PHARMACEUTICAL & BIOTECHNOLOGY

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UNITED STATES

Vetter's U.S. Sterile Plant Project Delayed

Construction of German CDMO Vetter’s new sterile injectables manufacturing facility—part of its $320 million plan to invest in a U.S. site in the Chicago area—appears to be getting pushed back until 2022.

The delay at the Des Plaines, IL, site is about four years later than first announced and is due to Vetter’s decision to establish customer commitments before pumping more money into the 17-acre site that used to be the Salvation Army’s central territory headquarters, the Daily Herald reported.

"As you can imagine, the creation of such a commercial site for manufacturing pharmaceutical and biotech drug products requires a significant initial investment of more than $300 million," company spokesman Markus Kirchner told the Herald. "Therefore, in order to seriously undertake such a large project, it is important that we have in place a stable financial plan that justifies this investment."

Currently, the company is renovating a five-story office building previously owned by Salvation Army that will house management, human resources and legal departments.

When first announced in 2016, the 1.2 million-square-foot facility was expected to feature a sterile injectables plant able to fill and finish of aseptically prefilled syringe systems, cartridges and vials. The plant was forecast to generate 300 to 500 jobs as the company expanded operations.

The Ravensburg, Germany-based company has a small clinical supply facility in the nearby Village of Skokie where about 70 people work. At the time of the project announcement, Vetter said it wanted to be able to offer its clients commercial manufacturing capabilities in the U.S

Laboratory Sciences Annex, University of West Florida

Cost: $26.26 million

Size: 52,790 sq. ft.

Project team: Caldwell Associates, Perkins+Will

The University of West Florida Hal Marcus College of Science and Engineering broke ground Jan. 5 on a Laboratory Sciences Annex, which will be connected to the Life Sciences Laboratory on the Pensacola campus to provide additional space for classroom and wet research lab needs.

"The University of West Florida is very grateful for the support of Governor Scott, the Board of Governors, and the Legislature for this facility,” said UWF President Martha D. Saunders. “I am especially thankful to our local delegation for their hard work over the last four years to secure the funding. This annex would not have been possible without their diligence on our behalf."

The $26.26 million, state-of-the-art facility, comprising 52,790 sq. ft., is being designed by local architecture firm, Caldwell Associates, and Perkins+Will, a global firm with a specialty in higher education science and technology. It will house 12 new teaching facilities for the University’s growing biology and chemistry programs, providing space for a steadily increasing number of students. More than 5,000 students were enrolled in biology and chemistry labs during the 2016-17 academic year, and over 2,400 students enrolled in the Fall 2017 semester. Based on this semester’s headcount, more than 1,000 students in biology, biomedical sciences, chemistry and marine biology will be able to utilize the new facility once it is completed in Summer 2019.

In addition to space, the facility will provide necessary technology upgrades and continued enhancement of the high-quality, hands-on educational experiences provided to STEM students at UWF. The Annex will also provide opportunities to expand research efforts currently underway in the college through the conversion of existing teaching labs into renovated research facilities.

Biodesign C Research Building, Arizona State University

Arizona State University (ASU) is constructing a research building named Biodesign C in its Biodesign Institute complex in Tempe, Arizona, US.

The new state-of-the-art $120m research facility will have a total floor space of approximately 188,000ft². Construction began in October 2016 and is expected to be completed in April 2018. A topping out ceremony for the building was held in June 2017.

The facility is being built to expand ASU’s capacity and capabilities in a number of scientific research areas, including chemistry, biological sciences and engineering. It will house 80 researchers and 300 personnel from the Biodesign Institute, the College of Liberal Arts and Sciences and the Ira A. Fulton Schools of Engineering.

The Biodesign C facility is part of ASU’s master plan for the Biodesign Institute, which comprises four interlinked buildings spanning an area of 800,000ft².

Completed in December 2004, the Biodesign A building is a four-story facility that occupies 172,000ft² of floor space, while the 175,000ft² Biodesign B building is a gateway to the complex. The reception area in Biodesign B consists of a cafe and a theatre for public seminars and institute meetings. Construction of the building was completed in January 2006.

Upon completion of Biodesign C, the three buildings will occupy a total area of 535,000ft².

The Biodesign C building will feature five floors and a basement. It will feature laboratories for scientific research, including wet laboratories and offices.

In addition, the ASU-Banner Neurodegenerative Disease Research Center and the Biodesign Center for Applied Structural Discovery will be part of the new facility.

The basement of the Biodesign C building will house a compact X-ray laser for use by the Center for Applied Structural Discovery. The new laser tool will be one of the world’s first compact X-ray free-electron lasers and is estimated to cost approximately $25m.

The new laser will be a cost-effective drug discovery and research tool accessible to scientists across the US.

Zimmer Gunsul Frasca and BWS Architects were contracted to provide architectural services for the project, while McCarthy Building Companies was awarded a contract to provide construction services for the building.

Advanced Structural Engineering-KPFF was awarded a contract to provide structural engineering services.

Biodesign C is being constructed to meet ASU’s green building standards with an aim to achieve Leadership in Energy and Environmental Design (LEED) Platinum® with an energy savings goal of 44%. The building will be equipped with a new heating, ventilation and air conditioning (HVAC) system to save energy and reduce its environmental impact.

The Biodesign C is a part of ASU’s future plans for its Biodesign Institute. ASU plans to increase its research expenditure to $700m by 2020, with the Biodesign Institute assigned with a target of $100m research expenditure a year.

Half of the planned 800,000ft² original master plan has been constructed so far and it is operating at full capacity. Further expansions will be made in the future depending upon the needs of the ASU.

Some current expansion plans include the establishment of five new centers, hiring of new recruits and an increase in clinical and industrial partnerships. ASU also plans to collaborate with international universities such as Dublin City University, Mexico and China.

Micronclean Achieves ISO 9001:2015

Micronclean, the specialist laundered garment rental service and cleanroom consumable manufacturer, has transitioned to the new ISO 9001: 2015 standard following a recent two-day BSI surveillance audit.

In comparison to the 2008 standard the 2015 standard includes the following:

puts greater emphasis on leadership engagement

helps address organizational risks and opportunities in a structured manner

addresses supply chain management more effectively

uses simplified language and a common structure and terms in line with other standards.

Robert Parker, Micronclean Managing Director, said: “This represents a huge achievement, given the scale and complexity attached to the transition from the 2008 standard to the 2015 standard and aligns with our business purpose statement which puts quality alongside innovation at the heart of our business.

“Critical Environmental Solutions the other company within the Micronclean Group has also achieved the same standard so as a group we will continue to provide quality and efficiency to our customers backed by outstanding customer care.”

CDC Seeking $400M to Replace Lab for Deadliest Germs

In 2005 the then newly constructed 11-story Emerging Infectious Diseases Laboratory was located at the CDC's Roybal campus in Atlanta. Thirteen years after building the state-of-the-art lab for the world’s most dangerous germs, the nation's top public health agency is asking for more than $400 million to build a new one. CDC is asking Congress for the money. Its officials say the current lab building in Atlanta is quickly wearing down, and cannot be upgraded without shutting down the facility for years. (Center for Disease Control and Prevention via AP)

The lab investigates deadly and exotic germs like Ebola, smallpox and dangerous new forms of flu.

The agency disclosed its plans for a new lab recently.

The CDC lab is one of only eight U.S. labs with the security and safety features necessary to work with the highest-threat germs, said James Le Duc, director of one of them, the University of Texas's Galveston National Laboratory. Five of the eight are run by the federal government.

The lab is housed in a 400,000-square-foot concrete building located in the heart of the CDC's main campus. It uses eye scanners and other James Bond-like security measures to restrict access. Workers wear protective gear and there's a web of computerized systems that monitor workers, lock doors, and ensure that dangerous germs don't escape.

