Turkish nonwovens producer Mogul is establishing its first North American and first overseas operations – Mogul South Carolina Nonwovens Corporation. The company is investing $17.6 million in an existing 91,000-square-foot building in Gray Court, SC. This plant will focus specifically on the production of spunlace nonwovens for medical, hygienic and personal wet wipes applications. Moving forward, Mogul expects to use its new facility to expand its product line.

“Mogul is excited to launch its new North American operations in Laurens County, South Carolina. Through our new facility in South Carolina, we will be able to better serve our North American customers with our diverse offerings of quality nonwoven products,” says Mogul Tekstil, A.S. founder and chairman Ekrem Kayali.

The facility is expected to be fully operational in the second quarter of 2016.

Established in 1997, Mogul is headquartered in Gaziantep, Turkey. The company boasts a diverse product portfolio, including spunlace, PP spunbond nonwovens, PET spunbond nonwovens, bico PET spunbond nonwovens and meltblown nonwovens, as well as coated and laminated fabrics and converted products made from nonwovens and composites.

Biomedical Research Facility, Grand Rapids Innovation Park, Michigan State University

In June 2015, ground was broken for the construction of a new biomedical research facility at the Michigan State University (MSU) College of Human Medicine.

The new facility will be located at the corner of Michigan Street and Monroe Avenue in Grand Rapids Innovation Park.

The Michigan State University Board of Trustees approved the biomedical research facility construction in February 2015. The project will create 728 jobs and will be instrumental in generating $95.6m in economic benefits to the area.

The biomedical research facility will be a six-story building with a total floor space of 162,800ft² that will be developed on 4.1 acres of seven acres of land. It will replace the existing Grand Rapids Press building.

It will include research programme spaces and five core labs, which will consist of bioinformatics, flow cytometer, long-term storage, and analytical and advanced microscopy.

The facility will have space to accommodate 260 members, including 34 principal investigators belonging to the MSU College of Human Medicine's scientific research teams. Up to 44 research teams can be accommodated at full-capacity.

The facility will be used to perform core scientific research on areas, including Parkinson's disease, Alzheimer's disease, pediatric neurology, autism, inflammation, transplantation, cancer, genetics, women's health and reproductive medicine. It will also carry out core research on skin cancer to help people live longer and better.

The new facility will benefit scientists at the College of Human Medicine and other partnering institutions of the MSU in collaborative medical research.

Construction began in June 2015 and is planned to be completed by the end of 2017. Pitsch Companies demolished the old Grand Rapids Press building prior to the start of construction in April 2015.

Demolition works involved removing 20,000ft² of asbestos floor tiles, 2,500ft of pipe insulation and 5,900 fluorescent light bulbs.

More than 90% of the old press building will be recycled, including copper cladding that lined the roof area.

SmithGroupJJR was contracted to provide engineering and architecture services for the biological research facility, while Ellenzweig was contracted to offer laboratory design and planning consultant services.

The joint venture of Clark Construction Company and Rockford Construction was contracted to provide construction management services.

The project is estimated to cost $88.1m, which will be funded through financial gifts, the MSU General Fund and tax-exempt financing.

CMO Regis Technologies Opens Potent API Site

Regis Technologies has opened a site for manufacturing highly potent active pharmaceutical ingredients (HPAPIs) in Illinois.

The contract manufacturing organization invested in a potent compound suite at its 36,000 sq. ft. cGMP site in Morton Grove, Illinois. The suite will produce potent compounds up to 1kg per batch for small molecule oncology drugs and linker payloads for antibody drug conjugates.

Construction and training of eleven staff in HPAPI handling took two years. Working with dangerous compounds means learning to use ventilated balance enclosures, containment isolators, a fog shower, and personal protective equipment.

The company said instead of choosing outside hires to lead the potent compound suite, it advertised for the position internally and used Safebridge Consultants to train supervisors.

Chemists must read more than 20 Standard Operating Procedures (SOPs) related to potent compound handling before beginning work in the controlled suite. SOPs for cGMP facilities are written documents which employees must follow perfectly without input from a supervisor to pass their training.

NuVasive to Expand Manufacturing

Officials with spine company NuVasive Inc. announced a planned expansion of the company’s manufacturing capabilities and that the NuVasive is “actively exploring” locations to build a new state-of-the-art medical device facility for its spinal implant and instrument manufacturing.

The new facility, which would extend the company's existing manufacturing capabilities, will support efforts to increase the amount of products it internally manufactures, and “enhance its focus on operational excellence and efforts to drive accelerated operating margin expansion,” company officials said in a release.

The construction and operation of the proposed 130,000-square-foot facility is expected to create hundreds of new jobs, employing more than 300 people on a permanent basis in the disciplines of manufacturing and quality engineers, tool makers, machinists and manufacturing technicians. The new planned facility is expected to house approximately 100 computer numerical control (CNC) machine tools, and inspection equipment, as well as clean-room operations.

The company has begun an outreach process in targeted locations to determine local officials' interest in supporting the site selection, with a decision expected by the end of the year. The goal is to begin manufacturing at the new facility by year-end 2016. A company spokesperson confirmed for MPO that they have not yet commented on the specific areas under consideration. "This new manufacturing facility reflects the demand for NuVasive's innovative spine technology,” said Gregory T. Lucier, NuVasive's Chairman and CEO. “Along with providing additional capacity to meet this rising demand, our new state-of-the-art facility will further our commitment to expand our internal capabilities to self-manufacture our spinal products and select instruments over time. In addition to providing expanded capacity to meet increased demand, the expansion of our manufacturing facility footprint will enable NuVasive to realize increased operating efficiencies and further our ability to achieve our goal of more than 20 percent operating margins as we drive beyond $1 billion in revenue. As we continue to move towards greater self-manufacturing, we also expect to strengthen our strategic relationships with key vendor partners to complement our internal efforts." The company will provide additional details regarding capital investment associated with the new facility once the site selection process is complete, officials noted. NuVasive is headquartered in San Diego, Calif.

Xellia Expands in North Carolina

Anti-infectives firm Xellia has moved its North American HQ to the lyophilisation plant in Raleigh, North Carolina that it bought from Fresenius Kabi last July.

Xellia has started relocating staff from its current base in Graylake, Illinois to a facility next to the Raleigh site that it acquired earlier this year. The drug and API maker said the move will enable it to better serve key local clients.

CEO Carl-Åke Carlsson said: “The US is a key market for Xellia and the expansion is part of our long term growth strategy and commitment to manufacturing in the US for our North American customers.”

"Consolidating our state-of-the-art production facility with our commercial headquarters will enable us to better serve our many customers – both with respect to proximity and working relationship. We are building a stronger, more connected US operation.”

The relocation is the second investment Xellia has made at the Raleigh site.

In September, the Denmark-headquartered firm announced its intention to spend $100m (€89m) to buy equipment and hire 40 additional staff shortly after securing tax breaks from the city of Raleigh.

On the other side of the Atlantic, Xellia – which is owned by Novo Nordisk’s backer Novo A/S – recently invested $2m to expand its R&D facility in Croatia.

Xellia’s decision to ramp up operations in Raleigh is in marked contrast with other pharmaceutical companies with facilities in North Carolina.

In recent months GlaxoSmithKline, Hospira and Salix announce cutbacks at their operations in the state. Since then layoffs have continued at Research Triangle Park.

Shortly after GSK announced the job cuts in a WARN it also said that some 450 employees would be taken on at a neighboring site by contract research organization (CRO) Parexel.

However, last month reports suggested as many as 200 of these employees would be laid off.

Banner Medical to Build Facility in Indiana

Banner Medical, a Carol Stream, Ill.-based supplier and processor of medical grade raw materials, announced plans to build a new facility in Warsaw, Ind.

The company will invest $6.3 million to construct a 43,000-square-foot material processing center at the Warsaw Technology Park. The company plans to use the plant to deliver medical grade materials and services for local and regional customers.

Construction on the site, which may accommodate future expansions up to 110,000 square feet, will start Sept. 1, with plans to begin Indiana operations by early 2016, and will create up to 76 new jobs for the region by 2019.

“Warsaw, Indiana is an integral part of our growth strategy, and we look forward to further serving existing and potential new customers in the region through this facility,” said Mark Redding, president and CEO of Banner Service Corporation. “Banner Medical will offer the best total solution through material accessibility, services offered and customer intimacy to the medical device industry that resides in Warsaw and the region.

The Indiana Economic Development Corporation offered Banner Medical Innovations Inc. up to $725,000 in conditional tax credits and up to $25,000 in training grants based on the company's job creation plans. These incentives are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives.

The city of Warsaw approved additional incentives at the request of the Kosciusko Economic Development Corporation.

“Banner Medical brings a reputation of innovation and advanced technology into our community,” said Warsaw Mayor Joe Thallemer. “Locating in the new Warsaw Technology Park gives Banner local access to over thirty of its existing customers creating a synergy that can only be found in our community of advanced orthopedic manufacturing. We are excited to welcome Banner to Warsaw."

AmbioPharm Expanding in South Carolina

AmbioPharm, Inc., a company that specializes in the manufacturing of peptides and the development of generic drugs, is expanding its existing Aiken County, South Carolina operations. The company is investing $18.8 million in an expansion that will create 100 new jobs over the next five years.

APi started their business in South Carolina in 2007 by establishing its company headquarters and downstream manufacturing operations in a 10,000-square-foot facility in the North Augusta Industrial Park. That same year, APi also opened its Shanghai, China operations, which focuses on synthesis, as well as the research and development of pharmaceutical products. In 2014, the company made major facility expansions by adding 10,000 square feet in North Augusta and 18,000 square feet in Shanghai. Between the two facilities, the company now employs more than 200 workers.

To expand its Aiken County operations, APi is planning to construct additional manufacturing suites and a new world headquarters building on the existing 32 acres that APi owns. In total, the new additions will add approximately 40,000 square feet to the company's existing facility.

The expansion in North Augusta is anticipated to be completed by the third quarter of 2018. APi currently has numerous openings and hiring for the new positions is expected to begin immediately.

"Our expansion is the product of our hard-working, talented team of employees, the trust of our customers in the quality of our product and delivery system and the support we have received from the City of North Augusta, Aiken County and the State of South Carolina The State truly knows how to work with rapidly growing enterprises," stated AmbioPharm Founder and CEO Dr. Chris Bai. "AmbioPharm's decision to build its headquarters in South Carolina is another example of how our workforce and business-friendly environment continue to attract companies to our state. This $18 million investment and the 100 new jobs it will create illustrates AmbioPharm's continued commitment to Aiken County and to South Carolina as a whole," added Governor Nikki Haley.

