programming for minimal disruption to the neighborhood. On the building’s east façade, which faces the residential neighborhood, the windows were downsized and the overall architectural expression was restrained to reflect the scale of the historic homes across the street. To minimize noise and movement, the building’s quiet functions—namely academic offices—were located along this perimeter.

By contrast, the west façade, which faces the center of campus, is designed to showcase the action within the facility. Public areas, labs, classrooms, and other lively spaces were placed along this perimeter. Large windows and three-story glass curtain wall elements maximize transparency, daylighting, and views of the campus. Electrochromic glass was installed along this façade to control solar heat gain, glare, and daylighting. The construction team built full-scale mockups to determine the best approach and to work through design and installation issues related to the dynamic glazing.

After construction commenced, the client requested that the project schedule be compressed by six weeks so that the building could be occupied by the spring semester. To meet the condensed schedule, the team employed a variety of Lean tactics, including pull-planning and streamlined overtime budgets. Rather than tracking overtime by trade, each company condensed all overtime in one collective budget. Each week during pull-planning, the team assessed what critical path trades made the most sense to work weekends based on how that work would advance the overall schedule and where the team could deliver the maximum value.

As a result, the project opened ahead of the revised schedule, and under budget.

Building Team — Submitting firm, general contractor Pepper Construction Owner North Central College Architect, structural engineer Holabird & Root Civil engineer Cemcon MEP engineer Ketchmark & Associates Owner’s rep. CBRE

General Information — Size 139,000 sq. ft.; Construction cost $60 million; Construction time July 2015 to March 2017; Delivery method CM at risk.

New Omaha VA Ambulatory Care Center

Leo A Daly designed the facility.

A new $86 million project will add 157,000-sf of space to the VA campus in Omaha, Neb. The Omaha VA Ambulatory Care Center will allow several outpatient services to move out of the main hospital, which opened in 1950.

Veteran symbolism is incorporated throughout the facility. The north façade is designed to resemble an American flag rippling in the wind and the western façade is lined with differently hued glass panes that evoke the ribbon bars awarded to service members. Separating the public spaces from the secure clinical areas is a limestone wall. It represents security, the foreign soil tracked home on soldiers’ boots, and the periods of conflict and peace through which veterans have served.

The three-story building will include seven primary-care units, an outpatient surgery suite, a women’s health clinic, and a specialty medicine unit allowing 400 additional outpatients to visit the clinic each day.

The building’s design focuses on patient-centered care and integrates refuge spaces, healing gardens, a labyrinth, positive distractions, access to views and nature, and natural daylight. It is linked to the existing 12-story hospital via an on-grade connector.

The project is the first to take advantage of the 2016 CHIP IN for Vets Act, a new federal law that allows the VA to accept private donations to complete construction projects. The facility is slated for completion in 2020. McCarthy Construction is the general contractor.

Novartis' Gene Therapy Player Avexis Will Build Plant

AveXis, the gene therapy biotech Novartis snapped up for $8.7 billion, will build a new manufacturing plant to produce its specialized therapies.

The company will build its $55 million plant in Durham, North Carolina, officials announced. The company, which expects to employ about 200 at the plant, will get up to $3 million in incentives from the state.

“Our primary focus is to bring gene therapies to patients suffering from devastating rare neurological diseases—such as SMA, genetic amyotrophic lateral sclerosis and Rett syndrome—and continued investment in establishing our manufacturing infrastructure is a critical component to accomplishing this goal,” Andrew Knudten, AveXis chief technical officer, said in a statement.

AVXS-101, the initial gene therapy candidate from the Bannockburn, Illinois-based biotech, is targeted at spinal muscular atrophy, or SMA, Type 1, which is the leading genetic cause of infant mortality.

The new plant compliments AveXis’ “existing state-of-the art manufacturing site in the Chicagoland area,” Knudten said. Bannockburn is about 30 miles from Chicago.

According to a spokesperson, the 170,000-square-foot facility in Durham will primarily produce drug substance, while the 50,000-square-foot plant in Illinois is expected to produce both clinical and commercial product. Construction on the new facility is slated to begin in the second half of this year and be completed in the second half of 2020.

Analysts said the $8.7 billion deal showed that Novartis’ new CEO, Vas Narasimhan, is prepared to make hefty bets to be a lead player in emerging therapies, which come with specialized manufacturing methods. The AveXis takeover gives Novartis an AAV9 gene therapy manufacturing operation, R&D capabilities and pipeline of prospects to support its ambition to claim a sizable slice of the sector.

Novartis was already the first company to win an FDA nod for a CAR-T therapy with the approval in August of Kymriah. The one-time treatment, which is priced at $475,000, is made from a patient’s own T cells, which are collected and then re-engineered at specialized manufacturing facilities, and then infused back into the patient to attack cancer.

Shire to Build New Plasma Mfg. Facility in GA

Shire plc has filed its first submission to the U.S. FDA for the company's new plasma manufacturing facility in Covington, GA. The facility will expand capacity by approximately 30% once fully operational. Commercial production is expected to begin in 2018.

The submission is for the transfer of GAMMAGARD LIQUID [Immune Globulin Infusion (Human)] 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI). The company expects to make a second submission to the FDA in 2018 for its albumin therapy, which is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

"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 additional capacity from this site is a key element to support the growth in our Immunology franchise," said Matt Walker, head of Technical Operations for Shire.

The Covington site currently employs approximately 900 full-time and contract employees. The company plans to begin hiring in 2018 to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse and other support and facility roles.

Shire also plans to continue expansion of its plasma collection network in Georgia and throughout the U.S. through its subsidiary, BioLife Plasma Services, which collects the human plasma that’s processed into the drugs manufactured at Shire's new Covington facility.

Fujifilm Expands Fill Finish Services

Fujifilm Diosynth Biotechnologies has extended its gene therapy and viral vaccine fill/finish capabilities to provide services in support of late phase candidates and commercial supply. Fujifilm has invested in Vanrx Pharmasystems' SA25 Aseptic Filling Workcell gloveless isolator technology with automated environmental monitoring and no glass to glass contact.

Fujifilm's fill finish services offer rapid changeover between drug products and containers, production predictability and the ability to scale up to support commercial production, even when filling and stoppering complex drug products while minimizing defect rates to maximize yield, which is of critical importance when filling very high value products.

"Developers of advanced therapies need to be ready to move swiftly into commercial production, from bulk drug substance and into final dosage form," said Gerry Farrell, chief operating officer of Fujifilm Diosynth Biotechnologies' Texas site. "We recognized that having Fill Finish capabilities that extend beyond the current clinical stage is essential to support the rapid delivery of clinical candidates to patients."

These extended fill/finish services will be provided from Fujifilm's state-of-the-art flexible biomanufacturing facility located in College Station, TX. This facility is a center of excellence for advanced therapies production.

AstraZeneca Opens South San Francisco Research Facility

AstraZeneca has officially opened its new research facility in South San Francisco, bundling five of its Bay Area sites into a single unit at the heart of California’s biotech cluster.

The new location—at the Cove at Oyster Point—is the new workplace for around 400 employees gathered from AZ’s TIDE (Technology Innovation & Delivery Excellence) unit, as well as subsidiaries Acerta Pharma, MedImmune, and Pearl Therapeutics.

There had been speculation that staff from ZS Pharma might also transfer to the new facility, but they were moved along with AZ's renal-cardio therapeutic area from San Mateo in California to Wilmington, Delaware as of January 1 this year.

AZ’s chief medical officer, Sean Bohen, M.D., Ph.D., described the opening as a “milestone” for the company and a “demonstration of our commitment to a strong and visible presence in California.” The new facility would enable “talent from four organizations to work side-by-side at the center of where biotechnology and high-tech industry intersects,” he added, alluding to the area’s close proximity with Silicon Valley.

AZ first announced the plans two years ago, saying the location of the unit would help it source talent and partnerships, provide convenient access to suppliers, and also allow it to cut operating costs.

Other benefits, it now says, are a smaller environmental footprint, an open lab design that allows viewing of science in action from public spaces, and a greater focus on health and safety for employees with “on-site pantries offering organic foods, adjustable desks and ergo dynamic chairs, treadmill-equipped team rooms, and an on-campus gym.” It's not prepared to reveal any of the costs associated with setting up the new site.

The company insists its investment in South San Francisco doesn’t imply a lessening of its commitment to the U.K., and particularly its £500 million ($667 million) corporate headquarters and R&D campus in Cambridge.

“Collaboration is at the core of our culture and a key driver of innovation,” a spokesman said. “Both the South San Francisco and the new Cambridge strategic R&D site bring together the best of both worlds—a shared drive across our employee base to advance great science and bring new treatments to patients, while providing an opportunity to tap into collaborations in and around the respective regions.”

A year on from the topping-out ceremony for the facility, it’s become apparent that progress in completing the project isn’t being made as hoped, with AZ now talking about moving staff there in 2019 rather than this year.

The spokesman says that the goal is to start occupation of the Cambridge site as soon as possible, adding “we anticipate significant numbers of staff will move in in 2019.” Once up and running, Cambridge will be AZ’s largest center globally for oncology research, as well as housing scientists focused on cardiovascular, renal and metabolism, and respiratory R&D, he adds.

AZ recently published commissioned research on the life sciences sector in the U.K. which concluded that Cambridge’s 430 biotech organizations support 15,500 jobs and contributed around £2.9 billion a year to the country’s economy, predicting that could rise to £4 billion over the next 15 years.

The report also warned that if current levels of investment and talent in the Cambridge cluster are not sustained—for example if Brexit has a detrimental impact—it could cost the U.K. economy £7.9 billion over the same period.

Rutgers University - Camden Nursing and Science Building

At $26,783 median family income, Camden, N.J., ranks just behind Reading, Pa., and Flint, Mich., in poverty level among U.S. cities of 65,000 or more. Lying just across the Delaware River from Philadelphia, the city of 74,420, home of Campbell’s Soup Company, has been battling economic decline for decades.

Civic leaders are crossing their fingers that the new Rutgers University–Camden: Nursing and Science Building will revivify the downtown. Located on a long-vacant triangle between City Hall, Roosevelt Plaza Park, and the River Line light rail that links to Trenton, the 101,000-sf nursing school adds to the “eds and meds” anchor institutions that provide 45% of the city’s jobs.

Designed by Perkins Eastman (with architect of record NELSON Architects), the $62.5 million angular structure involved the city, Rutgers University–Camden, Cooper University Hospital, and Cooper Medical School of Rowan University among its stakeholders.

The Building Team Awards jury was most impressed with the project team’s handling of the triangular site, whose awkward geometry posed difficulties for placing labs, simulation spaces, and classrooms. To accommodate an orthogonal spatial program inside a non-orthogonal building envelope, the designers organized the more flexible collaborative and social program elements along the building’s diagonal. This opened up the interior for teaching spaces while lending spatial dynamism to the building’s public spaces.

The nursing school’s remoteness from the main campus—a three- or four-block walk—meant that the students would likely spend nearly all their time in this one facility. This restriction demanded the crafting of an interior environment that could satisfy the many needs of the students—learning, socializing, collaborating, and studying—over a four-year period.

The designers created four unique two-story common areas for dining, individual activity, social interaction, and formal gatherings. The four spaces are knit together by a network of smaller social and study environments along the Student Street side of the building. Taken together, the collection of varied interior environments creates a campus within a single building.

In the midst of construction, the university requested a redesign of the 300-seat lecture hall to accommodate new AV/IT technology that would link Camden with two similar spaces at Rutgers’s campuses in New Brunswick and Newark—all part of an advanced distance learning initiative by the state university system. The design team, contractor Hunter Roberts Construction Group, city officials, and the AV/IT vendors worked to make it happen without undue disruption to the construction schedule.

Built to LEED Silver standards, the four-story building is heated and cooled via a radiant floor system. Other green features: chilled beams, low pressure drop air-handling systems, high-efficiency chillers, LED lighting, and low-flow plumbing.