It opened in 2005 and cost $214 million, although the lab area that handles the most fearsome bugs didn't begin work until 2009. It replaced a CDC lab that had operated for 20 years. The architect firm that worked on it, HDR Inc., predicted the building would serve the CDC for 50 years.

Some experts said they are a little surprised CDC is talking about replacing the high-containment lab so soon.

"Having a lab being replaced after about 12 years seems unusual," said Stephen Higgs, director of the Biosecurity Research Institute at Kansas State University.

Some parts needed at the CDC lab are no longer made and engineers determined a new building is necessary because of the complexity of the systems, said Dr. Inger Damon, who oversees much of the lab work involving dangerous germs.

It will take four years to construct a new building and related infrastructure, so the money is needed now, CDC officials said. The CDC is asking Congress for $350 million for the lab and more than $50 million for related work. Government officials last week approached Congress about a plan to fund the CDC project with discretionary funds.

"The longer it takes, the more likely there will be a failure. And if there's a failure, we lose an essential line of defense" against disease threats, said the CDC's former director, Dr. Tom Frieden.

A number of problems have been reported over the years in the building, including a 2009 decontamination shower failure and a 2015 fire in a lower-level lab. But Frieden said overall the facility has performed well and the incidents were not the reason for the replacement plans.

New Advanced Research Center for Pediatric Biomedical Research

The new $412 million advanced research center for St. Jude Children’s Research Hospital is designed as an interactive hub of exploration and discovery. The approximately 625,000 sq. ft. center is meant to cultivate transformative research and collaboration.

The center will be an interactive and interdisciplinary environment designed specifically to generate new ideas and teamwork. The labs and spaces will enable researchers to collaborate openly across departments. Open atriums and courtyards will bring in natural light and interaction zones will unite key science disciplines.

Labs will focus on immunology, neurobiology, cell and molecular biology, gene editing, metabolomics, advanced microscopy, epigenetics, genomics, immunotherapy, and RNA biology. Integrated advanced technologies and resources will help to accelerate the pace of discovery.

Two of the center’s eight floors are slated for future expansion and evolving technology in an effort to make sure the advanced research center propels St. Jude’s efforts for the long term.

Developed by The Crump Firm (lead architect) and Jacobs Engineering (lab design), the project is expected to break ground in 2018 and open in 2021.

Lonza Expands Encapsulation and HPAPI Capabilities

Lonza has expanded its late-stage clinical and commercial encapsulation capabilities for solid oral and inhaled dosage forms in North America. The company will install a new Harro Hӧfliger Modu-C MS encapsulation unit at its integrated product development and manufacturing facility in Tampa, FL to further strengthen its speed-to-market capabilities.

The specialized drum-dosing technology is used for powder-in-capsule (PIC) filling for oral solid dosage forms including dry powder inhaler (DPI) applications. Installation and validation of the Harro unit are on track to be completed by February 2018.

The investment strengthens Lonza's full-service product-development capabilities and capacity to support process development, clinical trial and commercial scale manufacturing utilizing encapsulation. In addition, the investment complements Lonza's abilities in PIC studies based on the company's Xcelodose Precision Powder Micro-Dosing Systems. The Harro unit and the Xcelodose system are key components in Lonza's toolkit for accelerated product development.

In addition, a new dispensing area and two new processing suites are anticipated to be completed by May 2018 that will broaden Lonza's capabilities for the handling of highly potent active pharmaceutical ingredients (HPAPIs).

"Our integrated full-service offering can reduce drug development timelines, complexity and costs, which are priorities for our customers," said Robert Beland, site head for Lonza Tampa. "The Tampa site is well known for exceptional capabilities in Xcelodose-based encapsulation, inclusive of highly potent compound applications. The addition of the new Harro unit allows us to offer our customers the option of one partner from concept to market for their encapsulated drug products."

The Tampa site already has Xcelodose capacity and expertise as teams there have completed more than 600 PIC programs across more than 200 compounds, which has resulted in a set of best practices for handling PIC challenges. This site hosts both developmental and cGMP Xcelodose units with capability to produce more than 15,000 capsules/day for a given product including highly potent compounds. The addition of the new Harro unit will boost operational capacity as it can fill more than 72,000 capsules per hour.

"We listen to our customers' needs and invest accordingly," said Gordon Bates, head of chemical division, Lonza Pharma & Biotech. "Expanding our capability into commercial-scale encapsulation responds to our customers' desire to maintain programs at the site from clinical development to commercialization."

LakePharma Increases Biologics Offering

CDMO LakePharma has acquired a former-Stryker facility in Massachusetts to boost clinical biomanufacturing services.

The US-based contract development and manufacturing organization (CDMO) moved into the 69,000 sq. ft. site – located at 35 South Street, Hopkinton, which includes laboratory, office space, and dedicated manufacturing space.

LakePharma said the site offers clients “microbiomanufacturing” services, which spokesperson Brendan Doherty said refers to single use, small scale bioprocessing.

And according to the CDMO, the facility will be used to “develop the site to perform GMP [good manufacturing practice] biologics manufacturing for Phase I clinical trials.”

“The increased capacity at the site will also support growth in LakePharma’s assay development, bioanalytical, process development and QC [quality control] services,” she added.

LakePharma plans to add approximately 100 positions at the site by 2020.

Doherty said offering more “integrated services” will be attractive to existing and potential new customers.

CEO Hua Tu said the site location will also be an advantage.

“Hopkinton is in close proximity to Cambridge/Boston, where we have a large cluster of clients, and we believe that this facility will increase our ability to serve their product development and manufacturing needs.”

The CDMO has a vector facility in Worcester, MA – where it plans to double its molecular biology and cell culture operations later this year – a development center in Hayward, CA, and antibody-focused centers in South San Francisco and Belmont, CA.

The South Road facility is a former Stryker site.

Olympus Biotech purchased Stryker Biotech in 2010.

In February, 2014 Olympus Corporation announced plans to discontinue its US biotechnology division, Olympus Biotech, including the closure of its Hopkinton, MA facility.

Avista Pharma Solutions Drug Product cGMP Manufacturing Expansion

Cost: about $5 million

Size: 20,000 sq. ft.

Project team: Ken Domagalski (Avista Pharma Longmont General Manager); Ralph Varrato (Avista Pharma VP of Facilities); Rich Shook (Associate Director of Drug Product Operations); Sampson Construction (construction); RDK Engineers (engineering); L2Partridge (architecture)

Avista Pharma Solutions has completed extensive facility upgrades at its Longmont, CO site, expanding its drug product manufacturing footprint by approximately 20,000 square feet and allowing for the formulation and manufacture of new dosage forms. The expansion includes four new, state-of-the-art cGMP processing suites and all associated manufacturing support areas. These upgrades demonstrate Avista Pharma’s commitment to delivering comprehensive, timely and reliable service for all clients, regardless of their product’s stage in the development lifecycle.

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

Immediate-release tablets and capsules
Enteric-release tablets
Modified-release, multi-particulate tablets and capsules
Hydrophilic and hydrophobic matrix extended-released tablets
Opiate tamper-resistant, modified-release tablets (using a surrogate drug)
Coated aqueous insoluble active ingredients

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

Completion date: December 2017

Cellenkos Receives FDA Registration of GMP Manufacturing Facility

Golden Meditech announced its associate, Cellenkos successfully registered its stand-alone, manufacturing facility as good manufacturing practice (GMP) compliant with United States Food and Drug Administration (FDA). Cellenkos is a clinical-stage biotechnology company focused on developing universal donor cell therapeutics derived from cord blood for the treatment of autoimmune diseases and inflammatory conditions.