GIANTS 300 REPORT: Hospital and Medical Office Construction Facing a Slow but Steady Recovery

The $180 million, 368,735-sf Kay Jewelers Pavilion, at Akron (Ohio) Children’s Hospital. The seven-story addition came in two months ahead of schedule and $60 million under its original estimate. On the Building Team: CBRE Healthcare (on-site PM), HKS, Inc. (design architect), Hasenstab Architects (associate architect), The Boldt Company (ILPD CM), and Welty Building Co. (CM).

Construction of hospitals and medical offices is expected to shake off its lethargy in 2015 and recover modestly over the next several years, as healthcare systems vie for patients who want the latest and most convenient services and technologies.

Hospital construction revenue should grow by 3.8% this year, to $20.3 billion, according to market research firm IBISWorld. Renovation and expansion projects will account for about 73% of total healthcare-related construction.

TOP HEALTHCARE SECTOR ARCHITECTURE FIRMS

2014 Healthcare Revenue ($)

1. HDR $198,699,134

2. Stantec $144,447,155

3. Perkins+Will $104,690,000

4. HKS $103,811,878

5. CannonDesign $95,000,000

TOP HEALTHCARE SECTOR ENGINEERING FIRMS

2014 Healthcare Revenue ($)

1. AECOM $458,485,000

2. Jacobs $93,920,000

3. Burns & McDonnell $42,896,090

4. KPFF Consulting Engineers $37,500,000

5. Smith Seckman Reid $35,847,890

TOP HEALTHCARE SECTOR CONSTRUCTION FIRMS

2014 Healthcare Revenue ($)

1. Turner Construction $2,109,854,708

2. McCarthy Holdings $1,181,270,640

3. Skanska USA $1,070,841,424

4. Brasfield & Gorrie $995,112,893

5. JE Dunn Construction $751,273,218

Gloria Drummond Physical Rehabilitation Institute for Boca Raton Regional Hospital

In Florida, where healthcare construction is up 20% from 2010, DPR Construction recently started on the 33,000-sf Gloria Drummond Physical Rehabilitation Institute for Boca Raton Regional Hospital. Working with architect HKS, the contractor is renovating existing therapy spaces, upgrading exterior features, and adding an aquatic therapy center.

Akron, Ohio Children’s Hospital

In May, Akron (Ohio) Children’s Hospital opened its $180 million Kay Jewelers Pavilion, a seven-story, 368,735-sf addition that includes a 39-bed expanded emergency department, a neonatal ICU with 75 private rooms, and a new outpatient center and special delivery unit for high-risk newborns.

Patients’ families and staff helped design the pediatric hospital. “Project teams addressed such issues as minimizing walking for patient families, doctors, and nurses, ensuring efficient movement of supplies in and out of operating rooms, and providing a calm environment that promotes privacy,” says Jeff Stouffer, AIA, ACHA, EVP and Healthcare Group Director for HKS, the project’s designer.

Medical office building starts should also experience an uptick this year, following a period when MOB construction dropped to 3.7 million sf in the first half of 2014, from 7.7 million sf in the first half of 2009, according to Colliers International.

“Strong demand for modern, flexible space will spur development of new medical office buildings concentrated near dominant hospitals and health systems and targeted population groups,” Colliers predicts. The research firm says developers are likely to favor new MOB construction over retrofits of older properties.

The healthcare facilities sector continues to adjust construction and renovation plans to meet consumer demands for flexible services. Clay Seckman, PE, Senior Principal with engineering firm Smith Seckman Reid (SSR), sees a migration of healthcare services to lower-cost outpatient settings, “where patients receive quality diagnostic and treatment without the ‘institutional’ feel.”

Colliers notes that pharmacies and supermarkets are elbowing their way into the healthcare arena, offering such services as vaccinations and treatment for common, non-acute illnesses. Kaiser Permanente, California’s largest HMO, recently entered into a partnership with Target to open clinics inside several of the retailer’s stores in Southern California. Minute Clinics, the leader in the retail clinic market, with more than 900 locations, intends to open 600 more through 2017.

Hospital systems must now figure out how to keep pace with growing demand from two sources: first, the 32 million Americans who have healthcare coverage under the Affordable Care Act; and, second, the seniors’ cohort, which is expected to swell by two-thirds through 2035.

To meet demand, hospitals are adding beds. Seckman says that increasing inpatient bed capacity was a motivating factor behind SSR’s $500 million, two-million-sf campus replacement project at CHI St. Luke’s Health in Houston. An SSR renovation at Lee Memorial Health System in Fort Myers, Fla., reactivated decommissioned beds.

Despite its growth potential, the healthcare sector remains volatile. Twenty hospitals declared bankruptcy last year, in some cases to make their assets more attractive acquisition targets. Colliers thinks this pattern could continue for the next five to seven years, “As weaker systems are unable to compete with larger, more financially sound systems seeking to capture greater market share and influence.”

Some healthcare systems are also closing older hospitals in poorer areas so they can open new facilities in more affluent markets with more insured patients.

Hospitals and other medical facilities are often viewed as engineers of neighborhood economic and social vitality. In San Francisco, construction of the $2 billion, 700,000-sf California Pacific Medical Center is spurring developers and property owners to line up projects near the hospital that, if approved, would result in 2,000 new housing units, a million sf of office space, and hundreds of hotel rooms.

HKS’s Stouffer sees hospitals “becoming catalysts for change in communities, beginning with urban planning, mixed-use design, and improving the patient and family experience.” He believes care will also be moving to the patient’s home, thanks to advances in technology linking the patient to the physician, hospital, or clinic.

Current hospital design and construction trends noted by Michael Gritters, EVP, McCarthy Building Companies:

• Hybrid operating rooms with intra-operative MRIs

• Adjustable and easily upgradable surgical suites

• Decentralized nurses’ stations at bedside or immediately outside the patient’s room

• More homelike environments for patients

• Collaborative design and construction methods that emphasize safety, quality, shorter schedules, and lower costs

Oakland University Engineering Center, in Rochester, MI

Oakland University Engineering Center, in Rochester, Mich., was completed last August by Walbridge (CM at risk). The five-story, 149,879-sf facility, designed by SmithGroupJJR, pulls together functions that were scattered over four buildings. The center provides instructional and R&D space for the university’s School of Engineering and Computer Science.

The State University of New York at Buffalo

628,000-sf, $375 million medical center, which was scheduled to open in August 2017, is the single largest medical education building under construction in the U.S.

University officials are hardly being coy about their intent to use this facility (which was designed by HOK) as bait to attract more than 100 physician-scientists and medical specialists, to say nothing of the 100 students who are expected to enroll.

Ohio State University invested in New Healthcare and Research Facilities

Ohio State University has invested more than $1 billion in new healthcare and research facilities that are being used to attract physicians and researchers to its campus in Columbus. The university is also spending $400 million on residence halls to support its new requirement that all students live on campus through sophomore year, says Kyle Rooney, Vice President/General Manager for Turner Construction in Central and Southern Ohio market.

At a time when competition for the cream of the student/faculty crop is intensifying, colleges and universities must recognize that students and parents are coming to expect an education environment that foments collaboration, says Tom McDuffie, AIA, RIBA, Group Vice President–Global Buildings at Jacobs. That’s resulting in larger research “neighborhoods” to accommodate “hoteling” benches and desks for undergrads, he says.

Institutions of higher learning are placing greater emphasis in their construction and renovation plans on unstructured spaces that encourage transformational learning: collaboration, creative thinking, and technology use, according to executives with construction firm Barton Malow: Vice Presidents Todd Ketola and David Price, and Senior Vice President Robert D. Grottenthaler, PE, LEED AP.

Bradley Lukanic, AIA, LEED AP, Executive Director–Education at CannonDesign, says, “The changing student profile and evolving demographics of traditional college and university students are driving institutions to adapt by creating spaces that foster learning paradigms and collaboration for tomorrow’s leaders.” Lukanic sees an “acute focus on learning pedagogies” intertwined with “a framework of social stewardship and enhancing the student experience” in the higher education sector.

New Rees-Jones Hall at Texas Christian University

The 62,000-sf Rees-Jones Hall at Texas Christian University, designed by Lukanic’s firm, is an incubator facility that fosters such a learning experience. A so-called “Idea Factory” on its second floor provides students with resources—mentors, 3D printers, mobile app developers, and so on—that can help them foster entrepreneurial ventures and develop product prototypes.

Texas lawmakers hadn’t approved tuition revenue bonds, known as TRBs, for university construction for nearly 10 years; that is, until last May, when the state legislature approved bills that appropriate $70 million (of a requested $190 million) for constructing a science and education innovation and research building at the University of Texas–Arlington.

Even so, three billion dollars in TRB funding remains on the table. That’s equivalent to about half of the $5.4 billion reflected in the University of Texas System’s six-year capital improvement plan, which encompasses 91 projects.

Jacobs’s McDuffie notes that the federal government, the single largest source of research funding for universities, has been cutting back. That reduction, along with rising construction costs, is forcing universities to become more efficient, build more economically, and partner more effectively with industry. “Technology platforms and increasing demands for scientific research—and the capacity to house specialty equipment—are driving evaluations of space,” he says.

McDuffie expects the higher education market to continue to grow, albeit in line with current trends demanding “smart strategies” around finances, the environment, and state-of-the-art facilities that create successful research and teaching environments.

Globally, universities are also looking to build and renovate. In England, AECOM has been appointed master planner for the University of Cambridge’s extension to the northwest, the largest expansion in the university’s 806-year history.

Mairi Johnson, AECOM’s Global Education Sector Leader, says this 15 million-sf project will feature a mixed-use sustainable development of research and teaching facilities, affordable housing for students and staff, market housing, community facilities, and public open space.

Resilience is becoming an increasingly recognized factor in the construction of new campus buildings. SUNY Buffalo’s new medical center project started with a 30x36-foot mockup that was subjected to simulations of powerful rain and windstorms. Michael Drozdowski, Project Manager for construction manager Gilbane/LiRo, says that fewer than 10% of newly constructed buildings in the U.S. undergo that level of testing.

Capsugel’s New R&D is Biggest Integrated Facility in North America

Capsugel, a manufacturer of drug dosage forms and solutions based in New Jersey, has completed the construction of a new pharmaceutical spray-dried dispersion (SDD) commercial manufacturing facility at its existing research and development (R&D) facility in Bend City, Oregon, US, in June 2015.

It is designed to accommodate future capacity additions and is scheduled for commissioning in late 2015.

Following the acquisition of Bend Research, a division of Capsugel Dosage Form Solutions (DFS) in 2013, Capsugel initiated an investment to add two more commercial-scale spray driers to its Bend site.

The latest SDD addition marks the completion of Capsugel's $25m investment plan aimed at expanding commercial SDD manufacturing capabilities at its Bend site.

