German CRO Proinnovera Establishes U.S. Facility

Size: 30,000 sq. ft.

Project team: KidderWachter Architecture & Design (architect), E. E. Austin & Son (general contractor)

Plastikos, Inc., a precision medical injection molder, is constructing a brand new medical molding facility in support of Plastikos’ cleanroom medical molding growth. The two-part expansion plan will consist of a stand-alone facility—Plastikos Medical—located less than a quarter-mile from its headquarters.

The brand new, state-of-the-art facility will include all of the corresponding support departments, including a dedicated tool maintenance room, mold storage, metrology lab and office space. Initially, Phase I of the project will accommodate 10 brand new medical injection molding machines. Each machine will be equipped with its own integrated 3-axis robot and cavity pressure monitoring system, among other advanced technologies. Additionally, in order to remain environmentally conscious, the new medical facility will incorporate LED lighting and utilizing natural light with advanced building system management technology.

The cleanroom (Medical Molding Floor) in the new facility will be an ISO 7 (Class 10,000) cleanroom, which is the same level as the current cleanroom. There will be a full-service utility tunnel/basement that runs the length of the new cleanroom molding floor, which will also include state-of-the-art material handling  capabilities in support of the medical molding operation.

Looking further ahead, Phase II of the Plastikos Medical expansion will consist of an additional 10 medical molding machines as customer demand further increases. Plastikos’ production fleet will increase to 45 injection molding machines with the completion of Phase I of the new stand-alone facility. Future Phase II expansion plans will add another 10 presses to the fleet, raising the total machine count to 55 molding machines.

Completion date: Summer 2019 (Phase I)

New Medical Plastics Manufacturing Facility

BMP has announced the upcoming opening of its new MA facility. Medical device & diagnostic companies will benefit from a premiere destination for injection molding, injection blow, 2-shot, & insert molding manufacturing services. To open 1/2019.

Platelet BioGenesis Moves to New Cambridge Lab Space

Platelet BioGenesis (PBG) has moved into brand new lab space in Cambridge, MA. Located next to MIT, the newly renovated property puts Platelet BioGenesis in the heart of the most dynamic biotech cluster in the world.

Platelet BioGenesis’ new space is located in Nest.Bio Labs, a unique incubator space that hosts a growing number of innovative early-stage life science companies.

"We are thrilled to have Platelet BioGenesis as one of our founding tenants,” said James Weis, CEO of Nest.Bio Labs. “As pioneers in cell therapy, this company is a standout in our carefully cultivated community of trailblazing ventures.”

The 14,000-square-foot facility includes more than 50 oversized wet lab benches as well as a state-of-the-art tissue culture and microscopy suites to support R&D operations.

“Platelet BioGenesis’ move to Cambridge will accelerate our continued growth as we scale our novel method of generating disease-free, GMP-compliant, donor-independent, functional human platelets,” said Ryan Chappell, lab manager of Platelet BioGenesis. “We anticipate hiring additional scientific and administrative personnel as we advance to the clinic.”

Amgen Breaks Ground for Next-Gen Bio-Mfg. Plant

Amgen broke ground for its new 120,000 sq.-ft. next-generation biomanufacturing plant that will be constructed at its West Greenwich, RI campus. The new plant is the first-of-its-kind in the U.S. and will use Amgen's next-generation biomanufacturing capabilities to manufacture products for the U.S. and global markets. Amgen plans to invest as much as $200 million and the plant is anticipated to create approximately 150 additional highly-skilled manufacturing positions.

"Biologics manufacturing is a complex science and has long been a competitive advantage for Amgen," said Robert A. Bradway, chairman and chief executive officer at Amgen. "We are working to extend that advantage even further with a next-generation biomanufacturing plant in Rhode Island that will produce medicines to serve patients around the world suffering from serious illnesses."

The biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built in half the construction time with approximately one half of the operating cost of a traditional plant. Next-generation biomanufacturing plants require a smaller manufacturing footprint and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions. Within the plant, the equipment is portable, smaller and some components are disposable, which provides greater flexibility and speed when manufacturing different medicines simultaneously.

"Since its inception in 2002, Amgen Rhode Island has evolved to a multi-product manufacturing facility, which is a testament to our focus on innovation, technology and great staff," said Tia Bush, vice president of Operations at Amgen Rhode Island.  "Constructing this next-generation plant in Rhode Island further enhances our manufacturing capabilities within Amgen's global operations network to deliver on our mission to serve patients."

The existing Amgen Rhode Island plant was licensed by the U.S. FDA in September 2005 and houses one of the world's largest mammalian protein manufacturing facilities. The facility manufactures commercial and clinical bulk drug substance. Amgen has invested more than $1.5 billion in its Rhode Island campus, adding more than 500,000 sq.-ft. of manufacturing, utility, administrative and lab space to the campus. There are approximately 625 full-time staff employed at the Rhode Island campus.

Mettler Toledo Holds Facility Opening Event

The Product Inspection Group of Mettler Toledo, the largest manufacturer of product inspection systems for the food and pharmaceutical industries, hosted a grand opening event for their customers and trade media on July 12 – 13th, 2018.

Attended by over 75 guests, the two day event was packed full of activities and sessions which utilized many of the amenities the new facility has to offer. The first day opened with scheduled meetings and a comprehensive tour of the facility followed by an afternoon of networking and outings. The day concluded with a courtyard reception, which included a product fair with displays from the other Mettler Toledo divisions, and a formal dinner at the on-site restaurant.

The 265,000 square feet of office and manufacturing space is the new Product Inspection Headquarters of the Americas and houses all of the Product Inspection business units – Safeline metal detection and x-ray inspection, Hi-Speed checkweighing, CI-Vision machine vision and PCE Track&Trace/Serialization.

This new state-of-the-art facility elevates Mettler Toledo's capabilities, with a large production area, first-class training and test labs, and multiple FAT rooms. With collaborating R&D resources and extensive combined industry application expertise, Mettler Toledo is positioned to deliver even more innovative solutions.

Moderna Opens Manufacturing Site in Massachusetts

Moderna Therapeutics has announced the opening of a state-of-the-art manufacturing site in Norwood, Massachusetts, built to advance their work in the messenger RNA (mRNA) platform, after announcing the plans for the site in 2016.

The new site will give the company the capacity to develop preclinical toxicology study materials, and continue clinical development programs that are in Phase 1 and 2. This will allow for Moderna to fulfill operations for its mRNA development pipeline​.

This pipeline currently has 21 on-going programs for potential treatments of cancer, rare and infectious diseases, and heart failure.

Stephane Bancel, CEO of Moderna, said, “The Norwood site is core to our long-term strategy, enabling us to leverage the potential of our mRNA platform, control our supply chain, and provide the necessary scale and flexibility to support the development of high-quality mRNA medicines for patients in decades ahead​.”

The site will also include a Personalized Cancer Vaccine (PCV) Unit that will enable Moderna to supply mRNA for potential PCVs. Through this PCV unit, Moderna will reduce manufacturing time for cancer vaccines designed for individual patients participating in clinical trials.

Juan Andres, senior vice president of manufacturing for Moderna, said in a press release​, “Our investment in Norwood brings us even closer to the industrialization of our mRNA platform. Norwood will allow us to own the end-to-end production of materials, run multiple programs simultaneously, and produce more than 100 cGMP batches annually in an automated and digitally-integrated environment​.”

Norwood site will be a digitally-enabled site using robotics to enable data and information for manufacturing activities, it will also be a paperless manufacturing

“Opening this new manufacturing facility in Massachusetts was also important as it enables close collaboration with our development and research teams in Cambridge as we advance our mRNA platform and science​,” said Bancel.

Pfizer Plans Investments across the US

Pfizer has revealed it will invest $5bn to support operations in the US, with the first step being the construction of a 400,000-square-foot production facility, costing $465m.

The new sterile injectable facility will create more than 450 jobs in Portage, Kalamazoo County, MI – joining the 2,200 Pfizer employees currently working in the city.

According to the press release​, the $465m (€397m) facility will “be one of the most technically advanced sterile injectable pharmaceutical production facilities in the world”.​

The facility will include multiple, self-contained modular manufacturing lines, which will allow each line, in each module, to work in isolation from other manufacturing lines.

Ground-breaking on the project is expected to take place in spring 2019 and construction is planned to be completed in 2021. Production at the facility was noted to begin in 2024, contingent on regulatory approval.

Pfizer's plant in Portage currently produces sterile injectable, liquids and semi-solid medicines, and active pharmaceutical ingredients (APIs).

The new development in Portage has been supported at the state level by tax breaks worth $10.5m​ and an additional $1m ‘performance-based grant’ agreed by the Michigan Strategic Fund Board.

A spokesperson for Pfizer outlined that this is the first of more such projects, “Following passage of the US tax reform, we announced that over the next five years, we plan to invest approximately $5bn in capital projects in the US, including the strengthening of our manufacturing presence in the US.”​

The spokesperson continued, “We expect to invest approximately $1.1bn in Kalamazoo County – which is in addition to the $1 billion we have invested in the site over the past decade with tax reform having a favorable influence on our investments in Kalamazoo.”​

The spokesperson did not reveal in what particular projects the total $5bn will be invested.

One of President Trump’s main calling cards for the pharmaceutical industry has been to return manufacturing to the US​ and Pfizer’s actions, spurred by the tax reform, corroborate statements made by other companies​ that this will happen.

Representing an investment of nearly half a billion dollars in US manufacturing, the project will create more than 450 jobs

Pfizer has announced it will increase its commitment to US manufacturing with a US$465 million investment to build a sterile injectable pharmaceutical production facility in Portage, Michigan.

This investment will strengthen Pfizer’s capability to produce and supply critical, life-saving injectable medicines for patients around the world.

Known as modular aseptic processing (MAP), the new, multi-story, 400,000 sq. ft. production facility will also support the area economy by creating an estimated 450 new jobs in the next few years.

This expands Pfizer’s presence in Portage, located in Kalamazoo County, where the company now employs more than 2200 people at one of its largest plants.

“This investment is part of our overall plan announced in January to invest approximately $5 billion in US-based capital projects as a result of the enactment of the Tax Cuts and Jobs Act. During the next six years, we expect to invest approximately $1.1 billion in Kalamazoo County, which is in addition to the $1 billion we have invested in the site over the past decade,” said Ian Read, Chairman and CEO.