The new Nursing and Science Building was the first new construction since the merger of Rutgers University and the University of Medicine and Dentistry of New Jersey, in 2013. The hope is that it will lead to a rebranding of Camden as a center of excellence for education and health.

Building Team — Submitting firm, architect, interior architect Perkins Eastman Owner Rutgers University–Camden Architect of record NELSON Architects SE O’Donnell & Naccarato CE Langan Engineering MEP Vanderweil Roofing consultant Roof Maintenance Systems Façade consultant Atelier 10 GC Hunter Roberts Construction Group CM Greyhawk

General information – Size 101,000 g. sq. ft.

Cost $62.5 million

Construction time July 2015 to November 2017. Delivery method Design-bid-build

Cleveland Clinic Taussig Cancer Center

Gold Award: Cleveland Clinic’s new cancer center is a transparent, collaborative hub for improved patient experiences and enhanced communication with caregivers.

The seven-story cancer center is clad in glass curtain wall to maximize daylighting and views of the campus. In the main lobby, greeters welcome patients upon arrival. A palette of wood, glass, and daylight provides clear wayfinding throughout the ground level.

The design of the Cleveland Clinic Taussig Cancer Center was developed with one main guiding principle: optimize patient treatment and provide multidisciplinary care for them under one roof. The new 390,220 sq. ft. facility condensed the cancer services into one efficient building while improving the overall treatment process for both the patients and their families.

The healthcare facility’s project team adopted the Cleveland Clinic’s Owner-Controlled Team Project Delivery Method (OCTPD) to complete the project on time and under budget. OCTPD is Cleveland Clinic’s practice model of project delivery where the owner provides the knowledge and leadership to lead a team of industry experts to define and deliver a project by maximizing the benefits of coordinated teamwork.

The resulting seven-story, patient-first facility includes 126 exam rooms, 98 infusion bays, diagnostic imaging and genetics/genomics testing, dedicated areas for clinical trials, and 176 physician offices with support and conference areas.

Natural light pierces the building from every angle, but the project team determined it was especially important for patient treatment areas to form a connection to nature. In the lower level radiation oncology treatment floor, high ceilings were used to bring in more light to the lower level and a large skylight structure allows daylight to pour in from above. Floors two through four are tabbed for infusion treatment with exam rooms and infusion bays that are all aligned along the north elevation to provide exterior views across the landscaped campus spine. Infusion patients may be in treatment for up to six hours, so providing this connection to nature with wide-open views was especially important.

The first floor focuses on support services that include a private cancer hematology lab, a wellness center with reflexology and massage therapies, art and music therapy, a retail pharmacy, a boutique where patients can get assistance with wigs, prosthetics, and makeup, a resource center, and a meditation space. Administrative offices are located on floors five and six and also include bountiful natural light.

The infusion treatment exam rooms and infusion bays are aligned along the north elevation to provide exterior views across the landscaped campus spine. Robert Benson Photography.

The steel-framed building uses composite floor slabs supported by a mat foundation. The building envelope consists of a unitized aluminum curtain wall with glass and granite panels. A 30-foot slab cantilevers out over the entire 350-foot span of the south façade and main entry.

Prefabrication methods were used to improve quality, enhance the schedule, and reduce the cost of the project. The MEP engineer set up a prefabrication warehouse a few miles from the project site where a significant portion of the above-ceiling MEP racks were built before being transferred to the site and installed.

BIM played a critical role in the project. A preliminary model was used during pre-construction to help inform the estimating effort as the design’s costs were being established. When design-assist contractors for mechanical, electrical, and fire protection were selected, they immediately began working with the design team to evaluate the early MEPFP models for cost and constructability. A common cloud-based server housed all the current models so any team member could see any other partner’s current model and perform “clash tests” between the models.

As each member of the team modeled their support system, they also modeled the hangers used to support them. This allowed the team to map the coordinates of the hangers and install them prior to the pouring of the concrete floors. Not only was the installation safer and faster, it also ensured 100% compliance with the approved model/design and eliminated any clashes in the field. Additionally, simple mockups created from tape and cardboard helped to ensure efficient room layout for users to provide the best care possible. These mockups helped save about $1.5 million from future user change requests.

Overall, the project team achieved substantial completion of the building on the same day identified 27 months earlier at ground breaking. The final construction cost resulted in an overall savings to the owner of $21 million, $17 million of which was directly attributed to the collaborative efforts of the design and construction team.

The team employed prefabrication techniques, including MEP trade racks, to improve quality, enhance the schedule, and reduce costs.

Building Team — Submitting firm, general contractor Turner Construction Company Owner Cleveland Clinic Architect William Rawn Associates Architect of record Stantec Structural engineer LeMessurier Consultants MEP engineer Bard, Rao + Athanas Consulting Engineers

General Information — Size 380,000 sq. ft.; Construction cost $190 million; Construction time September 2014 to June 2017; Delivery method CM at risk.

Alkermes Laboratory and Office Facility, Waltham, Massachusetts

Size: 220,000 sq. ft.

Project team: Davis Marcus Partners (a venture between Marcus Partners and The Davis Companies); Elkus Manfredi Architects

In development is a new laboratory and office facility for Alkermes, a global biopharmaceutical company that conducts cutting-edge research and drug development, on the Reservoir Woods Campus in Waltham, Mass. The new building, located at 900 Winter Street, represents an on-campus expansion of Alkermes’ current facility within Reservoir Woods at 852 Winter Street, enabling the company to expand both its research and development capabilities and comfortably accommodate its growing staff. Construction of the new facility will begin in 2019.

The new facility, designed by Elkus Manfredi Architects, offers an environmentally conscious LEED design and amenities including an eatery, coffee bar, state-of-the-art fitness center, outdoor amphitheater and a rooftop terrace all tailored to provide a collaborative and inspiring work environment for Alkermes’ employees to continue their work on an increasingly diversified portfolio of pharmaceutical products. As part of the build-to-suit arrangement, Alkermes will sign a 15-year lease at the new property.

900 Winter Street will be part of the Reservoir Woods Development, a vibrant, approximately 1.3 million sf campus in Waltham, featuring a diverse mix of office, research and development, retail, health and wellness offerings. Reservoir Woods is also highly commuter friendly, offering shuttle service to the MBTA Red Line at Alewife Station in Cambridge, and is less than a mile away from I-95, Route 128 and Route 2, and less than five miles from the Mass Pike.

Completion date: Q1 2020

Ecolab Expands Greensboro Site

Ecolab Inc., the water, hygiene and energy technologies and services giant, has announced the construction of a cleanroom manufacturing facility at its Greensboro campus. The expansion of the North Carolina-based site (US) has been planned to support the launch of the company’s Life Sciences solution portfolio in North America.

“This new, state-of-the-art production facility reinforces our commitment to meeting the needs of pharmaceutical and personal care manufacturers,” said Beth Simermeyer, Ecolab executive vice president for Life Sciences. “It also reinforces our commitment to the greater Greensboro area, where we’ve significantly expanded to meet the needs of our growing business.”

Ecolab’s Life Sciences division provides comprehensive cleaning and disinfection solutions for pharmaceutical and personal care product manufacturers. The company’s 3,000 sq. ft ISO 5 and ISO 7 certified cleanroom production area for the division’s cleaners, detergents and sanitizers will be housed within a new 12,000-square-foot facility. Cleanroom production is expected to begin in the first quarter of 2019.

Ecolab currently employs approximately 450 associates at its Greensboro campus, which produces cleaning and sanitizing products for food retail locations and quick-serve restaurants, and expects to add additional positions to support the new Life Sciences cleanroom manufacturing facility.

Earlier this year, Ecolab purchased the former Coca-Cola facility adjacent to its campus for additional storage space. The company also is in the process of commissioning its US$27 million manufacturing facility expansion and nearing completion of a remodel of its research and development facility and technical labs.

In 2017, Ecolab opened a 36,000-square-foot office building on the Greensboro campus for marketing, finance and other support positions.

About Ecolab: A trusted partner at nearly three million customer locations, Ecolab (ECL) is the global leader in water, hygiene and energy technologies and services that protect people and vital resources. With annual sales of $14 billion and 48,000 associates, Ecolab delivers comprehensive solutions, data-driven insights and on-site service to promote safe food, maintain clean environments, optimize water and energy use, and improve operational efficiencies for customers in the food, healthcare, energy, hospitality and industrial markets in more than 170 countries around the world.

Cambrex Completes Pilot Plant Expansion at High Point

Cambrex Corp., a manufacturer of small molecule innovator and generic APIs, has completed a pilot plant expansion at its High Point, NC facility with the installation and commissioning of a fourth reactor suite, increasing the site's reactor capacity by approximately 30%.

The new 400 sq. ft. suite includes two 2,000 liter glass lined reactors and a 0.6 sq. m. Hastelloy C22 filter dryer, allowing the manufacture of batch sizes typically 10-100kg under cGMP conditions for clinical phase projects.

The site has also completed and implemented an upgrade of its analytical chromatography data systems for QC and analytical R&D to Empower 3 software, which is designed to enhance capability, integrity and compliance to the site’s analytical systems.

Cambrex also recently completed the construction and validation of a new 11,000 sq. ft. analytical lab at its High Point facility, as well as the installation of multiple continuous flow reactor platforms.

Separately, Cambrex began construction of a new $24 million facility at its Charles City, IA plant for the manufacture of highly potent APIs (HPAPIs). The 4,500 sq.-ft. production area will operate to an occupational exposure limit (OEL) down to 0.1µg/m³ and will have a total reactor capacity of 2,200 gallons, consisting of a range of 200, 500 and 1,000 gallon glass and Hastelloy vessels to manufacture batches from 50 to 300kg.

The project also includes reconfiguration of the existing small scale manufacturing area, providing a single high containment building to support early stage development and manufacturing. The facility is expected to be operational in 1H19.

“Both of these US investments will enhance Cambrex’s cGMP capabilities and offer our customers expanded technologies and services,” said Shawn Cavanagh, chief operating officer of Cambrex. “We will continue to strategically invest across our global network of sites at all scales, from clinical through to commercial, to address customer demands and market Requirements.”

Agilent Expansion in Texas

Agilent's 15,000-square-foot expansion will increase its capacity to meet a growing demand for next-generation sequencing products from its genomics group.

The expanded facility will include cold chain storage required for temperature-sensitive genomic and bioreagent products.

“Following in the wake of recent natural disasters and severe weather events, we are taking steps to further ensure continuous service to customers,” said Henrik Ancher-Jensen, senior vice president, Agilent, and president of order fulfillment and supply chain, in a statement.

The expansion comes on the heels of Agilent completing its acquisition of Lasergen, a biotechnology company that researches and develops technologies for DNA sequencing. Agilent made an initial investment in the Houston, TX-based company in 2016 and since then, the companies have collaborated to develop a workflow solution for clinical applications based on next-generation sequencing.

“In 2016 we began our collaboration with Lasergen that reinforced our confidence in the team and technology,” said Kamni Vijay, vice president and general manager of Agilent’s genomics division, in a press release announcing the completed acquisition.

“As a unified team, we now have new opportunities to leverage our combined strengths and create significant value for our customers as we work towards our goal of creating an integrated clinical workflow solution and providing more labs with access to molecular diagnostics,” Vijay added.

Lonza Pharma & Biotech to Expand Portsmouth Site

Lonza Pharma & Biotech is investing in a new phase of development at their Portsmouth, NH site. The expansion will include mid-scale mammalian capacity and the addition of new cell-therapy suites.

The company is installing multiple 6,000L bioreactors at the site to meet existing and new customers' needs, with building expected to start in late 2018. Further expansion of mid-scale capacity is a key area of growth for the company driven by a favorable regulatory environment for developing products for niche indications.