It enables Capsugel to provide integrated services across feasibility, development, late-stage clinical and commercial manufacturing of spray-dried drug product intermediates to its customers.

The expansion created more than 20 new jobs in 2014 and is expected to create an additional 20 full-time positions in the second half of 2015. It has also made Capsugel the biggest integrated pharmaceutical SDD technology owner in North America.

The Bend site now houses three commercial-scale spray dryers, one for commercial-scale development and two for cGMP commercial production.

The plant features an innovative dryer design and manufacturing technology and is designed to accommodate high-potency compounds. The new dryers are more flexible and have the capability to generate optimally-engineered particles under the given formulation and therapeutic application.

A commercial wing at the plant allows for the production of registration lots, commercial launch and continued supply of new products from the Bend Research facilities.

Commercial production will be supported by a designed-for-purpose, risk-based quality system in accordance with the principles of ICH Q10 Pharmaceutical Quality System regulations.

Capsugel installed its first commercial-scale spray dryer at the Bend R&D facility in June 2014. The new pharmaceutical spray dryer (PSD) complemented the existing small and mid-sized spray dryers operating at the plant.

The dryer can also be used for the production of toxicology study supplies and for quality-by-design studies (QbD), whose scale-up aspects can be integrated into spray-dried product development.

It shortens the time taken for development activities in addition to help cut costs and allows for more flexible use of active pharmaceutical ingredients (APIs).

Spray drying is a widely-preferred method in the production of thermally-sensitive materials such as pharmaceuticals.

SDD is a single-phase, molecular dispersion of a drug in a polymer matrix that is achieved by dissolving the drug and the polymer in an organic solvent and then spray-drying the solution.

The formulation and process conditions cause the solvent to quickly evaporate from the droplets, preventing separation or crystallization.

SDD technology helps to increase the bioavailability of poorly water-soluble compounds, and allows for a scalable and controllable manufacturing

Amway Nutrilite Vitamins Manufacturing Facility

Amway, a direct-selling company based in the US, started the construction of a new Nutrilite^® production facility in May 2013. The new facility is located at Spaulding Avenue, close to Ada in Michigan.

The first phase of the facility was opened in June 2015. The new facility is engaged in the production of Nutrilite^® brand of vitamins and dietary supplements.

The new facility will create approximately 200 jobs by 2016. It is designed to produce more than three billion tablets and 1.3 billion softgel capsules a year.

"The facility is designed to produce more than three billion tablets and 1.3 billion softgel capsules a year."

The new facility is constructed adjacent to Amway's headquarters in Ada. It has a total floor space of 317,000ft². It includes a production facility and a warehouse facility.

It also features a 22,000ft² quality assurance laboratory for onsite testing of the products.

The plant includes three lines each for the production of gel capsules and tablets. The gel and tablet production lines have enough space provision for expansion in future.

Amway produces Nurtilite Vitamin C Plus Extended Release and Nurtilite Cal Mag D tablets, at the new vitamins and dietary supplements facility. It also produces Nurtilite Natural Carotene, Nurtilite Natural B Complex and Nurtilite Salmon Omega-3 at the facility.

Nurtilite is one of the best-selling brands of vitamins and dietary supplements internationally. It provides a complete range of supplements for a variety of health needs and general nutrition.

The new manufacturing facility has state-of-the-art equipment to produce high-quality Nutrilite® products. It uses organic plant concentrates harvested at Amway's farms.

The plant is equipped with technology to dehydrate, mill and extract the nutrients. It also has equipment for testing and measurement of concentrate powder.

It features more than 100 major pieces of equipment, including bending, coating, compression, inspection and sealing machines.

The facility is equipped with a fully integrated packaging line.

Pre-construction works began at the site in December 2012. Construction was started in May 2013.

Latest in design technologies, such as building information modelling (BIM) and 3D modelling, are used for the construction of the facility. The construction also includes measures to comply with Good Manufacturing Practices (GMP).

The design for the new manufacturing facility was provided by FTC&H. The general construction contract for the construction was awarded to Erhardt Construction.

The nutritional supplements production facility was constructed as part of $332m global manufacturing expansion by Amway across the world. The total investment on the construction of the facility was $81m.

The new plant was funded with $1.6m in financing by the Michigan Economic Development Corporation through its Michigan Strategic Fund. It was also offered tax abatement for 12 years by the Ada Township.

Amway is headquartered at Ada, Michigan, US. The company has more than three million distributors spread across 100 countries across the world.

It offers consumer products supported by global agribusiness, manufacturing and logistics supply chain. It employs more than 900 scientists, technical professionals and engineers in 75 R&D laboratory locations spanning internationally.

The top-selling brands of the company include Nutrilite^®, Artistry and eSpring. The sale of nutritional products alone by Amway accounted for 43% of its total sales in 2014.

LabCorp’s Covance Expands Clinical Research Unit in Texas

LabCorp’s Covance Drug Development has relocated its clinical research unit (CRU) in Dallas, TX, to a new facility with 28 more medical beds.

The upgraded facility features more than 55,000 square feet of space, a cGMP pharmacy, dedicated ophthalmology procedure rooms, an advanced telemetry system, and a glucose clamp suite, as well as dedicated screening and outpatient visit areas.

The pharmacy includes three sterile and two non-sterile manufacturing suites, while the telemetry system enables the team to perform continuous data monitoring, supporting improved monitoring of study participants and quick adjustments to treatment regimens, when necessary.

The new unit, which opened earlier this month, also includes a LabCorp patient service center where patients can learn more about volunteering and participating in early stage clinical trials.

Herman Scholtz, VP & General Manager of Early Clinical Services, said: “We have invested in a highly customized facility designed to facilitate the safety and quality of our studies and to enhance our clients’ and volunteers’ experience.”

The Dallas CRU currently employs about 75 medical and professional staff and Covance has plans to expand to 120 employees. Covance has another facility in Alice, Texas where 13 primates died due to overheating last year.

The LabCorp acquisition of Covance was finalized earlier this year.

Kite Pharma (KITE) Breaks Ground on New Facility

Kite Pharma, Inc. (KITE) broke ground on a 43,500 square-foot facility in El Segundo, Calif. that will be used to support the launch of the company’s lead cancer-treatment drug candidate KTE-C19, which could be available in 2017.

“We are committed to the rapid advancement of KTE-C19, which has the potential to address the significant, unmet needs of patients with aggressive, refractory B cell lymphomas and leukemia,” Arie Belldegrun, Kite’s chief executive officer, said in a statement.

Belldegrun said the company is initiating pivotal studies for KTE-C19 in multiple indications and believes the new facility will help with not only the completion of the studies, but also commercial launch.

“We also expect the facilities to support clinical trials and potential commercialization of our other eACT based product candidates, including both chimeric antigen receptor (CAR) and T cell receptor (TCR) based product candidates,” Belldegrun added.

Kite Pharma, Inc., is a clinical-stage biopharmaceutical company engaged in the development of cancer immunotherapy products, specializing in CAR-T therapies. CAR-T therapy involves removing particular white cells from the body called T cells. Fragments of an antibody that recognizes and targets specific cancer cells are then attached to the T cells and reinfused back into the patient. This programs the patient’s immune system to attack tumor cells. So far the technique has shown effectiveness and reasonable safety against blood cancers like leukemia and lymphomas. The results against solid tumors such as ovarian and pancreatic cancer have been less successful.

The new El Segundo site will not be ready for use until 2017, but will nearly triple the company’s manufacturing space. Currently Kite Pharmaceuticals operates a 18,000 square-foot facility in Santa Monica, which is used for manufacturing, research and development and corporate office space. Kite selected the El Segundo site due to its proximity to the Los Angeles airport, which will aid in product distribution.

Additionally, Kite has the option to add another 17,000 square feet to the El Segundo site before July 2017, the company said. The site will create about 200 new jobs when it’s ready for use.

Kite has partnerships with the National Institute for Clinical Excellence (NICE) and Amgen (AMGN) to develop therapies that engineer white blood cells to fight cancer. Under the agreement, which netted Kite a $60 million upfront payment earlier this year, Kite will leverage its CAR platform, research and development and manufacturing capabilities to develop and commercialize a next generation of novel CAR T cell immunotherapies.

Last year Kite acquired Netherlands-based TCF, which was renamed Kite Pharma EU, to establish a European presence for Kite operations. The transaction allows Kite to expand its product pipeline of TCRs for the treatment of solid tumors, complementing its CAR pipeline.

Although Kite fell short of expectations when the company released its 2014 annual financial report in March, analysts are still predicting a good year for 2015. Analysts at Canaccord Genuity set a $90 price target on Kite shares in April, while analysts at Credit Suisse set a target of $79. Both groups rated the stock a “buy.”

Lupin opens R&D Facility

Drug major Lupin said it has opened a research and development center for inhalation products in Florida, the US.

The facility at Coral Springs, Florida, will focus on the research and development of inhalation products for the treatment of asthma, allergic rhinitis, chronic obstructive pulmonary diseases and other lung diseases.

"With the talent and resources this state provides, our Coral Springs expansion will further strengthen our ability to bring quality, affordable pharmaceuticals to patients in the United States and other key markets globally," Lupin CEO Vinita Gupta said in a statement.

West Pharmaceutical Services Expands Scottsdale Facility

West Pharmaceutical Services Inc. has expanded capabilities at its facility in Scottsdale, Ariz., to meet increased customer demand for the SmartDose electronic wearable injector.

According to the company, the expansion in Scottsdale will enable continuing development and production of SmartDose to accommodate rising interest in the product to further demonstrate the ability to support customer launch plans and to provide supply chain security.

“Expanding our manufacturing capabilities in Scottsdale—and continuing scaling up production in Israel—will enable rapid, dual sourcing to our customers and help them bring innovative new treatments to market,” said Eric Resnick, president, Pharmaceutical Delivery Systems, Proprietary Products, at West.

With the treatment of many chronic illnesses shifting out of clinical settings to home care and self-administration, there is growing need for drug products that can be easily injected by patients. Designed to deliver high volumes of injectable drugs over an extended period of time, SmartDose makes it easier for patients to self-administer medication and encourages compliance with prescribed treatments. Patients have already self-administered thousands of doses using SmartDose in clinical settings. West has delivered more than 100,000 units of SmartDose and more than 800,000 validated Daikyo Crystal Zenith drug containers to pharmaceutical manufacturers for customer-funded development projects and clinical trials, including eight active programs at various stages of pre-commercial development.

“Medication adherence is an ongoing challenge in the pharmaceutical industry, and non-adherence is a leading cause of poor clinical outcomes and increased healthcare costs,” Resnick said. “We designed SmartDose to be an easy-to-use, intuitive and reliable drug delivery system that can help boost adherence for injectable medications—and the customer response has been tremendous.”