“Sterile drug product manufacturing is incredibly complex. This contemporary facility will combine cutting-edge technology and a highly talented workforce to assure we remain a trusted and reliable supplier of these therapies to patients,” said Ron Perry, Site Leader for the Portage plant.

MAP will incorporate the most technically advanced aseptic manufacturing equipment, systems and design, including multiple, self-contained modular manufacturing lines. This allows the manufacturing line in each module to be entirely separate from all other manufacturing lines.

Pfizer’s Portage site is a primary global supplier of sterile injectable, liquids and semi-solid medicines, and active pharmaceutical ingredients, producing more than 150 products. Its biggest product is Solu-Medrol, a widely used injectable anti-inflammatory medicine.

Jersey Shore University Medical Center Celebrates Grand Opening of HOPE Tower

Hackensack Meridian Health Jersey Shore University Medical Center celebrated the grand opening of HOPE Tower, a 10-story, 300,000-square-foot facility, in a ceremony with more than 300 community members in attendance, including Hackensack Meridian Health leadership, team members and elected officials last evening. The $265 million state-of-the-art facility, located on the east side of the hospital's campus in Neptune, features a world-class cancer treatment center, modern clinical offices for pediatric and adult specialties, and high-tech academic and research space, creating a groundbreaking outpatient facility that focuses on all aspects of health and wellness.

"At Jersey Shore University Medical Center, we are cultivating a culture of compassion, focused on providing high-quality care and enhancing the patient experience," said Kenneth N. Sable, M.D., MBA, FACEP, president of Jersey Shore University Medical Center and K. Hovnanian Children's Hospital. "HOPE Tower expands upon Jersey Shore's services, serving as a hub of clinical excellence while elevating the human experience. We are continuing to bring humanity back to health care, putting our patients at the center of everything we do."

HOPE Tower represents a new Healing OutPatient Experience, where advanced technology and unsurpassed medical expertise is combined in a stunning facility that has been designed with patient convenience, easy access and peace of mind as core elements in care delivery. "The new tower will foster a new healing outpatient experience for the communities we serve, setting the bar for the next generation of care," notes Dr. Sable.

"Hackensack Meridian Health is committed to transforming health care through innovation and education, with HOPE Tower leading the way in providing cutting-edge care, an exceptional patient experience, and novel learning," said Robert C. Garrett, FACHE, co-CEO of Hackensack Meridian Health. "HOPE Tower, designed to support medical education, research and clinical care, is the embodiment of our core mission to deliver high-quality family- and patient-centered care, world-class education, and tomorrow's research."

The first two levels of the tower are a 58,000-square-foot state-of-the-art cancer center, designed with patients' needs in mind. The warm and welcoming layout is intended to treat the whole person as well as the disease, offering patients cancer diagnosis, consultation and treatment planning with multidisciplinary teams, all under one roof. In addition, the new center offers the latest in technology and treatment options, including dedicated areas for infusion, radiation therapy with the most advanced TrueBeam™ linear accelerators, counseling and supportive care, all in one convenient location. The new cancer center is also part of Hackensack Meridian Health's historic partnership with Memorial Sloan Kettering Cancer Center, transforming cancer care for communities across Monmouth and Ocean counties.

"This world-class outpatient facility is a perfect setting for cancer patients, giving them access to highly trained surgeons, medical oncologists, radiation oncologists and clinical trials, all under one roof. This encourages collaboration and a multidisciplinary approach to better serve our patients," said Thomas L. Bauer II, M.D., FACS, thoracic surgeon and clinical medical director of oncology for Hackensack Meridian Health.

HOPE Tower also brings together a wide range of pediatric and adult physician and medical specialties across several floors of the facility.  The pediatric specialties housed in the tower include gastroenterology, endocrinology, infectious disease, neurology and hematology/oncology. The adult specialties are internal medicine, psychiatry and behavioral health, infectious disease, rheumatology, endocrinology, uro-gynecology, obstetrics and gynecology, maternal/fetal medicine, and surgery.

"By putting so many specialists and resources in one location, we are truly redesigning our approach to patient care. Care coordination is so important in delivering the most comprehensive and innovative treatment plans for our patients," added Dr. Bauer.

HOPE Tower also serves as a home to Jersey Shore's medical education programs and research services.  The new facility houses team members involved in research and clinical trials, and supports patients who are participating in trials with high-tech exam rooms for treatment and evaluation.

HOPE Tower features a 6,500+ square foot, state-of-the-art innovative simulation laboratory. The lab fosters experiential and simulation-based learning with an emphasis on patient safety, quality, innovation and patient interaction. 

"The integration of simulation-based and experiential learning into interdisciplinary education programs builds upon Hackensack Meridian Health's continued commitment to leadership in health care education," said Dr. Sable.

On the 10th floor of HOPE Tower is a conference center, featuring the John K. Lloyd Amphitheater. It is a 200-seat theater-style auditorium that includes the latest audio-visual technology with the ability to stream live broadcasts and record sessions. The conference center provides a state-of-the-art meeting space to host a variety of educational, clinical and community events.

"This is a significant moment for Jersey Shore University Medical Center that has been years in the making. HOPE Tower is a culmination of more than a decade of hard work, perseverance and partnership with the community," said John K. Lloyd, co-CEO of Hackensack Meridian Health.  "This groundbreaking facility builds upon a longstanding tradition of health care excellence and will help us meet the growing needs of our patients, families and the communities we serve. We have truly created a remarkable health care landscape in this region."

U.S. News & World Report ranked Jersey Shore University Medical Center the 4th best hospital in New Jersey and 11th best hospital in the New York metropolitan area in 2017. Jersey Shore University Medical Center is the region's only academic university-level teaching center.

"HOPE Tower demonstrates our deep commitment to this community. We have made a significant investment in innovation and first-class physicians, nurses and team members, to provide high-quality health care services that our patients deserve close to home," said Dr. Sable. HOPE Tower is slated to open the first four levels at the end of the month, and phase in the opening of the upper levels by the end of the summer.

About Hackensack Meridian Health:

Hackensack Meridian Health is a leading not-for-profit health care organization that is the most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care. Hackensack Meridian Health comprises 16 hospitals, including three academic medical centers, two children's hospitals and nine community hospitals, two rehabilitation hospitals, physician practices, more than 160 ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, fitness and wellness centers, rehabilitation centers, and urgent care facilities. Hackensack Meridian Health has 33,000 team members, more than 6,500 physicians and is a distinguished leader in health care philanthropy, committed to the health and well-being of the communities it serves.

The Network's notable distinctions include having one of only five major academic medical centers in the nation to receive Healthgrades America's 50 Best Hospitals Award for five or more consecutive years, four hospitals ranked among the top 10 in New Jersey, including Hackensack University Medical Center, the No. 1 hospital, Jersey Shore University Medical Center at No. 4 and Ocean and Riverview Medical Centers tied at No. 8., as ranked by U.S. News and World Report. Other honors include consistently achieving Magnet® recognition for nursing excellence from the American Nurses Credentialing Center, recipient of the John M. Eisenberg Award for Patient Safety and Quality from The Joint Commission and the National Quality Forum, a six-time recipient of Fortune's "100 Best Companies to Work For," one of the "20 Best Workplaces in Health Care" in the nation, and the number one "Best Place to Work for Women." Hackensack Meridian Health is a member of AllSpire Health Partners, an interstate consortium of leading health systems, to focus on the sharing of best practices in clinical care and achieving efficiencies.

Lonza Houston’s Biotech Facility, Pearland, Texas

In April 2018, viral and cell therapy manufacturer Lonza Houston completed constructing a new biotech facility for immunotherapy development and manufacturing in Pearland, Texas, US.

The City of Pearland and the Pearland Economic Development Corporation’s (PEDC) approved the project’s construction in December 2015. The build fulfils the city’s long-lasting goal of establishing a broad spectrum of medical and life sciences organization in the region.

“The new biotech facility fulfils the city’s long-lasting goal of establishing a broad spectrum of medical and life sciences organization in the region.”

A ground-breaking ceremony was held on March 2016 for the project, which was attended by Pearland’s Mayor Tom Reid, city manager Clay Pearson, state representative Ed Thompson, Lonza Houston’s site director Ricardo Jimenez, Lonza’s operations for emerging technologies senior vice-president (SVP) Stefan Troger, and the PEDC board chair Rushi Patel and board members Reid Wendell, Brandon Dansby and Lucy Stevener.

The facility was officially opened in April 2018.

The state-of-the-art facility is located on an 11-acre site on Kirby Drive in Pearland’s Lower Kirby District. It has a total floor space of 300,000ft2 (27,870m2) and is designed to accommodate office spaces, a process development unit, quality control laboratories and a fully segregated fill-and-finish suite.

The facility contains independent modular cleanrooms with a total capacity of up to 2,000l-scale production in single-use bioreactors.

The cleanrooms were designed to manufacture cell therapy products to meet the growing demand in the US and European markets. The facility doubles the company’s current capacity for the production of viral gene and virally modified therapeutics.

The facility initially generated more than 80 jobs and is expected to create more than 200 opportunities by the end of 2018 in the fields of administration, manufacturing, process development and quality assurance.

Lonza built the new biotech facility in collaboration with Pinchal & Co, Creed Commercial Development, ARCO Design/Build, and CRB.

Marketing commentary on Lonza:

Lonza is a global leader and trusted supplier in the pharma, biotech and specialty ingredients markets. Headquartered in Basel, Switzerland, the company is focused on advanced manufacturing, high-quality control systems, regulatory expertise, and research and development (R&D) capabilities.

The company’s products and services include active pharmaceutical ingredients (API), stem cell therapies, drinking water sanitizers, vitamin B compounds, organic personal care ingredients, industrial preservatives and microbial control solution to combat viruses, bacteria and other dangerous pathogens.

The company also provides agricultural services and products.

Berkshire Sterile Manufacturing gets US$2m Loan for expansion Plan

Finance agency MassDevelopment has approved a US$2 million loan to Berkshire Sterile Manufacturing Inc. (BSM) for the expansion of the company's sterile manufacturing facility located in Lee, Massachusetts.

BSM will use the funds to expand its current cleanroom and warehouse facilities, acquire additional sterile manufacturing equipment and construct new visual inspection and final drug packaging suites. The company will also be expanding its analytical services capabilities with the purchase of other test equipment and stability chambers.