Cellenkos manufacturing facility (CMF) manufactures cord blood-derived Regulatory T-cell (Treg) therapeutics. Located in Houston, Texas, CMF covers 2,000 square feet and includes a Class 10,000 (corresponding to International Organization for Standardization 7) cleanroom with gown-in/gown-out anteroom where all major equipment will remain under continuous monitoring with off-site data backup.

"FDA registration of our manufacturing facility is an important milestone as we prepare to enter company-sponsored clinical trials," said Chief Medical Officer, Simrit Parmar, MD. "Control over the manufacturing processes in our own facility will ensure that we are able to comply with cGMP requirements for biologics, drugs and pharmaceuticals as set out in the Code of Federal Regulations Title 21 and confirm that all manufacturing is accomplished with the highest level of safety, competence and proficiency as expected by the FDA and our clinical investigators."

All preclinical research and development, as well as clinical manufacturing and packaging of clinical product will take place at CMF. It is anticipated that CMF will have the capacity to supply sufficient quantities of Cellenkos' lead cellular therapy candidate, CK0801, for all company-sponsored clinical trials. Cellenkos plans to initiate Phase 1 study of CK0801 in the first half of 2018 to assess its activity, pharmacokinetics and safety in patients with a variety of autoimmune diseases and inflammatory disorders.

Amgen to Invest in New Biomanufacturing Facility

Amgen plans to invest approximately $300 million in a new biomanufacturing plant in the United States.

In its Feb. 1, 2018 earnings release for full-year 2017, Amgen announced that it expects to invest up to $300 million to build a new manufacturing facility in the United States as part of an overall $3.5-billion investment in capital expenditures over the next five years. Approximately 75% of the overall investment will be in the US.

The new manufacturing facility will employ Amgen's next-generation biomanufacturing capabilities and will be used to manufacture products for the US and export markets. According to the company, next-generation biomanufacturing requires less time and less capital investment to build than a traditional biomanufacturing plant. It is also less costly to operate and has less of an environmental impact, states the company.

Construction and validation work is expected to add 220 jobs to the local economy, and the company expects to employ up to 300 skilled employees at the new facility. The company expects to finalize the exact location of the new facility in the second quarter of 2018.

The company is increasing its investments to drive additional volume-driven growth of new therapeutics in large patient populations. In addition, the company is increasing the size of the Amgen Ventures fund by providing up to $300 million of growth capital for early stage, innovative biotechnology companies in the US.

"With strong volume-driven growth for our recently launched products and a promising new product pipeline, we are well positioned for future growth," said Robert A. Bradway, chairman and CEO of Amgen, in the company's earnings release. "We expect several developments to provide an additional boost for these products, most notably the recent inclusion of cardiovascular outcomes data in the Repatha (evolocumab) prescribing information."

For the fourth quarter of 2017, Amgen's total revenues decreased 3% versus the fourth quarter of 2016 to $5.8 billion. For the full year, total revenues decreased 1% to $22.8 billion.

Amgen Invests in Next-Gen US Biomanufacturing Plant

Amgen has announced plans for a US biomanufacturing facility, similar to its flexible and single-use Singapore plant, as part of $3.5bn freed through tax reforms.

Amgen’s newest biomanufacturing facility began commercial production last year. Commissioned in 2014, the $200m 120,000 sq. ft. facility, located in Singapore, was constructed based on Amgen’s so-called next-generation biomanufacturing platforms and consists of disposable technologies, a modular lay-out and real-time remote monitoring.

The firm has said the site incorporates all the areas of a conventional 750,000 sq ft facility but was built in half the time, at a quarter of the capital cost, and has a third of the operating expense.

And now Amgen is planning to replicate such a facility in the US, thanks to the ‘Tax Cuts and Jobs Act,’ signed into law in December.

“The timing of tax reform is particularly relevant for us right now as we are on the cusp of deploying our so-called next-generation biomanufacturing technologies, which enable us to make biologics with much improved productivity, a smaller footprint and much reduced levels of waste and environmental impact,” CEO Bob Bradway said during a financial call.

“We developed these technologies in the US and thanks to tax reform, we will now build new manufacturing capacity and add highly skilled jobs here in the US to capitalize on them.”

As well as slashing corporation tax from a top level of 35% to 21%, the Act makes it affordable for US firms to repatriate cash held overseas. Bradway told stakeholders he expects to invest around $3.5bn in capital expenditures in the US over the next five years on the back of these reforms.

CFO David Meline added a key component to Amgen’s US CAPEX plans included “a new drug substance manufacturing plant which will be built using our next-generation biomanufacturing capability.”

The plant – the location of which has not been divulged – will cost around $300m and is expected to lead to 300 new skilled jobs.

Amgen has been undergoing a reduction in its general manufacturing network since July 2014. Meline said investing in “next-generation biomanufacturing capability as well as other efforts to optimize fixed capital infrastructure,” keeps Amgen on track to meet its 2018 goal of reducing its facility footprint by 23%.

Bradway added a shift from traditional biomanufacturing facilities and their associated high fixed and operating costs will give Amgen the competitive advantage, especially in the biosimilar space:

“We still believe that manufacturing is a source of competitive advantage at Amgen. We have a track record of supplying every patient every time and we think when it comes to biosimilars, the reliability of the safe supply and reliable supply of biosimilar medicines from Amgen will be a differentiator.”

Novo Nordisk Equipment Boost in Clayton, NC

Novo Nordisk is planning a $65m (€53m) production capacity expansion at its finished product site in North Carolina, to meet demand for diabetes and obesity medicines.

The Danish firm said it will “acquire additional operational equipment” at the Diabetes Finished Product (DFP) facility in Clayton to respond to growing demand for drug products.

The existing facility – located on a 264-acre campus in Johnston County – offers enough open space to house the additional equipment, said spokesperson Erin O’Brien.

The site is responsible for making, filling and packaging diabetes and obesity products such as liraglutide, as well as assembling prefilled insulin devices for the US market.

Novo Nordisk predicts the project will be completed in Q4, 2019, and the site fully operational in 2020.

The expansion “is likely to create at least two dozen additional positions” from 2020 onwards.

“These positions include operators and technicians, as well as professional engineers and quality personnel,” said O’Brien.

The firm continues to assess plans for future expansions at the Clayton site.

We have “not reached a final decision at this time on whether we will move forward with any further initiatives,” said O’Brien.

Novo Nordisk has expanded its Clayton campus several times since it launched in 1993.

In 2015, the drugmaker announced plans to spend $2bn constructing diabetes active pharmaceutical ingredients (API) and production plants in Clayton, US and Måløv, Denmark.

Chemours Discovery Hub, University of Delaware

Cost: $150 million

Size: 312,000 sq. ft.

Project team: IMC Construction (general contractor/construction Manager), L2 Partridge (architect), Tetra Tech (civil engineer), RDK Engineers (MEP engineer), O’Donnell & Naccarato (structural engineer), Trammell Crow (owner’s representative)

Chemical giant Chemours has begun construction on a $150 million research facility to be located at the University of Delaware’s Science Technology and Advanced Research (STAR) Campus in Newark, Del. The 312,000 sq. ft., four-story Discovery Hub will consolidate laboratories and offices for approximately 330 scientists, engineers and researchers, and connect the industry leader with one of the foremost bio-engineering schools in the country. Built for collaboration and innovation by IMC Construction, the four-story Hub will include more than 100 labs, 50 specialty rooms, cafes, conference rooms and twenty “huddle” rooms for small group meetings.

The project will bring together scientists who are currently spread out among a number of sites, including Chemours’ New Castle, Del. facility, and consolidate their research in one location. The Hub joins buildings for technology and energy companies, the health sciences and a biopharmaceutical structure also under construction on the STAR Campus. It will be the headquarters for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIMBLE), a University of Delaware partnership dedicated to discovering and manufacturing biopharmaceuticals that treat cancer, Alzheimer’s, Parkinson’s, diabetes and autoimmune diseases.

