Ellenzweig collaborated with Framingham State University and the Massachusetts Division of Capital Asset Management and Maintenance in completing an eight-year study/design/construction project to expand and upgrade the University’s science facilities located in Hemenway Hall and the Hemenway Annex. The phased project began with a comprehensive feasibility and programming study, and continued with design and construction of a 57,000 sq. ft. addition and 100,000 sq. ft. of renovations to the existing buildings.

The new addition houses 16 teaching laboratories serving Chemistry, Food Science and Biology. The laboratories feature 49 filtered fume hoods, at time of construction the largest installation of filtering fume hoods in the world, reducing the building’s carbon footprint by 68 percent as compared with the national average of similar buildings. The project is tracking LEED Silver certification.

Upgraded facilities in the existing buildings include teaching labs, research labs, and departmental spaces for Physics, Mathematics, Nursing, Computer Sciences, Geography, Child Development and Psychology. Program spaces include a variety of classrooms and learning venues, social and interaction spaces, offices, and meeting rooms.

A newly constructed four-story central commons integrates the two Hemenway buildings, creating a unified Science Complex.

The project received an Honor Award from the Boston Society of Architects/Massachusetts Architectural Access Board for the significant improvements to the existing buildings and surrounding landscape that have resulted in full, universal access.

Completion date: December 2016

Physics & Astronomy Interdisciplinary Science (PAIS), University of New Mexico

Cost: $65,746,710

Size: 137,000 sq. ft.

Project team: Van Gilbert Architects and EYP Architecture & Engineering (architects); Bradbury Stamm Construction (contractors)

The Physics & Astronomy Interdisciplinary Science (PAIS) project at the University of New Mexico will provide an up-to-date complex to support teaching and research in the STEMH disciplines. The facility will replace the outdated 1951 Physics and Astronomy Building, as well as add Interdisciplinary Science Labs. A high percentage of research now being conducted in the sciences and health fields is interdisciplinary in nature, and UNM has limited space to support multi-disciplinary research grants and attract world-class students and faculty. The current Physics and Astronomy Building cannot compete with peer institutions: numerous safety issues and educational facility deficiencies have been cited in the building and the design is incompatible with modern research and educational needs. Many of the existing department faculty members are scheduled to retire within the next ten years. The building and its infrastructure does not support UNM’s world class physics research. This project is essential for the future of STEMH efforts at UNM and the recruitment of new faculty.

The Physics & Astronomy Interdisciplinary Science (PAIS) project will be new construction. Project budget and scope are identified in the Interdisciplinary Science Education Building Needs Assessment for Interdisciplinary Sciences Physics & Astronomy dated September 18, 2014. Phase 1 is identified as having 137,000 sq. ft. (84,940 sq. ft.) of new space. This first phase will include research laboratories, classrooms, class labs, faculty, staff and graduate student offices and support spaces. A wing of the facility, to replace Regener Hall spaces equaling 27,565 sq. ft., will be designed through Schematic Design only, as this is planned to be a (future) Phase 2, yet needs to be coordinated with Phase 1. The entire project will be designed and executed as a “LEED Silver” certified facility.

Completion date: March 2019

Catalent Breaks Ground on WI Expansion

The $34m expansion at its Madison, Wisconsin site will support Phase III and commercial biologics production, says Catalent.

In August, Catalent announced it was planning to invest $34m (€31m) into its single-use biologics production site in Madison to add two 2,000L single-use bioreactor systems.

And last month the contract development and manufacturing organization (CDMO) broke ground on the extension which, according to Mike Riley - VP and general manager of Catalent Biologics – will allow the firm to expand its offering to include commercial scale biologics.

“Upon completion of our expansion, we will be able to offer single use cGMP manufacturing batch sizes of 250 L, 500 L, 1,000 L, 2,000 L and 4,000 L,” he said. “This will provide a range of manufacturing options to our customers from early phase clinical to Phase III and commercial production.”

There has been continued investment at the former-GE Healthcare site ever since it began operations for Catalent in 2013, adding a 1,000L bioreactor in 2015 for example.

Riley said the firm has been responding to customers requiring small to medium scale capacity, but the latest expansion will “support the next phase of the site's growth into Phase III and commercial production.”

But according to Jim Miller at a recent industry event, over half of all commercial biologics being made by third-parties are currently contracted to Lonza and Boehringer-Ingelheim, and the rest of the bio-CMO space is “extremely consolidated.”

Therefore we asked Riley how Catalent intended to compete.

“We offer customers a compelling value proposition based on our proprietary technology platforms, flexible development and manufacturing solutions, and specialized capabilities in areas like protein characterization and bioassay services,” he said.

“This allows us to provide a high value-add, flexible solution to customers advancing biologic molecules through the clinic and to the market.”

He added the firm has attracted “some of the most innovative biotech companies in the world” and “this capacity expansion, along with continued advancement and deals around our proprietary technology platforms, will further strengthen our offering.”

Last month, the firm was contracted by Samsung Bioepis to provide fill/finish services for its Enbrel biosimilar, recently approved in the EU and Canada.

Aptar Pharma Expansion

Aptar Pharma is nearing completion of its US-based manufacturing site, as it continues to expand globally to keep pace with growth in the injectable drug delivery industry.

The expansion at Aptar Pharma’s manufacturing site at Congers, NY, enables the company to complete injectable elastomeric component manufacturing in the US for the first time, according to the company, including finishing operations for the company’s recently launched PremiumCoat™ coated stoppers.

The addition adds space for cleanrooms and integrated vision equipment, which will be used to perform automatic inspection of all parts during the finishing process.

Construction is expected to be completed by the end of the first quarter of 2017.

The expansion is part of a multi-year investment program to support the global growth of Aptar’s injectables business.

Anne Bailly, Product Communication Manager at Aptar Pharma said the company is benefiting from growth in the injectable drug delivery industry.

According to Bailly, the production facilities of Brécey and Granville (France) also benefited from an investment plan to increase their production capacities to support business growth.

“While our long-term objective was to establish a production facility closer to growing markets outside of Europe, our initial investment in capacity expansion was at Aptar Pharma’s existing facilities in Europe,” said Bailly – which she explained allowed the company to better serve its existing customers and integrate new technology before expanding globally.

Aptar Pharma expects a sustainable growth in the injectable market over the next five years – it also anticipates the demand for high quality components to expand geographically, including more emerging countries.

“The growth in biologics and vaccines is leading to greater demand for prefilled syringes, cartridges and barrier solutions such as PremiumCoat™,” Bailly said.

“One of the strong drivers for the growth in the use of Pre-filled syringe and cartridges is the need for safe and convenient solutions, including the growing market demand for auto-injectors and pen injectors.”

Skanska to Refit US GSK R&D Hub

GSK has hired Skanska AB to renovate its laboratory and office in Upper Providence, Pennsylvania, US in a $45m (€42m) project.

The deal will see the Sweden-headquartered construction firm demolish four floors of the Collegeville facility and build out of 100,068 sq. ft. (9,300 square meters) of lab space.

The project will start later this month is due to be completed next October.

The Upper Providence lab became one GSK’s two drug discovery hubs in 2015 – the other being at its headquarters in Stevenage – after the completion of a long running consolidation project.

GSK spokeswoman Mary Anne Rhyne told us: “This is the second phase of an update to our labs. We moved into other updated labs this fall and have found the redesign quite helpful.”

According to the UK, activities at the US lab include target identification, safety studies, active pharmaceutical ingredient (API) manufacture, clinical trial drug manufacture, clinical trial management, medical oversight and regulatory interactions.

The project will be carried out by Skanska USA, a subsidiary that helps the firm’s pharmaceutical and biotechnology clients build facilities that comply with US Food and Drug Administration (FDA) regulations.

By 2018, 40 percent of GlaxoSmithKline's global drug R&D team will be based in Collegeville.

R&D scientists from GSK’s facilities in Upper Merion, Pennsylvania and Research Triangle Park, N.C., will relocate to Upper Providence.

The UK drug manufacturer has said the headcount at the site will increase from 1,600 to 3,200 before 2018.

PPD Expands Wisconsin-based GMP Lab

PPD has expanded its stability sample storage capacity and capabilities at its Middleton, Wisconsin-based good manufacturing practices (GMP) lab.