"We are extremely grateful for the partnership with MassDevelopment allowing BSM to grow with low-interest loans. As BSM continues to expand our product and service offerings, we will bring more career opportunities to the Berkshires," said CEO Shawn Kinney, PhD.

Berkshire Sterile is recognized as a state-of-the-art fill/finish contract manufacturer providing formulation and sterile filling as well as analytical development and stability services to the biotech and pharmaceutical industries.

All sterile filling operations at BSM are performed utilizing isolator-based technology.

BSM also offers terminal steam sterilization of syringes, specialty filling and lyophilization of vials and syringes including dual chamber liquid/liquid and liquid/lyo configurations.

Shire Receives FDA Approval for New Plasma Manufacturing Facility

US-based global biotech company Shire has announced that the United States Food and Drug Administration (FDA) has approved the company’s first submission for its new plasma manufacturing facility near Covington, Georgia, for the production of Gammagard Liquid, – Immune Globulin Infusion (Human) – 10% Solution, a replacement therapy for primary humoral immunodeficiency (PI).

The Covington facility will add approximately 30% capacity to Shire’s internal plasma manufacturing network once fully operational. Commercial production at the site began in January 2018, and Shire expects to distribute product shortly now that approval has been granted.

The Covington facility contains more than 1 million square feet of space, including manufacturing buildings, laboratories, ambient, cold and freezer warehouse storage, utilities production and a variety of support buildings.

 “The approval of our Covington, Georgia facility is a significant milestone for Shire and for the patients we serve,” said Matt Walker, head of technical operations for Shire.

The Covington site’s manufacturing suites are ISO 8 cleanroom and the filling isolator operates at ISO 5

“The increased manufacturing capacity from the site will support Shire’s growing Immunology franchise and further strengthens our ability to deliver complex therapies for patients around the world living with a range of rare and immune-mediated conditions.”

In 2017, Shire’s immunoglobulin portfolio delivered significant growth, with product sales increasing +18% versus prior year. In the first quarter of 2018, Shire’s immunoglobulin portfolio grew +12% driven by continued strong sales of subcutaneous products.

“The demand for immunoglobulin continues to accelerate, and we understand that the safe production of these plasma-based therapies is a time-consuming, intricate and highly-regulated process,” said John G. Boyle, president and CEO of the Immune Deficiency Foundation.

“The fact that even more people with primary immunodeficiency diseases have the potential to be helped, with the approval of a new, cutting-edge manufacturing facility specifically designed to produce complex plasma-based therapies, is welcome news for our patient community.”

The Covington site currently employs approximately 900 full-time colleagues and contract employees. Since the beginning of 2018, Shire has ramped up hiring to fill roles in manufacturing, quality, engineering, maintenance, utilities, warehouse, and various support and facility roles.

Shire expects to make a second submission to the FDA in 2018 for development of its albumin therapy at the Covington facility. Shire’s albumin therapy is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions.

Shire also plans to continue expanding its plasma collection network in Georgia and throughout the United States through its subsidiary, BioLife Plasma Services. BioLife collects the human plasma used in the manufacturing process for immunology products at the Covington facility.

Germitec Gets €4 Million Funding

The GRED Group has announced that it has provided financial support for Germitec, a company that develops and sells innovative disinfection systems for hospital hygiene.

This €4m financing enables Germitec to meet the demand in the healthcare sector for a simple solution to ensure compliance with the new requirements in ultrasound probe disinfection. Thanks to this investment, Germitec will be able to expand its presence in the European market and apply for FDA approval in the US.

The new global standards introducing requirements for disinfecting ultrasound probes and Germitec’s proven disinfection chamber technology convinced the GRED group to provide new financing for the company.

According to current guidelines, endo-cavity and transesophageal (TO) ultrasound probes must be disinfected between each use. In 2017, new requirements from the World Federation for Ultrasound in Medicine and Biology (WFUMB), the European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) and the European Society of Radiology (ESR) highlighted the need for High Level Disinfection (HLD).

The traditional HLD techniques such as chemical soaking, the use of multiple wipes or semi-automated systems use hydrogen peroxide (H2O2), a toxic chemical product, are complex and take between 10 and 30 minutes. Alternative solutions are therefore demanded, especially in the US.

This automatic HLD photonic platform has increasingly been recognized by international authorities and societies, which consider it as an appropriate method for disinfecting ultrasound probes.

Germitec uses UV disinfection thus creating a photonic high-level disinfection (HLD) system. The company’s products, Antigermix AS1 for vaginal and rectal probes and Antigermix AE1 for TO probes, are high speed (90 seconds), easy to use and pose no toxic risk (neither fumes nor residues left on the instruments).

In contrast to other HLD techniques, these products do not require any consumables, the probe does not need to be removed from the system at the end of disinfection process and it does not require rinsing.

The system uses sensors to check that the disinfection has been successful, in contrast to chemical systems which are operator-dependent. It uses a single plug socket and offers automatic traceability using RFID probe identification.

There is no longer the need to manually update the traceability log book to ensure compliance for healthcare centers using such devices. Lastly, photonic disinfection has been shown to be effective against HPV, which is a specific problem for endo-cavity ultrasound probes.

This automatic HLD photonic platform has increasingly been recognized by international authorities and societies, which consider it as an appropriate method for disinfecting ultrasound probes. These include the FNMR (French National Federation of Radiologists), WFUMB, ESR, EFSUMB and DEGUM (German Society for Ultrasound in Medicine).

Used as a routine method, Antigermix achieves substantial savings for users by allowing them to increase by five-fold the number of examinations performed (Urology Department at the HEGP in Paris) or reduce the number of required probes to a fifth (IVF Department at Saint Joseph Marseille). Healthcare professionals can even substantially reduce the rate of probe breakage (Créteil Hospital).

“We are very enthusiastic as this new investment will enable us to distribute our technology more widely. In Europe, we will create sales networks in the UK and Germany. In the US, where we receive many inquiries, we plan to start sales in early 2019. Germitec aims to provide a simple solution for sonographers now faced with more stringent disinfection requirements. Since the beginning of the year, we have sold four times as many systems as in the same period in 2017,” said Clément Deshays, founder and CEO of Germitec.

“Our solution radically simplifies the lives of healthcare professionals. It gives them peace of mind so they can concentrate on their patients, without worrying about toxic chemical products, manual traceability or disinfection time," said Deshays.

Deshays continued: "Antigermix works more quickly than the time it takes to bring the next patient in, which maximizes the number of examinations that can be performed daily without necessitating the purchase of additional probes. We are most grateful to our shareholders and users who, through their commitment, are creating a new standard in ultrasound practice.”

Teva to Relocate US Headquarters to New Jersey

Teva Pharmaceuticals USA, the United States division of Teva Pharmaceutical Industries, will move its US headquarters from North Wales, PA, to Parsippany-Troy Hills, NJ.

The company will expand its existing Parsippany-Troy Hills location to nearly 350,000 square feet and expects to transfer and create 843 jobs while retaining 232 existing positions. According to Teva, the move will consolidate its operations into a more centralized location to drive efficiencies.

“While Teva will retain a significant presence in Pennsylvania, reducing the number of sites supports our drive to continue to improve productivity and efficiencies,” said Brendan O’Grady, executive vice president and head of North America Commercial, Teva Pharmaceuticals, in a July 5, 2018 statement issued by the Office of Phil Murphy, governor of New Jersey. “We’re pleased to expand our presence in New Jersey, having closer proximity to a vibrant business hub and a dynamic life sciences environment—all while increasing jobs and preserving many existing roles.”

Teva Pharmaceutical Industries is a manufacturer of specialty and generic pharmaceuticals based in Israel that has a global product portfolio of more than 1800 molecules and a presence in 60 countries, including 30 locations across the US and its territories.

UDG Buys Two US-Based Firms

UDG Healthcare has acquired two healthcare-focused firms, expanding its global footprint and service offerings – including those in health economics and outcomes research – in a deal worth up to $82.4m.

UDG​ purchased two NY-based companies, SmartAnalyst, a strategic commercialization consulting and analytics business, and the communications agency Create NYC.

“Both transactions meet all of UDG’s acquisition criteria – good strategic and cultural fit, hit target financial hurdle rates and expand the group’s current capabilities,​” said Brendan McAtamney, UDG’s CEO.

McAtamney said the acquisition of SmartAnalyst is in line with Ashfield’s strategy of expanding its advisory services and follows the acquisition of STEM​ and Vynamic​.

Ashfield, UDG’s commercialization services division, provides advisory, communication, commercial, and clinical services.

The acquisition of SmartAnalyst also will provide Ashfield with access to commercial development decision makers, as well as infrastructure in India, McAtamney told Outsourcing-Pharma.com.

“Ashfield will provide leverage and opportunities to grow Smart Analyst’s customer base outside the US through Ashfield’s global business,”​ he added.

In addition to strategic consulting services, SmartAnalyst provides Health Economics and Outcomes Research (HEOR) services – an area in which there is growing demand.

McAtamney said, “HEOR is a high growth area, driven by market dynamics such as the increasing complexity of drugs, the changing landscape of market access, cost and regulatory pressures, and the increased scrutiny of real-world outcomes.”​

SmartAnalyst is being acquired for a total consideration of up to $24m and will be integrated into the UDG’s Advisory pillar.

Create NYC is healthcare creative communications agency, offering sales and marketing services for international pharmaceutical clients.

“The acquisition of Create NYC is in line with Ashfield’s strategy to expand into the area of creative communications, complementing its existing capabilities in core scientific communication,” ​said McAtamney.

Create NYC – which will become part of Ashfield Communications – is being acquired for a total consideration of up to $58.4m.

BASi Joins Operations with CRO Seventh Wave Labs

BASi and Seventh Wave Laboratories are joining operations via an asset purchase agreement, through which BASi will lease the CRO's facility in Maryland Heights, MO.

Following news of its asset purchase deal with Seventh Wave Laboratories – a consulting-based contract research organization (CRO) – Bioanalytical Systems (BASi) shares​ were up approximately 34%.

As per the asset purchase agreement (APA), Maryland Heights, MO-based Seventh Wave Laboratories received 1,500,000 Common Shares of BASi and approximately $7m in cash in exchange for its assets.