Lonza is implementing full-suite process analytic technology (PAT) and advanced multi-variate analysis (MVA) to ensure consistent performance. The hybrid facility, which also incorporates single-use technologies for simplified processing, will be installed in an existing building.

Additionally, the company is installing multiple cell-therapy suites at the Portsmouth site. In February 2018, the company established centers of excellence in cell and gene therapy across its network, with Portsmouth as a clinical and commercial manufacturing center in this emerging technology. Customers will have access to facilities for phase I through to commercial manufacturing under one roof, which is expected to be fully operational by late 2018.

“These new facilities have been designed specifically to deliver for our customers and their patients,” said Marc Funk, chief operating officer, Lonza Pharma & Biotech. “They will be enabled by cutting-edge technology developed with our R&D team and the decades of expertise at our Portsmouth site”

US BIDMC Opens Immunotherapy Research Institute

The Cancer Center at the Beth Israel Deaconess Medical Center (BIDMC) in the US has opened a clinical and research institute focused on cancer immunotherapy. Beth Israel Deaconess Medical Center (BIDMC) is a world-class teaching hospital of Harvard Medical School located in the heart of Boston, MA.

The immunotherapy institute will encourage research, educational initiatives and faculty development to further advance immunotherapies.

Immunotherapy uses the body’s natural defense systems to detect and selectively target cancer cells while minimizing toxicity to vital tissues. It is currently used to treat different types of cancer, including blood, colon, kidney, skin and breast cancer.

The new facility will drive better insights into cancer immunotherapy for the development of new therapies.

Researchers at the institute are already working on combining clinical and translational research under a personalized cancer vaccine program.

“It’s incredibly powerful to bring together a community of scientists, clinicians, translational researchers, patients and families with the shared goal of improving patient outcomes.”

In previous clinical trials with certain blood cancer patients, the team observed that vaccines developed at BIDMC trigger anti-tumor immune responses, disease regression and protection from relapse.

Based on these findings, BIDMC is expanding access to this technology to patients across the country through a new clinical trial involving 17 US cancer centers.

The institute will be supported by BIDMC’s Randi and Brian Schwartz Family Cancer Immunotherapy and Cell Manipulation Facility to advance its vaccine research and develop innovative technologies.

BIDMC Cell Therapy and Bone Marrow Transplant Program, hematologic malignancies section chief David Avigan said: “The idea of using the immune system as a way of developing better and curative therapies is an incredible motivator for all of us.

“It’s incredibly powerful to bring together a community of scientists, clinicians, translational researchers, patients and families with the shared goal of improving patient outcomes.”

LSNE Acquires PSC Biotech’s Parenteral Mfg. Facility

Lyophilization Services of New England (LSNE) has acquired PSC Biotech’s 37,000 sq. ft. cGMP aseptic fill finish manufacturing facility in Madison, WI. This acquisition expands LSNE’s manufacturing capabilities, adds new service offerings and allows the company to accommodate its customers’ project timing requirements. The new facility will be called LSNE-Madison. Financial terms were not disclosed. LSNE anticipates full manufacturing activities to begin later this year, following a short period of renovation and validation of the facility.

The multi-product facility will be used for the manufacture of final drug products for preclinical to Phase III/commercial use. The facility currently includes a high speed, automated aseptic fill line and a 144-sq.-ft. lyophilizer with existing space for additional equipment and the ability to expand to over 100,000 sq.-ft. of production space over time.

The facility complements LSNE’s existing full-service parenteral manufacturing capabilities, which include vial filling, lyophilization, process development, QC analytical, secondary packaging, stability studies and regulatory support for clinical and commercial products at its three other FDA-inspected manufacturing sites. This new facility will also increase LSNE’s capabilities to include the terminal sterilization of final product and additional quality control services.

“This acquisition is a key part of our strategic growth plan to increase our operations and capacity and better serve our customers,” said Matthew Halvorsen, chief executive officer at LSNE. “We have experienced strong growth and increased demand over the last few years, and as the market continues to expand, we know it is imperative to be able to offer increased scheduling flexibility to existing and new clients. With the support of the Permira Funds, we are increasing our capacity to provide our clients with additional manufacturing redundancy backed by the outstanding level of service that LSNE is known for.”

“With this acquisition, we are gaining strong talent that complements LSNE’s experienced and successful teams,” said Shawn Cain, chief operation officer at LSNE. “We look forward to working with the staff to build LSNE-Madison into a world class aseptic fill/finish facility focused on the manufacturing of lyophilized and liquid drug products. “

Novartis-Penn Center for Advanced Cellular Therapeutics

Laboratory facility tours were offered as part of the 2018 Laboratory Design Conference in Philadelphia, organized by Controlled Environments’ sister publications Laboratory Design and R&D.

One of the five lab tours offered on April 25 was the Novartis-Penn Center for Advanced Cellular Therapeutics (CACT). Located on Penn Medicine’s campus, the lab facilities assist in Penn Medicine’s research using Chimeric Antigen Receptor (CAR) technology, which enables a patient’s own immune cells to be removed from their bodies, and reprogrammed as hunters to locate and destroy tumors.

Stephen Copenhagen, LEED AP, Principal, CannonDesign (left) and Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine

The tour was led by Dr. Bruce Levine, Barbara and Edward Netter Professor in Cancer Gene Therapy, University of Pennsylvania Perelman School of Medicine; Stephen Copenhagen, LEED AP, Principal, CannonDesign; and Kurt Buchholz, Director of Facility Operations, Center for Cellular Immunotherapies at University of Pennsylvania.

The cGMP facility employs 100 highly specialized professionals, and hosts 6,400 sq. ft. of cleanroom space as well as 24,000 sq. ft. of laboratory space. It has the capacity to manufacture cellular therapies for 400 patients per year.

The CACT facility is located on the ninth floor and houses eight processing cleanrooms, an automation room, a media prep room, and gown-in/gown-out rooms. The interior hallway and common areas are Class 100,000 (ISO 8) and the individual cell processing rooms are Class 10,000 (ISO 7). The CVPF-CACT footprint of the cleanroom manufacturing area measures about 4,500 sq. ft., and processing is performed in Class 100 (ISO 5) BSCs.

Then-Vice President Joe Biden visited the facility in January 2016, days after then-President Barack Obama’s State of the Union address in which he asked Biden to head up a national “moonshot” effort to eradicate cancer.

Thermo Fisher Advances Biologics Manufacturing

Thermo Fisher Scientific is expanding its biologics manufacturing capabilities in the US for clinical and commercial supply.

The vendor will invest $50m (€41m) into its Patheon contract development and manufacturing business, at a facility in St. Louis, Missouri.

Thermo Fisher completed its $7.2bn acquisition of Patheon in August last year, taking on large molecule contract manufacturing capacity, production plants and 9,000 staff.

The firm’s latest investment will see Patheon’s manufacturing building #2 expand by 64,000 sq. ft. to double capacity.

Approximately 80 technical jobs will be added to the site, which is due to open by 2019.

Spokesperson Mari Mansfield said the facility will implement Thermo Fisher single-use technologies, such as its HyPerforma single-use bioreactors and SmartFactory mixers and control systems.

The plant “will be able to fully utilize and deliver on the latest improvements in mammalian cell culture titer,” she added.

Mansfield said the investment responds to increased demand for biologic drug development.

“The Patheon biologics network is growing at a rapid pace based on the 2,000L platform demand as a preferred option in new drug development through commercialization,” she said.

“St. Louis was best positioned in the Patheon biologics network to increase the 2,000L fed-batch capacity and support the growth,” she added.

The investment comes just five weeks after Thermo Fisher announced plans to move manufacturing and R&D operations from its site in Kent, UK, to existing sites in Mexico, China and Denmark - and implement a phased redundancy of approximately 170 employees.

But Mansfield said the Kent site closure is not connected to its biologics strategy: "The investment in the St. Louis site is unrelated to the strategic relocation of operations in Ashford to other existing facilities."

Catalent Plans Capacity Expansions at Two Biologics Facilities

Catalent is planning to add capacity at two of its biologics manufacturing facilities, setting it up to grow in an area in which demand continues to outstrip supply.

Somerset, NJ-based Catalent made a major move into contract biologics manufacturing last year when it paid $950m (€793m) to acquire Cook Pharmica. The deal gave Catalent ownership of an 875,000 square-foot biologics facility in Bloomington, IN to complement its existing plant in Madison, WI.

Initially, Catalent indicated an interest in moving the fourth and fifth production trains it planned to open in Madison over to Bloomington. However, it is now looking to expand both facilities.

“We're moving forward with a fourth and fifth train in Madison. We're doing the engineering study right now and have had those conversations with our board,” said John Chiminski, CEO of Catalent, during the company's Q3 earnings call. “Then we're also looking at additional capacity, probably two by 2,000 [liters], within Bloomington."

Catalent’s interest in expanding both sites reflects a belief that the contract biologics manufacturing sector is poised for a period of sustained growth.

Contract manufacturing organizations (CMOs), most notably Samsung BioLogics, have brought a considerable amount of biologics capacity online in recent years and continue to add to their footprints.

Yet, Catalent thinks there continues to be plenty of opportunities in its chosen sub-5,000L part of the market. Chiminski sees a “supply and demand imbalance” that he expects to “support an attractive pricing environment” for at least the next five years.

Catalent has considerable scope to grow its operation to correct the imbalance. Chiminski said the Bloomington facility is using around 45% of its capacity, a figure he hopes to grow to 80% over the next four years.

Chiminski’s growth prediction is based on Catalent’s experience of expanding the Madison facility, where the addition of a third production train is increasing utilization. Like the mooted Bloomington expansion, the third train at Madison added two 2,000L bioreactors.

Catalent committed to the $34m expansion of the former GE Healthcare site in Madison in 2016 but ran into some difficulties along the way.

“This was not related to the equipment or this new suite itself, this was just the component filter that we use in the process,” said Chiminski.

Catalent has since resolved the challenges by identifying the root cause and the train is now operational, albeit a few months later than originally hoped.

The company is positioned to make a quick start now the train is ready. Catalent signed contracts with a number of companies during construction and expects utilization of the capacity to begin ramping up in the coming months.

Phillips-Medisize Adds Drug Handling Capability

Phillips-Medisize has completed a significant expansion at its New Richmond, WI facility, adding capabilities in drug handling for pharmaceutical customers with the complete manufacture of drug delivery devices and compliance with FDA 21 CFR 210/211 requirements.

The New Richmond facility will add nearly 70,000 sq.-ft. of space this year to accommodate automation, material handling, robotics and high-tech manufacturing to serve the diagnostics, drug delivery and medical device markets. Additionally, the facility offers services in molding, assembly, labeling, packaging, kitting, serialization, sterilization management and bulk distribution.

“This is the second expansion of our New Richmond facility in less than three years. We are excited about the continued growth we are experiencing and the addition of drug handling capabilities we are able to offer our customers at another facility. The expanded drug handling capability will allow Phillips-Medisize to further consolidate the supply chain for our customers,” said Matt Jennings, president Phillips-Medisize.

CordenPharma Expands API Mfg. Capabilities

CordenPharma has expanded operations with new commercial oligonucleotide API manufacturing capabilities at its FDA inspected CordenPharma Colorado facility.

The expansion, which was completed in the first quarter of 2018, will provide cGMP oligonucleotide manufacturing capacity up to 2mol, with a significant increase in total commercial capacity up to 500kg annually, making CordenPharma Colorado one the largest oligonucleotide manufacturing sites worldwide. The facility has not only enhanced capacity, but also put in place a dedicated team of experts with more than 20 years of experience in manufacturing oligonucleotides.

"This expansion will not only provide our customers timely and much needed oligonucleotide API manufacturing services to advance their drug development programs in clinical trials as planned, but also allow them to leverage our regulatory expertise for scale-up and manufacture of commercial products," said Matthieu Giraud, director, global peptides, oligonucleotides, lipids and carbohydrates platform, CordenPharma. "Drawing upon our strong history in highly potent peptide API manufacturing, CordenPharma Colorado's engineers implemented an innovative design to ensure low endotoxin / bioburden levels, which are a prerequisite for injectable APIs."

