Phenomenex is expanding sales internationally as demand for GC columns grows in North America and Europe as well as in India and China, particularly in food testing applications.

Emmet Welch, senior product development manager, said: "We are staffed with scientists and production experts with decades of leadership in every aspect of GC column technology and manufacturing. In fact, many of our current staff have more than 25 years of experience in column technology development.

"Detailed and exhaustive planning went into creating an efficient production floor, using lean principles to maximize the use of space while minimizing the movement of people and materials. We have also included a centralized piping system that reduces the cost and movement of process gasses."

The firm has also introduced a trio of Zebron GC columns developed for the analysis of fatty acid methyl esters (FAME) in food.

Identification and measurement of these compounds in products such as cheese, peanut butter, infant formula, cooking oils and oil-based nutritional supplements is increasingly important in meeting labeling requirements and testing for product adulteration, said the company.

Kristen Parnell, product marketing manager, said it has been able to improve the separations so they can be done on shorter columns, saving analysts up to 45 minutes per run.

“Cis/trans FAME analysis has historically been carried out with long columns, which produce corresponding long run times. These three new columns for FAME analysis add to the portfolio we already have in place for food testing.”

The Zebron ZB-FAME offers selectivity targeting a 37-compound mix, in a shorter column. It reduces run times to about 11 minutes while providing Rs values of 1.0 or greater.

The Zebron ZB-88 is a GC alternative to other 88-phase columns for the separation of cis/trans isomers. This column is for analysis of olive and hydrogenated oils.

The third column, Zebron ZB-23, is an alternative to existing 23-phase columns for the separation of cis/trans isomers in a group of products that includes omega-3 and fish oils.

Pfizer CentreOne Expands Fill-Finish Services to Its Michigan Facility

Global contract manufacturing organization Pfizer CentreOne has expanded its fill-finish services to its site in Kalamazoo, Michigan.

Along with vial-filling of small molecules and biologics, the facility also provides vial-filling of sterile suspensions, expanding Pfizer CentreOne’s service portfolio.

“Kalamazoo was the obvious choice for expansion of our fill-finish services,” said Peter Stevenson, Pfizer CentreOne’s Vice President and General Manager.

“Our Kalamazoo colleagues have been doing contract manufacturing for more than 40 years on the API side – it’s part of the culture.”

“This is also one of Pfizer’s premier sterile-injectables sites. It’s a natural fit,” he said.

Kalamazoo vial-filling services at the Kalamazoo site encompass:

Small molecules and biologics
Sterile suspensions
Potent and controlled substances
Aqueous and oil-based formulations
Lyophilisation
Vials 1-100mL; bulk formulation <1–1,600 liters

Bob Betzig, Kalamazoo site head, said: “We’re thrilled to expand our contract manufacturing services to include sterile injectables. We value our contract manufacturing partners and pride ourselves on producing difficult-to-make injectables. Our team is ready and waiting.”

AB BioTechnologies to Build a New GMP Mfg. Facility

AB BioTechnologies has unveiled plans to invest $10.5 million to construct and equip a new 23,000 square foot manufacturing facility in Bloomington, IN, and create up to 33 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 Jeff Schwegman, founder and chief executive officer, 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.

Avista Pharma Solutions Completes Expansion

Avista Pharma Solutions has completed the US$4m expansion of its 26,000ft2 contract testing facility in Agawam, Massachusetts.

For over 30 years, the Agawam site has served pharmaceutical and medical device clients. As part of an ongoing initiative, these facility and technology upgrades will enable Avista Pharma to deliver additional microbiology, sterility testing, and microbial ID service offerings.

As the result of Avista Pharma's 2016 capital investment, the improved facility has 4,200ft2 of additional space, featuring a new microbiology laboratory as well as a modular cleanroom area which houses isolator technology and an ISO 6 cleanroom used for sterility testing of medical devices, pharmaceuticals and biologics.

In addition, the laboratory support division has implemented new pass-through autoclaves and labware processing technologies that streamline workflow and complement Avista Pharma's extensive suite of microbiology services.