“We are all excited to have the APA complete and begin the integration process,”​ said Jill Blumhoff, CFO of BASi, a CRO based West Lafayette, IN. “We believe that our service offerings complement each other well and that we can leverage the scientific expertise of each company to achieve future growth.”​

According to the SEC filing​, BASi will lease “certain premises” in Maryland Heights, MO owned by SWL Properties LLC, an entity controlled by certain members of Seventh Wave Laboratories, including John Sagartz, Seventh Wave Laboratories’ president and CEO – who has joined the BASi Board of Directors as of today.

Under the lease arrangements, BASi has agreed to lease the premises for approximately seven years. The agreement will automatically extend for an additional two seven-year terms unless terminated.

Annual rent ranges from $390,000 for the first year to $440,987 for the seventh year, according to the filing.

Novartis-Penn Center for Advanced Cellular Therapeutics

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

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

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

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

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

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

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

German CRO Proinnovera Establishes U.S. Facility

The German dermatology CRO Proinnovera has opened a new U.S. base of operations through a wholly owned subsidiary based in Wilmington, North Carolina.

Proinnovera said it established an office in the U.S. in response to feedback from clients looking for a specialized global dermatology CRO in the country.

The subsidiary opened for business June 1, offering full-service clinical trial work in dermatology, immunology, inflammatory skin diseases, skin cancer and precancer, burns, wounds and aesthetics.

 “We’re seeing the need for global reach of dermatology studies ever increasing. We want to meet this need by offering our clients a global presence with deep and responsive local expertise,” Marion Breuer, who shares the role of CEO with owner Burkhard Breuer, said in a statement.

Headquartered in Münster, Germany, Proinnovera also named Sonja VanWye as vice president of U.S. clinical operations. VanWye will be responsible for general management, team development, vendor selection and expanding the CRO’s footprint in the country.

VanWye was director of clinical operations and head of project management for Novella Clinical, based in the state’s Raleigh-Durham-Chapel Hill research triangle area, which had previously acquired TKL Research’s phase 2-4 clinical trials division to serve as its dermatology unit.

Tate Hall at the University of Minnesota

The face of education is changing—how students learn, how instructors teach and how universities innovate. With the focus on collaboration and communication driving changes in educational facilities, many institutions are embarking on major renovations to modernize their buildings while tailoring them to better suit scholars’ needs. Designing the best learning environment possible while providing flexibility for future changes in technology or classroom configuration needs is a huge challenge in and of itself; combine that with large-scale renovations within an historic building in the heart of a college campus, and you have John T. Tate Hall at the University of Minnesota.

John T. Tate Hall now houses the School of Physics and Astronomy and the Department of Earth Sciences; it includes 29 teaching labs, 26 research labs, state-of-the-art classrooms and a rooftop space for stargazing.

With students and faculty spread out across multiple building on campus, the university wanted space to house the School of Physics and Astronomy and Department of Earth Sciences. Featuring 29 teaching labs and 26 research labs, as well as state-of-the-art classrooms, offices, an atrium and rooftop space for stargazing, the renovations allowed the university to leverage cross-departmental capabilities to create connections for research and discovery through co-locating. Now complete, the building houses 350 faculty, post-grad students and researchers, and serves 5,000 students per semester.

In total, Tate Hall accommodates 24 research clusters between the physics, astronomy and earth sciences schools. All not only have unique needs, but they also bring their own challenges. Designing and installing 21st century MEP systems in a 20th century building only compounded some of these, particularly due to extremely limited floor-to-floor heights. With 40-plus hoods in the labs requiring dedicated fume exhaust and lab services, fitting these systems into such a tight, constrained space required precision and coordination among the teams.

Since this was the third major addition/renovation to the building since its original construction in 1926, and there was no guarantee the previous drawings truly represented the as-built conditions, it was imperative to get an accurate picture of existing conditions. To do this, we performed a floor-by-floor laser scan after selective demolition to capture the existing structural conditions and then integrated the point cloud from the scan into our BIM model for coordination of new MEP, fire protection and structural systems. Here, we found variances in the existing structure and identified discrepancies from the design model, including pan and joist spacings that did not match as-built drawings and variances in the concrete slabs where the formwork had settled. Once identified, we were able to adjust all vertical penetrations and modify equipment sizes to accommodate existing structure, in some cases leaving less than a quarter-inch tolerance.

“We were able to leverage our laser scan technology to facilitate the BIM coordination process to a level that exceeded anything we had done previously,” said Superintendent Brad Meyer. “This allowed us to produce precise installation drawings that worked within the constraints the existing construction. We were also able ensure the systems were easy to maintain; for instance, the acid hoods in spaces below grade required long horizontal runs of fiberglass and Teflon-coated stainless steel duct, so the team designed and modeled access panels within the ductwork, to facilitate manual duct wash by university facilities management if needed.”

Highly energy efficient mechanical and electrical systems were not the only unique components; with various research and projects constantly underway, equipment requirements were wide-ranging as well. One of the most unique in the building was the shielded room, located within the lab for the Institute of Rock Magnetism. With such sensitive magnetic geoscience research taking place, the shielded room required some creative solutions to maintain the integrity of the space.

The renovation of John T. Tate Hall includes an atrium between previous additions to the historic building originally constructed in 1926.

Because the room is intended to divert the Earth’s magnetic field, the team worked in conjunction with researchers and other partners to ensure it met the requirements of the users as well as performed at an optimal level. The first step in designing the room was locating Earth’s magnetic field before designing and orienting the shield in such a way that would redirect the field, so it would not contaminate any of the research going on inside of the room. Once located and designed, construction followed stringent guidelines for materials and penetrations through the shield to ensure its final performance.

“Six feet above and below the room had to be non-ferrous construction—so to account for that, wood studs for adjacent spaces were utilized in lieu of steel and all surrounding building systems and services were constructed of aluminum, copper, stainless steel and other non-ferrous materials. We worked hand-in-hand with the researchers to identify materials that could not meet the non-ferrous requirement and de-magnetize them to ensure they would not disrupt the magnetic field in the space,” said Meyer.

Senior Scientist Peat Solheid is currently studying paleo-climate records using magnetic proxies from ocean and lake cores. Solheid’s input throughout design and construction was integral to building the shielded room to ensure it worked correctly. “Earth’s magnetic poles shift very slowly over time—millions of years—and everything is recorded in rocks and sediments that accumulate in the ocean. When settled, particles align to the magnetic field at that time, so, using samples, we can tell where a continent was located to see how it’s shifted since,” he said.

“The room is working great. It’s a little bit bigger and has more usable space around it, so we are able to add more equipment, such as a magnetic microscope, to further enhance our study of paleomagnetism,” he said.

Meeting the requirements of each lab, no matter how complex, was only one piece of the puzzle; keeping research groups operational while installing and moving research equipment was equally as challenging. Coming from multiple buildings on campus, we had to minimize downtime and get occupants up and running in new their labs with the least disruption as possible. Again, because this was a renovation, we had to work within the confines of the building and schedule equipment and installations accordingly. In the case of two 10,000+-pound presses we actually had to leave an opening in the exterior of the building to crane them into the third floor, then finish exterior construction following the equipment installation.

The presses were not the only challenging installation. For instance, we had to facilitate installation of a relocated XRCT machine, a 12,000-pound machine that X-rays cross-sections of objects to create virtual models, in the sub-basement. Due to its location within the building, a two-story vertical concrete shaft was constructed from sub-basement to grade, allowing a path for the equipment to be lowered into the building as late as possible; this allowed them to continue research in their existing space right up to the last minute.  The shaft was then capped in a manner that would allow for removal or replacement of the equipment in the future if needed.

“Giving them as much flexibility as we possibly could while maintaining the integrity of the space for future needs was extremely important to the process,” said Meyer.

The lab used by the Institute of Rock Magnetism includes a shielded room that diverts Earth’s magnetic field to protect the integrity of the research inside the room.

While many of the challenges of the renovation were a result of the existing conditions, the age of the building necessitated upgrades in other areas as well. As part of the historic Northrop Mall, the façade of the building was a very sensitive area of the project.  One of components most in need of attention was the existing wood windows. To keep the historic look, we removed and refurbished all windows, stripping them down to bare wood (selectively repaired frame and sash components were needed) and re-glazed them following abatement of glazing compounds.

Once refurbishing was complete, we re-installed the windows, but because of the stringent energy performance requirements on the project, we added insulated interior storm windows to create a high-performing building envelope. This allowed us to maintain the historic aesthetic of the building while meeting the requirements Minnesota’s rigorous B3 Guidelines for sustainability and building performance.

“The vitality of the building is so dramatically different inside after the renovation was complete, and yet the view from the Mall looks like a well-maintained old building.  It was exactly what the entire project team had always envisioned,” said Eric Danielson, National Director of Science & Technology at JE Dunn. “The new building systems we selected and installed will make this one of the most sustainable labs on campus.”

Sustainable, state-of-the-art and equipped for evolving technology, the renovation of John T. Tate Hall was a total team effort. From demo to virtual modeling, all the way to precise design and installation, every partner—along with university staff and researchers—was involved to ensure it met today’s demands while maintaining the historic building’s distinguishable façade. The result was a world-class facility researchers, faculty and students at the University of Minnesota will use to continue changing the future of science.

With nearly 20 years of professional experience, Brett Dunlap, Senior Project Manager, ICRA Accredited, JE Dunn Construction, has an impressive portfolio of completed projects focusing on science and technology, higher education, and cultural/arts facilities. He works closely with owners, architects and trade partners to find a balance between realizing the client’s goals, design intent and constructability. Brett holds a Bachelor of Science in Construction Management from the University of Minnesota. He has worked on a half-dozen high profile projects with his alma mater, including the Tate Science and Teaching Lab renovation and current work on the new Health Science Education Center.

REST OF WORLD

West Opens New Global Manufacturing Facility

West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, announced the official opening of its new Waterford, Ireland facility, a global center of excellence for West's advanced manufacturing network, and the launch of a new product line—Westar® Select.

"West is very pleased to celebrate the official opening of our state-of-the-art facility in Waterford, as well as the launch of Westar Select, both of which are the culmination of efforts by many to support our company's commitment to meeting the dynamic needs of our pharmaceutical and biotech partners," said Eric Green, President and CEO, West. "Our investment in Waterford, in addition to our previously announced investments in Kinston, N.C., Jurong, Singapore, and Dublin, Ireland, enable West to provide the highest levels of quality across the products and services we provide for the global customer base we serve."