The expanded capabilities at the Scottsdale site include cleanroom manufacturing and additional laboratory space. New jobs are being created in R&D, engineering, quality and operations functions to ramp-up production, new development and sustainment engineering, officials reported.

The silicone-free Daikyo Crystal Zenith drug container that is used within SmartDose is commercially available in the ready-to-use format, and the combined offering provides system reliability and accountability from one partner.

SmartDose is a single-use, electronic wearable injector that adheres to the patient’s body, usually on the abdomen, and is pre-programmed to deliver high volumes of viscous or sensitive drug products. SmartDose includes a Daikyo Crystal Zenith drug container with elastomer components using FluroTec barrier film. The needle is automatically shielded before and after use to help prevent the risk of accidental needlestick injury. West developed SmartDose with extensive human factors analysis to understand and design for the patient’s emotional and physical state at various stages of the journey of disease management.

West Pharmaceutical Services is a manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. West is headquartered in Exton, Pa.

Goodwin Biotechnology Completes cGMP Facility

Goodwin Biotechnology, Inc., a biological contract development and manufacturing organization (CDMO) that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing mammalian cell culture expression systems and bioconjugation technologies, has partnered with Q Therapeutics, Inc., a clinical-stage developer of novel cellular therapies for central nervous system (CNS) diseases to provide GMP antibodies for manufacture of clinical trial materials. To do so, Goodwin Biotechnology completed process development, scale up, and cGMP manufacturing of an IgM antibody and an IgM: ligand conjugate used in the isolation of Q-Cells, the first patented cellular therapeutic product candidate from Q Therapeutics under development for the treatment of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease.

"Q-Cells are glial-restricted progenitor cells (GRPs) – early descendants of neural stem cells that produce only 'glia' – which make up 50% of cells in the brain, and are essential for supporting, maintaining and even restoring neuron health. Based on the recently cleared investigational new drug application (IND) from the U.S. Food and Drug Administration (FDA), we're now on the cusp of performing groundbreaking human studies for the treatment of patients with ALS," said Deborah Eppstein, president and chief executive officer, Q Therapeutics.

"This is an excellent example that utilized the breadth of our capabilities at Goodwin Biotechnology," said Muctarr Sesay, chief scientific officer, Goodwin Biotechnology. "The technical team at Goodwin prides themselves in all facets of this project and being able to minimize the potential aggregation, stability, formulation, bioconjugation, and purification issues associated with a hybridoma IgM monoclonal antibody reflects our solutions oriented approach that we apply to all projects. We are proud to have partnered with and provided consultation to Q Therapeutics over the last 6 years where we manufactured the IgM and conjugated the antibody with a ligand and leveraged the regulatory skill sets of our team to prepare the antibody portion of the CMC section for their IND submission."

Q Therapeutics selected ALS as the first clinical indication for Q-Cells based on a combination of the large unmet medical need and the significant scientific rationale supporting the multiple pathways by which healthy glial cells are believed to protect and preserve the function of motor neurons.

Paratek Pharmaceuticals Opens New HQ

Paratek Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, opened its new corporate headquarters in Boston at 75 Park Plaza. "This move comes at an important time for Paratek, as we have recently initiated a global Phase 3 program for our lead antibiotic compound, omadacycline. With two important products in Phase 3 clinical studies, we are now preparing for the next phase of our growth as a biopharmaceutical company," said Michael Bigham, chairman and chief executive officer, Paratek. "The company takes pride in its origins as a Boston-based biopharmaceutical company, and we look forward to our continued growth here in Boston." The address of the new headquarters is 75 Park Plaza, 4th floor, Boston, MA 02116. Paratek was previously located at 75 Kneeland Street in Boston. In June Paratek opened a second office location in the Philadelphia area.

Seventh Wave Laboratories Expands

Seventh Wave Laboratories, a consulting-based contract research organization (CRO), recently purchased a 50,000 sq. ft. building in Maryland Heights, MO, which is more than three times the size of their current location. The company, which was established in 2003 by former Pharmacia/Pfizer nonclinical scientists, says it needed the space to enable strategic growth and the gradual transition of all offices to the new space will occur in September.

“We are excited about this growth,” said John Sagartz, president, chief executive officer and founder of Seventh Wave. “This expanded facility will enable us to better serve existing clients, attract new clients, grow existing services, and launch new ones.”

Sixty percent of the new space will be used for offices and laboratories. Plans for the remaining 40% include a vivarium, a wet lab and additional offices for future expansion. In fact, Seventh Wave has partnered with the Missouri Department of Economic Development and the St. Louis Economic Development Partners to develop a multi-year, $11 million program that includes the hiring of 42 technical and scientific professionals over the next five years.

In the midst of this company growth, Contract Pharma had the chance to ask Mr. Sagartz a few questions about the trends impacting his business and the market in general.

Contract Pharma: What are some of the latest drug development trends and how are they impacting CROs?

John Sagartz: I’ll start by characterizing our client experience. Our interactions are mostly with small- to medium-sized pharmaceutical companies. We work with over 100 of these sponsor companies every year. Some clients have literally just 2 employees, but a few are top 10 pharmaceutical companies. We hear a consistent message from all of them—that they are getting more funding and have aggressive goals to put more drug candidates into their pipeline.

The majority of our clients are smaller or virtual companies that don’t have fully staffed drug development teams or broad laboratory capabilities. They rely on us to actively participate on their drug development teams, and they also rely on us to provide laboratory services to characterize their drug candidates in order to improve the odds that they will make it into human clinical trials. We see a trend towards clients placing value on the more consultative approach that companies like ours can provide.

The impact to CROs is growth. In our case it has allowed us to purchase a building and renovate it to accommodate our expansion. Managing the growth is where a lot of CROs have stumbled in the past, and we know some still struggle now. The challenge we’ve laid out for ourselves is to be very responsible and aware of these challenges as we grow. We can’t jeopardize our clients’ needs by letting quality or timing slip. Staging our growth to meet our clients’ growing pipelines, while at the same time maintaining our quality standard, that’s our most important challenge.

A product of this strengthening market is that CROs become more attractive targets for mergers and acquisition. As these events happen they can be disruptive to the organizations involved; managing through these consolidations without losing key talent, processes, or quality will be difficult for some CROs. Sponsor companies will have to be more diligent in monitoring their chosen contract labs through these changes.

CP: What service areas are you seeing an increased demand for and from what sectors? Where do you think the biggest opportunities lie?

JS: Our emphasis is at the later stages of drug discovery and the earlier stages of drug development. As I mentioned, we see a real strengthening of pipelines at this stage. Our core clients are those smaller and virtual companies, where we can really impact the value of their assets with the advice we provide and the services we render. We see increased demand for drug candidate de-risking. As these drug candidates progress and the data needs become more diverse, these sponsors will need to use multiple CROs to get the quality and timing they need. As a result, we are experiencing an increased demand for study monitoring to make sure things go smoothly across all service providers.

Regarding opportunities, many of our clients ask us to support them in their licensing and milestone meetings with their big pharma suitors. Successful outcomes in these partnerships represent the largest opportunities for our industry.

These deals provide significant reward to the small companies that are discovering these new therapies. As a result they reinvest in discovery of more drug candidates. Success here also means that the big pharma partners eventually have more robust clinical pipelines, which ultimately result in better medicines to benefit all of us. It’s like a flywheel—each success helps spin it a little faster, a little more efficiently, as momentum builds and pipelines grow.

CP: With the first biosimilar approval in the U.S., and additional approvals set to rise, what sort of activity are you seeing and what do you anticipate for CROs in this area in the future?

JS: We do see increases in biotherapeutic drug discovery, consistent with industry reports. For our business model though, biosimilars have limited needs at the drug discovery stage because the target is already validated, safety and efficacy are established, etc. Therefore, we don’t anticipate significant impact to most of our service offerings. One exception to this would be in our pharmacokinetics area. We do expect that biosimilar development will result more bioequivelance studies, which should result in more opportunities for our pharmacokinetic services.

CP: What efforts are being made to streamline drug development within sponsor/CRO partnership models? What progress is being made and what are the continued challenges?

JS: Regarding progress, we’re finding that some CROs are doing a better job of working collaboratively within a network of drug development partners, so that our sponsors can have the best possible experience for their every need. No one CRO can be best-in-class at every aspect of drug development. In order to meet every client’s needs for science, regulatory considerations, quality and timing, we have to identify the right blend of service providers that align with the sponsor’s needs. Many of these CROs readily support our sponsors in a networked and collaborative model.

Regarding continued challenges, larger CROs are, and to some extent should be, very limited in their flexibility. In order to adhere to their quality and timing standards, and also produce very large volumes of work, they have to be comparatively rigid in their approach. To small and nimble clients, this rigidity can be cumbersome to navigate. When CROs are rigid in their offering and also less than collaborative with other service providers, it gets in the way of progress as an industry.

CP: Does oversight continue to present a challenge or do you find CROs are able to operate more independently? If so, in what areas?

JS: It’s hard to provide one answer to this question. I think the best way I can characterize what I see would be as follows: Contract lab sites that are well established and stable can operate very independently for the work performed at that site. When contract labs have multiple sites and a client’s program spans those sites, that’s where more oversight is necessary. Frequently the contract labs will have different systems, processes, culture, and organizational structures at their various sites, which can make it difficult to deliver consistently.

CP: To what extent are e-clinical solutions impacting clinical trials, services and partnerships?

JS: e-clinical solutions are having impact downstream from our expertise and I’m not in a good position to comment on that. However, there’s an electronic initiative underway that does have direct impact on preclinical development called SEND, or the Standard for Exchange of Nonclinical Data. In December of 2014 the FDA issued guidance enforcing the usage of SEND as part of IND and BLA submissions. Studies starting after December 15, 2016 will need to comply. The near term impact is that all service providers and sponsors that generate nonclinical data have to align with the data standards that have been set forth. In most cases this requires investments in systems and processes. At Seventh Wave, we are taking steps now to be compliant well before the mandated deadline.

The long-term impact remains to be seen, but there’s a reasonable expectation that this initiative will enable common data exchange model across the industry. It should enable better tools, improved information sharing across organizations, and streamlined nonclinical decision making.

CP: In what geographic markets do you see the most growth and investment?

JS: Since many of our clients depend on venture capital for seed and early series funding, they tend to be concentrated where venture funding is most readily available: San Diego, San Francisco, and Boston are where we have seen the most dramatic growth. However, the reductions in force at large pharmaceutical companies over the past 10 years has given many talented people the opportunity to scratch the entrepreneurial itch. As a result, we see clients popping up around the Midwest, and in cities that you don’t normally think of as pharma R&D centers. Of course, it’s also given rise to many startup CROs and consultants, some of which have become an important part of our network.