The facility's full range of comprehensive services will continue to include raw material and finished product release testing, ICH stability and storage, container closure integrity testing (CCIT), water system testing and validation, cleanroom monitoring and risk assessments, microbial identification via both MicroSEQ ID (rapid 16S rDNA sequencing) and Vitek MS (MALDI-TOF), mycoplasma testing, Antimicrobial Effectiveness Testing (AET), Microbial Enumeration Testing (MET), endotoxin and bioburden testing and disinfectant efficacy qualifications.

"We remain committed to providing best-in-class Microbiology, Analytical Chemistry and Cleanroom services," said Patrick Walsh, Chief Executive Officer of Avista Pharma. "This investment will complement our existing capabilities and expand our service offerings for our pharmaceutical and medical device clients."

Equashield to Open New Manufacturing Facility

Equashield, a Port Washington, New York-based provider of Closed System Transfer Devices (CSTDs) for the safe and simple handling of hazardous drugs, is building a new manufacturing plant.

Equashield's new facility will expand the manufacturing capabilities of its closed system transfer devices, as well as its closed system drug compounding robot.

The company will invest an estimated US$30m to build the new plant to meet the growing market demand for manual and automated hazardous drug compounding devices.

The new facility will be built on a three acre plot with an option to expand by another 1.5 acres.

The new plant will expand the manufacturing capabilities of Equashield's flagship CSTD, as well as the new Equashield Pro closed system drug compounding robot, first unveiled at the ASHP Midyear meeting.

"As Equashield continues to expand into new international markets, this plant will provide the capacity to significantly expand our product portfolio, while enabling us to fulfil worldwide need for current and future CSTD demand," said Marino Kriheli, co-founder of Equashield.

"With these enhanced capabilities Equashield can continue to make a difference for those who work with and around hazardous drugs."

Construction of the 112,000ft2 (10,405m2) building is expected to be completed in July 2019. It will include a 20,000ft2 (1,858m2) cleanroom space, incorporating the HVAC variable refrigerant flow (VRF) system for cooling and air conditioning. Production will be fully automated, from raw materials entry to packaging and palletizing, to preserve sterility of products.

Tapemark Manufacturing Facility Completes Successful FDA Inspections

The FDA has completed a successful pre-approval inspection (PAI) of Tapemark’s manufacturing process and a general good manufacturing practices (GMP) inspection. The pre-approval inspection assessed Tapemark’s readiness to commercially manufacture one of its customer’s transdermal pharmaceutical products that is awaiting FDA approval. The FDA thoroughly reviewed Tapemark’s facilities for compliance with its procedures and adherence to GMP.

“This successful PAI and GMP inspection represents another major success in the achievement of our CDMO strategic goals that includes full-service pharmaceutical commercial product manufacturing,” said Andy Rensink, President and COO of Tapemark. “We extend our appreciation and congratulations to all of our employees and contractors on this outstanding accomplishment.”

Tapemark is a world leading contract developer and manufacturer of drug delivery systems with a focus on transdermal patches and oral thin films serving the pharmaceutical and medical device markets. Whether companies are launching new products, or need life cycle management and patent extensions of existing ones, Tapemark provides the strategic guidance and manufacturing capabilities to help customers realize the breadth of optimal and alternative drug delivery formats.

University of Pennsylvania Announces $1.5 Billion Hospital Pavilion

The University of Pennsylvania will build a $1.5 billion new hospital on Penn Medicine’s West Philadelphia campus. The Pavilion, which will house inpatient care for the Abramson Cancer Center, heart and vascular medicine and surgery, neurology and neurosurgery, and a new emergency department, is expected to be completed in 2021. The facility will be the largest capital project in Penn’s history and Philadelphia’s most sophisticated and ambitious health care building project.

“Penn is proud to be the preeminent health system in the Philadelphia region. This building will be transformational, serving as the flagship facility for Penn Medicine and setting a new standard for modern health care delivery across the nation,” said Penn President Amy Gutmann. “This is the hospital that will define America’s best medicine for generations to come.”

At the heart of the new hospital’s design: flexibility to stand the test of time in the rapidly evolving health care field.

“We’re building a hospital that will allow us to deliver the very best care the 21st century can offer patients – but we’re also ‘future-proofing’ it to ensure that we can quickly and seamlessly adapt what we do to help our patients in the coming decades,” said J. Larry Jameson, MD, Ph.D., dean of the Perelman School of Medicine at the University of Pennsylvania and executive vice president of the University for the Health System.