Brian McCudden, managing director, president and chief executive officer, CordenPharma Boulder and CordenPharma Colorado, said, "The oligonucleotide expansion marks another important milestone in our strategic plan to offer comprehensive development and manufacturing API services. We now offer GMP manufacturing at multiple scales to leverage a seamless technology transfer process from our experienced oligo development team."

REST of the WORLD

GE Grows Flexfactory Presence in China

GE Healthcare has announced plans to install its second FlexFactory manufacturing platform for cell therapy, this time at Xiangxue Pharmaceutical’s site in Guangzhou, China.

Xiangxue Pharmaceutical (XPH) has selected GE Healthcare’s FlexFactory – a semi-automated manufacturing platform – to advance clinical and commercial production of cell therapies.

The project marks the first FlexFactory installation for the manufacture of cell immunotherapy drugs based on high-affinity and high-specificity T cell receptors.

A GE spokesperson said the companies have signed the agreement and are discussing next steps for installation.

“The FlexFactory platform is expected to be operational in March 2019," the spokesperson said.

According to GE’s general manager of cell and gene therapy Ger Brophy, a combination of innovation, regulation, and manufacturing is taking place at a “rapid speed” in China.

“XPH is an example of a company in China that is already preparing for future commercialization by collaborating with GE Healthcare to scale up their manufacturing processes,” he said.

The XPH deal follows Shanghai-based Cellular Biomedicine Group’s (CBMG) adoption of the FlexFactory platform – the first ever for the application of cell therapies – announced in January this year.

Later that month, GE continued to grow its FlexFactory presence in China, with the announcement that Clover Biopharmaceuticals would adopt the platform at its facility in Zhejiang, to make a biosimilar version of Amgen’s Enbrel.

Wasdell Group invests £500k in new microbiological and analytical lab

UK's Wasdell Group, the outsourcing partner to companies within the pharmaceutical, medical device and clinical trials industries, is investing £500k in a new laboratory at its site in Newcastle.

The purpose-built 1,200 sq. ft facility will allow Wasdell to offer in-house microbiological and analytical services to its customers and will support the business’ manufacturing, packaging and quality control (QC) teams.

The investment follows on from a growing customer base as well as an increase in the number of pre-clinical development projects that have recently been awarded to Wasdell.

Daniel Tedham, MD at Wasdell, said: “This latest investment is part of a client-centric strategy that ensures we continue to offer existing and new clients a fast and efficient service that meets their end-to-end supply needs.

“We’ve seen a notable increase in demand for analytical support from our existing clients and the investment in our microbiological capabilities has been driven by our planned move into the manufacture of sterile products later this year.”

The investment is the first phase of the company’s ongoing expansion strategy to bolster its laboratory capabilities and ensure seamless internal operations. The second phase will include the opening of a new laboratory facility in Ireland to futureproof Wasdell’s release testing offering for the European market in the event of a hard Brexit.

A microbiological laboratory team will deliver in-house environmental monitoring, sample analysis, water testing, microbiological identification analysis, component testing and growth promotion testing.

The lab will also offer analytical capabilities for chemical, physical and microbiological analysis including HPLC, FTIR and wet chemistry with QC testing of raw materials, drug substances (currently Schedule III with capacity to cater for Schedule II products) and drug products in accordance with pharmacopoeial monographs and client methods.

The facility is the latest addition to the company’s manufacturing site in Newcastle. The 26,000 sq. ft facility is MHRA approved for pharmaceutical manufacturing and has a Home Office Controlled Drugs license with onsite storage facilities.

It follows the recent announcement of the company’s new €30m pharmaceutical facility in Dundalk, Ireland, which will offer QC import testing, a variety of current and novel packaging technologies as well as storage and distribution.

Fully Automated Facility for Drug Discovery to Be Built in UK

The UK Government has revealed plans to build a fully automated facility at the Rosalind Franklin Institute in Oxfordshire to enable fast, effective and hands-free molecular discovery for new medicines.

Business Secretary Greg Clark has launched the new £103m institute, which will carry out a series of projects to develop new drug discovery technologies and accelerate medicine research.

One of the new projects is called Closing the Loop on Drug Discovery and it will work towards a range of technologies for driving discovery of quality lead molecules to minimize the costs associated with the discovery process.

For the project, companies, small and medium sized enterprises, universities and the Medicines Discovery Catapult will partner to conduct research and development of the new technology.

The Rosalind Franklin Institute will work with 11 collaborators, including the University of Leeds, across life sciences, physical sciences and engineering areas.

The primary goal of the new facility is to provide a rapid alternative for existing costly processes that usually require more than ten years to discover a new drug.

It will see 150 researchers leverage a variety of systems such as artificial intelligence (AI) and robotics to develop new diagnostics, drugs and treatments.

Furthermore, the facility will feature new instruments to facilitate direct observation of interactions between drug candidates and target proteins.

“It will allow hundreds or thousands of candidate molecules to be investigated at a time; we aim to increase productivity by five to ten times.”

University of Leeds lead scientist Adam Nelson said: “This won’t be a traditional chemistry lab. It will use robotics and AI to automate the discovery process. It will allow hundreds or thousands of candidate molecules to be investigated at a time, and we aim to increase productivity by five to ten times.

“But faster processing isn’t enough. We also want to find higher-quality starting points for drug discovery to maximize the chances of success at later stages in the pipeline.

“This will enable the UK to remain globally competitive in bringing new drugs to the market that can meet the needs of patients.”

Eurofins Expands Testing, Inspection and Certification Operations

Global lab has acquired two subsidiaries of the Finnish research center VTT Group

Eurofins Scientific, the international bioanalytical testing specialist, has acquired VTT Expert Services Ltd and Labtium Ltd, two wholly owned subsidiaries of VTT Technical Research Centre of Finland Ltd. These subsidiaries cover all of VTT’s testing, inspection and certification (TIC) operations.

The acquisition of VTT ES will complement Eurofins existing product testing services portfolio while the acquisition of Labtium will strengthen its leadership in environment testing. Both acquisitions reinforce the Group’s presence in the Finnish market. Eurofins entered this market last year with the acquisitions of Nab Labs, Ramboll Labs and Ahma.

VTT ES offers its clients versatile expert services including calibration services, certification services, structural safety testing, building material testing, electronics testing, fire safety testing and product failure and safety testing. It has accreditations covering over 1,300 standards.

Labtium offers advanced analytical services including environment testing, geochemistry, fuel and combustion chemistry, pulp mill chemistry, mineral processing services and material and products testing. The two companies operate 16 facilities in Finland with a total size of over 182,920 sq. ft. (17,000 sq. m.). In 2017, they generated annual revenues in excess of EUR 27m.

“We are very pleased to welcome VTT ES and Labtium to the Eurofins Group. These acquisitions will significantly expand Eurofins’ existing portfolio of competencies in the product testing market, environment testing market and materials and engineering sciences market. In return, VTT ES and Labtium will gain access to the Group’s entire portfolio of competencies, logistics and clients," said Dr. Gilles Martin, Eurofins CEO.

Zoetis’ Animal Vaccine Research and Manufacturing Complex, Suzhou

In April 2018, global animal health company Zoetis began constructing a new animal vaccine manufacturing and research facility in Suzhou, China.

The new facility will house a global manufacturing and supply facility, as well as a research and development (R&D) center.

The project is expected to be completed and awarded a certificate of good manufacturing practices (GMP) from the Chinese Ministry of Agriculture by 2021. Once in operation, it is also expected to generate more than 100 new jobs in R&D and manufacturing.

The animal vaccine manufacturing facility will be used for the development and production of high-quality vaccines for livestock, fish and companion animals. The products will be sold primarily in the Chinese animal health market.

The plant will allow Zoetis to help livestock farmers in China meet the increasing domestic demand for safe supply of pork, milk, beef and fish in large quantities. It will become the company’s second manufacturing complex in the country, joining an existing site in Jilin.

The vaccines manufactured at the new facility will help safeguard animals from the strains of infectious diseases.

The state-of-the-art Suzhou vaccine research and manufacturing complex will be developed in multiple phases. With a total of 462,680 sq. ft. (43,000m²), the first phase will accommodate six main buildings for vaccine manufacturing and an R&D laboratory.

The campus will also include a production facility, a warehouse and a central utility building.

In addition, the campus will be equipped with advanced technologies for the production of viral and bacterial medicines and include a pilot-scale manufacturing facility for the development of new vaccines.

Zoetis appointed engineering design, architecture, project and construction management services provider PM Group for the conceptual design and master planning of the new complex, while Australian building construction services contractor Cockram will assist in overall construction management.

China is one of the world’s largest animal health markets, with reported $4.3bn of sales in 2017 and witnessing a compound annual growth rate between 7% and 10%. The growth was primarily due to vaccines sales.

China also has one of the world’s largest pig market and raises approximately 700 million hogs a year.

In addition, spending on pet medications and vaccines in 2017 exceeded $300m, and the pet healthcare market and ownership in the country continues to grow.

About Zoetis:

Founded in 2013, Zoetis is engaged in producing medicine and vaccinations for livestock farmers and veterinarians. The company develops and manufactures a wide range of animal health medicines and vaccines, diagnostic products, genetic tests and biodevices.

Headquartered in Parsippany, New Jersey, Zoetis operates in more than 45 countries. Its products are sold in more than 100 countries worldwide.

Zoetis operates a network of 25 manufacturing sites across 12 countries, with a workforce of roughly 9,000. The company reported revenue of approximately $5.3bn in 2017.

Zoetis opened a medicated feed additive products manufacturing facility in 2015 for the production of water-soluble and pre-mix products, including Linco-Spectin®, Lincomix®, Tilmicosin® and COT (Check-O-Tox®).

Cambrex Invests In Lab Expansion at Sweden Facility

Cambrex Corporation, a manufacturer of small molecule and generic Active Pharmaceutical Ingredients (APIs), is about to commence a $5 million expansion of laboratory facilities at its Karlskoga, Sweden, site, to augment capability and capacity for process development and scale up, handling of potent substances, crystallization studies, and solid phase characterization.

Construction work on the three-story, 600-m2 (6,458-sq.-ft.) building will commence at the end of Q2 2018, with completion due in Q2 2019.

The expansion will create space for a new technical laboratory with walk-in hoods for large scale laboratory syntheses up to 10 liters, where engineers and chemists will undertake tech transfer studies. The new investment also will enable handling of potent substances at a large laboratory scale, high pressure reactions, and parallel synthesis for API route scouting and development.

In addition to the technical laboratory, the expansion will feature two analytical development and quality control laboratories and office space for 12 additional scientists and chemists, taking the total headcount to 60.

“We have a rich history in chemistry at our Karlskoga site, dating back 120 years to Alfred Nobel himself in 1896,” commented Bjarne Sandberg, managing director, Cambrex Karlskoga. “The new laboratory expansion will enhance our ability to provide global customers with scientific and chemical excellence.”

In 2017 Cambrex announced that it had upgraded its continuous flow capabilities in Karlskoga with a dedicated commercial-scale unit, capable of producing multiple metric tons of high purity API intermediates per annum.

To complement these capabilities, the company also completed the installation of multiple continuous flow reactor platforms at its process development facility in High Point, NC. The investment is said to focus on the rapid and successful development of processes to supply clinical as well as commercial demand for chemical syntheses.

Rentschler and Ultragenyx Start Fill and Finish Collaboration

Rentschler Fill Solutions, an Austria-based CMO and expert in aseptic fill and finish services, has announced a collaboration with Ultragenyx Pharmaceutical for drug product production of the injectable Mepsevii™ (vestronidase alfa). Mepsevii™ is a recombinant form of the human enzyme beta-glucuronidase, to treat patients with mucopolysaccharidosis (MPS) VII, a rare genetic disorder.