The expansion includes a 75% increase in capacity for aliquoting, storage, and worldwide distribution of reference standard materials as PPD looks to meet customer demand, according to the company.

"PPD® Laboratories is seeing growth across all service areas, but particularly those supporting the biopharmaceutical sector," said Darren Jantzi, Executive Director, GMP Lab, PPD® Laboratories.

"Companies are continuing to look for ways to manage their fixed costs by utilizing our services that offer flexibility in response to their changing needs for sample storage and distribution," he added.

Notably, the expansion gives the facility the capacity to be equipped with more than 120 new stability chambers – with the ability to expand to 150,000 cubic feet of chamber space and nearly doubling its storage capacity.

According to PPD, the operation enables the lab to offer “a significant expansion” of the more than 40 different temperature and humidity set points for routine International Conference on Harmonisation (ICH) stability storage conditions.

The expansion will also increase capacity for customized temperature and humidity, photostability, and shipping (freeze/thaw) studies, in addition to creating additional analytical lab space.

"We anticipate the facility will provide ample capacity for our clients into the next decade," said Jantzi. "We designed the space with flexibility in mind to enable us to make adjustments to the changing demands of the marketplace."

INC Research Moving Headquarters

INC Research announced its intent to expand at its headquarters in Wake County, creating 550 jobs over the next several years as part of a $37.9m investment.

As part of the investment, the contract research organization (CRO) is moving its headquarters from Raleigh to Morrisville, North Carolina, to make room for an additional 550 jobs.

Chris Gaenzle, Chief Administrative Officer and General Counsel, INC Research, said the company spent approximately 18 months exploring options throughout the area, with the goal of consolidating the two existing Raleigh offices.

“We believe the move to Morrisville will enable our two Raleigh offices to be housed at one location, better supporting collaboration and expansion as the company grows,” he said.

“A large corporate presence near Research Triangle Park will give us more visibility as a global company, facilitate air travel for our colleagues and customers due to its close proximity to Raleigh-Durham International Airport, and help us continue to attract the best and brightest talent.”

The expansion will be facilitated by a Job Development Investment Grant (JDIG) approved by the state’s Economic Investment Committee. According to a statement released by the Governor

Gaenzle cited robust outsourcing from the biopharmaceutical industry and continued investment in developing novel therapies to bring to market as the key business drivers for INC Research.

“The CRO industry as a whole is well-positioned to meet this need, and we see continued growth across the space,” he said.

Over the last few years, INC has grown its workforce by 10%, globally.

“This growth is a direct result of work we are being asked to do on behalf of Sponsors and, consequently, we are very focused on hiring and retaining talent into INC, including in the Asia-Pacific region, where we see a lot of opportunity,” explained Gaenzle.

BMS R&D Closures and Construction

Bristol-Myers Squibb has announced plans to pull the plug on some US facilities and streamline construction and investment around “vibrant academic ecosystems”.

Sites to be closed include B-MS’ Hopewell, NJ, Wallingford, CT and Seattle plants. Staff will be given the option of relocating to other US facilities.

In addition to the closures, the pharma firm also announced new construction plans to expand facilities in Massachusetts and New Jersey, in line with its plans to increase emphasis on biologics R&D.

Spokesman Ken Dominski said the aim is to “focus resources at locations in the heart of vibrant ecosystems of academia, world-class science, innovation and business opportunities.”

The 433-acre Hopewell site in New Jersey will be shut down gradually over the next 10 years, as part of efforts to streamline manufacturing processes.

In June 2015, the firm received planning permission to expand the Hopewell site with a new 21,986 foot building construction, to house an extra 58 employees.

Dominski explained B-MS’ subsequent decision to close the site was to “more closely integrate the work done by our R&D teams in Lawrenceville,” - a 16-minute drive from the Hopewell facility.

In addition, BMS said it will not renew its lease for the Lake Union Steam plant in Seattle, Washington, and confirmed it will continue to close the Wallingford facility in Connecticut by 2018.

Dominski continued “With the closing of Hopewell, [BMS] will co-locate lab-based Discovery and Translational Medicine activities on our Lawrenceville campus.”

The firm added the reason behind the new construction was to “modernize workspaces” and “build on previous investments.”

At its New Brunswick site in New Jersey, construction will also take place to support biologics manufacturing there – close to Rutgers University.

In 2013 the firm also invested over $250m into expanding a biologics plant in Devens, Massachusetts, which was completed in May this year.

BMS previously said the Devens expansion was in line with its portfolio shuffle to focus on biologicals in Immuno-Oncology by 2019.

Along with the construction announcements, the company will continue to expand the Devens facility, as well as its Cambridge hub.

Dominski added “In Cambridge, MA, we will focus on discovering new medicines, driving our Translational Medicine capabilities and enhancing our efforts in discovery technologies, and remain committed to opening the facility in 2018.”

Primate Breeding CRO Alpha Genesis Investing in SC Site

Alpha Genesis, Inc. (AGI) will expand its South Carolina facility and add 30 jobs to support its primate breeding capabilities.

The firm, which breeds primates and carries out preclinical research, announced it is investing $2m at its facilities and headquarters in Yemassee, South Carolina on the back of increased customer demand for its services.

“Our 2016 pace of new business growth was extremely strong, and our 2017 outlook is very positive,” the company said in an official statement. “As a result, we have made it an organizational priority to further enhance our facilities and technical staff to more efficiently meet the growing needs of our customers.”

The preclinical contract research organization (CRO) employs 125 at the site, but the investment will increase space by 50,000 sq. ft. and add up to 30 additional jobs by the end of next year.

Despite claims by animal rights group, the use of primates remains essential in the preclinical testing of potential new medicines due to their genetic similarity to humans. A 2011 National Institutes of Health (NIH) Working Group report, however, deemed many biomedical use of chimpanzees unnecessary due to advances in alternative research tools.

“Animals are used in research only when no alternatives exist,” said AGI. “The potential benefits of primate research include an improved understanding of cancer, infectious diseases, neurological disorders, spinal cord injuries, basic biological and behavioral processes, and the development of new medicines, vaccines, devices and other treatments, according to scientific researchers.”

Today’s news comes six months after the firm opened a $1m clinical health care facility aimed at improved housing, diagnostic, and treatment equipment for the animals on site.

CrownBio Expands Louisiana Primate Research Center

Crown Bioscience will invest $1m into a new subsidiary in Louisiana to work alongside a new research facility at the New Iberia Research Center (NIRC).

CrownBio offers preclinical services that use rodent and non-human primate models to investigate drug efficacy, safety and further develop candidate to target a range of cardiovascular and metabolic diseases (CVMD), from diabetes to NASH.

The New Iberia Research Center is an affiliate of the University of Louisiana, and one of the largest non-human primate centers in the US.

According to Reuters, CrownBio’s subsidiary will be called Crown Bioscience Louisiana. The new facility at the NIRC will further build on the firm’s development of CVMD therapies.

Jean-Pierre Wery, CEO of Crown Bioscience, said “We chose to expand in Louisiana because of the growing biomedical science community there and the operational excellence that exists at NIRC.”

Located around 20 miles south of the University’s Lafayette campus, the NIRC spans 100 acres with more than 6,000 non-human primates.

Although the NIRC uses both macaques and African green monkeys in their research programs, their chimpanzee population has been retired from research and instead reside in a ‘sanctuary’ of enclosures called primadomes.

The NIRC’s clinical research organization services include PMDK, safety and efficacy studies for vaccines and other metabolic diseases.

Along with the $1m capital investment, 10 new direct jobs and 14 indirect jobs will be created at the new CrownBio facility at the NIRC.

François Villinger, NIRC Director, said in a statement “Our center in New Iberia has the research and analytical expertise and infrastructure in place to assist CrownBio to respond to the needs of its global clientele very quickly.”

With its HQ in Santa Clara, California, CrownBio also has operations in Indianapolis, the UK and China.

Last March, the firm acquired PreClinOmics to expand its CVMD capabilities as part of its global expansion plan.

Other purchases included significant investment into a new oncology platform and Molecular Response’s bank of xenograft models. Last July the firm also opened its Center of Excellence for Oncology in San Diego.