The Pavilion will house 500 private patient rooms and 47 operating rooms in a 1.5 million square foot, 16-story facility on the former site of Penn Tower, across the street from the Hospital of the University of Pennsylvania and adjacent to the medical campus’s outpatient hub, the Perelman Center for Advanced Medicine.

“As the nation’s oldest teaching hospital, the Hospital of the University of Pennsylvania is rooted in a history of firsts going back nearly 150 years,” said Ralph W. Muller, CEO of the University of Pennsylvania Health System. “Now, with the Pavilion, we’re poised for the next hundred years of advances in patient care.”

Among distinguishing features in The Pavilion:

An adaptable room concept through which patient rooms are equipped to flex between an intensive care unit set-up, if needed, and a standard room as patients recover, or as the patient population and caregiving needs change in the coming years. Each spacious room will include a private bath and a comfortable area for family members and caregivers to stay close by.
A seamless flow of operations – from the emergency department through hybrid operating rooms used for both surgeries and high-tech interventional procedures through recovery and discharge – enhanced by technology and the latest research on how to facilitate and enhance care team collaboration.
Telemedicine functionality that allows remote monitoring and consultations, as well as technology to link patients to their friends and families at all times. In-room technology will strengthen communication between patients, families, and care teams.
An eco-friendly construction, design and operations plan that fortifies Penn’s commitment to the environment, through pursuit of LEED certification, innovations like the re-use of water, 100 percent outside air, and park-like, outdoor green space for patients, families and staff.

The design and planning process for the Pavilion has been orchestrated by PennFirst, an Integrated Project Delivery (IPD) team consisting of the global healthcare design firm HDR, the international architect Foster+Partners, and the innovative engineering design capabilities of BR+A, as well as the construction management expertise of L.F. Driscoll and Balfour Beatty. Staff from each group – as well as Penn Medicine clinical, facilities, and patient experience experts – work collaboratively in a specially designed “integration space” to ensure cohesion and strategic planning and reduce waste at each step of the project.

The building’s design has been informed by extensive and inclusive consultation with Penn Medicine staff, from physicians and nurses to environmental and dining services workers. These groups have engaged with the design team through a series of tours and patient care simulations in multiple full-size mock-ups of the new facility’s inpatient units as well as operating rooms, family waiting areas, and spaces for staff. Patients and families have also participated in tours and provided feedback to inform plans for the Pavilion’s patient experience.

SOURCE: University of Pennsylvania

The Albert Sherman Center Vivarium at the University of Massachusetts

The Albert Sherman Center Vivarium at the University of Massachusetts was named the 2015 TurnKey Facility of the Year.

In its 45 years of existence, the University of Massachusetts Medical School has become one of the nation’s premier biomedical research facilities. The school’s research community includes a Nobel laureate, a Lasker award recipient, two members of the National Academy of Sciences, two members of the Institute of Medicine, and seven Howard Hughes Medical Institute investigators. Because of its rapid growth, animal housing and procedural space were at a premium. In 2012, the Commonwealth of Massachusetts and the University of Massachusetts Medical School partnered to build a new 512,000 square foot biomedical research and teaching building, the Albert Sherman Center and its new vivarium. The Sherman Center has received LEED Gold Certification, signifying that it meets a nationally accepted benchmark for design, construction, and operation of high performance green buildings.

The design of the Albert Sherman Center’s vivarium is based on three suites of rooms which permit isolation of the individual suites in the event of a disease outbreak. Each suite has eight animal housing rooms and each pair of housing rooms shares a dedicated procedure room that is accessed directly from the housing rooms. This arrangement provides an extremely efficient layout by reducing circulation to a single corridor for the housing rooms within each suite.

ARC/Architectural Resources Cambridge (ARC) was the lead architect and the Jacobs Consultancy was the consulting planner for the vivarium. ARC convened frequent meetings and led overall architectural coordination. Jacobs took the design lead for the vivarium and made numerous suggestions for certain engineering requirements. The atmosphere was always professional but relaxed. Suggestions were discussed, accepted, rejected, or modified as needed. Other stakeholders, such as University of Massachusetts Medical School architectural and engineering personnel, attended most meetings. Other meetings might have a lighting specialist, an HVAC specialist, or the general contractor’s representative. The vivarium staff was always represented. As a result, the vivarium planning was always well ahead of the rest of the Sherman Center project.