The new, 220,580 sq. ft. (20,500 square meter) facility, situated on a 44-acre campus, will produce West's proprietary elastomeric laminate sheeting, which is used to package insulin for use in pen injectors. Additionally, it will offer high-value finishing for components, including stoppers and plungers, produced at other West facilities around the world. These services, designed to mitigate the risk of potential contamination and compatibility issues with packaging components, include pharmaceutical washing (Westar® RS components), Envision® verification, steam sterilization (Westar® RU components), and flexible packaging offerings.

The Waterford site will also be among the first in West's global manufacturing network to produce Westar Select, the latest in West's Westar® quality enhancement offering. In addition to a tighter particulate specification, Westar Select will be made available through an optimized global manufacturing network with multi-site production capabilities to ensure a continuous supply chain, while helping to reduce regulatory complexity for customers.

"At West, we understand that our customers are increasingly challenged to meet new and expanding regulatory requirements, and with that comes an expectation for the highest quality in drug delivery and packaging components," said David Montecalvo, Senior Vice President, Global Operations and Supply Chain, West.  "Westar Select employs next generation manufacturing capabilities and product attributes that enable us to optimize product specifications, and to respond more rapidly and flexibly to customer demand and evolving market needs."

West's Waterford facility currently employs approximately 100 people in both local and global functions, with plans for additional hiring. Commercial production in Waterford is expected this year. West also has a manufacturing and development center in Dublin that provides design, development and manufacturing services for pharmaceutical and medical technology customers. The Dublin site recently completed an expansion to accommodate new customer programs and employs approximately 600 people.

About West:

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 net sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.

Promolding Operates New ISO Class 7 Cleanroom

Promolding, a Dutch injection molding company, has announced the opening of a new ISO Class 7 cleanroom. The 3,766 sq. ft. (350 sqm), dust-free and clean space entered operation in July. The company awarded the build to Connect 2 Cleanrooms BV.

In this cleanroom mainly medical instruments are produced and assembled. Promolding said the new cleanroom will further strengthen its connection with the medical sector.

Products for the medical industry require a clean working environment. In the ISO Class 7 cleanroom, Promolding can now guarantee a clean injection molding and assembly process under ISO 14644 regulated conditions.

The cleanroom with an internal change/transfer area, various assembly machines, a laser welding machine and a fully autonomous handling system

As requested by Promolding, Connect 2 Cleanrooms BV equipped this ISO Class 7 cleanroom with an internal change/transfer area, various assembly machines, a laser welding machine and a fully autonomous handling system.

Two injection molding machines are connected to the cleanroom: a full electric injection molding machine with 80 tons capacity and a 2K 300 tons injection molding machine.

Commenting on the investment, Menco Verduin, Promolding MD, said: "The conditions under which you can develop medical instruments are very strict; the inspection criteria are also stringent, especially for invasive use. The final product must be thoroughly tested for contamination. In this new cleanroom the risks have been reduced to a minimum and circumstances stabilized optimally."

Promolding offers customers complete solutions with development and injection molding of hi-tech plastic products, from product design, engineering to injection molding and assembling.

Chugai Pharmaceutical’s New Synthetic Research Facility, Tokyo

Chugai Pharmaceutical is developing a new synthetic research facility at its existing location in Kita-ku, Tokyo, Japan.

Announced in June 2018, construction on the new research facility is expected to begin in October 2018 and is scheduled for completion by November 2019. Operations are estimated to commence by January 2020.

Chugai Pharmaceutical is investing CNY4.5bn ($40.5m) in the project, which is expected to enhance the process development for small and middle molecule active pharmaceutical ingredients (API).

Chugai Pharmaceutical’s existing Ukima Research Laboratories in Kita-ku is built on a 337,035 sq. ft. (31,323m²) site and has a total floor area of 636,970 sq. ft. (59,198m²).

The research activities carried out at Ukima Research Laboratories include API manufacturing and product design. The facility also develops quality testing methods and analyses the structure and physical properties of pharmaceuticals.

Chugai Pharmaceutical’s new synthetic research facility will be a six-story building with a total site area of 105,986 (985m²) and floor area of 52,993 sq. ft. (4,925m²).

Advanced containment technologies and research equipment will be installed, which will be leak-proof to protect researchers from being exposed to harmful chemical compounds.

The layout of the new facility will be designed to improve communication among researchers. The facility will be equipped with high-potency API (HPAPI) facilities, which will enable Chugai Pharmaceutical to carry out process development ranging from early development to commercial production of new drug candidates.

The new facility will enable an expansion of existing research activities in regards to high-potency APIs. It will carry out synthetic research, which is expected to further strengthen the process development for small and middle molecule APIs.

The project is aimed to accelerate innovation and productivity through research by speeding up the development processes for new middle molecule pharmaceuticals.

Small molecule drugs penetrate into cells but cannot block protein-protein interactions. They have a molecular weight of 500g per mole (gm/mol), are manufactured through organic synthesis and can be administered either orally or through injection method. Conversely, therapeutic antibodies can act on specific target bodies but cannot pass through cell membranes due to their size.

Middle molecule drugs combine the advantages of both small molecule drugs and therapeutic antibodies. They are able to reach targets that are unapproachable by small molecule drugs and therapeutic antibodies alone, as they have the capability to enter cells and act actively and specifically on targets.

These next-generation medicines have a molecular weight in the range of 500gm/mol and 2,000gm/mol.

Marketing commentary on Chugai Pharmaceutical:

Based in Tokyo, Chugai Pharmaceutical is a research-based pharmaceutical company that manufactures biotechnological products.

The company specializes in prescription pharmaceuticals and is a member of the Roche Group. It develops innovative products to satisfy unmet medical needs with a specific focus in the field of oncology.

Chugai Pharmaceutical’s research facilities are located in Gotemba and Kamakura in Japan. The company also operates a facility in Singapore, which focuses on generating novel antibody drugs using its proprietary innovative antibody engineering technologies.

Chugai Pharma USA and Chugai Pharma Marketing are two subsidiaries of Chugai Pharmaceutical, which are involved in clinical development activities in the US and Europe.

Wockhardt Sets Up Manufacturing and R&D Plant in Dubai

Wockhardt, the global pharmaceutical and biotech group, has built a 107,600 sq. ft. (10,000sqm) manufacturing and R&D facility in Dubai. The building, a US$40 million investment, is the company's first in the Middle East.

Located in the Jebel Ali Free Zone (Jafza), Wockhardt's new plant has been designed for production and packaging of sterile dry powder injection.

India’s Wockhardt is working to develop antimicrobial drugs to fight the emerging threat of superbugs. On approval of the new drug by the US Food and Drug Administration, FDA, the manufacturing facility will be commissioned for commercial production. The plant will be used for manufacturing of NCEs (New Chemical Entities) catering to the global markets through the Dubai arm of its subsidiary Wockhardt Bio AG.

Wockhardt currently has five novel antibiotic drugs in advanced stages of global clinical development, which will be effective against the “superbugs” threats identified by the Center of Disease Control, in the US. Considering the strategic importance of these antibiotics, the FDA has granted Qualified Infectious Disease Program (QIDP) status to these antibiotic drugs.

Speaking at the opening ceremony, Dr Habil Khorakiwala, founder chairman of Wockhardt, said: “Wockhardt is poised for a quantum leap into the future. It is a future of dynamic changes, exciting possibilities and endless potential to further its goal of ‘Life Wins’ and Wockhardt is committed to shaping this future.

Dr Habil Khorakiwala said, "With Wockhardt’s commitment to R&D, we have five, breakthrough NCEs that have been accorded Qualified Infectious Disease Product (QIDP) status by US FDA. With the new facility in the Middle East, we aim to focus on our commitment to developing NCEs to fight the health issues faced.”

The Wockhardt Bio AG manufacturing facility is designed to meet the standards of various international regulatory agencies and those set by the Local Ministry of Health. "The plant meets the needs of aseptic dry powder injectable manufacturing and filling with a high-quality operation, the company said.

The facility is spread over 10,000 sqm (107,639-square-foot) self-sufficient for handling Warehousing, Manufacturing Operations, Product Testing and Product Stability. It is equipped with best-in-class and fully automated manufacturing machinery and clean utility systems. The design takes into account the requirements for Product and Personnel Safety and Product Quality with complete close transfers and high levels of sterility assurances.

Wockhardt employs over 9,000 people and 27 nationalities with a presence in the US, UK, Ireland, Switzerland, France, Mexico, Russia.

Lindstrom Launches Cleanroom Services In India

Lindström India, a wholly-owned subsidiary of the Finnish textile rental service company Lindström Oy, has opened its first a cleanroom workwear services in India.

Located in the town of Chakan, Pune, in the western Indian state of Maharashtra, Lindström India's cleanroom workwear services will cater to customers in the pharmaceutical, food and electronics industry.

Lindström's cleanroom services ensure hygienic production facilities by providing garments serviced in cleanroom laundries, which prevent contamination during process thus ensuring complete safety of the products being manufactured. The facility, built with ISO 8 classification, operates according to ISO 14644 and adhere to GMP procedures. Processes in the cleanroom include RFID reader, soil sorting, washing, folding and packing.

Serum Institute of India, an immunobiological drugs manufacturer headquartered in Pune, is the first client to sign up for the service. Lindstrom told Cleanroom Technology that the company is actively seeking new clients in the region.

Anupam Chakrabarty, senior VP sales and markets, Lindström Global, and managing director at Lindström India, said: “In highly controlled production conditions, people are the most common sources of contamination. The cleanroom unit ensures that the workwear being serviced is free from dust, viable, organism or particles thereby allowing the customer to run their business smoothly and safely.

"We’re delighted to launch our first cleanroom unit for the Serum Institute of India, a leader and innovator in the Indian pharmaceutical industry that focuses heavily on the quality standards for its consumers.”

The cleanroom covers more than 50,000 sq. ft. of space and has a capacity of servicing 400,000 items of uniforms per month.

The staff has received training from experts in Finland and operates under classified cleanroom environment to guarantee the supply of particle-free and contamination-free garments to its customers.

Commenting on the inauguration, Dr Suresh Jadhav, executive director at Serum Institute of India, said: “We’re very excited about the launch of Lindström’s first cleanroom unit for us. We have been working with Lindström for the last two years on this project and see huge value in the professional workwear services they offer. The cleanroom unit is a huge step in our mission of conforming to the highest industry standards and our commitment to quality."