AB BioTechnologies Expanding in Monroe County

AB BioTechnologies, a pharmaceutical development company located in Monroe County, will invest $10.5 million to construct and equip a new 23,000 square foot manufacturing facility in Monroe County, and create up to 33 new high-wage jobs by 2020. The company will add manufacturing services for formulating, filling, freeze-drying, and packaging injectable drugs for Clinical Trial studies.

“This is a fantastic opportunity for AB BioTechnologies, Bloomington, Monroe County, and the state of Indiana,” said J. Jeff Schwegman, Ph.D., founder and chief executive officer of AB BioTechnologies. “We are one of only a handful of companies in the world that will offer all of these services in a small, nimble company format, and Monroe County is the perfect place for us to expand. The presence of a locally skilled workforce and access to graduates from Indiana University and Ivy Tech will assist us in hiring a competent workforce.”

AB BioTechnologies was founded in 2008 and has expanded into an internationally-recognized drug development company in the pharmaceutical industry. With the addition of its contract manufacturing services, the company will be able to shorten the time it takes to transfer a drug from concept to the clinic.

“AB BioTechnologies is an example of the future of Monroe County’s economic potential,” said Lynn Coyne, President of the Bloomington Economic Development Corporation. “It began as an entrepreneurial effort and through talent and commitment is becoming an important participant in the global economy, providing quality employment opportunities in our community.”

The Indiana Economic Development Corporation offered AB BioTechnologies, Inc. up to $290,000 in conditional tax credits and up to $30,000 in training grants based on the company’s job creation plans. Monroe County offered a tax abatement over a ten-year period.

“We are excited to have AB BioTechnologies choose to invest in the county’s westside economic development area,” Monroe County Councilmember Geoff McKim said. “AB BioTechnologies will contribute to our vibrant local economy, and bring new high-wage jobs to Monroe County residents. We are pleased that the company recognizes our community’s skilled workforce, and we welcome their expansion with open arms.”

The company plans to begin hiring early this year for technical and support positions.

AB BioTechnologies was founded in February 2008 and is in the process of an expansion which will include a new building, new employees, and new equipment. The expansion will allow the company to manufacture and test injectable drug products that will be used in early phase Clinical Trials on humans and animals. The company plans to employ a staff of approximately 25 people including scientists, operators, and support staff.

Whitney Museum of American Art Conservation Lab, New York, N.Y.

Size: 2,600 sq. ft.

Project Team: Cooper Robertson, in collaboration with Renzo Piano Building Workshop

The Whitney conservation lab was designed to be both a treatment and a research center, and serves three specific activities—painting, objects (including sculpture) and paper conservation—in an expansive and open volume space. The programmatic idea of a single, shared lab supports the museum’s philosophy, allows for the efficient use of space, maximizes proximity requirements and facilitates the sharing of custom equipment.

“Everybody who walks in here feels that this space is an endorsement of the importance of conservation,” noted Carol Mancusi-Ungaro, who leads the Whitney conservation department.

The lab is conceived as semi-public suite and affords partial views from the adjacent galleries, as well as from the High Line park, which underscores the new position of the department within the building and the institution at large. It is open to scholars by appointment.

The lab is well-served with abundant north light via tall glazing with integral ultraviolet filtration, and motorized glare, diffusion and blackout shades. Ceiling heights, lighting conditions, wall finishes and wood flooring duplicate gallery conditions. Much of the lab equipment and fittings are flexible in terms of location and may be reconfigured to suit the various special needs of the art at hand. “One of the thought-provoking challenges presented by the conservation lab furnishings is that while some of the component parts may be found in disparate catalog sources, they must be pieced together in unlikely assemblies in order to create flexible tools for the treatment and study of art,” adds Cooper Robertson architect Greg Weithman.

All millwork is custom-designed to suit the particular methods and preferences of the conservators. The department includes a photography documentation room to record the treatment process at various intervals for historic purposes.

Importantly, the lab, including its paper conservation component, is located directly adjacent to the Works on Paper Study Center and Collection Storage areas. Works on paper comprise roughly two-thirds of the Whitney’s permanent collection. The Study Center space is also used to evaluate works of art that are candidates for acquisition.

Completion Date: May 2015

AGC Adds Capacity with CMC Biiologics

After buying two CMOs, Japanese glassmaker AGC has made “a full-fledged launch” into the biologics manufacturing space and says it will consider further M&A opportunities.

Within the past four months, AGC Asahi Glass – a subsidiary of industrial glass, ceramic and chemical maker the AGC Group – has bought two biologics contract manufacturing organizations (CMOs).

In September, the firm launched itself into the space through the acquisition of Heidelberg, Germany-based Biomeva, and weeks later signed an agreement to cement its stake in the industry through the ¥60bn ($516m) addition of Søborg, Denmark-headquartered CMC Biologics.

Spokeswoman Tomoko Komazaki said that with Danish manufacturing capacity and US sites in Seattle and Berkeley, the CMC Biologics deal meant AGC has made “a full-fledged launch into not only microbial but also mammalian CMO businesses in US and European markets which are fast growing and account for the main part of biopharmaceuticals business in the world.”

“Life science business is one of AGC’s strategically focusing business areas to achieve further growth,” she told us. “CMO business is an important part of AGC’s life science business and we have decided to expand into this field.”

AGC had some biomanufacturing capacity in its network, including a 4,500L fermentor at a site in Chiba, Japan, but once the CMC deal is complete – expected later this month – the Tokyo-headquartered firm will boast 10,000L of microbial capacity and 34,000L of mammalian capacity.

24,000L of the mammalian capacity will be single-use bioreactors, Komazaki said, including three Thermo Fisher 2,000L systems recently added by CMC Biologics in Denmark.

Komazaki also added the company will take into consideration any opportunities further M&A acquisitions in order to grow further its contract biomanufacturing business in the future.

Novo Nordisk Hires Fluor to Build US Diabetes Drug API Plant

Novo Nordisk has hired Fluor Corporation to design and build the diabetes drug API plant it is setting up in Clayton, North Carolina.

The Danish drug manufacturer announced plans for the drug ingredient facility in August 2015, citing a desire to expand its production presence in its largest market.

At present, all the drug actives Novo uses are made at its facility in Kalundborg, Denmark.

Texas-based Fluor announced it had been tasked with designing, procuring materials for and constructing the facility last month. The engineering firm explained the $1.2bn (€1.13bn) it will generate from the project has been included in its fourth quarter financial results.

Construction of the 830,000 sq. ft. facility is expected to be completed in mid-2019 according to Fluor, which said 2,500 employees and subcontractors will be involved in the project.

Novo expects to employ 700 people at the facility when it is operational in 2020.

Manufacturing activities will focus on the production of finished APIs from raw material shipped to the site, including the ingredient for its oral diabetes candidate, semaglutide.

The drug was filed for US Food and Drug Administration (FDA) and European Medicines Agency (EMA) assessment in December.

Novo’s exiting site in Clayton is responsible for the formulation, filling and packaging of its diabetes care products. The facility also produces the firm’s Felxpen and FlexTouch prefilled insulin devices for the US market.

GSK Opens Global Vaccines R&D Center in Maryland

On Dec. 13, 2016, GlaxoSmithKline (GSK) announced the inauguration of the company’s new global vaccines R&D center in Rockville, MD. The company said the new facility will create approximately 200 new jobs, and the company will invest more than $50 million in the next two years to continue to develop the site.

The facility will house 12 vaccine development programs including projects supporting the company’s candidate shingles vaccine, programs for respiratory syncytial virus, Group B Streptococcus, and dengue fever.

The Rockville site becomes one of three global vaccines R&D centers for GSK including centers in Rixensart, Belgium, and in Siena, Italy. Rockville is also the location of GSK’s proposed biopreparedness organization (BPO), a dedicated, permanent organization using a no profit/no loss model that will design and develop new vaccines against emerging viruses, bacteria, and other pathogens that potentially pose a threat to global public health.

Encapsys LLC Facility, Appleton, WI

Size: 40,000 sq. ft.

Project Team: EUA, Ring & DuChateau (MEP+F), Miron Construction, Pierce (structural), Point of Beginning (civil and landscaping)

Encapsys LLC, a global encapsulation technology leader in Appleton, Wisc., is currently housed in three different facilities on one campus. This 90-person company was looking to consolidate all operations into one building, while creating a strong corporate identity and improving the ongoing safety of their operations. Encapsys chose the team of Commercial Horizons (CHI), Eppstein Uhen Architects (EUA) and Miron Construction to help them to program and design a new corporate headquarters.