Although open for a relatively short time, the Sherman Center vivarium is already more than half filled and has been very positively received by the research faculty and technicians. Important research on gene therapy and gene expression is ongoing and they look forward to significant life science discoveries that will advance the health and well-being of the people of the commonwealth and the world.

Lubrizol Unveils Expansion Plan

Lubrizol LifeSciences is spending $60 million on new product solutions, capacity expansion and additional cGMP manufacturing, the company announced. It says these investments will bolster its excipients, polymers, drug formulation and manufacturing, and medical device contract manufacturing capabilities at Lubrizol LifeSciences’ global facilities.

Commercial drug product manufacturing will be added at the company’s Particle Sciences facility in Bethlehem, PA. Leveraging the company’s knowledge in complex formulations and production, the facility will be adjacent to the existing development and clinical trial manufacturing site, offering customers a seamless flow from development through manufacturing. This new space, which is expected to be operational in the fourth quarter of 2017, will accommodate both sterile and non-sterile products, highly potent compounds, and organic solvent processing.

Additionally, LifeSciences is investing to expand its global facilities for excipients, polymers and contract manufacturing, with a focus on quality and efficiency. This capital investment will impact multiple sites to increase in-house engineering capacity across the LifeSciences portfolio of medical and pharmaceutical applications. This includes new investments in design, manufacturing and sterilization technologies for the production of interventional catheters and long-term implantable devices, an area of strategic importance to the medical device segment.

"We have significantly enhanced our capabilities through the combination of strong polymer technology, application know-how and world-class manufacturing," said Deb Langer, vice president, Lubrizol Personal Home and Health Care. "As healthcare companies look for total solution providers, we continue to invest in the right areas to provide valuable offerings where our customers are experiencing the most growth."

Boston Analytical, Salem, NH

Size: 30,000 sq. ft.

Project team: Margulies Perruzzi Architects, Bowdoin Construction, Daigle Engineers (structural), Environmental Solutions Inc. (HVAC design and build), Piquette & Howard Electric Inc. (electrical design and build).

Description: Margulies Perruzzi Architects (MPA) has completed of a new 30,000 sq. ft. laboratory and office facility for Boston Analytical, the life sciences division of Alpha Analytical. Located in Salem, N.H., Boston Analytical’s new and expanded space houses high-tech chemistry and microbiology laboratories equipped with the most sophisticated and up-to-date analytical testing equipment. Boston Analytical’s testing services are used by pharmaceutical, biopharmaceutical, and medical device companies worldwide.

Seeking to consolidate and expand its operations, Boston Analytical, a premier current Good Manufacturing Practice (cGMP) compliant laboratory, engaged MPA to program and design the spaces in its new facility. Most of the newly outfitted space is production space for testing, including 20,000 SF of chemistry, stability, and microbial labs and 2,000 sq. ft. of ISO 8 to

ISO 5 cleanrooms. This expanded space with cutting-edge equipment has increased lab capacity by 55 percent and stability storage by 130 percent, with eight new chambers including a large capacity walk-in chamber. Additional space in the facility supports office and administrative functions, including reception, open and closed offices and conference rooms, and a kitchen/dining area.

Built by Bowdoin Construction, interior features include new lab casework, fume hoods, epoxy floors, and a new energy efficient HVAC system with a high efficiency boiler plant. MPA coordinated closely with contractors to provide appropriate space for the specialized mechanical and support systems required to maintain the strict airborne particulate and cleanliness standards. Those systems include high-efficiency particulate air (HEPA), wastewater treatment, and reverse osmosis and deionization (RO/DI) systems. Adherence to the design/build schedule was key: Boston Analytical had to carefully move on a phased basis, concluding work in the existing space and then moving to the new space after it was validated and certified for production.

Boston Analytical provides a variety of the highest quality analytical testing services to support CMC for Drug Development and Release Testing, including complete Stability Testing, Analytical Development Testing, and Microbiology Testing.