Headquartered in Mumbai, Lindström India is backed by 600 employees. The company entered the country in 2007 and has put up 11 service centers in many cities including Mumbai, Delhi NCR, Kolkata, Chennai, Bengaluru, Hyderabad, Pune, Vadodara, Panchkula, Tinsukia and Vishakhapatnam. These units have a combined capacity to process about 2.5 million garments per month.

Serum Institute India was founded in 1966 by Dr Cyrus Poonawalla. Ranked as India’s no. 1 biotechnology company, it is deemed the world’s biggest vaccine manufacturer with a sale record of more than 1.6 billion doses. Serum Institute exports vaccines to more than 170 countries.

Lindström Group employs 4,000 people in various locations across Europe and Asia. The company clothes more than 100,000 people on a daily basis across India and over one million people globally.

Infrastructure Boost To Bhadrachalam Hospital

An air-conditioned conference hall with LCD projector has become operational at the government area hospital in Bhadrachalam, further augmenting the infrastructure facilities in the State-run healthcare facility in Telangana’s tribal heartland.

The new facility is expected to facilitate smooth conduct of training sessions for the doctors and other staff members of the hospital as well as continuous medical education programs in a conducive ambience.

The long-awaited facility becoming a reality comes close on the heels of the Government Area Hospital in Bhadrachalam reportedly securing the coveted National Quality Assurance Standards (NQAS) certification recently.

A town-based doctor has donated ₹4 lakh towards purchase of air-conditioners, furniture and other necessary equipment for the new conference hall, sources added.

The recently-opened dialysis center at the hospital has emerged as a sought-after facility with 10 to 14 kidney patients from the Agency areas availing services at the center daily.

The more than half-century old hospital in the temple town has witnessed marked improvement in healthcare infrastructure facilities in the past few years. However, the hospital continues to grapple with severe shortage of staff nurses. As against the sanctioned strength of 62 staff nurses, the hospital presently has only 15, sources added.

Hospital Superintendent Dr. Koti Reddy told The Hindu that the hospital is the first Area Hospital in the State to get the coveted NQAS certification. The newly opened conference hall is set to prove immensely beneficial in conducting CME and other training programs in a productive manner. As many as 20 posts of specialist doctors, including pediatricians, physicians, and surgeons, have been filled, he said.

Chugai Pharmaceutical to Expand Singaporean Research Subsidiary

Japan-based Chugai Pharmaceutical has revealed plans to expand its research subsidiary in Singapore, Chugai Pharmabody Research (CPR), in order to enhance its drug discovery capabilities.

As part of the expansion, the company is extending the operations of the subsidiary for additional five years from 2022 to 2026, with SGD282m ($207.03m) investment.

CPR was founded in 2012 to carry out research for the discovery of new antibody drugs using Chugai’s antibody engineering technologies.

Originally, the operation period was planned to be five years until 2016, but an initial investment of SGD476m ($349.46m) was announced for ten years from 2012 to 2021.

Chugai Pharmaceutical Research and Translational Clinical Research executive vice-president Hisafumi Okabe said: “Chugai Group’s drug discovery approach has successfully generated new breakthrough drugs including Actemra and Hemlibra by utilizing our proprietary advantage including antibody engineering technologies.

“We seek to accelerate creation of drug candidates with the next-generation antibody technologies by combining expertise of our three research laboratories, CPR, Kamakura Research Laboratories, and Fuji Gotemba Research Laboratories, toward continuous creation of innovation in the future.”

The company is also planning to build a new synthetic research facility at its Ukima Research Laboratories in Tokyo, Japan, to advance the process development of small and medium-sized molecule active pharmaceutical ingredients (APIs).

Chugai will equip the new building with research facilities for high-potency APIs (HPAPIs). The facility will feature advanced containment technologies to ensure safety by preventing leakage and exposure to chemical compounds.

Additionally, the company will install new equipment and instruments in order to increase research efficiency and adopt a layout that expedites communication among researchers.

The improved innovation and research productivity are aimed at accelerating the process development for new therapeutic candidates.

ACG Becomes India’s First In-House Packaging Provider for Oral Solid Meds

ACG has expanded its capabilities by completing its work on a lamination facility to be able to complete all packaging requirements for solid oral medication in-house.

The upgraded operations means that the Associate Capsule Group (ACG) Films & Foil business, based in Pune, India, becomes the first in the country to be able to produce the packaging of oral solid dosage formulation medication in one facility from the raw materials involved – from the resin used to produce films to the raw aluminum used to create the laminate.

CEO of the company, S. R. Shivshankar, answered our question on what the opening of the new facility brings to the company: “The new facility houses a high precision machine with excellent process controls, ensuring the control of specification within the allowed global standards of the final product. By manufacturing the aluminum packaging laminates on this machine, ACG will be ensuring high productivity on the packing line at our customers' end and minimal wastage and appropriate protection of end medicines as per the requirements of the end customers.”​

The latter point, in regards to minimal wastage, is one that Shivshankar noted is a growing trend in the industry: “Companies are aligning more and more towards sustainability in the ecosystem – be it a reduction in carbon footprint or more recyclable initiatives or even biodegradability of packaging material.”​

Shivshankar highlighted how being able to produce everything in the same facility will allow his company to achieve “identical performance as produced by our competitors in Europe.”​

He revealed why this is attractive to potential customers: “We are able to offer comprehensive solutions to customers with all high-performance barrier packaging needs being catered to under one roof. It also helps them mitigate risks in their supply chain and look for newer and more affordable alternatives.”​

The Asia-Pacific region is now beginning to accrue a larger share of global pharmaceutical market, through the development of low-cost generics​; such growth means that global companies are now looking to make in-roads in the local market​ and so the evolution of services, such as ACG’s work to match European standards, will be of increasing importance into the future.

Wuxi Biologics Completes First cGMP Run in MFG3 Facility

WuXi Biologics has announced that the first GMP run in the new facility in Shanghai was completed successfully. The Chinese CDMO said it now operates the largest mammalian cell culture capacity in China with total bioreactor capacity of approximately 43,000L and can run 10 GMP campaigns of different products ranging from 50L-12,000L scale at the same time.

The 200,000 sq. ft. MFG3 facility (third manufacturing plant) includes process development labs and six production lines: 2 x 2,000L fed-batch, 1 x 1,000L fed-batch and 1 x 200L fed-batch, 1 x 1,000L perfusion and 1 x 500L perfusion.

The flexible design can handle production from 50L-2,000L scale fed-batch production and 125L-1,000L scale perfusion production.

In addition, the facility includes both traditional fed-batch operations and new continuous perfusion suites coupled with continuous purification; one of the first next-generation manufacturing platforms to be implemented in the global biologics industry, the company said.

“We are continuing to expand our capacity to enable global partners and expedite biologics development. With this newly added capacity, WuXi Biologics will be able to enable 60 IND projects and 3 BLA projects per year, which showcases our unparalleled capacities,” said Dr Chris Chen, WuXi Biologics CEO.

“With globally recognized technical capabilities and unparalleled capacities, we are transforming how biologics are developed and manufactured globally," Chen concluded.

WuXi Biologics product is intended for the global market for a client in China, and that the company will soon start production for a client in the US.

Sterigenics Expands European Capacity

Sterigenics, a global provider of sterilization and advisory services, is building a new facility in Markham Vale North in Chesterfield/Derbyshire, UK, significantly expanding its European footprint.

The new 60,000-square-foot facility, scheduled for completion in 4Q18, will include the installation of a state-of-the-art Nordion JS10000 gamma irradiator with a research loop, adding gamma sterilization capabilities in the UK to complement its existing ethylene oxide (EtO) facility in Somercotes/Derbyshire.

“Sterigenics is committed to being the world’s leading provider of sterilization services and partnering with our customers to eliminate threats to human health,” said Philip Macnabb, president of Sterigenics. “We continue to invest in our global network to meet our customers’ growing demand for gamma irradiation capacity as a critical step in their product development processes. Our new Markham Vale facility will strengthen our ability to serve our European customers, particularly in the MedTech and pharmaceutical fields, and help them innovate with success.”

The new facility will provide routine gamma, GammaStat rapid processing and process validation, as well as laboratory testing services in nearby Somercotes through its Nelson Labs business. The facility will expand Sterigenics’ total gamma irradiation capacity in Europe, adding to existing gamma facilities located in Belgium and Italy.

Sterigenics is making significant investments to expand both gamma and ethylene oxide (EtO) sterilization capacity throughout its global network. In August 2017, the company completed a major expansion of its Forth Worth facility, adding gamma capacity and increasing total sterilization throughput, and in June 2017 completed a project that significantly increased throughput at its operation in West Memphis, AR.

Aspen Pharma’s High-Containment Manufacturing Facility, Port Elizabeth, South Africa

Estimated to have cost more than R1bn ($70m), the new facility is part of Aspen’s commitment to expand its manufacturing capacity and strengthen South Africa’s industrialization program by supporting the production of local products.

Aspen is also developing a new small-volume facility at the same site, which is expected to create more than 500 jobs.

The new high-containment suite is spread over an area of 247,480 sq. ft. (23,000m²). More than 95% of products produced at the facility will be exported to Asia, Europe, Africa and Latin America.

The sterile facility at the site will be equipped with pre-filled syringe capability for low molecular weight heparin injectables. The products will be supplied to the domestic and offshore markets.

Aspen is also undertaking numerous capacity enhancement projects at the project site.

The new facility will be used for manufacturing high potent oncological compounds. It will produce drugs such as Alkeran, Leukeran, and Purinethol, which are indicated for the treatment of late-stage cancers, as well as Benztropine and Imuran.

Imuran is used for the treatment of autoimmune diseases, while Benztropine is indicated for the treatment of Parkinson’s disease will also be produced at the site.

The facility will manufacture more than 3.6 billion tablets a year. It will also be capable of packaging three million bottles a month when operating at full capacity.

The parental facility will produce MDR-TB injection Capreomycin and more than 40 million units of Murine® eye drops, one of the biggest over-the-counter (OTC) eye drop brand in the US.

The Republic of South Africa’s Department of Trade and Industry provided Aspen Pharma with R209m ($16m) in tax incentives under its 12I tax incentive.

The tax incentive is designed to support greenfield investments such as new industrial projects and brownfield investments, including retrofitting and upgrading of existing industrial projects.