EUA understands that collaboration for this start-up was a key driver to ensure a successful design. Over 4,400 sq. ft. was designed as collaborative workplaces for the Encapsys team members, included within the workplace and laboratory areas. One large collaboration space, the Hub, will be used for small team discussions, large all staff gatherings and as a dining area for the team and clients. The two-story space will be located near the lobby, has views to the laboratory and the second floor administration areas, and features a lot of daylight.

The collaboration spaces extend to the laboratory which has been designed as one open laboratory. Within the laboratory, there are featured collaborative zones specifically designed around technology sharing monitors and equipment. Flexible lab spaces/benches will be added to support three different teams consisting of Scientists, Process Engineers and Technicians. This allows for many growth possibilities for each team. The integrated, but distinctly identified Pilot Capsule Plant (PCP) will be a high bay scale-up facility, while the manufacturing of finished products will continue to occur offsite. The PCP also includes specialized high-technology spaces and process piping for drying and processing materials developed in the laboratory before they are approved for large scale manufacturing.

As a growing specialty chemicals company, Encapsys’ new facility has an infrastructure designed with the flexibility for near-term expansion, if needed. The building is oriented so the office spaces are facing north which allows for more diffused light for most occupants; while the laboratory includes windows facing south for more daylighting. Special care has been taken in the design to allow for proper personnel and material flows so as to eliminate potential cross-contamination of product between the lab/PCP areas and offices.

Unique features include:

an 8-ft. fume hood for each scientist, with a large sink, lattice rods and combination sashes;
a shared 12-ft., floor-mounted hood for processing powders has been included and outfitted with a system for bag-in, bag-out filtration should it be required in the future;
small scale liquid chemical dispensing will take place in a custom-vented enclosure in the dispensary portion of the PCP which will provide the scientists with materials for their research and development;
cup sinks and local exhaust vents (snorkels) are included throughout the laboratory to provide exhaust and drains for benchtop equipment;
collaboration spaces built into laboratory space, allowing sharing of ideas and solutions without leaving the lab;
emissions control devices that represent best practices for research labs are being installed.

Completion Date: 2018

NSU’s Center for Collaborative Research, Davie, Florida

Nova Southeastern University (NSU) has opened the Center for Collaborative Research (CCR) on its main campus in Davie, Florida.

Opened in September, the new facility is one of the biggest in Florida and it brings together researchers, students, and industries to work at one location by pooling resources.

Funded through NSU's own reserves and tax-exempt financing, the $100m facility will help in the development of new solutions in specific areas such as healthcare, bioinformatics, technology, cyber security, and business.

Construction of the facility, which began in February 2014, generated more than 300 jobs, while 150 research jobs were generated after completion.

The new research center has achieved Leadership in Energy and Environmental Design (LEED) Silver certification and is pursuing LEED Gold certification from the US Green Building Council.

The new collaborative research center is a six-floor building with a total area of 215,000ft².

A 130in (10.8ft)-tall tower with a dome on top marks the entrance of the building.

The building is designed with a capability to withstand a live load of 125 per square feet. It was constructed with a modular and flexible design and features microscope laboratories, which are vibration-sensitive.

A deep foundation system, consisting of auger-cast concrete piles, was constructed to support the structure.

The floor systems are made of strong concrete beams and mild concrete slabs. The lateral wind-resisting systems of the facility feature both concrete shear walls and a concrete frame.

The research center houses class A wet and dry laboratories with wet labs occupying an area of 60,000ft². Sufficient wet lab space is available for leasing to private biotech and life sciences companies.

The center accommodates a number of research institutes such as the Autonation Institute for breast and solid tumor cancer research, Cell Therapy Institute (in partnership with karolinska institute researchers), and a technology incubator. In addition, it houses the Institute for Natural and Ocean Sciences Research, Institute for Neuro-Immune Medicine, Rumbaugh-Goodwin Institute for Cancer Research, and Emil Buehler Research Center for Science, Technology, Engineering, and Mathematics.

The United States Geological Survey (USGS) occupies the first floor of CCR's building. USGS will collaborate with NSU to carry out inter-disciplinary research comprising Everglades restoration efforts, hydrology, and water resources.

The facility will also provide access to IBM supercomputer Megalodon and connectivity to Florida LambdaRail, a high-speed broadband network.

ACAI Associates was contracted to provide architectural services for the facility, while construction service ANF Group was the general / construction contractor. RGD served as the consulting engineer.

TRC Worldwide Engineering was awarded a $26m-worth contract to provide engineering design, construction, and inspection services for the project, while Crawford-Tracey was responsible for the installation of its Pro-Tech 7SG curtain wall.

Michigan State University (MSU) Opens New Bioengineering Facility

Michigan State University (MSU) has opened a new bioengineering facility in its East Lansing campus in Michigan.

Opened in October, the facility has been developed in a 130,000ft² area in the south side of the MSU campus. Construction began in September 2013 and was completed by December 2015 at a cost of $69.8m. The facility is built to further develop bioengineering and engineering health sciences at the university.

The facility includes four floors with an elegant staircase in the atrium resembling a DNA strand. The laboratories of the facility feature open-floor plans with a modular design to provide flexibility and promote collaborative biomedical research. The design of the laboratories enables bench experiments and computational analysis to be integrated at a single location.

The laboratories also include space for an on-site imaging facility.

The bioengineering facility houses the College of Engineering, the College of Human Medicine, and the College of Natural Science. It has enough space for new recruits and collaborators to work together at one location.

In addition, the facility houses the Institute for Quantitative Health Science and Engineering, and a research center for basic and applied research. It is interlinked to the Clinical Center C-Wing, Life Science B-Wing buildings, and the radiology building, which will help in sharing resources resulting in the creation of a biomedical research hub on the campus.

Automated research laboratories, offices, collaborative rooms for shared equipment, and a safe parking facility for two-wheelers are also part of the facility.

The bioengineering facility will focus on cardiac computational modelling, which will help in understanding the causes behind heart diseases to develop sophisticated treatments.

Development of electrodes implanted in the brain will be another area of focus. Electrodes will be utilized to understand brain function and develop treatments for specific neurological disorders.

The facility will also carry out research related to lower leg prosthetics, hand function, and seating mechanics of the human body. It will enable collaboration among many on-campus units such as nursing, osteopathic medicines, veterinary medicines, and communication arts and science.

Clarks Construction was awarded the contract to provide construction services for the project. Integrated Design Solutions provided architectural, mechanical engineering, electrical engineering, interior designing, and technological designing services for the project.

The facility is designed to achieve 20% savings in energy consumption by 2020 through the use of energy recovery systems and MSU's co-generation plant. It is equipped with a water-based and air-based recovery system, which helps to recover energy from both air and water.

The State of Michigan contributed $30m towards the development of the facility, while the university contributed the rest of the investment.

Biodesign C Research Building, Arizona State University, Tempe, Arizona

Arizona State University (ASU) is constructing a third research building named Biodesign C in its Biodesign Institute complex in Tempe, Arizona, US. The new state-of-the-art research building will have a total floor space of approximately 188,000ft².

Construction on the $120m facility began in October 2016 and is expected to be completed in mid-2018.

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

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

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

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

The Biodesign C building will feature five floors in addition to the cellar. It will include laboratory rooms for scientific researchers, mostly wet laboratories and offices. The facility will be interlinked to the Biodesign B building at the ground level.

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

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

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

Zimmer Gunsul Frasca and BWS Architects were contracted to provide architectural services for the project.

McCarthy Building Companies was awarded a contract to provide construction services for the building.

The facility is being constructed in compliance with ASU's green building standards with an aim to achieve at least LEED Silver or higher certification. The building will be equipped with a new HVAC system to save energy and reduce its environmental impact.

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

The complex is currently half of the planned 800,000ft² of its original master plan and is operating at full capacity. Depending upon the needs of the ASU, future expansions will be made in the institute.

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

SRI to Accelerate Production of HIV-Prevention Products

US-based SRI International has been contracted by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases and the Division of AIDS (NIAID-DAIDS) to provide development and manufacturing support for HIV microbicides and other non-vaccine pre-exposure (PreP) agents.