“Identifying a reliable and proactive drug product CMO partner for Mepsevii™ was critical for Ultragenyx,” explained Dennis Huang, chief technical operations officer for California-based Ultragenyx.

“Mepsevii™ is our first commercial product and treats an ultra-rare disease. Rentschler Fill Solutions understood our specific needs and shared our vision of serving patients with MPS VII who previously had an important unmet medical need. We look forward to working with Rentschler Fill Solutions and Rentschler Biopharma to smoothly transition the fill and finish activities," he added.

Mepsevii™ was developed by US-based Ultragenyx in close collaboration with the biopharmaceutical CDMO Rentschler Biopharma SE in Laupheim, Germany, and was approved by the US FDA in November 2017.

Ultragenyx has applied for European marketing approval of Mepsevii™ and the application is currently under review.

Fill and finish activities for the drug product will be transferred from Rentschler Biopharma SE to Austria-based Rentschler Fill Solutions GmbH, the new center of excellence, featuring comprehensive services for the aseptic filling and freeze-drying of drug products.

Reinhold Elsaesser, one of the two managing directors of Rentschler Fill Solutions, commented: “We are delighted to be working with Ultragenyx at our facility in Austria, the cutting-edge center of excellence for fill and finish solutions. The US is a key market for us. We are pleased that this collaboration provides the opportunity for us to demonstrate our facility’s US FDA compliance."

Elsaesser said the company will be closely collaborating with Rentschler Biopharma throughout the project, from drug substance delivery to regulatory affairs and drug product supply. "Our processes are aligned to ultimately deliver a high-quality product for our joint client Ultragenyx," he added.

Rentschler Biopharma SE will continue to manufacture the drug substance. Ultragenyx benefits from the advantages of the strategic partnership between Rentschler Fill Solutions GmbH and Rentschler Biopharma SE.

“For many years, Rentschler Biopharma has been a trusted partner of Ultragenyx in the development of Mepsevii™,” Dr. Frank Mathias, CEO of Rentschler Biopharma SE, said. “We welcome their decision to continue and broaden our joint success story together with Rentschler Fill Solutions. This project reaffirms our strategic partnership with Rentschler Fill Solutions, announced a year ago, as we are able to meet our clients’ needs not only as a solution provider for clinical trials but also for market supply in growing international markets.”

Rentschler Fill Solutions offers its clients fill and finish services on both a clinical and commercial scale. Through the strategic partnership of Rentschler Fill Solutions, Rentschler Biopharma and Leukocare clients also benefit from one-stop solutions from gene to vial and clinic to market.

Contract for Bioquell in Qatar for Sidra Medicine

Bioquell has announced the completion of a 6-log decontamination of key clinical areas within Sidra Medicine, a newly constructed world-class hospital in Qatar. The disinfection of 450 rooms totaling 56,000m³ was implemented in a short 15-day time frame ahead of the Ar-Rayyan-based facility’s grand opening.

The contract saw Bioquell performed a 6-log decontamination of a suite of 12 operating theatres, a sterile processing unit, pediatric and neonatal intensive care units and other high-risk patient areas such as oncology and dialysis. Working alongside numerous departments at Sidra Medicine, the project was successfully completed within the allocated three-week time frame.

Russell Gates of Sidra Medicine commented: “The Bioquell team worked well with our people and were very flexible in their approach. The planning prior to their arrival in Doha made the implementation of the project much easier as we were able to ensure the right people were in place to support the process."

The process was validated with Bioquell’s 6-log Geobacillus stearothermophilus biological indicators as well as a third party air sampling procedure organized by Sidra Medicine.

A 6-log reduction was achieved in all areas within the scope of 100% of the independent air sampling results being within the acceptable range.

Gates continued: "Our infection control team were very pleased with the results, especially as we were able to get initial indications within 24 hours. We are now looking forward to having our staff trained on the Bioquell BQ-50 machines that we have purchased.”

Bioquell’s Rapid Bio-decontamination Service (RBDS) was chosen to establish a degree of sterility as high as practically possible within key areas. The company said it used its scientifically-proven hydrogen peroxide vapor (HPV) technology due to its ability to offer a scalable solution while maintaining a high efficacy standard.

The intensive care units and the hospital’s operating theatre complex among other large areas targeted were treated as single, discrete decontamination zones, which minimized the risk of cross-contamination between rooms and corridors and allowed the project to be completed in time.

The largest area of the hospital to be treated as a single zone was the operating theatre complex with a total volume of about 7,000m³. This entire suite was decontaminated within one day using 32 of Bioquell’s HPV generators simultaneously to provide effective decontamination.

Distribution fans were also used to disperse the vapor within specified zones, while Bioquell’s aeration units provided the capacity to quickly break down the vapor to complete the decontamination cycle rapidly.

Bioquell’s 6-log Geobacillus stearothermophilus spore biological indicators were placed in challenging locations within each area, as well as proprietary Bioquell chemical indicators designed to give a real-time verification of a successful bio-decontamination process. Biological indicators provide insight to the success of a cycle after a 24-hour incubation period, with final results available after seven days.

All areas decontaminated strictly adhered to Bioquell safety protocols with doors giving access to each target area sealed using Bioquell tape to prevent leaks, warning signs placed to prevent entry to the area during the cycle and calibrated low-level sensors to continually monitor the perimeter of each area throughout the cycle. The sensors also ensure that the HPV concentration had fallen below the safety limits after the cycle was complete.

Bioquell used 800 biological indicators to confirm the efficacy of the process. Additionally, Sidra Medicine also arranged for third-party air sampling tests in all of the decontaminated areas. All the air sampling results were within the acceptable limits.

The full inactivation of biological indicators and successful air sampling results demonstrated that the project was completed safely and within the required time.

Bioquell said that following the successful delivery of the project, Sidra Medicine purchased multiple Bioquell BQ-50 hydrogen peroxide vapor systems to perform regular decontamination cycles of single rooms and other small areas within the hospital.

Ardena CMO Expansion

CDMO Ardena has added drug product capabilities with the purchase of active pharmaceutical ingredient and excipient-focused Syntagon.

The acquisition enables the contract manufacturing and development organization (CDMO) to handle larger batch sizes up to 100kg, adding a manufacturing facility in Södertälje, Sweden, and development and quality control (QC) laboratory in Riga, Latvia, to its site network.

Syntagon’s 30 employees and client portfolio will also be transferred to Ardena.

According to Ardena CEO Harry Christiaens, the firm’s Syntagon acquisition is in line with the its M&A strategy.

Ardena – which launched in September 2017 – is the product of a merger between Belgium-based Pharmavize, Dutch firm Crystallics, and Analytical Biochemical Laboratory (ABL) in The Netherlands.

And in March this year, the CDMO bought Dutch active pharmaceutical ingredient (API) maker ChemConnection.

Ardena is focused on building a “complementary service portfolio that spans the clinical supply chain from molecule to clinic,” said Christiaens.

Services include chemical-pharmaceutical development and manufacturing services, analytical and bioanalytical support, and regulatory dossier development support, he added.

The acquisition marks the CDMO’s first outside of the Benelux region.

In Scandinavia, Ardena will be “well positioned to capitalize on the emerging biotech segment and broader pharmaceutical market,” the CEO said in a statement.

Canadian Genvion Adds Spray Drying

Genvion has invested approximately $1.5m in spray drying and coating technology for solid dosage forms at its manufacturing facility in Canada.

The contract development and manufacturing organization (CDMO) has added on-line spray dryers and Wurster coaters to its 80,000 sq. ft. site in Winnipeg, Manitoba.

The investment will see the firm offer spray drying services in R&D and manufacturing for commercial production.

According to Genvion, the investment responds to increased demand for spray drying and drug layering services.

“Customer demand for GMP (good manufacturing practice) spray drying is increasing because of the need to support poorly soluble drugs,” said vice president Tony Cocci in a statement.

“Market response to the investment in our capabilities has been very encouraging,” he added.

ConvaTec Cleanroom Facility, Deeside, UK

Cleanrooms Size: 10,652 sq. ft. (990 m²)

Project team: Connect 2 Cleanrooms

Convatec, a global medical products and technologies company, has added an ISO Class 8 cleanroom facility that was constructed using offsite construction and Building Information Modeling (BIM) techniques. Kingspan UltraTech Precision cleanroom panels, with an ECOsafe PIR core, were used to create a fully flush finish — suitable for the stringently regulated environment. To ensure the cleanroom was aligned with the current facility, where the corridors incorporate windows and doors, a point cloud 3D scan of the entire building was conducted in the initial stages to provide a virtual view of the space. This resulted in the cleanroom being applied efficiently with seamless interfaces. This scan provided the accuracy required to pre-engineer all components of the cleanroom prior to installation, using off-site construction methods to optimize project management.

Localized air conditioning and dehumidifier units were used to supply processed air to fan filter units. This approach meant a significantly lower initial investment and increased energy efficiency when operational, than an AHU. There is enough resilience calculated to ensure continuous operation.

Other features include fully flush panel system, roller shutter doors, custom control system including three particle counters, BMS integration, and more.

A cleanroom of this size would typically use an Air Handling Unit (AHU) to supply HEPA filtered and temperature controlled air. Instead, localized air conditioning and dehumidifier units were used to supply processed air to fan filter units. This approach meant a significantly lower initial investment and it is more energy efficient when operational than an AHU.

The design stage was split into two elements: Aesthetics of the room, such as the doors, panels, and layout to meet the existing sensitive layout; and functionality, taking into account the exact temperature and humidity control requirements and the requirement for low level extract panels.

The cleanroom design required a suspended ceiling to achieve an open plan layout, so a full structural assessment was required to identify the building’s load capacity and the load capacity after the build.

Following the install, a detailed commissioning process was carried out to ensure the cleanroom is functioning as it should. Extreme testing of all elements, alongside the design against resilience, ensures the room continues to operate 24/7.

Key features:

The cleanroom measures an area of 10,652 sq. ft. (990 m²) with a volume of 3045 m³

The cleanroom achieves ISO 14644-1:2015 Class 8 through HEPA filtration

Validated to “as built” occupancy state

Comprehensive cleanroom validation report supplied, detailing compliance to the agreed scope of works

The control system logs data in audit-compliant formats, using FTP technology

Air temperature is maintained at 21°C ± 2°C, with 35 percent to 65 percent Relative Humidity

Kingspan Monobloc Panel System

ECO 2 custom control system integrated with ConvaTec’s BMS integration

Close control temperature and humidity control to protect processes

Individual fan filter units to control airborne particles — more energy efficient than an AHU

Fully suspended walkable ceiling allowing for non-disruptive maintenance with no ground-level pillars for an open plan area

Interlocked rapid roll doors and breakout panel

Windows and doors fitted in-line with their existing structure, while still offering a standalone room

Safe step LED lighting — room side replaceable

Completion date: 2017

Avara Acquires Sterile Mfg. Facility in Canada

Avara Pharmaceutical Services has agreed to acquire the largest sterile manufacturing facility for injectable medicines in Canada from a leading global pharmaceutical company, as part of a continuing expansion of its global footprint.

"This acquisition represents our first entry into the Canadian market and further expands our sterile processing capability, which is in very high demand," said Timothy C. Tyson, Avara's chairman and chief executive officer. "It comes with a world-class development center and a dedicated team of experts that will support us in delivering high-quality pharmaceuticals that meet or exceed customer expectations and regulatory requirements."

The proposed acquisition of Novartis Technical Operations' sterile manufacturing facility and the adjacent Sandoz Development Center located on the Sandoz Canada campus in Boucherville, Quebec, is expected to be finalized in the next few months, following the completion of a number of closing conditions including receipt of anti-trust approvals. It follows Avara's acquisition of another sterile facility in the past year, one from Pfizer in Liscate, Italy, and one solid dose manufacturing facility from GlaxoSmithKline in Aiken, SC. It will bring the number of manufacturing and development sites operated by Avara worldwide to ten: two in Canada; three in the U.S., including corporate headquarters; one in Puerto Rico; one in the UK; one in Ireland; one in Italy; and one in France.