Investment in the new facility will enable Aspen to increase and expand its product portfolio that requires complex manufacturing processes.

The facility will also strengthen South Africa’s export capability by adding skilled workforce and introducing new technologies.

More than 90% of the jobs generated at the new facility will be from the local and surrounding communities.

Marketing commentary on Aspen Pharma:

Based in South Africa, Aspen is a pharmaceutical company that provides generic pharmaceuticals for the treatment of acute and chronic diseases.

The company’s product portfolio includes oral solid dose products, liquids, biologicals, active pharmaceutical ingredients (API) and infant nutrition products. Aspen supplies its products to more than 150 countries globally.

Aspen is present in more than 50 countries across six continents employing more than 10,000 people. It has more than 28 manufacturing facilities at eight locations around the world, including three in South Africa.

The company employs more than 3,000 members across Port Elizabeth, Eastern Cape, and East London sites of South Africa.

Merck Serono’s Pharmaceutical Manufacturing Facility, Nantong

In August 2014, Merck Serono began constructing a new pharmaceutical manufacturing facility in Nantong, China.

Inaugurated in November 2016, the facility is Merck’s second largest pharmaceutical manufacturing plant worldwide. It produces and packages drug brands, including Glucophage, Concor and Euthyrox, which are used for the treatment of diabetes, cardiovascular diseases and thyroid disorders respectively.

The large-scale greenfield investment strengthens Merck’s presence in China and localizes research and development (R&D) to further enhance its portfolio of medicines in general and specialized segments.

It made Merck one of the first multinational companies (MNC) in China to produce drugs listed in China’s Essential Drug List (EDL), which contains therapies meant to meet the healthcare needs of the public.

Merck’s Nantong pharmaceutical manufacturing facility background

“The new biopharma facility in China is dedicated to the bulk production of multiple types of oral solid dosage (OSD) drugs and their final packaging.”

Merck announced its plans to build a €80m ($86.8m) pharmaceutical manufacturing facility in China in November 2013.

During the signing ceremony, Merck announced it would make a total investment of €170m ($188m) in China’s pharmaceutical and healthcare industry.

The new plant was constructed in the BioSpark zone of Nantong Economical Technological Development Area (NETDA) in the Greater Shanghai region. This is located approximately 100km north in the City of Nantong, Jiangsu Province, China.

BioSpark is a high-tech industrial park in the NETDA region that is designed to attract multinational and small and medium-sized companies to establish pharmaceutical manufacturing, R&D and related supply chain activities in China.

Nantong, the eastern coastal city of China, offers unique advantages in terms of geography, resource allocation, supply and other factors.

Merck’s Pharmaceutical Packaging Facility, Hangzhou, China

Merck officially inaugurated a new drug packaging facility at Hangzhou in April 2013.

The new pharmaceutical facility was constructed in a 430,400 sq. ft. (40,000m²) area, which has provision for further extension by up to 215,200 sq. ft. (20,000m²).

It has a total built-up area of 408,880 sq. ft. (38,000m²), with the production building occupying 247,480 sq. ft. (23,000m²) and the warehouse and logistics building occupying 96,840 sq. ft. (9,000m²).

Both production and warehouse facilities are dedicated to high-level current good manufacturing practice (cGMP) activities. The support buildings will comprise central utilities, a fire-fighting pump station, a canteen and offices.

The plant is designed in accordance with international standards in terms of quality, environment and health and safety to ensure the availability of high-quality medicines for patients. Sustainable measures are being implemented during the plant’s construction to maximize resource efficiency and minimize waste generation during manufacturing.

The manufacturing site currently provides employment to 180 people, which is expected to increase to more than 400 by 2021.

The new biopharma facility in China is dedicated to the bulk production of multiple types of oral solid dosage (OSD) drugs and their final packaging, as well as the company’s pharmaceutical preparations for the treatment of diabetes, cardiovascular disease, thyroid disorders and other diseases.

Merck awarded the project’s construction contract to German high-tech engineering and construction company M+W Group in October 2014.

The contractual scope includes engineering design, procurement, construction management and validation.

Merck has been operating in China for more than eight decades and is consistently expanding its presence.

The company focuses on the pharmaceutical, chemical and life science sectors of the rapidly growing Chinese market, which is one of its eight strategic countries.

Besides the new manufacturing site in Nantong, Merck’s recent investments in China include a pharmaceutical research center in Beijing, a biopharmaceutical technical and training center in Shanghai and a liquid crystals production unit in Shanghai.

Boehringer Ingelheim Biologicals Development Centre (BDC), Biberach, Germany

Boehringer Ingelheim is developing a new biologicals development center (BDC) within its Biberach plant site in Germany.

The new facility will focus on therapeutic areas such as cancer and immunological diseases.

The foundation stone for Boehringer Ingelheim Biologicals Development Centre was laid in June 2018 and a phased opening is expected to commence in early-2020. Boehringer Ingelheim is making an estimated investment of €230m ($266.4m) in the facility.

The project is expected to create approximately 100 new jobs and increase the size of the development team at Biberach to 500.

The new development center will complement Boehringer Ingelheim’s investments in its global biopharmaceutical development network. The company is already investing in a cell culture plant in Vienna, a new production facility for biopharmaceuticals in China, and a production expansion project in California, US.

Details of Boehringer Ingelheim biologicals development center:

The new biologicals development center at Biberach is part of Boehringer Ingelheim’s long-term plan to expand its biologic drugs development segment, including key therapeutic areas immuno-oncology and immunology.

The share of biologically active substances in the company’s pipeline has been steadily increasing and currently stands at 40%.

The new investment is expected to consolidate the biological analysis, process development and drug manufacturing for clinical trials departments, and minimize the pathways and generating synergies.

The facility is expected to conduct biopharmaceutical drug development in addition to research and development (R&D), increasing the overall development capacity. It is also expected to create capacity for contract manufacturing.

The Biberach plant is one of the biggest biopharmaceutical manufacturing plants in Europe and produces medicinal proteins and antibodies from cell cultures of mammals.

The company’s BioXcellence unit operates a pilot plant and two large-scale manufacturing plants for contract manufacturing at the site. It offers an entire production chain that starts from DNA to fill and finish, alongside customized contract development and manufacturing solutions.

The plant employs fed-batch process as its core technology, but also offers perfusion processes in 2,000l fermenters established as an integral part of the commercial plant. A single-use plant comprising bioreactors from 100l to 500l, as well as a fully-disposable downstream processing facility is also part of the plant.

The facility manufactures clinical and commercial cell banks under good manufacturing practice (GMP), and has generated and released approximately 200 master, working and bioassay cell banks during the last 15 years.

Marketing commentary on Boehringer Ingelheim:

Founded in 1885, Boehringer Ingelheim has established itself as one of biggest pharmaceutical companies in the world. Headquartered in Ingelheim, Germany, the family-owned company operates globally with 181 subsidiaries and employs approximately 50,000 people.

The company’s operations centers around core business areas, human health, animal health and biopharmaceuticals. It focuses on adding value through innovation and invests more than 20% of its net sales towards the R&D of human pharmaceuticals.

Boehringer also focuses on organic growth from its own resources by forming partnerships and strategic alliances in research. The company recorded net sales of approximately €18.1bn ($21.6bn) in 2017 and spent more than €3bn ($3.59bn) on R&D, which is equivalent to 17% of net sales.

Minakem’s High-Containment Production Facility, Louvain-la-Neuve, Belgium

The facility will be equipped with a preparative chromatography system that permits the isolation and purification of target molecules.

The new Belgian high-containment facility consists of six production lines.

A GMP kilo-lab manufacturing laboratory has already been commissioned at the facility.

The new facility will enable Minakem to produce highly potent active pharmaceutical ingredients and antibody drug conjugates.

Minakem plans to open its new high-containment production facility in Louvain-la-Neuve, Belgium in August 2018.

Minakem is developing a new high-containment production facility at its Louvain-la-Neuve site in Belgium.

The new facility will enable Minakem to safely develop and produce bulk quantities of highly potent compounds economically. It will also extend the company’s capability to manufacture highly potent active pharmaceutical ingredients (API) and antibody drug conjugates (ADC) from small-scale to full-scale good manufacturing practice (GMP) batch releases.

Minakem plans to open the new facility in August 2018 and commence commercial operations in September. The company is expected to employ more than 110 qualified personnel at the new facility.

Minakem is a contract development and manufacturing organization (CDMO) division of chemical production company Minafin.

The new facility is located in Minakem’s Louvain-la-Neuve site in Belgium, which operates as a separate entity named Minakem High Potent.

It is in close proximity to two of Minakem’s existing API sites in Louvain-la-Neuve.

Minakem’s high-containment facility details:

The new high-class production facility will be equipped with a high-pressure preparative chromatography system that permits the isolation and purification of target molecules at different scales ranging from milligrams to hundreds of grams.

Minakem has already commissioned a laboratory covering an area of 130m². The laboratory is engaged in the development of GMP kilo-lab manufacturing, along with appropriate zoning for materials.

“The new Belgian high-containment facility consists of six production lines that are equipped with stainless steel and hastelloy jacketed reactors.”

The laboratory is equipped with state-of-the-art equipment and comprises nine fume hoods and a double-barrier of protection in the form of new generation glove bins dedicated for dry powder handling and high-efficiency particulate air (HEPA) air filters.

Minakem’s HPAPI production is expected to be carried out with an occupational exposure limit (OEL) level lower than 0.1µg/m3.8h. The new facility will also produce antibody-drug conjugate (ADC) toxins at 10ng/m³ levels.

Minakem’s new high-containment facility consists of six production lines that are equipped with stainless steel and hastelloy jacketed reactors varying from 5l to 1,600l in size are equipped with technologies such as complex multi-step synthesis, halogenation chemistry and steroid chemistry.

The facility is equipped with different kinds of isolation equipment for batch sizes ranging from 100g to 100kg designed for the safe handling of potent compounds.

The high-pressure chromatography system installed at the facility includes a 50mm column Hipersep® Prep-HPLC system and 300mm column HPLC system capability. It will enable Minakem to manufacture pharmaceutical ingredients that require a high level of purity.

The first phase of the new system is set to commence operations in September 2018.