CP: With respect to establishing global standards (i.e. site accreditation and standards for sustainability and best practices), what progress is being made? Where are greater efficiencies needed?

JS: Regarding global standards for site accreditation, OECD member countries have a reasonable level of harmony, and China is catching up. The emerging pharma initiatives in places like Brazil, Russia, and elsewhere still have some work to do. For example, we are seeing an increase in requests from those developing regions to help support their locally discovered drug candidates in order to pursue development in the U.S. because the path for developing and approving in their country is not yet well defined.

Five Biotech Startups

Metabiota - The Ebola outbreak in West Africa raised many questions regarding proper procedures for pinpointing the start of outbreaks and how to efficiently contain them. The pathogen quickly spread among the population in Liberia, Guinea, and Sierra Leone. According to the World Health Organization's estimates, more than 10,000 people have succumbed to the virus.

Metabiota, a seven-year-old San Francisco-based business, works with clients to help them prepare for the potential of another outbreak of this scale.

Non-governmental organizations like the World Health Organization (WHO) usually rely on collecting data on outbreaks when they are out in field, and then attempt to work with governments on an action plan.

TechCrunch notes Metabiota, “is one of the first companies to use a combination of data and analytics to help governments and insurers stem these epidemics.”

Investors gave Metabiota $30 million in additional funding in May. The new financing will help the company essentially increase its client base and develop new insurance products to hedge against a global pandemic, writes The Wall Street Journal.

Syapse - Healthcare providers are working with Syapse to help physicians create more precise diagnoses and treatment plans for different medical conditions.

The company operates out of Palo Alto, California. Its client base is comprised of a diverse array of medical institutions, like Sanford Health, Stanford University School of Medicine, and the Swedish Cancer Institute.

They use Syapse’s Precision Medicine Data Platform to collect data from three primary sources to help with analysis: molecular testing labs, billing systems, and electronic health records. These three resources help doctors with diagnoses, treatment, and outcome tracking for their patients, according to VentureBeat.

One feature built into Syapse is the ability to discern how a patient will react to a certain drug based on his or her genetic signature.

Buzzfeed News reports, though, the software can only search for the gene-drug relationships it has been programmed to find.

Still, Buzzfeed News explains the tool was able to save the life of Hollis Klendenberg, a 73-year old recipient of a heart stent procedure from a few years prior. Hollis’s doctor was about to prescribe him the blood-cutting drug Plavix when Syapse sent the doctor a software alert telling him to stop. Klindenberg had a genetic mutation that would make his body more vulnerable to clotting from Plavix so his doctor needed to prescribe him a new blood thinner.

Impossible Foods - Impossible Foods, located in Redwood City, California, is part of a growing group of biotech startups seeking ways to revolutionize food and agriculture.

The team is working on ways to make new forms of cheese and meat products. Lab technicians working for the firm use proteins and nutrients from natural sources like greens, seeds, and grains to produce new types of hamburgers.

New York Magazine recently profiled the firm earlier this summer.

AOBiome - Are you looking for a new way to keep your skin healthy? AOBiome has a slew of products that can help with that by feeding the microbes that live on skin.

BetaBoston reports the founder of AOBiome David Whitlock traveled the scientific conference circuit around 2000 to “explain his theories on how bacteria had kept our pre-soap ancestors clean.”

Whitlock told BetaBoston these microbes operated as “personal groomers” because they would devour sweat and oils. Whitlock felt we are destroying these good bacterium when we apply soap and shampoos.

The company, founded in 2013 in Cambridge, Massachusetts, sells cosmetic products like AO+ Mist, which contains Ammonia Oxidizing Bacteria (AOB). The formula works by “consuming irritating components in sweat and converting them into beneficial ingredients for the skin.”

AOBiome began selling a new shower gel and shampoo built on the same formula found in AO+ Mist on July 7.

Theranos - Two weeks ago, 12-year-old biotech firm Theranos was granted FDA approval for its blood-based herpes test.

Theranos’s goal is to offer faster and cheaper lab diagnostic tests for public use regardless of insurance status. The herpes test, which will cost $10, can quickly find traces of the virus in a single fingerprick of blood.

The organization signed a deal with Pennsylvania’s largest health insurer Capital BlueCross to become the company’s preferred lab-work provider. This deal helped Theranos gain a new foothold on the east coast after it spent the past few years selling its services at Walgreens locations in Arizona and California.

DelMar Pharmaceuticals Expands Clinical Sites

DelMar Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing proven cancer therapies in new orphan drug indications, announced that the Sarah Cannon Cancer Research Center at HealthOne, Denver, CO has been added as a clinical trial site for the ongoing, multicenter Phase I/II study of VAL-083 in patients with refractory glioblastoma multiforme (GBM), the most common and deadly form of human brain cancer.

"This fifth clinical site greatly adds to our recruitment bandwidth as part of our strategy to increase patient access as we continue with the expansion phase of our Phase I/II GBM clinical trial. Our goal is to complete the expansion phase and advance VAL-083 into registration-directed Phase II/III clinical trials for refractory glioblastoma in the timeliest manner possible," said Jeffrey Bacha, president & CEO of DelMar Pharmaceuticals.

Sarah Cannon Research Institute (SCRI) is the research arm of HCA's global cancer enterprise, Sarah Cannon. SCRI's Denver site is directed by Gerald Falchook, M.D., M.S. Dr. Falchook completed his oncology training at MD Anderson Cancer Center, where he also served as a faculty member for six years developing investigator-initiated clinical trials as well as collaborating with pharma/biotech industry partners to bring promising new drugs to cancer patients.

"Expanding our collaboration with SCRI provides access to leading oncologists to support the development of VAL-083 as a novel cancer chemotherapy and will enable more rapid patient enrollment to our GBM clinical trial by accessing SCRI's large network of patients," added Mr. Bacha.

DelMar's multicenter Phase I/II study with VAL-083 is ongoing in patients with recurrent GBM. The clinical trial is an open-label, single arm, safety and tolerability dose-escalation study utilizing a standard dose escalation design, until the maximum tolerated dose (MTD) or the maximum specified dose has been reached. Eligible GBM inclusion criteria requires previous treatment with surgery and/or radiation, if appropriate. Eligible GBM patients must have failed both Avastin^® (bevacizumab) and Temodar^® (temozolomide) unless either of these therapies was contraindicated. (ClinicalTrials.gov Identifier NCT01478178).

Recently DelMar presented interim data from this ongoing study in GBM at the American Association of Clinical Oncology (ASCO) Annual meeting. The Company confirmed the completion of the Phase I dose-escalation portion of the trial and presented data supporting a dose response trend: Patients receiving a dose ≥30mg/m2 had a median survival of 9.0 months vs. 4.4 months at doses <10mg/m². DelMar also confirmed the initiation of a 14-patient Phase II expansion cohort at a dose of 40mg/m2. The purpose of the Phase II expansion cohort is to gain additional information about the safety and efficacy of VAL-083 at the 40mg/m2 dose prior to advancement into registration-directed Phase II/III clinical trials.

DelMar is also enrolling patients in the trial at four other oncology centers of excellence: The Mayo Clinic Cancer Center in Rochester, MN, The Brain Tumor Center at University of California, San Francisco (UCSF),.; The Sarah Cannon Cancer Research Center in Nashville, TN.; The Sarah Cannon Research Institute affiliate site at the Florida Cancer Specialist Research Institute in Sarasota, FL.

REST OF WORLD

Novo Nordisk to Develop New Production Facilities in US and Denmark

Healthcare firm Novo Nordisk has unveiled plans to invest around $2bn to develop new production facilities in the US and Denmark, in a bid to meet the increasing demand for its diabetes medicines across the globe.

The company will invest the amount over the next five years to build the new facilities in Clayton of the US and Måløv of Denmark.

Clayton facilities will be involved in the production of active pharmaceutical ingredients (API) for both oral semaglutide and a range of the firm's current and future GLP-1 and insulin products.

The investment in Clayton is expected to create around 700 new production and engineering jobs, the firm already employs about 700 people.

Novo Nordisk executive vice-president and product supply head Henrik Wulff said: "We decided to place the new API facilities in the US for strategic reasons.

"The US is by far our largest market and there are many logistical and economic advantages of having a larger part of our manufacturing in our main market."

Novo Nordisk will develop new production facility in Måløv, which will involve in tableting and packaging of oral semaglutide and future oral products. The investment is expected to create around 100 new jobs.

In 2016, the firm's board of directors will present the final design and cost of the new production facilities, which are expected to start operations by 2020.

The firm's current facility in Clayton of North Carolina is involved in the formulation, filling and packaging of diabetes care products. It also assembles and packages the FlexPen and FlexTouch prefilled insulin device for the US market.

The Kalundborg production site in Denmark includes several production plants, producing both diabetes and hemophilia products.

UK's Cell Therapy Catapult Planning Immunotherapy Plant

The site is in Stevenage, about 40 miles north of London

The UK’s Cell Therapy Catapult has received planning permission to build a £55m ($87m) large-scale manufacturing plant.

The 7,200m² (77,472 sq. ft.) site to be built in Stevenage - about 40 miles north of London - will be run by the UK Government-backed group the Cell Therapy Catapult (CTC), offering late-phase and commercial cell therapy manufacturing capabilities to UK-based SME biotech and life sciences companies.

While the center was first announced in December 2014, today marks a milestone with the CTC being awarded planning permission to construct the £55 million large-scale GMP manufacturing center by Stevenage Borough Council.

CEO Keith Thompson welcomed the council’s decision, saying the site “will advance the industry into becoming a world leader in advanced therapy development and commercialization.”

He added: “The large-scale GMP manufacturing center will provide global scientific and medical communities with the assistance they need to turn research into products that have the potential to address many unmet medical needs.”

Planned to open in 2017, the plant will be equipped with technology provided by GE Healthcare which pledged support for the project. Up to 150 jobs will be created at the site.

The CTC was established in 2012 to help grow the UK’s cell and gene therapy industry, and through centers such as this intends to bridge the gap between scientific research and full-scale commercialization.

According to a recent CTC report, there has been a drop from 45% to 26% in available capacity which can be contracted out for cell therapy production since 2014, as a result of increased cell therapy development projects in the UK.

BeiGene Plans First cGMP Manufacturing Facility in Suzhou, China

BeiGene, a clinical-stage biopharmaceutical company based in Beijing and focused on developing molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced on Aug. 20, 2015 that it is establishing its first cGMP biopharmaceutical manufacturing facility for commercial use. The facility will be built at BioBAY in the Suzhou Industrial Park (SIP) in Suzhou, China.