The Boucherville site is the biggest injectables production facility in Canada and provides a number of strategic and lifesaving medicines to the Canadian healthcare system, mostly hospitals. As part of the asset purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of products manufactured in Boucherville. No impact on jobs is anticipated at the moment and Avara intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base.

"We look forward to a seamless transition for employees, patients, customers, partners and other stakeholders," said Mr. Tyson. "We are impressed by the know-how at the Boucherville plant and Sandoz Development Center team and intend to leverage their expertise to develop new opportunities in the contract pharmaceutical market, in Canada and elsewhere."

Carleton University Health Sciences Building, Ottawa, Ontario, Canada

Cost: $52 million CAD (about $40.3 million USD)

Size: 132,000 gross sq. ft.; includes 30,000 sq. ft. of research laboratories and support;

10,000 sq. ft .of teaching labs and support; a 13,500 sq. ft. vivarium

Project team: NXL Architects (research area and vivarium architect); Montgomery Sisam Architects Inc. (lead architect)

Carleton University’s Health Sciences Building broke ground in October 2015 and co-locates two rapidly growing university programs. With seven floors divided between the University’s newly formed Health Sciences department and existing Neuroscience Program, the design and layout of the labs, offices and workspace help to encourage and facilitate collaborative interaction between faculty and students.

This new-build facility includes modular laboratories for teaching and research, vivarium, electronic and interactive classrooms; four lecture theatres; a student resource center; informal student study and social spaces; offices and public assembly space. The interior was also designed to allow for future program growth, while accommodating changing research needs.

The design of this facility incorporates a scalable utility distribution strategy, stacked in a sidehouse concept, which replaces the traditional penthouse, thereby enabling utilities to feed into the building horizontally. This breakthrough in utility strategies has also allowed the vivarium to be located on an upper level, gaining access to ample natural light while remaining isolated from vibration and noise-producing air handling and related equipment (reciprocating chillers, air handlers, compressors, etc.) thanks to a segregated structure. The top floors incorporate a double height sidehouse which stacks the air handlers on top of each other, with internal service stairs and catwalks to provide access to all high-level equipment; while ceiling voids provide access above the vivarium space where required. The sidehouse allows utilities to be right-sized for the program they are supporting, or changed to accommodate new program areas. With all of the equipment within the sidehouse the labs, support, offices and open workspaces can connect in a much more dynamic environment.

The new Carleton Health Sciences building includes the latest technology in high-quality undergraduate teaching labs, providing greater access to experiential learning opportunities for students while encouraging interdisciplinary collaboration and closer interactions within departments.

Completion date: several floors are currently operational, with an official opening expected in mid-2018

Wood Group Wins Contracts for Teva Biotech Facility

Wood Group (John) PLC (WDGJF.PK,WG.L) announced that it has been awarded a US multi-million dollar contract by TEVA Biotech GmbH to provide engineering, procurement, construction management, commissioning and qualification or EPCmQ for a new biotechnological facility to be built in Ulm, Germany.

The completion is expected to be in 2020, while tech transfer is planned to begin in 2021.

The plant will produce pharmaceutical ingredients from cell cultures in a new eight-story building to be constructed within TEVA's existing biotechnology production site.

Wood EAAA Capital Projects Group will execute detailed design and procurements services for a lump sum fee, as well as construction management and commissioning/qualification services under a reimbursable contract.

Prior to the award, Wood completed basic design and an investment cost estimate for the same facility under a previous contract, which was awarded on a competitive basis.

Tedor Pharma Multi-Million Dollar Investment

The newly-formed investment firm DORA Ventures has recapitalized Tedor Pharma, which recently completed a multi-million-dollar expansion of its manufacturing capabilities.

Tedor Pharma is a contract development and manufacturing company (CDMO) founded in 2001.

"We are already seeing an increase in volumes and projects from existing customers and our business development efforts continue to create new opportunities," Drysdale said.

WuXi to Establish Biologics Manufacturing Unit in Singapore

WuXi Biologics, a global open-access biologics technology platform company, plans to invest S$80 million (US$60 million) and hire approximately 150 employees to establish a biologics manufacturing facility in Singapore. It would be the company's 10th global drug substance manufacturing facility.

A total of approximately 4,500 L bioreactor capacity will be installed, including two 2,000 L traditional fed-batch and one 500 L perfusion-based continuous processing units.

The manufacturing facility, supported by the Singapore Economic Development Board (EDB), will be capable of handling both clinical and small volume commercial production. An early-stage bioprocess development lab also will be included.

"We are delighted that WuXi Biologics has chosen Singapore as its first overseas manufacturing site in Asia," Dr. Beh Swan Gin, chairman of Singapore's EDB, said. "This will introduce the company's next-generation bioprocessing technology platform to this region. WuXi Biologics' decision is a testament to Singapore's strong talent pool for the biomedical sciences sector and our capabilities in advanced manufacturing. Its presence here will also strengthen our ecosystem for supporting biotech companies from Singapore and beyond."

Headquartered in Wuxi city, Jiangsu province, China, WuXi Biologics provides biologics solutions with a mission to accelerate discovery, development, and manufacturing.

Gerresheimer Expands Production in Brazil

Gerresheimer has announced that is has expanded its production capabilities at its plastic primary packaging manufacturing site in Anápolis, Goiás, Brazil.

Further expanding its strong presence on the South American market, the new Gerresheimer Anápolis plant has commenced production to secure and support the continued strong growth.

Gerresheimer’s vice-president of Europe and Latin America Jens Friis says: “We are delighted about the strong demand for our plastic packaging in South America and with the additional plant we will be able to further expand our presence and support our customers.”

Ten years ago, in 2008, Gerresheimer acquired Allplas, adding Vedat three years later. The company has thus steadily consolidated its position as one of Brazil’s market leaders with some strategically astute acquisitions.

Gerresheimer’s general manager of Brazil Wellington Lentini said: “We’re in a position to provide our customers with customized plastic packaging solutions for their products.”

However, its standard range of dropper bottles of various sizes, droppers, caps, vials for individual doses with corresponding caps, polyethene terephthalate (PET) bottles, and closures for plastic and glass bottles also boasts a wide range of uses.

In the future, Gerresheimer Anápolis will produce the entire range of plastic containers from polypropylene (PP), polyethene (PE), and PET, along with the corresponding closures and caps. The products will also be assembled and decorated in the plant, providing customers with a complete concept solution.

The newly built plant will initially operate more than 34,432 sq. ft. (3,200m²) and will be equipped with 30 machines during the course of 2018. The plan is to extend further to 20,000m² by 2021. Just like all the other Gerresheimer plants, the new one will be certified to ISO 9001 too. The requisite audit will be held in June.

With its new plant, Gerresheimer has a presence in two Brazilian states. Alongside Goiás, Gerresheimer is also represented in the São Paulo region, where plants in Butantã, Cotia, and Embu provide the full range of pharmaceutical primary packaging made from plastic. The company also has another factory in Argentina (Buenos Aires). Gerresheimer produces insulin pens for South America in Indaiatuba, some 100km north of São Paulo, and manufactures pharmaceutical ampoules and vials from glass in Querétaro, Mexico.

This year, Gerresheimer will once again be presenting its products to a specialist audience at FCE Pharma in Sao Paulo, Brazil.

Gerresheimer has already won the prestigious Sinduspharma Award many times down the years.

Connect 2 Cleanrooms Receives Cleanroom Facility Award for Convatec Project

British cleanroom specialist Connect 2 Cleanrooms said it is delighted to pick up the Best Cleanroom Facility Award at this year's Cleanroom Technology Conference. The award recognized its work on the 990sq m, ISO class 8 facility for global medical products and technologies company, Convatec.

Connect 2 Cleanrooms worked closely with distribution partners, exhibiting at the Cleanroom Technology Conference 2018 alongside DuPont and Particles Plus.

The judges praised the Convatec medical technology cleanroom as the winning entry because of the company's comprehensive project presentation, which was not only broad in scope but also showed careful consideration of aesthetics, energy efficiency and sustainability, while meeting budget and timeline constraints, and making good use of the latest build technology and method.

Connect 2 Cleanrooms used offsite construction and building information modelling (BIM) techniques to deliver this cleanroom project on time, on budget and to a high specification. Kingspan UltraTech Precision cleanroom panels, with an ECOsafe PIR core, were used to create a fully flush finish suitable for the stringently regulated environment.

Having supported the conference for a second time, this year saw Connect 2 Cleanrooms’ national territories manager, Rebecca Smith, present a talk on Industry 4.0.

Parker Bioscience’s Site to Get Major Investments

Parker Bioscience’s UK-based site will be expanded as part of a multi-million dollar phased investment program to be completed throughout 2018.

Parker Hannifin has announced a major investment in its Parker Bioscience division, which supplies and delivers systems for upstream and downstream pharmaceutical and biopharmaceutical manufacturing. The division has sites in Birtley, UK and Oxnard, CA in the US.

The investment will expand Parker Bioscience’s laboratory, clean room, office and warehouse facilities. According to the company, it also will make the division’s Birtley premises “one of the most modern manufacturing sites for integrated bioprocessing solutions in EMEA.”

Mike Brailsford, General Manager at Parker Bioscience, said: “The increased capacity will help us to offer larger scale services to biopharmaceutical manufacturers in Europe and across the globe, and is a major milestone in the division’s growth.”

Tjoapack Expansion of Blistering Lines

A predicted increase of complex molecule production and last-minute packaging requirements is behind Tjoapack’s latest investment in the Netherlands.

The contract packaging organization (CPO) has added an eighth blistering line – fitted with late-stage customization printing capabilities – to its facility in Etten-Leur, The Netherlands.

Postponement printing could help reduce repackaging waste, costs, and time-to-market said Tjoapack's director of corporate strategy Dexter Tjoa in a statement.

“We’ve started to explore this type of packaging with some of our customers already and as more complex molecules continue to enter the drug pipeline, demand for last-minute packaging is likely to increase.

“This investment will allow us to futureproof our lines for projected demands,” he said.

Tjoapack expects the blistering line to be operational in Q3 2018.

The expansion follows on from Tjoapack’s investment in its bottling capacity at the same facility last year. In December 2017, the CPO said the expansion – which tripled its bottle-packing capacity – responded directly to increased demand.

AstraZeneca Contracts DPS Group for New Projects

AstraZeneca has contracted the engineering and construction management firm DPS Group to support projects at its site in Södertälje, Sweden.

As per the “major contract,” DPS Group will provide engineering, procurement, construction management and validation (EPCMV) services for small- and medium-sized projects at the Södertälje-based site.

While financial details were not disclosed, the company said it predicts more than 100 DPS engineering personnel will work on AstraZeneca projects “depending on capital expenditure levels.”

DPS is establishing an office in Sweden following the award. The office will initially support AstraZeneca projects exclusively, but will eventually provide services to other clients in the area, according to the company.

DPS employs more than 1,300 people in its offices and on client sites in Ireland, Netherlands, Belgium, Sweden, Israel, Singapore, Switzerland, the UK, and the US.

Kite to Open Netherlands Cell Therapy Manufacturing Facility

Kite Therapeutics, a subsidiary of Gilead Sciences, has announced it has leased a facility in the Netherlands to engineer cell therapies in Europe.

The 117,000 square-foot facility will engineer and produce cell therapies, including axicabtagene ciloleucel, a Chimeric Antigen Receptor T cell (CAR T) therapy that is currently under review by the European Medicines Agency and approved in the US as of October 2017 under the name Yescarta. Yescarta is one of just two CAR T drugs approved in the US.

In a statement, Kite said that it hoped the new facility would make it easier to deliver cell therapies to cancer patients living in Europe.