Valued at up to $150m, the contract requires SRI to provide a wide range of preclinical product development services for candidate HIV-prevention products developed as part of investigator-initiated studies or from collaborations with outside companies and organizations.

Under the seven-year contract, the company’s division SRI Biosciences will manufacture and characterize drug products to support the progression of microbicide and PreP agents through both preclinical and clinical studies.

The contract also covers support for specific activities required by the US Food and Drug Administration to move products into clinical testing.

SRI Biosciences Center for Pharmaceutical and Chemical Technologies Formulations R&D director Gita Shankar said: “Since the early 2000s, researchers at SRI International have been involved in drug development activities to help move many microbicides, PrEP agents, and multipurpose prevention technologies through IND-enabling studies.

“We are very pleased to be given an opportunity to contribute to the acceleration of promising HIV products into clinical testing and the creation of a sustainable pipeline of prevention products and strategies.”

The use of non-vaccine biomedical prevention products could reduce the estimated 5,000 new HIV infections per day worldwide.

G-CON Delivers a Custom Built POD System to Lonza

G-CON of Texas, has delivered a custom built cleanroom POD system to Lonza for the manufacture of virally-modified cell therapy products in Houston, Texas, U.S.

Lonza, a global leader in viral gene and cell therapy manufacturing, required cleanroom capacity on an accelerated timeframe to be able to meet rising customer demand.

POD cleanroom units can provide extra capacity with a fast turnaround. The cleanroom POD system will be used for the manufacture of virally-modified cell therapy products in the US.

The customized POD system provides integrated gown in and gown out areas, cleanroom space, dedicated exits for personnel and material, a gas fire suppression system, HVAC control system and onboard HVAC, modular wall panels and a NORA floor system.

The POD system provides ISO 6 and ISO 7 areas and a dedicated mechanical space.

Ricardo Jimenez, Lonza’s Site Director for Lonza Houston, explained what set G-CON apart: “G-CON understood our needs to quickly install a comprehensive solution that allowed us the flexibility we needed for our existing clinical manufacturing facility. Their substantial experience with design, engineering, project management, construction and operation of the POD was evident throughout the project from our decision to purchase all the way to delivery and commissioning.”

Maik Jornitz, President and CEO of G-CON Manufacturing said: “We committed to an aggressive timeframe for delivery and installation of the custom-built POD system because we knew of the importance of the timeline for Lonza in this cell therapy application, a major new area of drug development for Lonza as well as G-CON.

"In working with Lonza we gained further understanding of what the cell therapy industry requires in the provision of cleanrooms and found that PODs are uniquely able to fill all of the requirements of that industry while also providing scalability as needed and without interrupting existing operations.”

G-CON’s cleanroom POD portfolio provides a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms.

The POD cleanroom units offer scalability, mobility and the possibility of repurposing the PODs once the production process reaches its lifecycle end.

REST OF WORLD

Recipharm Invests in Italian Small-Scale API Capabilities

Smaller drugmakers are shifting away from generics and towards niche new molecules says Recipharm, which has expanded a small-scale API facility to feed demand.

The site in Paderno Dugnano, Italy was added to Recipharm’s manufacturing network when the firm acquired Corvette Pharmaceutical Services in 2014.

And the contract development and manufacturing organization (CDMO) has announced it has invested upwards of €1.2m ($1.3m) at the site to enhance its small scale GMP active pharmaceutical ingredient (API) capabilities on the back of growing demand for custom synthesis and early phase API manufacturing.

“Due to the patent cliff which is coming over the next few years, even small companies are shifting from the generics business to a sort of business which in the past was only performed by innovators,” said Matteo Zacché, Recipharm’s R&D manager at Paderno Dugnano.

“Also, many health organizations are increasingly sponsoring research on rare diseases which have been mainly ignored by big pharma companies over the years. Because of this, many companies are searching for new molecules to be introduced as APIs, or even testing old molecules for different applications in early clinical phases to explore new business opportunities.”

He added the new R&D area and analytical development lab – which houses a team of eight - is already operational, while a new GMP-kilo lab is awaiting authorization, expected by the end of the year.

The new plant will be the fourth manufacturing facility at the Paderno Dugnano site.

“One plant - batch sizes of around 300 – 400 kgs - is mainly manufacturing Erdosteine, a mucolytic which is the main API of the company,” said Zacché. “The second one is a multi-purpose plant which manufactures various APIs, including anesthetics, NSAIDs, anti-diabetes drugs, CNS drugs, cardiovascular and blood-pressure drugs.

“The third one is a small plant which is manufacturing niche APIs including cardiovascular drugs, Beta2-agonists and sedatives; this small plant serves a very niche market with an extremely high demand for quality and excellence in GMP manufacturing.”

Lonza Opens Formulation Development and Testing Lab

Lonza has opened a drug quality testing and formulation laboratory in Basel, Switzerland.

The facility at the Stücki Science Park in Basel will initially on formulation development, drug product analytical development and quality control.

The site will also provide particle testing or container closure integrity testing services.

The contract manufacturing organization (CMO) said that all services offered at the new laboratory will be available standalone or as part of larger services product development programs.

A Lonza spokeswoman said "We chose Basel for Lonza’s first-ever drug product development facility because it offers us access to the world-leading experts in a central location, one that’s a hub of innovation in the pharma industry."

Novartis, Roche, Basilea Pharmaceutica and Actelion are all headquartered in the city.

The spokeswoman also explained that "the lab will support development of large molecules and small molecules that require a parenteral dosage form."

"We have invested significant capital and operational expenses in order to staff, provide equipment and infrastructure to serve our customers with latest innovation, for competitive reasons we will however not be able to disclose the amount."

She added that the firm will not be relocating any of its current testing facilities, explaining that: "Operations at other facilities will not be affected by the opening of the new laboratory."

Lonza employs 25 people at the laboratory.

Last month, Lonza raised its full year guidance after growth of its biopharma businesses in the third quarter.

The Swiss life sciences revised its forecast this week, predicting that operating profit, EBIT, for 2016 will be 15% higher than the CHF524m ($527m) it generated last year.

Saneca Gets Grant to Invest in API Plant

The Slovakian Government has granted Saneca Pharma €1.5m ($1.6m) to invest in ‘green’ API manufacturing and anti-abuse technologies for its opiate-based drugs.

The funding – from the Ministry of Education, Science, Research and Sport – was awarded to Saneca and partner Tau-Chem Ltd, which have established a dedicated 25-strong R&D team at the former’s facility in Hlohovec, Slovakia.

Research efforts will be concentrated in a number of areas, with the development of sustainable production methods for chiral active pharmaceutical ingredients (APIs) and use of renewable raw materials being the core focus.

Saneca noted, "We have been trying to incorporate an energy efficiency policy and production and usage of renewable raw material into our production processes, however, there is no specific goal within this project to enhance this process."

In addition, Saneca said its opiate development team will use some of the money to fund assessment of anti-abuse technologies for finished dosage form products.

Saneca has made a number of investments at the Hlohovec facility in recent months. In September, it said it would spend €3.5m to increase small-scale API production capacity.

The firm has also signed a number of supply contracts, most notably with Xantis Pharma for which it will make 20 generic drugs.

In 2015, it was hired to supply opiate chemical intermediates to US-based manufacturer AMRI.

Both contracts will be based at the Hlohovec facility.

Sartorius Stedim Cellca Plans to Build Laboratory at Acquired Site in Ulm, Germany

Sartorius Stedim Cellca has said it will build a laboratory at newly acquired site in Ulm, Germany and hire additional staff.

The firm – which was formed when Sartorius Stedim Biotech SA (SSB) acquired cell line and process development contractor Cellca GmbH in 2015 – said the lab will provide room for expansion and increase its access to nearby academic research institutions.

Managing Director Hugo de Wit said: “Our new site’s proximity to universities and research institutes in Ulm’s Scientific Park offers an excellent environment to promote our growing business for which we are also seeking additional highly qualified staff.”

At present Sartorius Stedim Cellca, which employs 80 people, is based at a rented facility in neighboring Laupheim.

News of the new lab comes a week after Sartorius Stedim Cellca teamed up with cell line developer Edinburgh, Scotland-based Synpromics.