The new, 9000-m2 (96,875-ft2) facility expands the company's production facilities and will supply materials for future clinical trials and subsequent commercial demand. The facility is expected to be completed by 2017.

"This new manufacturing facility is a key component to our strategic growth to become an integrated biopharma company and to accelerate and expand our development programs, which allows us to continue to focus on developing global best-in-class drugs for various cancer treatments and attract additional highly talented professionals to our organization," said John V. Oyler, BeiGene CEO. "With a manufacturing site in BioBAY, we are well positioned to fully leverage the domestic regulatory pathway for our drugs in China and to build a global business."

“This will be a truly cutting-edge, state-of-the-art facility utilizing the leading technologies in biomanufacturing that will also meet the utmost regulatory standards,” said Wendy Yan, head of Regulatory Affairs, in the release. “Upon completion, we will seek the necessary approvals to ensure our new site is fully compliant with regulatory procedures in all key global markets, including the United States, Europe, and China.”

BioCity Built in Nottingham, UK

The UK’s BioCity in Nottingham is adding a £30m ($47m) facility to house life science start-ups including CROs. The site will also become a hunting ground for a soon-to-launch venture capital fund which will invest in the SME tenants.

The five-story building is an expansion of the existing BioCity complex, which rents lab and office space to 48 companies that employ, collectively, 650 workers.

Director Toby Reid said the complex boasts a 91% survival rate for the SMEs that moved in over the last twelve years, which have received a total of £50m ($78m) in venture funding.

Growth of these companies prompted BioCity to create more space and begin construction on a second, 50,000 sq. ft. building due for completion in 2017, he said. It is expected to provide workspace to 250 scientists, rising to 700 over the next 30 years.

The £30m facility is funded by Nottingham City Council and a D2N2 Local Enterprise Partnership grant of £6.5m ($10m).

The first company to sign up is Sygnature Discovery, a preclinical drug discovery CRO which will rent 60% of the building’s floor space. Sygnature plans to hire an extra 70 staff after the move, bringing its headcount to 200 by 2018.

BioCity is presently seeking more tenants among small-to-medium contract research organizations and contract manufacturing organizations. It is also looking for financers for a venture fund it hopes to launch at the end of the year which will invest money in BioCity Nottingham companies.

BioCity’s Manchester hub runs a similar £5m fund which announced its first investment this week: £200,000 in Alderley Analytical, a bioanalytical services company.

Reid said BioCity has made small investments in its tenants in the past and received a 6.7 times return.

“We think as landlords we get an almost unfair advantage in terms of assessing early-stage investment opportunities. Because we see what time they get in in the morning, whether management sits together in the café at lunch, we know how they listen to advice and deal with adversity, and these are key things when it comes to assessing a team with previously no trading history.”

Many of BioCity Nottingham’s small companies have scooped up employees laid off after big pharma closures, like AstraZeneca’s Alderley Park, Sanofi in Dagenham and Pfizer in Sandwich.

Medpace’s European Expansion Continues in UK

CRO Medpace has tripled the size of its Stirling, Scotland office with a new office, also in Stirling, that will allow for growth in data management, biostatistics, quality assurance, regulatory affairs, clinical operations and safety services.

The UK offices in London and Stirling now house nearly 130 Medpace employees as the company has increased its expansion efforts in Europe over the past few years.

The European activities have included adding additional clinical research professionals and expanding facilities in the UK, Poland, Russia, France, Germany and other expected expansions this year and next year in Leuven, Belgium, Prague and Madrid.

“We have been adding and enlarging our office spaces globally, however Europe continues to be a growth market for us – enabling us to better support a number of large global studies on behalf of our sponsors,” said spokeswoman Mary Kuramoto. “Our key therapeutic areas are endocrinology, cardiovascular, oncology, and infectious disease….Medpace now has 12 offices in the EU and a Central Lab in Belgium.”

Ohio-based Medpace established its first European office in the Czech Republic in 2005, and then boosted its device offerings in the region with the acquisition of Meditech in 2012. Last year, UK-based private equity firm Cinven acquired Medpace for $915m, saying the company is particularly attractive given its focus on small- and mid-sized biotech, pharma and med device clients. The company also expanded into Asia last year by opening a new central lab in Singapore.

Medpace employees in Europe now account for over one third of its 2000 staffers. The company says it will continue to grow and offer services for studies in oncology, cardio metabolic, infectious disease, CNS, and other therapeutic areas.

Green Cross Biotherapeutics’ Bio-manufacturing Facility, Montreal, Canada

Green Cross Biotherapeutics (GCBT), a biopharmaceutical company and member of the Green Cross family, broke ground on the construction of Canada's first intravenous immunoglobulin (IVIG) and albumin manufacturing plant in Montreal, Quebec, in June 2015.

The new facility, claimed to be one of the biggest green field investments in the Canadian biopharmaceutical industry, is part of GCBT's global expansion strategy and will serve as the North American headquarters for the group. It is also the first project to be set up through the Canada-Korea Free Trade Agreement.

The plant will be completed in the third quarter of 2016, while commercial production is scheduled to begin in 2019.

It will supply/export therapeutic plasma-derived products to local and international markets, including the US and China, while also establishing a stable local source for Canadian customers.

Héma-Québec, a non-profit organization that manages the supply of blood in Quebec, agreed to purchase IVIG products manufactured by GCBT's plant for five years after the plant begins production.

Green Cross Biotherapeutics' new state-of-the-art manufacturing facility is being constructed in the Saint-Laurent campus of Montreal Technoparc, an industrial park in Montreal.

The Saint-Laurent campus, a science park with more than 90 technology companies, facilitates the emergence of new companies.

The campus currently has more than 5,620 employees, while GCBT will add 200 more jobs through the new facility that requires qualified engineers, scientists, microbiologists and other professionals for the production and distribution of products.

GCBT planned Project Oasis with an aim to expand its business to North America and Europe.

The new plant marks the beginning of Project Oasis and will become the key project by serving as a North American hub for the production and distribution of various therapeutic products from the company.

Conceptual design for the plant was completed in January 2015 and the basic design was ready by April 2015.

The plant will have a gross floor area of 225,000ft² constructed on a 700,000ft² plot. The plant will be built in accordance with current US and Canadian good manufacturing practices (cGMP). It will be equipped with innovative and technologically advanced process equipment.

The plasma fractionation facility will have state-of-the-art filling and packaging areas to produce final bulk products for commercial use.

The new plant will manufacture two plasma-derived products including intravenous immunoglobulin (IVIG) 5% and 10%, and albumin 5%, 20% and 25%.

IVIG is a high-purity IgG manufactured from plasma derivates collected from individual donors. It is a key therapeutic solution for infectious and immune diseases.

Albumin is a hypoalbuminemia drug manufactured from normal plasma, using the cold ethanol plasma fractionation method. It is used in the treatment of burns and as a blood-volatizing agent.

The new plant will have an initial capacity of one million liters of plasma a year.

At full capacity, it is expected to generate annual revenue of approximately $228m through its own manufacturing products and a total sales turnover of more than $380m, including imported and distributed goods.

The total estimated investment for the project is C$315m ($239m).

Investissement Québec, a joint stock company that promotes investments in Quebec through financial assistance, provided a loan of C$17m ($12.9m) for the project along with a tax benefit of C$8m ($6m).

The Korean National Pension Service, a private equity fund, is contributing C$70m ($53m) in equity.

Green Cross Corporation established GCBT in 2014 in a strategic move to expand its business into North America and Europe. Based in Yongin, South Korea, the company provides safe and effective healthcare solutions and specializes in developing and manufacturing plasma derivatives, recombinant proteins, preventive vaccines and therapeutic antibodies.

Accelovance Sets Up European Facility in South Wales

US-based contract research organization (CRO) Accelovance is to set up a new European facility in Swansea, South Wales, creating 70 highly skilled clinical research jobs.

The move follows the Rockville, MD-headquartered company’s acquisition of Altair Clinical (now called Accelovance Europe) in Bury St Edmunds in January, and will complement other offices in Russia and Israel. Accelovance Europe's Managing Director Nigel Trim will oversee the expansion to Swansea.

'This opportunity provided by the Welsh Government will allow us to shift our primary UK operations to Wales, which provides a highly-talented scientific workforce to support the continued growth of Accelovance,' said Jamie Oliver, Executive Director for European and Asian Operations.

The expansion has been made possible with financial support from the Welsh Government.

Economy Minister Edwina Hart said: 'Wales is making a name for itself as a great location for businesses in the life sciences sector and gaining a reputation as a UK hotspot for pharmaceutical services.

Accelovance is focused primarily on oncology, vaccines, and general medicine. The CRO offers clinical development services including management and implementation of Phase I–IV clinical trials and a Clinical Engagement Solution used for recruitment, post-marketing surveillance, and long-term survival follow-up.

Japan's First Maximum-Security Biolab

The number of nations with a top-level infectious-disease lab has grown with Japan's upgrade of an existing facility.

Japan is set to join an elite club with its decision to upgrade an existing infectious-disease lab to handle the most-hazardous pathogens. The move sweeps away more than three decades of political opposition to operating a top-biosafety-level facility 30 kilometers west of Tokyo in the city of Musashi-Murayama.

An agreement reached on 3 August between Japan's health ministry and the mayor of Musashi-Murayama clears the way for the facility to begin limited work with pathogens such as the Lassa and Ebola viruses. Japan's National Institute of Infectious Diseases (NIID) built the biosafety-level-4 (BSL-4) lab in 1981, but it has been limited to operating as a BSL-3 lab because of community safety concerns. Fears that Ebola might reach Japan during last year's outbreak in West Africa partly motivated the policy change.

The deal sets several conditions for the lab's activities: the NIID has committed to maintain transparency in reporting lab operations and any accident, and the lab must also restrict its BSL-4 work to diagnosing and treating patients instead of running a broader research programme. However, virologist Ayato Takada at Hokkaido University in Sapporo, Japan, hopes that the agreement will ease the way for other facilities where scientists can perform basic infectious disease research at the BSL-4 level. Discussions are under way to build a bigger and more modern BSL-4 lab at Nagasaki University — a move that has similarly met with community opposition.

For the time being, Takada's studies of Ebola virus must be conducted in collaboration with international partners; he flies to the United States several times a year to perform BSL-4 experiments. "It's time-consuming and expensive," he says. "I really hope the decision at Murayama will have a good influence on the likelihood of the Nagasaki University BSL-4 plan."

Upgrading day-to-day operations from BSL-3 to full BSL-4 status may take several months, says virologist Masato Tashiro, former director of the NIID's Influenza Virus Research Center.