Marketing commentary on Minakem:

Founded in 2004, Minakem is an affiliate of the Minafin Group and headquartered in France. It specializes in the manufacture of fine chemicals, APIs, and production of key intermediates and building blocks for pharmaceutical companies.

Minakem employs more than 450 people at its three facilities located in Dunkirk and Beuvry-la-Forêt in France and Louvain-la-Neuve in Belgium. The company gained ownership of the Louvain-la-Neuve site through the acquisition of Ajinomoto OmniChem, which enabled Minakem to expand its pharmaceutical services and fortify the development of its pharmaceutical market share.

All the facilities of the company are engaged in the production of small, medium and large volumes of complex, regulated intermediates and APIs for the pharmaceutical and life science industries.

Almac Expands Analytical Services Capability

Almac Group has unveiled plans for a £375,000 (~$500mn) investment in additional NMR instrumentation at its global headquarters in Craigavon, UK.

As part of Almac Sciences' state-of-the-art cGMP facility, enhanced NMR services will be offered to help deliver comprehensive solutions supporting drug substance (API) and drug product development programs from early phase to commercialization. These services include advanced characterization and purity assessment abilities in line with regulatory requirements. This investment boosts the existing Almac NMR testing service already available to clients.

The new 500MHz NMR instrument setup at Almac incorporates Bruker's cutting-edge Avance Neo platform, in addition to a Prodigy Cryoprobe all within a temperature controlled environment. This provides greater flexibility, higher sensitivity and resolution. The capability to analyze nuclei from 15N to 31P, in addition to a wide range of 2D and quantitative NMR experiments, now allows Almac to increase its NMR service offering.

Almac's dedicated NMR team has worked with many pharmaceutical companies providing novel solutions to their scientific problems, and now, with analysis running up to ten times faster, the increased through-put and capacity will increase efficiency and turnaround times. In addition, the latest software includes additional processing capabilities and provides superior data integrity controls which will ensure increasing regulatory compliance needs are met. 

AWAK Technologies Relocates to New HQ in Singapore

AWAK Technologies (AWAK), a medical technology company focused on dialysis using regeneration technology for end-stage renal disease, has moved to its new headquarters in Singapore. The relocation aims to strengthen its presence in the region to support growth over the next few years.

The new 6,000 square foot office in Tuas houses 16 employees in research, regulatory and business development functions. AWAK said the new HQ features a fully-equipped chemistry lab, engineering lab and a cleanroom manufacturing facility to support the company’s research, development, manufacturing and commercial activities.

AWAK’s move to its new headquarters follows the appointment of its new management team in late-2017. Led by chief executive officer Suresh Venkataraya, the management team consists of:

Mandar Gori, Director of Marketing and Business Development

Daniel Tan, Director of Program Management and Operations

Joel Preetham Fernandes, Director of R&D and Quality

Carol Lim, Head of Finance and HR

The new management team has a combined global commercial experience of close to 50 years in medical devices covering R&D, Finance, QA/RA, supply chain, manufacturing, sales, marketing and FDA and CE approvals, and underscores AWAK’s vision in bringing its patented sorbent technology that enables the development of ultra-portable peritoneal and haemodialysis machines to market globally.

AWAK has also recently formed a Technical Advisory Committee, which will provide scientific guidance and advice on product development, comprised of senior advisors who are scientific experts in biochemistry, biopharmaceuticals and commercialization of dialysis technologies.

CEO Venkataraya commented: “We have made significant progress in recent years, including securing financing from Southeast Asia’s largest medtech company, Accuron MedTech, which will accelerate the research and development of our product. We expect to complete our first-in-human trial this quarter, a significant milestone for AWAK.

"I am excited about AWAK’s next phase of growth as we look to bring our revolutionary technology to markets globally and change the lives of end-stage renal disease patients worldwide," he concluded.

Headquartered in Singapore with an office in Burbank, California (US,) Awak is dedicated to the research, development and marketing of novel, sorbent-based kidney dialysis machine for the treatment of patients with end-stage renal disease.

MilliporeSigma to Expand UK Operations

MilliporeSigma announced on July 2, 2018 that it plans to expand its Gillingham, UK, distribution center with a EUR 9 million (approximately US$10.5 million) investment.

The investment will improve the company’s distribution capabilities. The company’s plans to increase the existing distribution footprint by 56,490 sq. ft. (5,250 square meters) was approved by the local planning authority in June 2018. The new building will add to the site’s existing 9500-square-meter facility.

According to the company, the new facility will serve as the primary distribution center for the UK and is expected to open in early 2019.

The Gillingham site distributes more than 1.9 million units of products each year to support the life-science industry across the UK as part of the company’s global supply chain. The site supplies the pharmaceutical industry, biotechnology companies, research institutes, and academic centers with biochemical and chemical reagents, laboratory supplies, and testing services. The distribution center receives nearly half a million orders each year, nearly 98% of which are shipped the same day they are received, the company reports.

AGC Expands CDMO Services

AGC Inc. has unveiled plans for a major expansion of facilities at its Chiba Plant in Japan that will result in an approximately tenfold increase in the company's GMP-compliant synthetic pharmaceutical intermediate and active ingredient production capacity. The new capacity is set to come online in October 2019.

AGC began developing and manufacturing pharmaceutical and agrochemical intermediates and active ingredients on a contract basis in the 1980s. Leveraging its edge in fluorine technologies and experience in in-house drug discovery and other fields, AGC now offers a range of CDMO services tailored to customer needs.

While AGC has to date mainly provided CDMO services for the development stage of new drugs, this expansion will give AGC the end-to-end capability to produce commercial drugs too, allowing it to deliver more advanced one-stop solutions. The new facilities will also be capable of producing hard-to-handle active ingredients, such as the highly potent active pharmaceutical ingredients (HPAPIs) typically used in cancer therapy.

The AGC Group's "AGC plus" management policy identifies the life sciences as one of its strategic businesses. Moving forward, the group says it will continue to invest in the capacity needed to meet ongoing growth in demand for pharmaceutical intermediate and active ingredient CDMO services.

Facility Profile: Tekni-Plex Inc. Manufacturing Facility and Cleanrooms, Suzhou, China

Cost: $15 million USD

Size: 140,000 sq. ft.

Project team: Russell Hubbard, vice president-international and general manager

Tekni-Plex Inc.’s new China manufacturing facility will be supporting the growing needs of the Asia-Pacific pharmaceutical and medical device markets. The facility will produce products developed by Tekni-Plex’s Colorite, Natvar, and Action Technology business units.

The facility features three Class 100,000 cleanrooms to accommodate medical-grade tubing and components production plus one Class 10,000 cleanroom that will produce Natvar’s pharma-grade tubing.

The facility is in the process of commercializing Natvar’s recently-announced silicone extrusion tubing for catheters, feeding tubes, drug delivery, and peristaltic pump applications. Production for microextrusion tubing that targets a wide variety of demanding neurovascular interventional therapies and surgical applications is expected to be on stream early next year.

The facility will also manufacture Colorite custom compounds for medical device applications, and Action Technology’s dip tubes used in a wide variety of food/beverage, pharmaceutical, personal care, industrial and household pump applications.

Tekni-Plex’s investment in this new facility is another step in its continuing commitment to support its customers with robust global supply. Pharmaceutical, medical device and other manufacturers want access to exactly the same components and materials regardless of where in the world their manufacturing facility is located. The facilities geographic location helps meet the company’s objectives.

Origin Pharma Packaging Expand Cleanroom Manufacturing

As legislation and ethical awareness evolves, Origin Pharma Packaging has seen the demand for innovative design and production of child-safe packaging increase on a global scale.

Our new product development (NPD) team are continually investing their time and knowledge in developing commercial solutions for child-resistant compliant packaging for the UK, Europe, the US and beyond.

During the past twenty-four months, Origin Pharma Packaging has partnered custom design and manufacturing projects not compatible with the larger manufacturing sites across the Hybrid Pharma Packaging  (HP3) network. As a result, Origin has added a new cleanroom manufacturing facility to the HP3 network, located in Melton, East Yorkshire, UK.

Origin has executed a multi-million-pound investment program at its Centre of Excellence for Pharmaceutical Packaging Design & Innovation. Installing and delivering a cleanroom production facility to ISO 7 (Class 10,000) or ISO8 (Class 100,000) boosting the capabilities of the existing HP3 network. The facility is equipped for the manufacture of injection molded (IM), injection stretch blow molded (ISBM) and injection blow molded (IBM) parts.

Cleanroom production facility key facts:

Classification: ISO7/ Class 10,000 to ISO8/ Class 100,000

Compliant with ISO14644 and ISO9001-ISO 15378

Processes (all-electric): IM), ISBM and IBM

Automatic assembly

The HP3 network required the addition of this specific facility at a regional level, combining cleanroom classification, multiple ISO and good manufacturing practice (GMP) compliance, Medicines and Healthcare Products Regulatory Agency (MHRA) pursuit, European Pharmacopoeia (EUPh) compliant raw material sources, custom flexibility and integral supply chain assurance.

Due to the urgency of a sponsor project, a global pharmaceuticals manufacturing company, Origin executed and delivered the cleanroom production facility within four months. It is now fully functional, and production commenced in Q1 2018.

Connect 2 Cleanrooms to Build for Cubic Pharmaceuticals

Connect 2 Cleanrooms has been commissioned by Cubic Pharmaceuticals to build a cleanroom suite for the manufacture of solid and liquid dose medicines.

Cubic Pharmaceuticals is the first life science company in the UK to achieve a patented design for its novel continuous granulation process for processing water insoluble active pharmaceutical ingredients (APIs) using hot melt extrusion (HME).

With a unique continuous manufacturing technique for processing most challenging APIs, its technology increases the solubility of ibuprofen to 80% within 15-20 minutes and 97% within two hours.

"We invented the manufacture of Ibuprofen through hot melt extrusion, which is a world first,” said Saumil Bhatt of Cubic Pharmaceuticals.

"We also use platform technology to manufacture another 30 different non-soluble molecules through hot dry extruded granulation."

"This GMP grade cleanroom will transform Cubic Pharmaceuticals to a contract research organization (CRO), allowing pharma companies to benefit from our technology breakthroughs."

The single block cleanroom suite encompasses five areas for mixing, production, cleaning and dispensing, plus a change area for operatives. It will be constructed offsite for efficient installation.

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail:  editor@mcilvainecompany.com

Web site:  www.mcilvainecompany.com