The accord will use the latter’s PromPT promoter platform to increase stability and reduce the lead time for Sartorius Stedim Cellca’s CHO expression platform.

The idea is that more robust and effective cell lines will be attractive to biopharmaceutical firms interested in reducing manufacturing costs.

Merck/MilliporeSigma Opens Production Facility in Spain

Merck, a leading science and technology company, announced the opening of a facility in Mollet des Vallès, Spain dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media.

The facility, validated by the FDA, is the only location in Europe that manufactures meglumine, an amino sugar derived from glucose. The facility in Spain is solely dedicated to the production of meglumine, thereby ensuring continuity of supply to customers as well as meeting increasing demand for the excipient. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility. Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as APIs.

"Our new facility was optimized around the manufacturing process to achieve greater efficiencies and meets the most stringent quality standards for manufacturing meglumine," said Andrew Bulpin, Head of Process Solutions Strategic Marketing & Innovation, Life Science. "The result is a high level of confidence in quality and security of supply for our customers."

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Sartorius Stedim Biotech Opens a New Validation Service Laboratory in Shanghai

Sartorius Stedim Biotech (SSB), a leading international supplier for the biopharmaceutical industry, opened a new validation service laboratory at its site in Shanghai Zhangjiang Hi-Tech Park. The opening event was attended by business partners from the biopharmaceutical industry and representatives of the local community.

With its new laboratory, Sartorius Stedim Biotech is making validation of membrane filters even more convenient and time-saving. Chinese customers can have their entire process steps validated locally and will also benefit from direct interaction with Sartorius specialists on site. “Our Shanghai validation lab provides high-quality services that are fully compliant with applicable GMP and GLP principles. At this validation service lab, we now offer comprehensive process validation studies for the strongly growing Chinese pharma market,” stated Dr. Jörg Lindenblatt, SSB’s Senior Vice President of Sales for Bioprocess Solutions in Asia, in his opening speech. The validation lab, together with SSB’s Application Center in Shanghai, provides a full range of extended services to the biopharmaceutical industry.

SSB’s new Shanghai laboratory covers approximately 4,000 square feet (370 square meters). Equipped with the latest instrumentation, it offers microbiological testing services and physical-chemical testing to provide a full range of data for process validation studies in compliance with all regulatory requirements. Certified according to Biosafety Level II (BSL-2), the facility is permitted to handle specific critical bacteria and customer products.

Sartorius Stedim Biotech is a leading international supplier of products and services that enable the biopharmaceutical industry to develop and manufacture drugs safely and efficiently. As a total solutions provider, Sartorius Stedim Biotech offers a portfolio covering nearly all steps of biopharmaceutical manufacture. The company focuses on single-use technologies and value-added services to meet the rapidly changing technology requirements of the industry it serves.

Headquartered in Aubagne, France, Sartorius Stedim Biotech is quoted on the Eurolist of Euronext Paris. With its own manufacturing and R&D sites in Europe, North America and Asia and a global network of sales companies, Sartorius Stedim Biotech has a global reach. The company employs approx. 4,200 people, and earned sales revenue of 884.3 million euros in 2015

Bischof + Klein Expands Extrusion Capacity

A new extrusion line will double capacity for CleanFlex cleanroom films

Demand for high-purity packaging for the pharmaceuticals and medical technology industries has been increasing for years.

German plastic packaging and technical films producer Bischof + Klein has responded by investing in a new coex extrusion line, doubling its extrusion capacity for CleanFlex cleanroom films.

The extension will take place away from the current cleanroom extrusion facilities, as two separate areas. This is important for risk management. Production can switch to another extrusion area in the event of malfunctions, ensuring supply security.

Planning and construction were undertaken using of cleanroom construction on the basis of current standards such as DIN EN ISO 14644, and the latest online monitoring technology has been implemented.

Production is scheduled to start in the spring of 2017, following successful initial qualification of the new cleanroom, as well as qualification and validation of the new production line and the products.

CleanFlex sales manager Benjamin Kepp has said he is certain this investment “hits the spot” and that the company is setting new standards in cleanroom packaging.

Takeda to Invest in New Production Facility at Grange Castle Site in Dublin

Minister for Jobs, Enterprise, and Innovation Mary Mitchell O'Connor TD has announced that Takeda Pharmaceutical Company will invest €40m in a new facility at their Grange Castle site in Dublin.

Takeda's investment will expand the site's existing footprint, with the construction of a new standalone high-containment production facility dedicated to manufacturing its oncology product NINLAROTM for global markets. The investment will create approximately 40 new jobs.

Takeda first set up operations in Ireland in 1997 manufacturing products for global markets. In 2002, Takeda chose Dublin as the location for its first active pharmaceutical ingredient (API) facility outside of Japan.

Welcoming the new investment, Minister Mitchell O'Connor said: "The pharmaceutical industry makes a huge contribution to the Irish economy in terms of jobs and exports and is one of the fastest growing sectors.

"Takeda's decision to manufacture their new cancer treatment in Ireland is a great win and vote of confidence in Ireland and it builds on our ongoing expansion of the sector here.

"I'm delighted that this investment will bring a further 40 jobs to the company's existing Clondalkin facility".

Plant Director at Takeda Ireland Grange Castle Mr. Paul Keogh said: "We are delighted that Takeda has chosen Ireland for this investment and proud that we have been entrusted with the responsibility to produce and deliver this very important treatment for cancer patients worldwide.

"We have a great team here in Ireland and are committed to continuing to put patients first through the timely manufacture and supply of high-quality products from our site".

Commenting on the investment, chief executive officer (CEO) of IDA Ireland Martin Shanahan said: "Ireland is a globally recognized center of excellence in life sciences due to the country's strong regulatory track record and talent availability.

"Today's investment by Takeda demonstrates their continued commitment to Ireland. I wish the Takeda team every success as they continue to grow their operations in Ireland."

Ardmac Delivers West Pharmaceutical Services New Facility

Ardmac, a leader in construction services, joined West Pharmaceutical Services and government leaders to announce the opening of the new medical device facility in Damastown, Co Dublin.

Ardmac is delighted with the completion of the Medical Device Design & Build Project for West Pharmaceutical Services, providing the handover four weeks early. The 60,000 sq. ft. building includes new cleanrooms, production, warehousing, office support and canteen along with associated site facilities near Damastown, County Dublin. The expansion is in response to customer demand for medical device manufacturing—especially in the area of diabetes—and represents West’s most recent investment in Ireland.

The additional capacity in Dublin will make it possible to better service the Company’s growing healthcare and medical device contract manufacturing business. West anticipates 100 new jobs will be added to the business over the next five years as a result of the expansion.

“As the healthcare market becomes increasingly complex, West is advancing our core competencies in the development, manufacturing and final packaging of complex drug delivery systems and diagnostic devices for our customers,” said Karen Flynn, Senior Vice President and Chief Commercial Officer, West. “We are excited about the growth and expansion we are experiencing in both our contract manufacturing business in Dublin as well as our proprietary products business in Waterford, both of which will support increasing demand from our global customer base.”

According to Alan Coakley, Managing Director of Ardmac, “We are delighted to be celebrating another successful completion on behalf of West Pharmaceutical Services. Being a global leader in cleanroom construction for the pharmaceutical and life sciences sector, coupled with our construction capability, Ardmac were uniquely suited to design and build this medical device manufacturing facility. This facility is a testament to the excellent reputation of West Pharmaceutical Service as leaders in integrated packaging and delivery for injectable medicines.

“We are very proud to have been selected; delivering the project safely, early and on budget. We look forward to continuing our great partnership with West Pharmaceutical Services in the future.”

The green-field project included the design of all Structural, Civil, Architectural, Mechanical and Electrical elements, which included:

Use of 3d Revit modelling throughout the design and construction phases of the project
Fit-out of new office, canteen, and toilet areas
Construction of warehouse & plant areas
Construction of cleanrooms
Mechanical, electrical, sprinkler and process installations
External works including roads, car parking, loading docks, drainage and attenuation tanks.