The original BSL-4 infrastructure at Musashi-Murayama has been maintained over the decades, but new protocols will need to be established and staff trained for the higher-security-level work. The lab will also need to import samples from other countries to build a reference library for diagnosing suspected infections.

Typical BSL-3 labs include two sets of self-locking doors and directional airflow to prevent the escape of potentially lethal, airborne pathogens. But BSL-4 labs have extra features that protect the workers and prevent the escape of highly lethal microbes that cause infections for which there are no treatments or vaccines.

Over the years, the NIID made various attempts to gain public support for BSL-4 operations at the site, but some citizens and politicians remained concerned that the potential risks outweighed the benefits. That equation began to shift last year as the Ebola outbreak raged in West Africa. Japan, like many other countries, worried that the virus could cross its borders through international travel.

Japan joins a growing club of nations that have considered or expanded BSL-4 capabilities over the past decade — many spurred by the 11 September 2001 terrorist attacks. The Federation of American Scientists in Washington DC, a non-profit organization specializing in security matters, estimated in 2011 that roughly 40 BSL-4 labs existed or were under construction worldwide, although some researchers consider that an overestimate.

"It was odd that a global player in science and a highly developed industrialized country such as Japan has not had that type of facility. It's brilliant that they have one now," says virologist Paul Duprex at Boston University School of Medicine in Massachusetts.

Others, however, argue that BSL-4 labs serve only a small slice of infectious-disease research, and that existing facilities already exceed global needs. "BSL-4 facilities are fantastically expensive to construct and operate, and that comes at the cost of other areas of biomedical research," says molecular biologist and biosecurity specialist Richard Ebright at Rutgers University in Piscataway, New Jersey. Although the Musashi-Murayama lab itself is limited in scope, Ebright says, "The most likely impact is that this will influence more nations to join this club."

Novo Nordisk Insulin Formulation and Filling Facility, Kaluga, Russia

The facility produces high-quality insulin for the treatment of diabetes.

A new insulin formulation and filling facility at Grabtsevo Industrial Park in the Kaluga region of Russia was inaugurated by Novo Nordisk in April 2015.

It is the first greenfield, modern insulin production facility in Russia. Its insulin production capacity is sufficient to meet the demand in the Russian market.

The facility will produce modern insulin products, including Penfill cartridges and FlexPen prefilled insulin injection pens for the treatment of diabetes in the Russian market. It is equipped with sophisticated technology, research facilities and cleanrooms.

It will meet the demand for modern insulin for more than 200,000 Russian patients and ensures Novo Nordisk produces insulin of the highest standards to reach more than 467,000 people a day.

The insulin formulation and filling facility at Grabtsevo technopark has a total floor space of 8,700m². It was designed under the European and Russian good manufacturing practices (GMP) standards, as well as environment and energy-efficiency requirements.

Novo Nordisk constructed the high-tech complex of manufacturing and infrastructure facilities at Grabtsevo technopark in partnership with Kaluga Pharmaceutical Cluster with an investment of $100m.

The investment contributes to Russia's Strategy Pharma 2020 programme, which is aimed at boosting the pharmaceutical industry by improving its production capacity.

The plant will also be used for developing key regional programs such as a center for professional training for the pharmaceutical industry. It currently employs 150 people and is expected to offer more jobs in the near future.

The government of the Kaluga region and Novo Nordisk signed a co-operation agreement for the construction of the new insulin production facility in April 2010.

The construction began with the ground breaking ceremony held in April 2012 and took approximately three years to complete. The state-of-the-art facility was officially opened in April 2015.

Spectrum Group was contracted to provide project management, quality control, construction supervision and management, as well as administrative general contract and permitting consulting services for the facility.

The project construction team included specialists from Denmark, the UK, US and Russia.

The building was constructed using energy efficient methods that are in compliance with environmental targets, including CO2 emissions, water consumption and use of energy.

Novo Nordisk is a global healthcare company headquartered in Denmark. It has more than 90 years of experience in producing innovative diabetic care products.

It is also engaged in the development of products and treatments for hemophilia care, growth hormone therapy and hormone replacement therapy.

The company employs approximately 41,500 people in 75 countries, and sells products in more than 180 countries.

Bi-Link's U.S. and Mexico Operations Receive ISO 13485 Certification

Officials with Bi-Link, a global contract manufacturer headquartered in Bloomingdale, Ill., report that the company’s Bloomingdale and Juarez, Mexico, facilities have been certified for ISO 13485:2003.

Joining Bi-Link’s manufacturing facility in Shanghai, China, the certification of compliance recognizes Bi-Link’s policies, practices and procedures are able to consistently meet customer and regulatory requirements for medical device manufacturing and other related services.

“Although Bi-Link has been serving the healthcare and medical device industries for over a decade, certification of its North American manufacturing facilities demonstrates Bi-Link’s dedication to delivering a consistent level of quality, efficiency and responsiveness across the globe,” said Terri Marion, medical segment marketing manager of Bi-Link. “Many of our current customers are global, industry-leading OEMs who must meet increasingly strict technical, functional and regulatory requirements. Being ISO 13485-certified ensures our customers that we are committed to supporting them and their needs.”

Bi-Link has more than 50 years of experience helping product engineers solve complex design challenges with a process the company calls “Mind to Market”— a vertically integrated process that officials claim lowers overall life-cycle cost and accelerates time to market by helping engineers validate designs based on solid DFM principles and rapid “pre-prototypes.”

Bi-Link was founded in 1961 and provides rapid prototyping, in-house tooling, precision metal stamping, plastic injection and insert molding, and automated assembly. Bi-link collaborates with healthcare and medical device engineering teams to solve complex design challenges from early stages through full-scale manufacturing.

Amneal Purchases Manufacturing Site in Ireland

US generics manufacturer Amneal acquires a former J&J plant in Ireland.

Amneal Pharmaceuticals, a US-based generic drug manufacturer, has purchased a 200,000-ft² facility in Cashel, County Tipperary, Ireland, the company announced on July 31, 2015. The Cashel site will be dedicated to R&D and production of metered dose and dry powder inhalers as well as biosimilars.

Amneal purchased the former Johnson & Johnson plant from owner Solidus Private Equity, a Singapore-based investment firm. Amneal worked closely with the Foreign Direct Investment agency IDA Ireland, and the investment was supported by the department of Jobs, Enterprise, and Innovation through IDA Ireland. Amneal expects to hire an estimated 250–300 employees at full build-out.

“Our new Ireland facility is critical to Amneal’s long-term global growth, in Europe, the US, and throughout the world,” explained Chintu Patel, Amneal co-CEO and co-chairman. Amneal is targeting expansion in Europe, Australia, Japan, Southeast Asia, and Latin America. The company notes that it is pursuing strategic acquisitions or partnerships in Ireland and other countries that welcome US businesses. It is also working on diversifying into more complex, high-value products.

Amneal Pharmaceuticals has launched four new products since June 2015, the company said in a press release. On July 13, the company obtained FDA approval for its tobramycin inhalation solution (a generic equivalent for Tobi inhalation solution). On July 11, Amneal started shipping memantine hydrochloride immediate-release tablets in 5-mg and 10-mg strengths; this product is one of the first generic equivalents to Namenda on the market. Earlier in June, Amneal launched temozolomide capsules (AB-rated to Temodar) in six different strengths along with divalproex sodium extended release (AB-rated to Depakote ER) in 250-mg and 500-mg tablets.

GSK Investing in Singapore Amoxicillin Plant

GSK is investing £38m ($60m) in enzymatic manufacturing at an antibiotic facility in Singapore which the firm says is greener and more efficient than traditional approaches.

The Quality Road, Singapore facility is GlaxoSmithKline’s sole manufacturing site for amoxicillin, the API used in the antibiotic treatment Augmentin, and the firm has announced it is looking to increase capacity through this latest investment.

According to spokesman Raymond Francis, the investment will be used to construct an additional downstream isolation facility at the site which will “increase production by 50% and help the company meet the growing demand for antibiotics in emerging markets.”

Following a $35m injection in 2012, this latest cash injection further boosts amoxicillin capabilities at the plant using enzymatic manufacturing, which the firm says is a greener alternative to traditional chemical processes.

“This aqueous process involves fewer steps under milder conditions, typically ambient temperatures and utilizes significantly reduced quantities of organic solvents, resulting in the elimination of much of the organic waste associated with the chemical process,” said Francis.

“Moving to this new manufacturing method should result in a significant reduction in our carbon footprint at the Quality Road site - by as much as 25% - and reduce organic waste by approximately 80% while maintaining our industry leading product quality standards.”

Quality Road is one of three GSK production sites in Singapore and the shift to enzymatic manufacturing is an example of the firm’s ongoing advances to improve the efficiency of manufacturing in the island-state, Francis said.

Last year, £19m was invested in GSK’s continuous manufacturing facility in Jurong which Francis said will produce key respiratory APIs.

Funding Boost for Precision Medicine Research in Glasgow

The University of Glasgow’s position as a leading center for the development of precision medicine has been bolstered by the award of £3.4 million from the Medical Research Council and the Engineering and Physical Sciences Research Council (EPSRC) to create the largest MRC Molecular Pathology Node in the UK.

The vision of precision medicine is to find treatments based on an individual patients’ own physiology and response to diseases, rather than relying on one-size-fits-all therapies that fail to help many.

Based in the purpose-built Laboratory Medicine Building at The Queen Elizabeth University Hospital, the Glasgow Molecular Pathology Node will enable scientists, pathologists and clinicians to collaborate with our industry partners in developing new diagnostic tests. The University’s investments at The Queen Elizabeth University Hospital have already established a world-leading reputation for Glasgow in precision medicine.

The Node will co-locate with the £20m the Stratified Medicine Scotland Innovation Centre; a £32m Imaging Centre of Excellence, housing the UK’s first 7-Tesla MRI scanner on a clinical site, which will provide ultra-high-resolution imaging to support researchers and clinical trials; a £5m clinical research facility that will host precision medicine clinical trials; and the £30m Queen Elizabeth Teaching & Learning Centre, including dedicated incubator space for life sciences companies to engage with researchers and the NHS.

The Glasgow Molecular Pathology Node will integrate laboratory medicine, including pathology and informatics disciplines, which handle and analyses the large datasets that emerge from molecular research.

Professor Anna Dominiczak, Vice Principal and Head of the College of Medical, Veterinary and Life Sciences at the University of Glasgow, said: “The goal of precision medicine is to provide the right treatment, to the right patient, at the right time, for the right cost and the right outcome.

“We now understand more about abnormalities in DNA and other molecules which occur in disease.