Headquartered in Wilmington, Chemours was founded in 2015 when DuPont spun-off its performance chemicals division of titanium technologies, fluoroproducts and chemical solutions.

Completion date: Early 2020

Amneal Expects New York Plant Expansion After Merger with Impax Laboratories

Amneal CEO Chintu Patel says the drugmaker’s plants on Long Island, New York, are already near capacity. With a merger with pharma peer Impax Laboratories expected to close in the first half of the year, he figures the company needs even more space and employees to meet growing demand.

The company expects to add 100,000 square feet to its 500,000-square-foot plant in South Yaphank, Long Island, and hire about 400 employees over the next 18 months, a spokesman said in an email. The facility, which makes a range of generic solid dose and softgel products, currently employs about 600.

Patel’s remarks came during an event in which the company received an energy rebate check of more than $600,000 from the local utility tied to a $150 million energy efficiency project Amneal recently completed at the South Yaphank facility. Amneal is also eligible for up to $3 million from the state for the project, for which it has already received $1.5 million.

The company said the project allowed it to reduce its electric consumption by 976,257-kilowatt hours (kWh) per year, the equivalent of taking 156 cars off the road for a year.

No details were given on when a plant expansion might start or what it would cost, but Patel’s talk of expansion also comes after Impax announced a merger deal with Amneal valued at about $6.4 billion. The deal is expected to close by the end of the second quarter. Patel said he hopes some of Impax' products might be produced at Amneal plants. Amneal employs nearly 1,100 at its three Long Island locations, South Yaphank, Hauppauge and Commack.

After the merger with Impax, Amneal says it would be the fifth largest generics maker in the U.S.

New Virginia Tech Biomedical Research Addition

The project is a collaboration between Carilion Clinic and Virginia Tech.

Skanska USA will complete the AECOM-designed Virginia Tech Carilion Biomedical Research Addition on the Virginia Tech Carilion Health Sciences and Technology Campus in Roanoke, Va.

The primary focus of the new four-story, 140,000 sq. ft. building is to provide state-of-the-art research facilities for enhanced biomedical research programs in five major thematic areas. These areas include body device interfaces, brain health and disorders, cardiovascular science, infection diseases and immunology, and metabolism and obesity.

The new facility will house next-generation core instrumentation facilities including those for molecular, cellular, and whole-body imaging, and powerful computing facilities. Wet laboratories requiring direct ventilation and specialized piped utilities for water and various gases, MRI and CT scanning, high-resolution electron microscopy, necropsy, and pathology will also be included. An atrium and multiple green roofs will bring a touch of nature to the addition.

The expansion will connect to the four-story, 152,850 sq. ft. Virginia Tech Carilion School of Medicine and Research Institute via an elevated walkway. “The end result of our efforts will be an expansion of the biomedical research they’ve been conducting, greater learning opportunities for students, and expanded business opportunities for a highly-trained technical work force in the region,” says Greg Peele, Executive Vice President and general Manager of Skanska’s building operations in Virginia/North Carolina, in a release.

The facility is slated for completion by February 2020.

PRA Opens New Clinic for Early-Stage Clinical Research

PRA Health Sciences has opened a new clinic in Salt Lake City, UT, which will offer full-service early stage clinical research capabilities for healthy participants and specialized patient populations.

The new facility joins the contract research organization’s (CRO) four other locations in the Salt Lake area, and increases its space by more than 20,000 square feet, to 65,000.

The expansion will give PRA the ability to accommodate 120 clinical research participants, which is a capacity increase of 20%.

"The new space will allow our full service of early stage, Phase I-III clinical research services in specialized patient populations for both inpatient and outpatient settings to fully integrate into one cohesive location," said Mark Slama, executive director, Clinical Research Services at PRA Health Sciences.

“The new PRA facility will have three clinical floors dedicated to participant study specific needs,” he said. “In addition, the building houses training facilities, surgical suite, dedicated pupilometer area, telemetry monitoring system, and state of the art security.”

The facility – located across the street from a full-service trauma hospital – also enhances its capabilities in conducting studies involving new drug candidates for psychiatric and neurological disorders, in addition to Human Abuse Potential (HAP) studies.

The company’s research activities in Salt Lake City usually range from studies in addiction, pain, psychiatry, and neurology, to pediatric and infectious disease services, according to the Raleigh, NC-based CRO.

Additionally, Eddie Caffrey, senior vice president, Early Development Services, said the investment will enable the company to expand its sleep disorder and pain-related studies.

“The new clinic will include an on-site surgical suite equipped for cerebrospinal fluid sampling and post-surgical pain and device implantation allowing us to deliver high quality scientific results,” he explained in a press release.

It will also feature a GCP-compliant pharmacy and a lab with larger centralized processing capabilities.

Cancer Center Expands at the University of Nebraska

In early 2019, the three-story, 80,000-sf SECU Comprehensive Cancer Center is scheduled to open on the campus of CarolinaEast Medical Center, in New Bern, N.C.

The $35 million SECU cancer center—so named for a $3.5 million donation to the project from the North Carolina State Employees Credit Union—will provide radiation oncology, medical oncology, nutrition services, a specialty pharmacy, social worker and psychological services, and a palliative and survivorship program.

CarolinaEast is consolidating cancer treatment and recovery options that currently are scattered across the Tar Heel State’s Craven County. Its new cancer center will be located adjacent to a $15 million diagnostic center, also under construction, which offers imaging services, and where CarolinaEast and UNC Health will provide access to clinical trials, community outreach, and telemedicine.

CarolinaEast Foundation, the nonprofit organization that provides financial support to this health system, declined BD+C’s request for information beyond what’s been reported about the cancer center. But what’s clear is that this new facility reflects an “all in one” design and programming philosophy that is in vogue among healthcare networks.

“Cancer centers are now intended to be one-stop-shop facilities,” says Steve Yanke, PE, LEED AP, Managing Principal with Affiliated Engineers Inc. (AEI), in Phoenix.

One of AEI’s recent projects is the 220,000-sf, $100 million University of Arizona Cancer Center at Dignity Health St. Joseph’s Hospital and Medical Center in Phoenix. Its infusion rooms are more comfortable, quiet, and wired. A full suite of sophisticated diagnostic and treatment equipment stands at the ready. The facility also features a women’s center, patient wellness and support services, a prevention/executive health clinic, and clinical lab space.

Healthcare systems ask their AEC partners for design flexibility that is adjustable to advances in medicine and technology.

The Fred and Pamela Buffett Cancer Center at the University of Nebraska Medical Center in Omaha, Neb., matches each floor of its research tower dedicated to a specific disease with a corresponding and connected floor in the adjacent clinical tower that includes clinical-trial areas and “knowledge transfer” zones where clinical and research faculty offices reside.

Visitors of the Fred and Pamela Buffett Cancer Center, in Omaha, Neb., take in colorful artwork and sculptures by world-renowned glass artist Dale Chihuly. The multi-level gallery and healing garden, called the Chihuly Sanctuary, is the centerpiece of the 10-story, 615,000 sq. ft. cancer center, which includes state-of-the-art equipment and facilities for cancer treatment.

Jim Mynott, LEED AP, Vice President of Integrated Design Delivery with McCarthy Building Companies in Los Angeles, notes that even the smallest cancer centers include infusion rooms, Class 10000 cleanrooms (the number signifying the particles 0.5 microns or larger permitted per cubic foot of air), and compound labs for mixing isotopes.

In some cases, Mynott adds, cancer centers are attached to medical office buildings that include a retail component for cosmetic products like wigs or clothing.