“We are very pleased with West’s commitment to furthering operations in Ireland,” said Mary Mitchell O’Connor TD, Ireland’s Minister for Jobs, Enterprise & Innovation. “With this most recent expansion in Dublin and the company’s previously announced investment in Waterford, West is affirming its presence as an important employer in Ireland. I am delighted with this new investment, which strongly aligns with the Government’s ongoing strategy to attract investment in high-quality, high-value, medical device manufacturing to Ireland. We look forward to strengthening our relationship with West.”

Martin Shanahan, CEO, IDA Ireland said, “IDA’s life science sector continues to grow from strength-to-strength and this investment by West is a good example of the potential for convergence across the life sciences sector. Ireland has seen hundreds of millions invested in recent years in the development and manufacturing of new injectable drugs for diabetes, cardiovascular disease, autoimmune disease and cancer. The patients who will benefit from these exciting new drugs will also benefit from West’s innovation in drug delivery devices. IDA welcomes this investment and looks forward to continuing to work with West and their partner biotech companies in further developing the Irish cluster.”

Aurobindo to Add Portuguese Capsule and Tablet Capacity

Aurobindo Pharma Limited has agreed to buy Portugal-based Generis Farmaceutica SA for €135m in a deal that includes a tablet and capsule plant in Amadora.

The takeover – detailed in a post on the Bombay Stock Exchange (BSE) will see Aurobindo’s Dutch subsidiary Agile Pharma BV buy Generis from current owners private equity investor Magnum Capital Partners.

The Hyderabad, India headquartered firm said the acquisition will consolidate its manufacturing operations in Portugal, which includes Aurovitas, Unipessoal LDA and Unipessoal Limitada.

SVP of European operations, Mr. V Muralidharan, said the Amadora facility will allow it to “better serve both the Portuguese market and the broader European market, particularly with regard to small volume products.”

The deal is expected to complete in February.

Freudenberg Invests in Medical Technology Facilities

The investment will expand its medical technology division worldwide and includes a new cleanroom in Germany.

The Freudenberg Group is investing globally in the expansion of the company’s medical technology division with the aim of further extending its innovation strength and ensuring long-term market success.

The company, which makes products that are used in the treatment of diseases such as cancer and diabetes as well as innovative wound dressings that accelerate the healing process chronic wounds, says demand for such products is rising around the globe.

At the Kaiserslautern site in Germany, Freudenberg is expanding its cleanroom production for the second time in recent years to meet growing demand among its customers.

Furthermore, a 10m euro development center for innovative catheter technology has recently been built at Carrick-on-Shannon, Ireland, creating 200 jobs.

The company also made additional investments in Carpenteria, California, where the site is to be expanded by around 10,000 sq. ft. (930m2).

In Shenzhen, China, Freudenberg is currently doubling its production capacities for medical technology. To meet the needs of Chinese patients, Freudenberg relies on targeted development work and decades of experience in the country.

Innovations such as biodegradable wound dressings, coatings for implants or seals for medical devices all make the lives of patients and physicians easier, says the company.

MilliporeSigma Expands End-to-End Biodevelopment Centers Around the World

MilliporeSigma, a leading science and technology company, announced the expansion of its end-to-end biodevelopment centers to meet increasing customer demand for its turnkey portfolio of bioprocessing products, manufacturing capabilities and industry leading technological expertise.

The expansion, which includes the opening of two new process development centers in the U.S. and China, follows the commercial success of MilliporeSigma's biodevelopment center in Martillac, France. The two new units will be located in close proximity to customers in the Shanghai and Boston metropolitan areas. Each will provide a full range of process development capabilities and services. This includes cell line development services, both upstream and downstream process development, as well as non-GMP clinical production.

"We are seeing an increasing global demand for end-to-end process development solutions and MilliporeSigma offers a one-stop shop for biopharma customers," said Udit Batra, Member of the Executive Board, Merck KGaA, Darmstadt, Germany and CEO, MilliporeSigma. "This expansion reinforces our position as the premier supplier of all process development and clinical stage manufacturing solutions, materials and services needed for the production of biologics. This is a strategic, high-potential investment for MilliporeSigma specifically designed to meet customer needs on three continents."

MilliporeSigma's biodevelopment center in Martillac, France, is a fully operational single-use, GMP facility for manufacturing clinical stage batches. Equipped with a full suite of MilliporeSigma technologies, including the 2000 liter single-use Mobius® bioreactor, Martillac offers biopharma companies a complete solution to support their clinical development programs.

MilliporeSigma's end-to-end offering delivers important benefits and addresses key challenges for biopharmaceutical companies at all stages of molecule development and commercialization in any geography. In addition to the Mobius® bioreactor, the end-to-end portfolio includes solutions such as Lynx^® CDR, Viresolve® Process Area Modules, Pellicon® and Centinel^™ Intelligence Virus Defense.

Early-stage companies with limited resources and infrastructure benefit from a partner with strong expertise and experience developing processes and GMP clinical manufacturing to help accelerate early clinical development programs. Companies in more advanced stages need to overcome the challenges of moving from late phase clinical development into commercial manufacturing, accelerating availability of affordable life-enhancing drugs. With an end-to-end approach, MilliporeSigma can facilitate and accelerate scaling and technical transfer of an entire process to a new location.

Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.

Merck KGaA, Darmstadt, Germany is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of €12.85 billion in 2015. Around 50,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges.

Merck KGaA, Darmstadt, Germany is the world's oldest pharmaceutical and chemical

company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. The company holds the global rights to the name and the trademark "Merck" internationally except for the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Aerie to Build Manufacturing Facility in Ireland

Aerie Pharmaceuticals Inc. will lease a 30,000 sq. ft. manufacturing facility in Ireland to commercialize its eye-drop product for Glaucoma after delays at a third party CMO.

Working alongside the Industrial Development Agency (IDA) in Ireland, the California-based biotech has settled on a site in Athlone, which it claims will be ready for commercialization of the small molecule Rhopressa by 2020.

Rhopressa is Aerie’s ophthalmic solution of small-molecule netarsudil to treat Glaucoma - a group of degenerative eye diseases that can lead to vision loss.

Aerie has also developed a second Phase III product – Roclatan – currently in two trials combining Rhopressa with an FDA-approved small-molecule generic, latanoprost.

Aerie withdrew its new drug application (NDA) for Rhopressa in October after its Tampa, Florida-based contract manufacturing organization (CMO) announced it would not be ready for US FDA inspection.

Following further delays, Aerie has said it will now resubmit the NDA next month, and if successful, both Rhopressa and Roclatan will be manufactured at the Athlone facility instead.

“As we prepare for commercialization, it is increasingly important that we ensure greater independence regarding our finished product sourcing while also meaningfully reducing our future product costs,” said Vicente Anido, CEO of Aerie.

The building shell was initially constructed by the IDA in the Athlone Business and Technology Park, around 130km from Dublin. Aerie will now lease the space with internal construction with equipment purchase to begin immediately.

Projected costs are expected to total $25M, excluding the lease.

In a statement, the firm claims its move to manufacture in Ireland was also based on some incentives set by the IDA, including employment and capital investment.

Anido added “We are grateful to our IDA colleagues in Ireland for their cooperation throughout this process and the incentives that we have been granted.”

Aerie withdrew their NDA submission of Rhopressa in October after its CMO announced it would not be ready for its FDA pre-approval inspection of the facility in Tampa, Florida.

A second delay in December was announced by the unnamed CMO, further pushing back plans to commercialize the drug.

In a statement, the Aerie decided it would re-submit the NDA this February, with plans to submit a marketing authorization application (MAA) for Rhopressa to the EMA by the end of 2017.

Three Novasep Custom Manufacturing Sites

Successful FDA inspections confirm Novasep’s longstanding reputation in maintaining

quality assurance systems fully compliant with the highest world standards

Novasep, a leading supplier of services and technologies for the life sciences industry, announces that three of its custom manufacturing sites individually passed the general inspection process of the US Food and Drug Administration (FDA) free of any 483 form.

All three FDA general inspections have taken place at Novasep’s manufacturing sites in France (Mourenx and Le Mans), and in Germany (Leverkusen) over the course of 2016.

Novasep’s manufacturing site in Le Mans, France, produces highly potent cytotoxic active pharmaceutical ingredients (HPAPI) and registered advanced intermediates for commercial or clinical development use. The site also provides customers with regulatory and containment evaluation support. It produces paclitaxel, for which Novasep holds a valid Drug Master File and a European CEP (Certificate of Suitability). The site is also renowned for Antibody Drug Conjugate (ADC) payload production services that will soon be extended to ADC conjugation.