Completion date: September 2016

Fresenius Kabi's Pharmaceutical Manufacturing Facility Expansion

German pharmaceutical company Fresenius Kabi announced a proposal to expand its pharmaceutical manufacturing capabilities at its Melrose Park, IL site.

Announced in August 2016, the expanded facility will be used for the production of generic sterile injectable pharmaceuticals used in hospitals and clinics across the U.S.

Construction on the project will commence this year and full operations are expected to commence by 2026.

The expansion will create new jobs for construction and highly skilled workers in Melrose Park.

New buildings will be constructed in close proximity to Fresenius Kabi's existing plant, built in 2008 at 2020 N. Ruby St. They will be connected to the 124,267ft² old manufacturing plant.

The existing manufacturing plant at Melrose Park is located in the outskirts of Chicago, five miles away from the O`Hare International Airport. It is located in the general industrial area and employs approximately 700 people.

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

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

The expansion will boost the production of injectable drugs used for anesthesia, pain management, cancer treatment, and eliminating infections. The project will be completed in compliance with the latest regulatory and quality requirements.

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

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

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

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

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

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

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

Rosalind Franklin University’s Innovation and Research Park, Chicago

Rosalind Franklin University (RFU) has announced plans for the construction of a new innovation and research park at 3333 Green Bay road in the university's North Chicago campus.

The new facility will comprise sophisticated laboratory and incubator space, which can be used by faculty and commercial biotech start-ups. It will help national and international life science firms promote research synergy.

RFU obtained endorsement for phase I of development from the university's board of trustees in March.

The innovation and research park will be constructed in RFU's medicine and science campus adjacent to the Lovell Federal Health Care Centre (FHCC) in Lake County. The site will be surrounded by numerous bioscience companies in the Midwest.

The facility will be located in the Greater Chicago area, which houses a number of equity and venture capital firms.

The two-phased development is expected to commence in September, while operations are expected to begin in 2019.

The project is estimated to provide 498 job vacancies in the first phase of construction, bringing a total economic impact of approximately $117m a year for North Chicago and Lake County upon completion.

As part of the long-term expansion, the new facility will include two additional buildings in the second phase of development. The biopark project will create 4,000 new jobs and an estimated economic impact of $278m a year for Lake County, if both phases of development are implemented.

The new innovation and research park will be four-stories high, with a total floor space of 10,000ft². It will feature space for offices, small and large meeting rooms, and common areas on the first floor.

Designed to encourage collaboration among academic and industry scientists, innovators, and entrepreneurs, the building aims to translate RFU's nationally recognized research into treatments for conditions including Alzheimer's disease, diabetes, cancer, and mental illness.

The research park can accommodate up to 175 researchers in the first phase of development. Areas of focus for research will be developing solutions for neuroscience and neurodegenerative diseases, including Alzheimer's, Parkinson's, Huntington's, and muscular dystrophy. Scope of research and investigations will include genetic diseases, inflammation, and proteomics.

The co-location of disease-specific laboratory space will generate new synergies, boost competitiveness for federal grant funding and venture capital, and draw interest from philanthropic partners.

RFU will partner with SmartHealth Activator to accelerate innovations at the new research park. SmartHealth Activator will serve to connect researchers with biotech businesses and will offer biotech start-ups access to customers, elite mentors, experienced operators, investors, seed funding, and co-working space.

RFU has also partnered with Abbvie, Zoll Medical, and Ironwood Pharmaceuticals, as well as Celgene, Lundbeck, Smith & Nephew, and Ionis in a number of research areas. It also shares collaborative research programs with DePaul University, Northern Illinois University, Advocate/Lutheran General Hospital, and the Lovell Federal Health Care Centre.

The new facility is estimated to be completed with an investment of $50m under a public/private partnership. RFU is working with a non-profit foundation called The University Financing Foundation (TUFF) for funding and development of the build.

The project is also endorsed by the City of North Chicago and a number of elected officials.

Knight Cancer Institute Research Building, Oregon

Oregon Health & Science University (OHSU)'s Knight Cancer Institute commenced construction of a new research building at South Waterfront district in south-west Portland, Oregon.