Indeed, healthcare systems appear to be squeezing as many services and machines as possible into cancer centers, with the only inhibiting factor being the size of the building. For Genesis HealthCare System in Zanesville, Ohio, SmithGroupJJR designed a 50,000 sq. ft. cancer center (which opened 18 months ago) with radiation oncology on one floor, medical oncology on another floor, and clinics for exams and infusion separated by an open workspace for the center’s staff. That space is designed to encourage collaboration, and includes 50 sq. ft. mini offices with sliding glass doors.

“The goal was to create spaces and experiences that support the patient, their families, and the care staff,” says Simon Bruce, RIBA, Assoc. AIA, Vice President in SmithGroup’s San Francisco office.

REST of the WORLD

Torrent Pharmaceuticals and Novo Nordisk’s Parenteral Facility

Torrent Pharmaceuticals and Novo Nordisk India opened a new greenfield insulin and parenteral facility at the former’s parenteral facility in Indrad, Gujarat, India, in December 2017.

The new facility was built as part of an agreement signed by Torrent Pharma with Novo Nordisk India in August 2005 to dedicate a part of its Indrad parenteral facility to carry out works related to insulin formulating and packaging.

The plant has been manufacturing insulin for Novo Nordisk products for more than 15 years. The new greenfield site will enable Novo Nordisk to meet the increasing demand for insulin products in India.
According to the International Diabetes Federation 8th Atlas, India has approximately 72.9 million people with diabetes, which is expected to rise approximately 134.3 million by 2045. The new plant will enable Novo Nordisk to provide affordable and quality medication to address the growing challenge.

The new facility incorporates state-of-art technology from the formulation of insulin to the packaging of insulin formulations. It has a systematic and single directional movement for both the people and material in the entire pharmaceutical area.

Provisions have been made for utilities such as WFI and Clean Steam Generator with capacities of 3m³/h and 800kg/h respectively. The civil structure of the facility was built using prefabricated modular partitions.

Designed to comply with cGMP and EU GMP standards, the greenfield facility will produce insulin vials, lyophilized products and liquid ampoules/vials.

The existing Indrad parenteral facility has a capacity of 12.5 million insulin vials, 14.4 million vials of lyopholizer and 15 million ampoules. The new facility will increase the capacity to 15 million insulin vials and 30 million ampoules.

The plant’s initial capacity will be enough to meet the market demand for a period of five years, following which a second line is planned to be added. The plant’s capacity will be increased to 300 million insulin vials with the addition of the second line
.
The Indrad facility is built on a 194,000m² site, with a 46,000m² built-up area for formulations operations and 14,000m² for active pharmaceutical ingredients (API) operations.

Set up in 1989, the plant manufactures finished products in the oral, injectable and freeze-dried sterile injections form. It is compliant with various regulatory norms such as USFDA, WHO, cGMP and MHRA, and is also ISO-certified.

Based in Denmark, Novo Nordisk is a leading global healthcare company that has been involved in diabetes care for more than 90 years. It markets various treatments for obesity, hemophilia, growth disorders and other serious chronic diseases.

Novo Nordisk has more than 41,700 employees in 77 countries and has a global footprint in 165 countries. It partnered with Torrent Pharma in 1992 to manufacture insulin vials.

New Flexible Serialization Suite Operational at PCI Site

PCI, the international pharmaceutical outsourcing services provider, has completed the installation and validation of the suite at its recently acquired site in Ireland.

This installation increases PCI’s serialization capability to support clients in advance of meeting the implementation dates of the European Falsified Medicines Directive (EU FMD) in February 2019.

The highly flexible technology delivers machine and human-readable coding, tamper evident solutions and Bollini labelling, which in turn is linked to a case loading and aggregation station, with a final aggregation station connecting cases to pallet.

PCI is a strong supporter of the advanced use of aggregation to realize the significant benefits in packaging operations, as well as the broader pharmaceutical supply chain.

PCI’s site near Dublin already offers excellence in commercial packaging services for customers globally and this new serialization technology further strengthens PCI’s offering across Europe.

The investment in PCI’s Dublin facility is part of a significant global initiative from PCI to develop its serialization services across its global network, plans that will triple its overall serialization capacity.

Ian Parsonage, PCI’s Senior Director of Global Serialization, said: "This is an important addition to the site’s capabilities and PCI as a whole. Ensuring supply chain integrity and patient safety is of critical importance. We pride ourselves on real-life experience and expertise in this area and our commitment through such significant strategic investment continues to demonstrate and deliver a truly industry-leading solution for our customers."

"Being able to offer this fully flexible service and work in partnership with our customers from our site in the EU is essential ahead of the timelines for compliance with the EU FMD. Our customers also enjoy the benefits of a single B2B data exchange providing access to each site within our integrated global supply network."

As part of the overall strategy, the four sites in Ireland have been subject to a full rebranding exercise to become fully integrated into PCI Pharma Services.

ProJect Pharmaceutics Expands Safety Facilities

ProJect Pharmaceutics (PJP) of Martinsried, Germany, a company specializing in formulation and process development for parenteral drug products, has extended its safety facilities with laboratories dedicated to handle GMO S2 and BSL-2 based biologic products, such as live virus vaccines, protective and therapeutic vaccines, as well as gene and cell therapy products.

The GMO S2 and BSL-2 safety lab is equipped with a dedicated pilot freeze dryer to design tailored lyophilization cycles. Also, analytical high-throughput methods have been implemented in order to select the most effective combination of excipients for the final drug product to maintain the active quaternary structure of a virus capsid and avoiding aggregation, even under stress conditions like elevated temperature, freezing and freeze drying, according to the company.

PJP provides smart formulations and manufacturing processes for virus vaccines or other classified drug products in their dedicated labs in compliance with mandatory safety requirements up to GMO S2 and BSL-2 classification.

Pall Biotech Expands Hoegaarden Facility

Pall Corp., a provider of filtration, separation and purification products and services, has opened its newly expanded Hoegaarden facility that includes more than 21,000 sq.-ft. of new office space with work stations for 100 employees, new research and development, customer demonstration labs, and manufacturing space. Three Belgian locations have been combined into the one location, bringing headcount in the Hoegaarden office to more than 300 full time employees.

“The expanded Hoegaarden site has it all: offices, labs, and manufacturing space for development and optimization of customer processes. With this site, we will be better equipped to provide whole service to customers in the area, while supporting the local economy,” said Mario Philips, vice president and general manager of Pall Biotech. “In this new space, we have consolidated three Pall Belgian offices as one, which is why we have designated Hoegaarden as a hub of strategic importance for our future growth.”

Almac Group Completes Expansion

Almac Group announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000 sq. ft. custom built cold store facility at its global headquarters in Northern Ireland.

With over 30 years’ experience in the field of global distribution and management of temperature sensitive drug products, Almac says this expansion strengthens their ability to provide a best-in-class service to its growing global client base by ensuring efficient and effective delivery of both clinical supplies and commercial drug products.

The new facility complements Almac’s existing global clinical supply and drug product capabilities by boasting over 3,000 pallet spaces including -15°C to -25°C storage capacity, additional 2°C - 8°C secondary production rooms, 3PL processing areas and a custom designed clinical labelling suite. Supplementary office space has also been included to accommodate an additional 100 new employees who will be recruited because of the expansion.

Alan Armstrong, chief executive officer Almac Group said, “This new facility at our global headquarters expands our cold storage capacity by 300% and our frozen storage capabilities by over 50%, enabling us to better serve our clients, and ultimately patients, worldwide thereby maintaining our position as a global leader in the life sciences sector.”

This news comes just weeks after the company announced a £30 million investment in its new European campus based in Dundalk, Ireland, including a new QC laboratory, packaging facility for commercial drug products and a dedicated 79,000 sq. ft. EU Distribution Centre for clinical trial supply.