“This so-called ‘molecular pathology’ is revealing significant variation in diseases which by standard classifications, for example by a pathologist using a microscope, have been indistinguishable. So, for instance, we now know that pancreatic cancer is not just one disease but many different ones, potentially with different treatments.”

Dr. Karin Oien, the lead investigator, said: “Glasgow is central to stratified therapeutic development in the UK and worldwide. Our investigators include global opinion leaders with major roles in international academic studies and industry efforts.

“Our Node will immediately integrate with current and emerging large-scale initiatives such as the Stratified Medicine Scotland Innovation Centre, the Precision Medicine Catapult, the Scottish Genomes Partnership, Genome England and the International Cancer Genome Consortium, the next iteration of which is focused on clinical delivery, to exploit opportunities provided through these mechanisms, and in turn substantially enhance them.

“Our excellent training in molecular pathology, genetics, informatics and stratified medicine will address national skill shortages and contribute to a workforce capable of developing, undertaking, interpreting, and applying the results of novel molecular diagnostics, across a range of professions and expertise from geneticists, pathologists, clinical and other scientists, informaticians and clinicians across hospital practice and primary care.”

Minister for Life Sciences George Freeman said: “Advances in medical genetics and the use of data are making it possible to design a new generation of 'Stratified' or 'Precision' medicines which work more effectively, with fewer side effects, in more targeted groups of patients. In cancer this is leading to personally-tailored therapies.

“As an integrated healthcare system underpinned by our £1billion per annum National Institute for Health Research expenditure, the NHS is perfectly placed to pioneer this field.

“This £5.4 million investment in projects at the Universities of Glasgow, Edinburgh and St Andrews will enhance our UK-wide capability to deliver 21st Century diagnostics and complement initiatives such as the Precision Medicine Catapult Centre to make sure that ground-breaking medicines technologies are adopted by the NHS and delivered to patients as quickly as possible.”

Robert Calderwood, Chief Executive of NHS Greater Glasgow & Clyde, said: “This is a wonderful opportunity for our staff to work collaboratively with the University of Glasgow and industry partners in this exciting and innovative area of research which will be for the benefit of patients, both within NHS Greater Glasgow and Clyde and across Scotland and the UK.”

Jim Reid, CEO of Sistemic, one of the industrial collaboration partners for the Glasgow Molecular Pathology Node and a Director of the Scottish Life Science Association stated: "This is a great boost for Glasgow and the UK. The formation of these Nodes will act to accelerate the development and translation of a range of molecular pathology products into the clinic and bring undoubted benefit to patients and the health service.

“Additionally, as can be seen from the involvement of a number of SME's including Sistemic, there is the immediate potential to boost local industry and the broader economy. Bringing industry, academic research and the NHS closer together, which will be a key objective of the Pathology Nodes, will provide the ideal environment for the rapid development of health solutions, bring improved patient care and ensure the creation of sustainable economic growth."

Funding for six nodes across the UK was announced, with Glasgow receiving the largest single award.

Merck to Acquire Israel’s cCAM Biotherapeutics

US-based Merck has signed an agreement to acquire Israel-based biopharmaceutical firm cCAM Biotherapeutics for around $605m.

As part of the deal, Merck, through its subsidiary, will purchase all outstanding stock of cCAM for $95m. The deal will also allow cCAM shareholders to receive up to $510m based on the attainment of certain clinical development, regulatory and commercial milestones.

Merck Research Laboratories president Dr. Roger Perlmutter said: "We continue to strengthen our portfolio of immunotherapeutic candidates through strategic collaborations and acquisitions.

"The acquisition of cCAM supports our objective to advance the care of patients with cancer by stimulating tumor-directed immune responses."

cCAM includes several early immunotherapy candidates, including the novel monoclonal antibody (mAb) CM-24.

CM-24 has been designed to target the immune checkpoint protein CEACAM1 and is currently being assessed in a Phase I study to treat advanced or recurrent malignancies, comprising melanoma, non-small-cell lung, bladder, gastric, colorectal, and ovarian cancers.

Under the deal, cCAM as the wholly owned subsidiary of Merck, will advance the development of CM-24 in its ongoing Phase I clinical trial.

According to Merck, preclinical studies demonstrated that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various CEACAM1-positive tumor cell lines.

cCAM Biotherapeutics chairman Dr. Pini Orbach said: "Merck's excellence and leadership in immuno-oncology provides a strong foundation for advancing CM-24, for the treatment of people with cancer."

The deal is subject to certain closing conditions, said Merck.

Capsugel Expanding Encap Plant

The facility in Ediburgh, Scotland was acquired when Capsugel bought Encap in 2013

Capsugel is doubling the size of a facility in Scotland to support demand for the encapsulating of drugs containing high-potency active pharmaceutical ingredients (HPAPIs).

The Edinburgh, UK facility was taken over by Capsugel when the dosage form solutions firm bought Encap Drug Delivery in March 2013. The plant is one of the largest in the world to manufacture liquid and semi-solid filled capsules but is now set to double in size through the addition of 40,000 sq. ft. of production space.

Stephen Brown, Managing Director of Capsugel’s Encap Drug Delivery division, said the expansion was due to rising customer demand for its encapsulating services “across the entire pharma spectrum,” and across global markets.

“We are seeing demand both at development scale – which is growing at around 40% per year – and for commercial products,” he said, adding that two products encapsulated at the site were approved last year with a further NDA submitted so far in 2015.

But one specific driver for the deal is the rise in high-potency active pharmaceutical ingredients (HPAPIs) among drugmakers, and the demand for services to support this. Encap has been offering such services since 2008, Brown said, but this expansion will double the facility's capacity for HPAPI encapsulation.

The expansion is likely to lead to new jobs at the site, though Brown did not divulge how many. However, he told us the workforce has increased by over 50% since the Capsugel acquisition, with the headcount presently standing at 110.

He also said the Encap business is now “completely integrated within Capsugel’s DFS (Dosage Form Solutions) unit and works very closely with its other facilities around the world.”

The news is the latest expansion for Capsugel, which last month completed a $25m spray-dried dispersion (SDD) plant at a site in Bend, Oregon, and in March announced it was investing the same amount to expand production of its vegetarian food and drug capsules across sites in South Carolina, Mexico, France and Japan.

BioOutsource to Open New Glasgow Facility

A surge of demand in biologics contract testing and biosimilar characterization has caused BioOutsource to double its capacity with the opening of a new facility in Glasgow, Scotland.

The Scottish company offers a range of development and manufacturing services for recombinant proteins, monoclonal antibodies, biosimilars, regenerative medicine, gene therapy vectors and vaccines. The opening of this new facility will create about 50 new jobs in the next six months.

“Our opening of this new, state-of-the-art facility demonstrates our commitment to our growing list of global customers,” said BioOutsource CEO Gerry MacKay. “Demand for our services remains high and we are doubling our capacity to make sure we are ready to support the robust pipeline of biotech and biosimilar products currently in development.”

The company’s current partnerships and clients include work with Actavis Biologics, Oncobiologics and MediWound.

Spokeswoman Gemma Fulton told us the company is seeing particularly strong growth in the characterization and comparability testing services it provides for biosimilar drug candidates.

The company offers off-the-shelf assay packages to complete a comparability study for the biological characterization of a range of biosimilar molecules, including for Herceptin (trastuzumab), Humira (adalimumab), Enbrel (etanercept), Remicade (infliximab) and others. In addition, the company supports biosafety testing, lot release and stability and development of custom Phase III host cell protein assays.

“As biopharma companies expand their focus on biosimilars, the requirement for off-the-shelf assays to rapidly characterize the candidate molecules in their pipelines has increased,” Fulton added.

The new Scottish facility comes three months after the company was acquired by Sartorius Stedim Biotech. And a little more than a year ago, BioOutsource expanded into the US with a new Cambridge, Massachusetts sales office. The company told us that it’s seeing its highest growth in biosimilar testing come from the US market.

The company currently employs about 80 others and reported annual revenues of around $10m last year.

LIVIA Group Acquires Patheon Facility in Capua, Italy

LIVIA Group has entered an agreement to acquire the Capua manufacturing facility and associated employees from Patheon.

Capua, one of the world's largest independent microbial fermentation-based manufacturing facilities with 1,400m³ fermentor capacity, represents an investment opportunity for LIVIA in the attractive market of enzymes and small molecules.

LIVIA Group founder professor Dr. Peter Löw said: "LIVIA Group is enthusiastic about working with Capua to build on their existing strong market position through a focus on product development, a revitalized sales function and improved production efficiency.

"We are very pleased to be invested in the business and look forward to supporting its future growth."

Capua delivers enzymes, therapeutic proteins and high-value small molecules for applications in the food, feed, pharma, agrochemical and fine chemical industries.

The facility is both FDA and EMEA (Pharma cGMP) approved. It is ISO: 14001 certified and serves customers in more than 60 countries.

In addition to its regular production, Capua offers pilot plant capabilities for customized product development, process scale-up and validation.

Patheon president drug substance services Lukas Utiger said: "We are very pleased to find a buyer for the Capua facility that is focused on servicing existing customers and adding new ones.

"Selling the Capua site is part of Patheon's efforts to focus its core business strategy as a leading global provider of outsourced, end-to-end pharmaceutical development and manufacturing services.

"We elected to sell the operations to LIVIA Group, who is very focused on growing the operations and continuing to provide a positive work environment for employees."

Sandoz will Close Three Manufacturing Sites in Germany and India

Head of Sandoz Richard Francis told investors he made the “difficult decision” to improve cost efficiency of manufacturing in the “very competitive” generics sector.

The sites in Gerlingen and Frankfurt, Germany and Turbhe, near Mumbai, India will close by the end of 2016.

The Gerlingen facility manufactures generic oral solids, including ibuprofen, cetirizine, amlodipine and omeprazole. Frankfurt makes cephalosporin antibiotics, (7-ACA) while Turbhe is an API site for Sandoz’s antibiotics business.

German manufacturing will remain in Europe, with Gerlingen’s production transferred to Sandoz’s Strykow site in Poland and Barleben in Germany. Cephalosporin will move to Sandoz’s giant antibiotics facility in Austria. Turbhe will send its manufacturing to the company’s other Indian sites.

A Sandoz spokesperson told us several hundred jobs will be cut during the moves, “however we are keeping a strong presence in Germany – and India, with jobs also being created elsewhere.”

Sandoz had a successful Q2, as parent company Novartis revealed this week the generics business saw core operating income of $423m for the quarter, a 30% increase on 2014.

In April, the company received FDA approval for Glatopa, the first generic of Teva’s Copaxone for MS. A court ruled Sandoz may launch Zarxio in September, a biosimilar of Amgen’s Neupogen.

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail: editor@mcilvainecompany.com

Web site: www.mcilvainecompany.com