Gilead President and CEO Dr John Milligan said: “We are pleased to be leading a new frontier of cancer innovation that is bringing hope for people living with cancer. This new European manufacturing facility will enable personalized cell therapies to be manufactured in closer geographic proximity to the patients who will receive them, potentially shortening the turnaround time for people who urgently need care.”

According to Kite, the new facility will provide 300 new jobs when fully operational in 2020.

As well as this site, Kite also recently purchased two buildings in Santa Monica and Maryland respectively, which will both also be used for cell therapy research.

The Maryland site will support the work of a new Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute to develop adoptive cell therapies targeting patient-specific tumor neoantigens─mutations found on the surface of cancer cells.

Gilead senior vice-president, hematology and oncology therapeutic area head Alessandro Riva said: “We are proud to be at the forefront of advancing cell therapy, which we believe has the potential to transform cancer treatment. The addition of these three new facilities and the expanded CRADA with our research collaborators at the NCI will help us bring cell therapies to more people with cancer around the world.”

Kite was acquired by Gilead for $11.9bn in October 2017, part of the company’s increased focus on developing CAR T therapies. Gilead also agreed to acquire Cell Design Labs in a $567m deal in December last year.

Gilead to Build Manufacturing Facility at Amsterdam Airport

In addition to a new manufacturing site in Amsterdam, Kite has acquired facilities in Santa Monica, California, and Gaithersburg, Maryland, for R&D and manufacturing for CAR-T treatments.

Speed is of the essence when it comes to manufacturing CAR T drugs—personalized treatments in which immune cells are engineered to recognize and destroy patients’ cancers. With that in mind, Gilead will locate a new European manufacturing site for its CAR-T therapy Yescarta at an airport in the Netherlands.

Kite, the Gilead company that developed the personalized treatment, said it has leased a 117,000 square-foot facility in Hoofddorp at the SEGRO Park Amsterdam Airport. It did not say how much it will invest in the manufacturing operation but indicated it expects to have 300 employees there when it is fully operational in 2020.

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Yescarta was approved by the FDA last fall to treat adults with relapsed or refractory large B-cell lymphoma, including aggressive non-Hodgkin lymphoma, who have failed two or more traditional treatments. It is priced at $375,000 in the U.S. and is currently under review by regulators in Europe.

“This new European manufacturing facility will enable personalized cell therapies to be manufactured in closer geographic proximity to the patients who will receive them, potentially shortening the turnaround time for people who urgently need care,” Gilead CEO John Milligan said in a statement.

In addition to the Amsterdam site, Kite said it recently acquired a new building in Santa Monica, California, from Astellas Pharma that it will use for clinical manufacturing and cell therapy R&D.

It also picked up a 26,000-square foot facility in Gaithersburg, Maryland, which it will use in support of a new agreement with National Cancer Institute (NCI). The plan is to develop adoptive cell therapies targeting patient-specific tumor neoantigens. Neoantigens are mutations found on the surface of cancer cells that are unique to each person and tumor, offering the potential for more targeted antitumor activity.

Gilead bought Kite for nearly $12 billion last year to move into the new field as sales of its hep C franchise lagged.

So far, only two CAR-T drugs have been approved in the U.S.—Yescarta’s FDA nod followed the approval in August 2017 of Novartis’ Kymriah. The Novartis treatment, priced at $475,000, was initially approved to treat pediatric patients with acute lymphoblastic leukemia.

Novartis is producing its CAR-T product at its global head cell & gene technical development and manufacturing site in Morris Plains, New Jersey. It also has an agreement with the Fraunhofer Institute for Cell Therapy and Immunology for the cell processing of its personalized T cell therapy in Europe.

AMRI Launches Aseptic API Line

AMRI has launched its new multipurpose aseptic API line at its facility in Valladolid, Spain. The line expands capacity at the site and complements AMRI's other aseptic API manufacturing plants in Bon Encontre and Tonneins, France.

This investment, along with the build-out of analytical services and a new warehouse, provides additional capacity, technology and capabilities for increasing demand for sterile API.

"We continue to see an increase in interest in our sterile capabilities and are ready to support increasing demand," said Michael J. Mulhern, chief executive officer of AMRI. "By adding critical analytical services, we are well-positioned to help customers accelerate the pace of their product development while ensuring their performance and quality."

AMRI's lines are designed to meet requirements from pilot-scale to multi-ton scale manufacturing, and the company's sterilization capability can be integrated with API production or operate as a separate outsourced step for customers who do not have bulk sterile facilities or who may need additional capacity. The company also offers integration with drug product capabilities.

"We would like to thank the region of Castilla y León for their generosity and continued support," said Mr. Mulhern. "There is a talented scientific and engineering workforce in the region and we are happy to reaffirm our commitment to the region and the expansion of our capabilities and expertise to customers in Europe."

Novasep Invests in Commercial Aseptic Fill/Finish Facility

Novasep is investing €10m ($11.88) in a commercial fill/finish facility for viral vectors, mAbs, and other low-volume biologics, as part of its plan to double in size by 2022.

The facility will be located in Seneffe, Belgium and is expected to be operational in H2 2019.

According to Novasep, the facility will be able to deliver up to 10 000 vials per session, with 2 to 3 sessions per week. The investment – part of the company’s Rise-2 strategic growth cycle – will also allow Novasep to respond to demand for orphan and targeted biopharmaceutical drugs.

Jean Bléhaut, president of Novasep's manufacturing solutions business unit said: "The trend towards targeted therapies has created a growing need for specialized capacities."

Subsequently, the company has launched a “series of major projects” to expand its biomanufacturing services for selected types of drug substances and fill/finish activities, he added.

Novaep previous announced an investment of €17m ($20.19) in a dedicated cGMP clinical scale mAb production facility in Pompey, France. The facility will be commissioned in H2 2019.

The company has also invested €27m ($32.07) in a new commercial-scale viral vector production facility in Seneffe, Belgium, which is expected to be fully qualified by Q1 2019.

“With this third investment, Novasep furthers its engagement to the RISE-2 strategic plan aimed at doubling the company's size by 2022," said Dr. Michel Spagnol, Novasep, chairman and CEO.

Baccinex Awards Telstar the Design and Construction of Aseptic Filling Process Plant

Baccinex has entrusted Telstar with the design and construction of a cleanroom installation to accommodate an aseptic and lyophilized filling process line, enlarging the existing pharmaceutical plant in the Switzerland region of Jura.

Expected to be completed in 2019, the new building will cover around 10,760 sq. ft. (1,000m²) and will be devoted to the manufacturing of sterile pharmaceutical product batches for clinical trials.

This complex turnkey technological project will be equipped with a complete automatic aseptic filling line, which is made up of a vials washing machine followed by a dehydrogenation and sterilization tunnel, as well as a vials filling machine operating under laminar flow equipped with a restricted access barrier system (oRABS).

Vials are transferred to two freeze-dryers with automatic loading systems via a conveyor belt, following on to a capping machine to complete the packaging process. There is also an option for both non-lyophilized products and products requiring terminal sterilization to be manufactured, providing improved versatility.

The aseptic area integrates some auxiliary installations intended to complete the manufacturing process, including raw material dispensing, compounding, washing and preparation for the sterilization process.

The plant design, for which the latest technological solutions existing in the markets have been taken into account, responds to a demanding implementation of oRABS isolation technology whereby the product is exposed in order to minimize the contamination risk.

The scope of the project awarded to Telstar incorporates the conceptual, basic and detailed engineering, the construction of a new manufacturing area and the provision of process equipment for pharmaceutical production, almost entirely designed and manufactured by Telstar.

The project covers the cleanroom architecture provision; a heating, ventilation and air conditioning (HVAC) system fitted with integrated decontamination technology; critical utilities such as highly purified water, water for injection using a distillation method, pure steam and nitrogen gas; non-critical utilities such as compressed air, softened water, chilled and hot water and industrial steam; electricity and the complete automation system, which integrates HVAC control process, decontamination and particles monitoring system.

In connection with the pharmaceutical process production equipment, the new plant will be fitted with two liquid nitrogen freeze-dryers with vial automatic loading and unloading systems performing under laminar flow oRABS, as well as two autoclaves used for material sterilization and product terminal sterilization.

In addition, ten items of containment equipment have also been purchased, including weighing booths, pass-through boxes integrating biological disinfection systems and laminar airflow cabinets.

Telstar will also perform and manage a validation service, including risk analysis, design qualification (DQ), commissioning, installation qualification (IQ), operation qualification (OP) and performance qualification (PQ), in addition to support services for quality assurance.

Telstar specializes in the development of aseptic manufacturing installations, undertakes both the design and the complete execution of the project from its conception to the final validation, as well as the supply of equipment designed and manufactured using in-house technology.

The allocation of the turnkey construction project was agreed in July 2017, after completing the engineering, design and equipment definition phases in May 2017. The complete installation is planned to be finished in Q1 2019.

Taking into consideration aspects related to good manufacturing practice (GMP) compliance and the latest trends in the industry field, the design of the new pharmaceutical plant has also integrated energy efficiency systems, generating power and production cost savings.

The review of the European Pharmacopoeia monograph 169, promoted by the European Medicines Agency (EMA) on water for injection, allowed water to be obtained by non-distillation methods from the 1 April. It has led Telstar to implement a generation system for WFI using reverse osmosis and ultrafiltration in the new plant for Baccinex. The installation has also got a small production of WFI by distillation.

Baccinex:

Headquartered in Courroux, Baccinex is a full-service pharmaceutical contract manufacturing organization (CMO) specialized in filling and finishing of sterile lyophilized or liquid dosage forms.

The company cooperates with major international companies offering complete services from pharmaceutical development and manufacturing of clinical trial batches to commercial manufacturing, packaging, analytical services and logistics.

Porton Biopharma Opens New Facility

John Glen MP for Salisbury and South Wiltshire officially opened Porton Biopharma Limited’s new fermentation facility, which will be used to manufacture the company’s life-saving leukemia drug Erwinase.

The new state-of-the-art facility opened by Porton Biopharma Limited (PBL) has been designed and built around a new 3000 liter fermenter, which is a significant increase compared with existing capacity and will enable PBL to increase the amount of product it will be able to manufacture in the future.

Dr Roger Hinton Managing Director of PBL, said: “We are looking forward to the day when this facility comes online because that, along with the other investments that we have made, means that we will be able to meet the growing global demand for our product. This helps to grow the value of Porton Biopharma, but most importantly it means that we will be able to save the lives of more children who suffer from this form of leukemia in the future.”

The new multi-million pound building has a footprint of approximately 22,596 sq. ft. (2100 m²). This includes the main fermentation hall, downstream processing rooms for harvesting product, plus all the associated services of purified water, steam, air and effluent treatment, required in a modern pharmaceutical facility that meets the latest regulatory standards.

Mike Raine Director of Engineering for PBL, said: “Today represents an important milestone where we can see the physical results of all the hard work in the design, planning and build that have gone into this project. We are now looking forward to the next challenge of qualifying and validating the equipment to ensure that everything is working as specified, before going into full production sometime in the next year.”

These systems have been designed to interact seamlessly and are operated by the latest process-control system. This will enable PBL’s production technicians to easily view and control any of the component parts via a series of hi-tech interactive screens.

John Glen said: “I was delighted to be welcomed back to open this new facility after having performed the ground-breaking ceremony in May 2016, the transformation of the site is astounding. Having this facility in Wiltshire is also a superb local example of the government’s industrial strategy, which specifically includes supporting the life-sciences sector and building prosperous communities – a good news event for Salisbury!”

PCI Opens New High Containment Packaging Facility

The pharmaceutical outsourcing services provider has launched the new facility, located in Dublin, Ireland

Specialist pharmaceutical outsourcing services provider, PCI Pharma Services (PCI) has premiered its new contained packaging facility for the primary and secondary packaging of highly potent products at its newly acquired site near Dublin, Ireland.