Catalent Completes Singapore Expansion

Catalent Pharma Solutions has completed a two-year, $4.6 million expansion at its Singapore clinical supply facility, which serves as a strategic hub in Catalent’s Asia-Pacific network and global clinical supply business. The expansion provides additional GMP space for secondary packaging, and has doubled ambient storage, and quadrupled cold storage capacity at the site.

The site opened in 1998 and has seen significant growth, almost tripling in size to almost 20,000-sq. ft., and headcount since 2012.

“We are particularly pleased to have completed the expansion in a year that marks the 20th anniversary of what was Catalent’s first facility in the Asia-Pacific region,” said Bernie Clark, vice president marketing, Catalent Clinical Supply Services. “Supported by many long-serving employees, the Singapore site has undergone tremendous growth over the past two decades and now routinely distributes to 18 countries in the region.”

Catalent’s clinical supply services business has facilities in the U.S., U.K., Germany, Japan and China, and an extended network of over 50 audited depots.

Fujifilm Building Facility to Support Liposome Drugs

Toyama Chemical’s facility will support trials of liposome drugs produced using technologies cultured through Fujifilm’s photographic film business.

The 4bn yen ($37m) facility will be built at a site in Toyama, Japan run by Toyama Chemicals, a subsidiary of Fujifilm Corporation.

“The first purpose [of the plant] is the manufacturing of [our] own liposome drugs, including FF-10832 which will start clinical trial in the US this year,” said Fujifilm spokesperson Kana Matsumoto.

Liposomes, or artificially constructed vesicles, are made from the same organic phospholipids that make up cell and bio membranes and can be designed to deliver active pharmaceutical ingredients (APIs) to specific areas.

Toyama’s FF-10832 consists of an anti-cancer drug Gemzar (gemcitabine), developed by Eli Lilly for the treatment of pancreatic cancer, formulated with liposomes with a uniform size of approximately 80nm.

But “Fujifilm will also collaborate with other companies for offering the liposome technology,” Matsumoto told us. “Fujifilm has advanced liposome technology, cultivated through photographic film business, and the production facility will be designed and developed by Fujifilm.”

She added the facility will make liposome drugs in compliance with international GMP standards, and will use Fujifilm’s Information and communication Technologies (ICT), including “centralized management of various data such as production process, quality evaluation and operation data.”

Construction of the new facility will begin in September, and operations are expected to begin in February 2020.

Samsung BioLogics Wins Contract for Plant 3 Facility

Samsung BioLogics, headquartered in Incheon, South Korea, has entered into the first manufacturing contract for its Plant 3 facility. According to the company, the contract is valued at approximately $148 million, if the product is successful in clinical development and moves to commercial launch.

The Plant 3 facility was completed last November and has 18has 180,000 liters total capacity and is expected to be cGMP operational by 4Q18.

TH Kim, chief executive officer of Samsung BioLogics, said, “We are excited to enter into this partnership with a fast-growing company and very pleased to be chosen to provide a high quality life-saving product to their patients. As products from our Plant 1 (6 x 5,000L) and Plant 2 (10 x 15,000L) facilities mature, Plant 3 will be utilized to supply those with increasing demand to ensure that we continue to meet our client’s demand. We continue to discuss long term partnerships with multiple biopharmaceutical companies for Plant 3. As such, the utilization rate in Plant 3 may ramp up more quickly than anticipated.”

Pall Launches NYP Centre of Excellence

Pall Corporation has announced the opening of a $2 million Nanyang Polytechnic (NYP) Centre of Excellence in biologics manufacturing featuring various Pall Biotech technologies for practical training and application.

On January 4th, Pall hosted official opening ceremonies to celebrate the NYP Centre of Excellence. In its first year, it is showcasing single-use technologies, including chromatography column packing and filter integrity testing apparatus supplied by Pall Biotech. Annually, the one-stop, integrated training Centre will introduce 300 NYP School of Chemical and Life Sciences students to the latest technologies and advances in the industry.

“Large molecule drugs offer the potential to treat debilitating and life-threatening diseases in ways that were not possible before. Yet, to achieve this, manufacturing processes need to evolve for greater speed, reduced cost, and higher quality outputs,” commented Steve Waters, vice president of Biotechnologies, Pall Biotech Asia. “The NYP Centre will benefit students and the wider Biotech industry through direct access to the latest technologies. Overall, the goal is to increase workforce skill levels in Singapore and its neighboring countries.”

The Centre complements the existing labs located at NYP with 120 training targets for industry professionals to learn the latest technologies as they grow in their careers. NYP also plans to support industry professionals with short industry courses on cell culture, sterilization techniques, and filtration technologies.

ClearSphere Delivered Design and Build of Class 7 Cleanroom to ABEC in Ireland

Equipment for use by the biopharma sector requires that all GMP compliance needs are met and the equipment is produced under cleanroom conditions. So, when equipment supplier ABEC wanted a new cleanroom it turned to cleanroom solutions provider ClearSphere for help with the design and build.

ABEC specializes in delivering bioprocess equipment, integrated solutions and services for biopharmaceutical manufacturers. Its customer base features many of the world's pharmaceutical and biotech companies for whom it provides equipment engineering manufacture and installation.

The company manufactures all custom-single run (CSR) single-use plastics/disposable containers (DCs) in-house, and ensures there is redundancy of CSR-DC supply for its customers. ABEC decided that a new ISO Class 7 cleanroom was needed for manufacturing its Custom Single Run (CSR) single-use technology disposable containers (DCs).

The cleanroom requirements for its facility in Fermoy, Ireland, are similar to an existing cleanroom of ABEC’s located at Bethlehem, Pennsylvania; its US headquarters. A major requirement for ABEC cleanrooms involves accommodating the manufacture of the largest single-use disposable container available to the industry, which is 4,000 L.

ABEC contacted ClearSphere in 2016 about providing a turnkey cleanroom system located in the main production building. ClearSphere, based in Ireland, was founded in 1989 and specializes in controlled environment solutions. It has been delivering cleanroom and containment technology to blue chip clients worldwide ever since.

The scope of works from ABEC was to include 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 ceiling rated at 1.5 Kn/m² in a fully certified ISO 14644 Class 7, 8 and CNC production suite.

The specification was developed over a series of design meetings into a final functional requirement specification (FRS) document and ClearSphere was able to offer a complete solution presenting the Kingspan Ultra Tech Precision cleanroom system to the client along with its other quality ISO approved suppliers.

The M&E package was designed and specified fully in-house in conjunction with the FRS. The ventilation system was designed to meet the ISO classification 7 and 8 with HEPA filtration and low-level return grilles.

ClearSphere specified an HTM 03-01 compliant air handling unit (AHU) with a gas module unit and duty stand by fan/motors.

Cork-based Mark Eire BV was selected as the AHU vendor. ClearSphere has been partnering with the Irish firm for a number of years based on its wealth of knowledge and experience.

The cleanroom door matrix consisted of fully flush interlocked doors and two automatic rapid roll doors for goods movement into the CNC areas and incorporated into the BMS system. Hormann Ireland, was selected as the vendor to supply and fit.

The in-house validation team at ClearSphere was positioned to ensure that everything – from design and installation through to operation and performance qualification – was covered to satisfy regulatory requirements. Following a successful tender process ClearSphere was awarded the project in December 2016.

The success of the project centered on reliable communications to the relevant project stakeholders, which were located in both the Fermoy site and in the US headquarters. Agreement of the main project master schedule and milestones allowed for the coordination, distribution and sign-off of the 3D/2D layouts, elevations, M&E process and instrumentation diagrams as well as product specifications.

An accurate schedule ensured long lead items were placed on order and the use of Revit software ensured clash detection was eliminated prior to commencement of site works.

A “just in time” (JIT) delivery matrix was scheduled and managed by the ClearSphere team – project manager, construction manager, site supervisor and installation personnel – to allow the client’s facility to operate on a 24-hour production cycle with zero downtime on any of the site facilities.