The manufacturing site in Mourenx, France, produces APIs and advanced intermediates. Novasep’s site in Leverkusen, Germany, amongst its set of technical expertise, can handle hazardous chemicals at industrial scale. This know-how is particularly suitable for designing shorter, cost-effective synthetic routes for producing APIs and advanced intermediates. The site also produces and sells pre-formulated nitroglycerin products for the pharmaceutical market. In each case, the FDA inspection confirmed that commercial APIs produced at each site are suitable for drugs marketed in the US.

“This success has been made possible by the day-to-day good practices adopted by every colleague involved in operations. The robust system implemented by Novasep’s quality assurance team ensures these high standards,” said Jean-Claude Romain, VP quality at Novasep. “These three successful inspections reward this long-term teamwork and commitment.”

Global professional juries have recognized Novasep several times for the reliability and the robustness of its quality system.

Novozymes Innovation Campus, Copenhagen, Denmark

Global biotechnology company Novozymes is constructing a new innovation campus in Copenhagen, Denmark.

The new campus will be located in the Lyngby-Taarbæk municipality, approximately 13km north of Copenhagen. Its first phase of construction was expected to begin in October and is scheduled for completion in late-2018.

The proposed campus will host Novozymes' biotech research and development (R&D). It has provision for expansion in future to accommodate between 2,000 and 2,500 personnel.

The project is expected to create 800 jobs in the region in the areas of R&D and other businesses. It is also expected to support education, research, and business in the Lyngby-Taarbæk municipality.

Digital tools were used in the design process with the creation of virtual buildings. In addition, 4D films were used to plan construction.

Green spaces and landscaping will be a key part of the new facility. The buildings of the campus are designed to be low-harmonic, complementing the surroundings and preserving existing forest areas.

In addition, a park and nature trail will be developed, which will be open to the public. Landscaping for the project is inspired by the adjacent Deer Park.

The buildings will feature large glass windows to provide optimal illumination and will be interlinked with corridors to support transdisciplinary collaboration.

The new campus will be built on a 140,000ft² site. It will include laboratories, a learning center featuring teaching labs, a small cinema, and a café. The learning center will provide opportunities for students and visitors to learn about nature and biology.

Phase I of the innovation campus will occupy 432,552 sq. ft. (40,200m²) and provide enough space for Novozymes' operation needs until 2023, while the remaining 1,073,848 sq. ft. (99,800m²) area will be developed in future phases.

Construction of Phase I will include four buildings with around three floors comprising research facilities, laboratories, and other business development areas.

A parking garage with a floor space of 10,000m² will also be built in this phase.

NCC was awarded a contract to provide construction services for the first phase of the innovation campus in October.

Ramboll is serving as lead consultant for the project and is responsible for co-ordinating with Novozymes to ensure progression.

Vilhelm Lauritzen was contracted to act as the architect for the new facility, while GHB Landscape is responsible for the landscaping design.

Headquartered in Denmark, Novozymes is one of the world's leading biotechnology companies. Founded in 2000 by a demerger from Novo Nordisk, Novozymes is engaged in the supply of industrial enzymes and microorganisms for use in agriculture, animal health, industrial cleaning, and wastewater treatment.

Novozymes achieved sales of DKK14bn ($2.06bn) in 2015 and holds a 48% market share in the industrial enzymes market. It has invested approximately 14% of its revenue on research every year, since its formation, resulting in the development of more than 100 innovative products.

Novozymes employs more than 20% of its 6,500 personnel in R&D. The number of employees has increased by 600, since 2005, to reach 2,700 in Denmark.

AstraZeneca Opens UK Plant

AstraZeneca has opened a £120m ($148m) cancer treatment manufacturing site in Macclesfield in the UK.

The facility will manufacture the delivery device for Zoladex (goserelin), which is a hormone-based treatment for the symptoms of prostate cancer, breast cancer and endometriosis.

It is based at AstraZeneca's large Macclesfield campus which has facilities for bulk drug manufacture, formulation and packaging.

AstraZeneca media relations head Neil Burrows said “The plant will produce the formulated Zoladex product and pack it in a syringe” explaining that the device is supplied to the factory.

Before developing the Zoladex plant AstraZeneca sought advice from UK drug watchdog the Medicines and Healthcare products Regulatory Agency (MHRA).

At the time AstraZeneca said the MHRA had reviewed the construction plans, conducted manufacturing technology assessments and analyzed its validation plan free of charge.

MHRA spokeswoman Sarah-Rose Burke confirmed the agency's involvment, telling us "as part of our Innovation Office we generally meet free of charge for this type of advice in the Inspectorate."

AstraZeneca announced its intention to build the plant in 2013, which is around three years before the referendum on June 23 that will see the UK leave the European Union (EU) next year.

Burrows confirmed this, stating: “The facility was sanctioned in 2013 and construction began in 2015. It will replace older facilities so as such no new jobs but naturally safeguards existing ones. Brexit vote was not a factor in the decision.”

Biotica to Build Facility for Biotica

HempTech Corp., a provider of Controlled Environment Agriculture (CEA) with sophisticated automation and analytical tools for the cultivators of legal industrial hemp and marijuana, has agreed to build a drug development and manufacturing facility for Biotica Pharmaceuticals beginning second quarter 2017.

The new drug development and manufacturing facility will contain grow, lab extraction and laboratory capabilities. HempTech will use its most sophisticated grow system, the grow droid, in conjunction with CognetiX for development and delivery of pharmaceutical grade strains for use of medical discovery by Biotica.

According to the company, HempTech is the only cannabis grow technology provider offering advanced CEA and sophisticated analytics for development of pharmaceutical grade marijuana strains for pharmaceuticals globally. Biotica Pharmaceuticals has developed BPRx Technology, which is a novel combinatorial library of phytocannabinoids and endocannabinoids for treating various human diseases.

Biotica's current technology includes: BPRx-060216, a lead drug candidate to treat eosinopilic esophagitis (EoE); and BPRx-060234, a lead drug candidate to treat early stages of Alzheimer's disease.

Biotica, a privately held pharmaceutical company, has applied for two worldwide patent rights for the platform technologies and for specific novel drug formulations. "We are on mark to have an amazing year in 2017,” said HempTech’s acting chief executive officer, Sam Talari. "With expected legal and recreational cannabis market to reach billions of dollars in coming years, we will be positioned to capitalize on this tremendous opportunity."

JHL Biotech Opens Single-Use Plant

The world’s largest modular cGMP biopharmaceutical manufacturing facility came online in Wuhan, China.

The first-of-its-kind factory, JHL-1, built by GE Healthcare’s Life Science business for JHL Biotech, is compliant with international regulatory requirements and will be the largest monoclonal antibody manufacturing facility in China to be constructed around single-use bioreactor technologies – after site validation is completed next month.

“It is the first facility of its kind,” BrandonPence, global marketing leader, BioProcess, GE Healthcare Life Sciences, related at Interphex in New York. “We’re excited to see what it brings to the market through the implementation of modular manufacturing designs and single use technologies all coming together.”

Fabtech Technologies Gains Facility Project

The facility for avian flu vaccines will be built in the 6th of October City near Cairo, Egypt.

Fabtech Technologies of Mumbai, India, has won a project for an avian influenza (bird flu) vaccine facility In Egypt.

The US$19m project will produce 400 million doses of the avian influenza vaccine in the first year and over 800 million doses from the second year onwards.

The project is scheduled to be completed in 18 months and is funded by a loan of $15m from development partners Hassan of the Islamic Development Bank and another loan of $4m from the Saudi finance fund.

Dr Khalid Mujahid, spokesperson for the Ministry of Health in Egypt and the Health Minister Dr Ahmed Imad Eddin witnessed the signing of the contract between Vacsera (Egyvet) and Fabtech.

Fabtech is a global engineering and fabrication company with a strong presence in Asia, Middle East and the US. It specializes in innovative turnkey solutions for the pharmaceutical, biotechnology and healthcare sectors and has more than 700 installations in 42 plus countries.

The company now provides a complete turnkey solution and has its own manufacturing setup for pre-fabricated panels.

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