According to PCI, the company is the recognized global leader in the manufacturing of highly potent molecules at its purpose-built contained manufacturing facility at its Tredegar site in Wales, UK.

This latest investment in contained packaging capabilities at the PCI Ireland site ensures PCI’s ongoing commitment to delivering the highest standards of safety and regulatory adherence for specialized medicines. It is also the most recent part of PCI’s strategic initiative to develop its high containment operations (HCO) services globally.

“We are very excited to officially launch our state-of-the-art high contained packaging facility here in Ireland,” said Bill Mitchell, President and CEO.

“The Republic of Ireland has a thriving pharmaceutical and biotech community which PCI has been fortunate to support for many years. We have already received a tremendous response to the acquisition and investments such as this high containment packaging facility are part of our strategic plan to continue business growth and service development for our customers. PCI is proud to provide services for medicines destined to more than 100 countries around the world and the Dublin site itself to more than 50 countries.”

After the acquisition of Millmount Healthcare, PCI has added approximately 30 positions at the Dublin area facilities and anticipates adding more than 100 positions in the next five years as the sites continue to expand and grow its operations.

ABEC Cleanroom, Fermoy, Co. Cork, Ireland

Size: ISO 7 cleanroom: 1,896 sq. ft.; CNC: 1,222 sq. ft.; airlock: 217 sq. ft.; total: 3,335 sq. ft.

Project team: ABEC, Clearsphere and Kingspan

ABEC has established an ISO 7 cleanroom at its European headquarters, enhancing supply assurance for its global Custom Single Run (CSR®) customers. The scope of the cleanroom installation included a standalone structural steel system, mechanical and electrical services (M&E), gas tie-in to house utilities, de-ionized water, compressed air, a new building management system (BMS) with PC and network capability and fully flush cleanroom system with maintenance access above the fully certified ISO 14644 Class 7, Class 8 and CNC production suite.

Cleanroom features include 1.5Kn walk-on ceiling 3 m internal height and an HTM 03-01 compliant HVAC system supplying air through terminal HEPA filtration to ISO 14644 Class 7 and Class 8 rooms. Energy efficiency fully flush LED lighting with top access for maintenance was incorporated into the cleanroom ceiling. Kingspan’s Ultra Tech precision fully flush panel system was used throughout to minimize potential area for contaminants to gather. The system uses the CLEANsafe 55 coating, which boasts superior durability, chemical resistance and antibacterial properties. The cleanroom door matrix consisting of fully flush interlocked doors and automatic rapid roll doors for goods movement. ClearSphere’s own CTCB-I qualified validation engineers managed the qualification process. This included bringing the cleanroom from Design Qualification through Installation Qualification and on to Performance Qualification. ClearSphere looks forward to working with ABEC in the future as there are plans in place to provide an ISO 14644 Class 4 unidirectional airflow along with ongoing validation and maintenance servicing ensuring continued compliance for ABEC Technologies and its customers.

Completion date: April 2018

Sterling Expands Small to Mid-Scale API Capabilities

Sterling Pharma Solutions is boosting its small to mid-scale active pharmaceutical ingredient manufacturing capabilities, marking the CDMO’s second £6m investment in as many years.

The contract development and manufacturing organization’s (CDMO) investment will see reactor trains at scales of 225L, 500L and 1,360L added to its Dudley, UK-based site, which will increase capacity by 33%.

The investment will boost the CDMO’s small to mid-scale batch production capabilities, sales and marketing director Andrew Henderson said at CPhI North America.

“We will are adding three reactor trains at the site,” he said, bringing the total number of trains to eight.

According to the firm, the investment responds to increased demand for active pharmaceutical batch sizes in the 10-100kg range.

“More and more of our customers are interested in outsourcing the entire process and by adding more small-scale equipment to our facility we’ll be able to increase our capacity and cater for additional projects from proof of concept through to commercial manufacture,” said CEO Kevin Cook in a statement.

The investment marks the firm’s second £6m ($8m) investment in two years.

In October 2017, Sterling added four milling areas to its Dudley, UK-based site to increase its solid form capabilities.

The investment also saw the CDMO add polymorph screening, salt selection, particle engineering and crystallization scale-up capabilities to its drug development services, as well as occupational exposure band (OEB) 4 classified molecule capabilities and International Standards Organization (ISO) 9 cleanrooms.

The facilities are expected to be operational by mid-2018.

Wuxi Biologics Investment in Northern China

CDMO WuXi Biologics has announced plans to build a biologics center in China, where it will develop and manufacture large molecule drugs for clinical and commercial production.

The contract development and manufacturing organization (CDMO) is investing $240m (€203m) in the 25-acre site – located in Shijiazhuang, Hebei province – which will house process development labs, as well as clinical manufacturing capabilities with 5,000L bioreactor capacity, and 48,000L bioreactor capacity for commercial manufacturing.

Operations at the Northern China site are expected to begin in 2020, and will serve both Chinese and global clients, CEO Chris Chen told us.

In an earlier statement, Chen said the center will “enable local companies to more effectively develop and manufacture biologics and in the meantime provide a robust supply chain network for our global clients.”

“We will quickly and cost-effectively expand our manufacturing capacity,” he added.

The announcement marks WuXi Biologics’ second site investment in as many months. In late April, the CDMO said it would build a biomanufacturing facility for commercial production in Ireland, with single-use bioreactors and continuous bioprocessing capabilities.

The €325m site will be built on Ireland’s Industrial Development Authority’s (IDA) greenfield site in Mullagharlin, Dundalk, Co. Louth.

WuXi STA's Site in Jinshan District, China

The R&D facility will help clients advance pharmaceutical ingredients from preclinical to commercial stage, says the contract development and manufacturing organization.

STA Pharmaceutical (WuXi STA) – a subsidiary of WuXi AppTec – has signed an investment agreement with the government of Shanghai, Jinshan District, China to build a research and development (R&D) site.

The facility will be located next to the firm’s active pharmaceutical ingredient (API) and intermediates manufacturing site, adding 30,000 square meters of laboratory space at the campus.

The firm said it will employ more than 500 scientists within the next two to five years at the center, which it plans to open in 2020.

According to the contract development and manufacturing organization (CDMO), the campus will offer a “one-site solution” for firms looking to advance APIs and intermediates from preclinical and clinical development through to commercial manufacturing.

Spokesperson Yu Lu said the facility will serve STA’s global customers – the majority of which are based in Europe and the US.

“However, we are also seeing a rapidly rising demand coming from Chinese biotechs, which is a reflection of the booming innovative drug development ecosystem in China,” said Yu.

STA Pharmaceutical merged with WuXi AppTech’s Pharmaceutical Development Services (PDS) in July last year.

Three months later, the newly formed WuXi STA announced plans to launch an API R&D and manufacturing facility in Changzhou, China.

Sharp Invests In Injectable and Cold Storage Tech

Sharp will boost syringe assembly and cold storage capabilities at facilities in the US and the Netherlands.

In Allentown, US, Sharp Packaging Services has added Groninger labeling machines to its syringe assembly capacity to improve manufacturing speed and in-line safety device capabilities for its clients.

The firm will also add DEA-approved caged cold storage to the site, increasing temperature-controlled storage capacity by 61%.

At its facility in Belgium, Sharp will add Groninger labeling machines and a high-speed syringe assembly Bausch+Ströbel machine, and boost vial labeling capabilities and cold storage capacity in Oudehaske, the Netherlands.

At CPhI North America, senior vice president of technology and innovation Rick Seibert said the improved services will benefit both pharmaceutical and biotech firms.

The executive has observed a shift in the market he said, from oral solid dosage forms to injection pens and pre-filled syringes, which have particular storage requirements.

The investment responds to both an immediate need from current customers, as well as to predicted increased demand from "virtual" companies, he said.

“As soon as our capabilities reach about 60% utilization, we invest in growth,” he added.

In April last year, Sharp bought Daiichi Sankyo’s packaging facility in Bethlehem, Pennsylvania.

The firm also announced plans to invest £9m ($11.3m) in a clinical packaging facility in South Wales, UK.

Wuxi Biologics Invests in Ireland

The Chinese CDMO says it will build a biomanufacturing facility in Ireland with single-use bioreactors and continuous bioprocessing capabilities.

WuXi Biologics will build the €325m ($390m) site for commercial production with support from Ireland’s Industrial Development Authority (IDA) at the latter’s greenfield site in Mullagharlin, Dundalk, Co. Louth.

The 26-hectare campus will house a 48,000L fed-batch and 6,000L perfusion bioreactor capacity and enable continuous bioprocessing methods.

Ireland – which will house what WuXi Biologics says is the largest biomanufacturing plant to use single-use bioreactors – is an attractive investment option, because it will remain a Member State once the UK withdraws from the EU, Chris Chen, WuXi Biologics CEO said.

Further, Ireland’s proximity to mainland Europe provides the contract development and manufacturing organization (CDMO) “access to [the] EU market,” he said.

The investment is also designed to target US-based clients, he added.

Neither Chen nor IDA Ireland provided details on "support" provided by the Irish Government authority, but an IDA spokesperson said the facility could encourage further international investment.

“The announcement by WuXi Biologics represents a strong addition to Ireland’s growing cluster of next-generation biopharmaceutical companies and will be an excellent reference seller for new greenfield Asia Pacific investment into Ireland,” said the spokesperson.

With a low 12.5% corporate tax rate, Ireland has become a popular investment option for international companies, including biopharmaceutical firms.

This year alone, biopharma-focused Abbvie, ABEC, and Merck Sharp & Dohme (MSD) – known as Merck & Co. in North America – have invested in facilities on the Green Isle.

“While the US continues to be our largest source market for foreign direct investment, we believe that China offers Ireland significant potential for high value, employment and capital intensive investment into Ireland,” the spokesperson added.

IDA Ireland also said it supports WuXi’s decision to invest outside of the larger Dublin and Cork hubs: “The selection of a regional location is a strong endorsement of IDA’s regional strategy and property strategy to acquire and secure pre-approved planning for biopharma strategic sites.”

Canadian Institute Award for New Research Facility

More than $1.57 million in funding, recently awarded to the Canadian Institut National de la Recherche Scientifique (INRS), will go toward new research facilities, including one to study motor neuron diseases like spinal muscular atrophy (SMA).

The award, given by the Canada Foundation for Innovation’s John R. Evans Leaders Fund and the government of Quebec, is aimed at establishing four facilities that foster innovative research and train highly qualified personnel. The funding will help advance scientific breakthroughs in the areas of environmental science, healthcare, innovative semiconductor development, and bio-imaging.

A new facility for studying the mechanisms of synaptic dysfunction in motor neuron diseases will enable Kessen Patten, PhD, a professor of genetics, to combine genetic, electrophysiological and real-time imaging approaches to study how connections between nerve cells and muscles, or synapses, become dysfunctional in amyotrophic lateral sclerosis (ALS) and SMA.

Patten, who earlier this year received a $627,300 grant from the Canadian Institutes for Health Research (CIHR) to study the mechanisms involved in SMA, focuses his research primarily on the early stages of SMA onset.

He studies SMA-associated genes in zebra fish to understand how they cause abnormalities in synapses. Specifically, he and his team look at genetic causes of pediatric musculoskeletal conditions, genetic mechanisms of neuronal survival in neurodegenerative diseases, zebra fish models of human neurological diseases and drug discovery.

Patten’s goal is to identify chemical compounds that restore connectivity between the nerve and muscle, as well as to develop targeted treatments to fight these neurodegenerative diseases.

Other facilities included in the grant are an Ecotoxicogenomics Research Centre to study the effects of environmental chemicals on the health of living organisms; a high-speed bio-imaging lab to map neuronal activity in order to study the origin and evolution of neurological disorders; and a molecular and device physics laboratory to design new lightweight, transparent, flexible, and large-area devices for applications in electronics, photonics, and energy.

McIlvaine Company

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061

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