Site works commenced in February 2017 with the installation of a new independent structural steel; it required the addition of new foundation pads in the center of the production factory. This steel frame system would be utilized to support a new AHU located above the cleanroom and the suspension of the 1.5 Kn walk-on ceiling. Installation of M&E services followed once the ceiling was completed.

ClearSphere operated a “bib” system to manage access and the use of the ceiling as a working platform, and to eliminate damage to ceiling panels’ integral structure. In tandem to this, installation of the floor track and cleanroom walls was ongoing.

Paneling was delivered as required and as per planned approach hence ensuring different trades having access to the areas speeding up the overall project and eliminating any risks associated with the build. Co-ordination was strictly managed by construction management on-site.

The facility was a live environment; hence safety was the top priority for both ClearSphere and ABEC in the speed of build. This process was managed through weekly toolbox briefings and daily white board meetings. Regular safety and quality audits were conducted throughout the project. First fix mechanical and electrical installation were ongoing and managed by ClearSphere team with project supervisor construction stage (PSCS) responsibility.

With the cleanroom fabric practically complete, second fix M&E followed along with final sealing and commissioning of the HVAC, lighting, door controls, and BMS. ClearSphere’s own CTCB-I qualified validation engineers provided validation services. Certification was awarded less than seven months after award of project.

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 and its customers.

“The feedback from ABEC is very positive, with the project being completed on schedule and budget,” commented Eric Rudolph, ABEC’s Vice President, Business Unit Manager, CSR.

“ClearSphere’s experience delivering turnkey projects, and ability to manage validation processes in-house was a major factor in selecting ClearSphere for ABEC’s Fermoy, Ireland cleanroom. ABEC is definitely prepared to manufacture CSR single-use disposable containers for our global customers. We look forward to working with ClearSphere in the future,” Rudolph concluded.

GE Healthcare’s FlexFactory Selected for Clover’s Changxing Zhejiang Facility

Clover Biopharmaceuticals has chosen GE Healthcare’s biomanufacturing platform FlexFactory for its new facility located in Changxing, Zhejiang, China.

The new facility will mainly be used to produce biological fusion protein products, including innovative drugs and biosimilars. This will help Clover Biopharmaceuticals to bring local access to biologic therapies faster, while also opening global markets through the proven track record of FlexFactory in meeting global regulatory requirements and quality standards.

The biomanufacturing facility includes two 2000-liter bioreactors from GE, and it will be operational in the latter half of 2018.

Co-founder, chairman and president of Clover Biopharmaceuticals Dr. Peng Liang said: “Adopting high-quality technologies and driving innovation in our manufacturing operations is important for Clover Biopharmaceuticals. GE’s FlexFactory represents the latest in biomanufacturing technologies, and it will help us establish flexible production capacity quickly, while fulfilling good manufacturing practices (GMP) requirements.

“The first therapeutic product produced using this biomanufacturing platform is SCB-808, a prefilled syringe formulation Enbrel® (etanercept) biosimilar candidate for the treatment of rheumatoid arthritis. We believe that SCB-808 addresses a major unmet need for patients in China and hope that we can provide patients with safer, more efficacious and convenient modern biologic therapies.”

Clover Biopharmaceuticals’ new production facility will be located in one of the national economic development zones in China, Changxing Economic and Technological Development Zone, where a new biopharmaceutical industrial cluster is being developed.

China has a broader strategy on biotechnological innovation per the government’s 13th Five-Year Plan, and there are plans to build up to twenty science parks for biomedicine by 2020 to accelerate local research and development (R&D) activities.

In 2015, the Chinese biopharmaceutical market was valued approximately at $13bn, and the estimated annual growth rate (CAGR) is around 13% for the next few years.

General manager of global commercial bioprocess at GE Healthcare Life Sciences Sven Henrichwark said: “China has one of the fastest growing biopharmaceutical industries in the world, and it is important when new production facilities are being built that the chosen biomanufacturing technologies support this positive development, bringing high-quality biologics fast to market. We are excited to collaborate with Clover Biopharmaceuticals and to contribute to their promising and ambitious product pipeline by delivering a flexible, start-to-finish biomanufacturing platform based on single-use technologies.”

Ferring to Invest in New Biotech Center

Ferring Pharmaceuticals, a biopharmaceutical company specializing in reproductive medicine, announced on Feb. 14, 2018 that it is making a CHF 30-million (US$32 million) investment in a new biotech center to expand its capabilities in biologics

The center, which will be installed at the company’s existing headquarters and manufacturing site in Saint-Prex, Switzerland, over the course of three years, will incorporate discovery and development capabilities for monoclonal antibodies (mAbs) as well as biologics manufacturing capabilities. The active pharmaceutical ingredient for the company’s fertility treatment, Rekovelle (follitropin delta), will also be manufactured at the new center.

“Ferring is committed to investing in innovative technology platforms to create new solutions for patients in our core areas of reproductive medicine and women’s health, gastroenterology, and urology,” said Michel Pettigrew, president of the executive board and chief operating officer at Ferring, in a company press release. “This significant investment in state-of-the art manufacturing and development technologies fits our strategy to address unmet patient needs in these areas and will open up additional opportunities for Ferring to help people live better lives.”

Additionally, in early 2018, Ferring announced a worldwide license agreement with Ligand Pharmaceuticals to use Ligand’s OmniAb platform to discover new human mAbs and accelerate development solutions for unmet patient needs in reproductive medicine and women’s health, urology, and gastroenterology. Together, these investments significantly expand Ferring’s growing capabilities in biologics, according to the company.

Over the next three years, Ferring will invest approximately 30 million CHF in the new Ferring Biotech Centre.

Over the next three years, Ferring will invest approximately 30 million CHF in the new Ferring Biotech Centre, which will incorporate discovery and development capabilities for monoclonal antibodies as well as biologics manufacturing capabilities.

Michel Pettigrew, president of the Executive Board and chief operating officer, Ferring Pharmaceuticals. “This significant investment in state-of-the art manufacturing and development technologies fits our strategy to address unmet patient needs in these areas and will open up additional opportunities for Ferring to help people live better lives.”

MedPharm Announces Expansion of Formulation Development Laboratory

MedPharm has announced a laboratory expansion following an internal investment of £1 million to increase its laboratory footprint in the UK by 60%. The expansion is to accommodate the new scientists needed to service the increase in demand for its formulation development, performance testing and manufacturing services. This increased capacity will allow MedPharm to extend its service offerings across these key areas of expertise.

“We are very pleased to announce this investment which reflects the trust an increasing number of clients are placing in our services”, said Dr. Andrew Muddle, MedPharm’s co-founder and Chief Executive Officer. “Our focus on the development topical and transdermal medicines which can benefit developers of new chemical entities, generics or OTC products alike is attracting ever increasing interest and this expansion will accommodate the demand for our services in the coming years”.

MSD Repurposing Dormant Irish Site

Merck Sharp & Dohme (MSD) plans to build a biologics facility at a former small molecule manufacturing site in Swords, Ireland, which it closed last year.

In 2013, MSD (known as Merck & Co. in North America) announced it was shutting its women’s health, anesthesia and psychiatry finished formulation facility in Swords, County Dublin with a loss of 570 jobs.

Swords closed its doors last year and was put up for sale, but the firm has now decided to repurpose the site to support production of its immune-oncology portfolio, and in particular, its bestselling cancer antibody Keytruda (pembrolizumab), said a MSD spokesperson.

“We were actively partnering with agencies to find a suitable successor for the site, and there were a lot of interested parties,” the spokesperson said. However, they added the growth of its biologics business meant an additional biomanufacturing capabilities are needed.

By building on an old site and harnessing the equipment within the firm will be able to achieve its ambition of bringing a new biomanufacturing facility online by 2021.

“It will be an entirely new facility at the site in Swords. It is still owned by MSD so we will be building within the shell of the former facility with a view to dismantle the shell once construction is complete.”

Planning is in its infancy but MSD expects to create 350 jobs by the time the facility opens, including 50 in the next year in mostly overseeing roles in the facility design. The spokesperson said it is too early to comment on further details and potential costs.

Keytruda, a humanized antibody used in cancer immunotherapy, is MSD’s second largest selling product. In 2017, the drug clocked in sales of $3.8bn for the firm, up 172% on the previous year.

This will be the latest investment in Keytruda and Ireland for MSD, which last year committed $280m to biomanufacturing in the country.

Science and Food Laboratories, Abertay University, Dundee, Scotland

Cost: £3.5 million (about $4.9 million)

Size: 8,608 sq. ft. (800 sm)

Project team: Oberlanders Architects (architect); RSP Consulting Engineers (M&E engineers); Waterman Group (structural engineers); Christie & Partners (project manager and QS); Morrison Construction (main contractor)

Abertay University in Dundee, Scotland, has recently opened its new suite of science and food laboratories. Designed specifically to support both the undergraduate and postgraduate programs in Forensic Science, Biomedical Science and Food and Drink, the labs feature the latest technologies for enhancing learning as well as study and social space.

Significantly, the laboratories also include a food product development laboratory and consumer experience laboratory designed to support the Scottish food industry in both process and product development, as well as for the understanding of sensory perception of foods, which is critical to success of the food business. The laboratories have been designed to enhance the industry-informed teaching programs and to be a focal point for local, regional and national business and enterprise.

The suite includes a Consumer Experience Laboratory, which is unique in Scotland and comprises 12 climatically controlled booths designed for the sensory analysis of food. It has a preparation and serving room linked to a kitchen, as well as a waiting room which can be used for consumer experience testing, student tutorials and small group working.

The New Product Development Laboratory is well-equipped with a range of equipment for pilot scale food manufacture schemes across a range of food processes and industries. Designed to food manufacturing and environmental health standards, the zone features a controlled barrier, change area, walk-in cold room and store.

A teaching area features two new labs used by the forensic science and biomedical science students. Both are linked, equipped with two high-tech fume cupboards and designed specifically to accommodate 30 students each. Features include a controllable camera, independent monitors and display screens which can be operated collectively or independently by teaching staff and students.

The suite contains 15 flat screens, an 84-inch touchscreen and cameras in each lab for presenting and recording, using Kramer's VIA's software, which allows remote and wireless sharing and presenting of information using any laptop or mobile device. Students and tutors can view, edit and share files with fellow student either individually or collectively simultaneously.

The facility also includes a multi-purpose learning/social area with an 84-inch screen and seating; a link corridor around all the labs has seating and lockers, equipped with the latest IT; viewing galleries into all the laboratories which allow visitors to view safely the work undertaken inside the laboratories.

The labs have four distinct areas to support the teaching and research of the School of Science, Engineering and Technology, which includes the Division of Food and Drink and the Division of Science. In addition to providing a cutting-edge teaching and learning space, the labs support external business projects such as food testing and product development.

Completion date: February 2018

Delmar to Upgrade Canadian API Plant

Italian API maker Delmar Chemicals will up production capacity at a plant in Quebec, Canada.

The $45.8m investment will increase active pharmaceutical ingredient (API) production capacity at Delmar’s LaSalle Borough facility in the Quebec region of Canada.

The firm will purchase specialized equipment for its finishing room to complete the production cycle of active pharmaceutical ingredients in-house, and expand the plant to make room for the indoor storage of production materials.

The Government of Quebec is supporting the expansion through a repayable $10m grant and a $1.5m contribution through its Canada Economic Development for Quebec Regions (CED) program.

25 jobs are expected to be created.

Delmar is part of Italian firm Holding F.I.S. S.p.A which owns F.I.S. (Fabbrica Italiana Sintetici) and P.H.F. (Partner of Holding F.I.S. S.p.A)

Johnson & Johnson Opens First European JLABS Incubator

Johnson & Johnson has opened its first JLABS incubator in Europe. The 30-startup hub will supersede the JLINX incubator J&J helped to set up at its R&D site in Beerse, Belgium.

J&J first established an incubator in Beerse in 2016. Back then, the site was dubbed JLINX, not JLABS, and day-to-day management was handled by a team from Bioqube Ventures. That gave Bioqube a key role in managing the portfolio, liaising with external investors, attracting new startups and growing the initiative. J&J contributed VC money and supported the Bioqube team.

Asked whether Bioqube is still involved after the JLINX-JLABS transition, J&J said the group "has advised us of their plans to raise a VC fund ... after a successful 2 years establishing an incubator at the Beerse campus."

JLINX followed the broad model established by JLABS but sought to tweak it to the situation in Europe. The tweaks reflected a belief that the lower level of entrepreneurial activity in Europe compared to the U.S. would make it difficult to directly transpose the JLABS model across the Atlantic. That belief led J&J to conclude that the incubator needed to proactively identify academics working on exciting science and help them transition to industry rather than wait for them to independently found startups.

The incubator has reached into academia to facilitate the creation of some of the 10 companies that now make up its community, such as ProteoFormiX. But in other cases it has just given a boost to firms that already existed but were still finding their feet.

Despite its prior reservations about bringing JLABS to Europe, J&J now thinks the model will work.

"While both JLABS and JLINX are complementary company incubation models, the differentiating factor is that the JLABS model is predicated on the premise that it is “no strings attached” meaning that we do not make investments or take any rights in any of the companies coming into JLABS.

"Additionally, JLABS provides the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. This model has proven highly successful in other regions of the world and we are optimistic that this will be an important progression for the EMEA region," a spokesperson for J&J said.

Shaanxi Aoxing Pharmaceutical Renewed its GMP Certification

Biostar Pharmaceuticals, a PRC-based manufacturer and marketer of pharmaceutical and health supplement products in China for a variety of diseases and conditions, announced its variable interest entity in China, Shaanxi Aoxing Pharmaceutical, has renewed its Good Manufacturing Practices (GMP) certificate and Pharmaceutical Production License. The company received the renewed GMP certificate evidencing compliance on January 31, 2018.

"The Company is pleased to have completed the GMP certification inspection and approval process. We expect that the GMP certification renewal will allow us to resume our production in the coming months as the company makes preparations to carry on with the implementation of its business plan and growth objectives," said Wang Ronghua, Chairman of Biostar.

Cavendish III Lab Soon to Be Built at University of Cambridge

Plans for the new Cavendish Laboratory – a new facility for the University of Cambridge UK – are now well underway. Construction of the new facilities is set to begin in early 2019 with a target completion date of December 2021.

With a gross internal area of around 344,500 ft2, Cavendish III will house a range of laboratories, cleanrooms, workshops and multiple lecture theatres and offices. The basement area will incorporate specialist acoustic and vibration treatments to achieve the stringent control criteria necessary for operating equipment highly sensitive to vibration. There are also challenging criteria to be met in relation to temperature and humidity control and EMI protection.

Bouygues UK, a leading construction companies, along with group company Bouygues Energies & Services and design partners NBBJ and BDP, have been selected by the University of Cambridge to provide consultancy support to the university’s existing project team to develop proposals for a new state-of-the-art physics laboratory and a neighboring shared facilities hub.

Scheme design is by Jestico + Whiles with CH2M. NBBJ and BDP are taking the design through to completion.

In addition to serving as a home for physics research at Cambridge, the new Cavendish Laboratory will be a top-class facility for the whole of the UK – much of the specialized research equipment in the new building will be made available to other institutions.

The new building will also provide space in which to communicate findings with student and wider audiences, through teaching labs, seminar rooms and two lecture theaters.

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