The facility will accommodate up to 600 scientists, physicians and administrators focusing on early cancer detection, computational biology, and immuno-oncology.

Construction having commenced in June 2016 with an estimated investment of $160m, the facility is expected to be ready for occupation in July 2018. Oregon's State Legislature passed a bill to fund $200m for the project in 2014 as part of the $1bn Knight Cancer Challenge initiated by Phil Knight.

Knight Cancer Institute and Immunovia announced collaboration in October 2015 to confirm, validate, and commercialize blood tests for the early diagnosis of cancer. The institute also reached a collaboration agreement with Cancer Research UK in December 2015 to accelerate research in early detection of cancer.

The building's design was aimed at bringing collaboration and interaction. It will feature shared spaces and laboratories, including small-group, informal work spaces to allow researchers to undertake reflective and privately-focused work. The laboratories are designed to receive day lighting and solar control.

The design will also create social opportunities, with a central kitchen, a lounge, and a casual seating area. The exterior balconies and roof top terrace will provide views of the Willamette River and the Cascade Mountains. The building will also include administrative offices and a car parking area.

The seven-story research facility will have a total floor space of 320,000ft², situated to the north of the collaborative life sciences building on the OHSU campus.

Research and wet lab spaces will be featured from floors two to five, while the ground floor will contain a 200-seat auditorium, meeting rooms, and a conference center. It will also include spaces for street-level retail, a café, and other amenities.

Two floors of the building will be used to house the Early Cancer Detection Centre. This will provide multi-disciplinary research teams a collaborative environment to perform early detection research under the guidance of nanotechnology expert Sadik Esener.

A ground breaking ceremony for the construction of Knight Cancer Institute's research building was attended by Oregon State Governor Kate Brown, doctors, and cancer survivors in June 2016.

The construction crew are using interactive 3D building information modelling (BIM).

The designs for the Knight Cancer Institute research building were provided by architect SRG Partnership.

The joint venture of McCarthy Building Companies and Andersen Construction (McCarthy/Andersen) was awarded a $160m-worth contract for construction of the building.

SDC Announces Strategic Expansion to Greater Boston Area

SDC, a specialized data services Contract Research Organization (CRO) providing scalable clinical trial solutions, has opened a new office in Waltham, Mass. Fueled by accelerated growth and continued high demand for its services, SDC’s strategic expansion to the greater Boston area will stimulate further employee growth in a key talent market, and expand the company’s footprint in support of local and global clientele.

“The Massachusetts life sciences economy continues to grow and strengthen, spurring a number of expansions and newly created companies geared toward services specific to the industry,” said Massachusetts Governor Charlie Baker. “We welcome SDC to the Commonwealth and congratulate them on their expansion into a robust ecosystem of local service providers working directly with the best life science companies in the country to improve patient care.”

“We are very excited to open this new office in the Boston area,” said Dale W. Usner, Ph.D., President of SDC. “This is a great step forward for SDC’s future, facilitating continued high levels of local and global client engagement, and enabling local employee recruitment from a diverse talent pool.”

SDC has supported more than 250 clinical trials for pharmaceutical, biotechnology and medical device companies since its incorporation in 2005. From early phase and Proof of Concept through global submission (Phase 3/Pivotal) studies, SDC’s biostatistics and clinical data management experience spans a wide range of therapeutic areas, including, but not limited to: oncology, neurology, ophthalmology, gastroenterology, cardiovascular, nephrology and dermatology. SDC also provides scalable full-service clinical trial solutions via a diverse and complementary network of strategic partnerships and technologies.

“Since 2005, SDC has provided leading-edge biostatistics and clinical data management services focused on the highest data quality and best possible customer experience,” said Richard Abelson, Ph.D., CEO of SDC. “We look forward to the continuation of that mission with SDC’s expanded footprint in the Boston area.”

SDC invites local biometrics and clinical trial professionals to their new office on June 13, 2017, for a Grand Opening celebration.

Cold Chain Technologies Opens New HQ

Cold Chain Technologies (CCT), a provider of temperature-controlled packaging solutions for the life science supply chain, has relocated its corporate headquarters to Franklin, MA. The expanded facility houses a manufacturing operation supported by thermal package engineering and an R&D center. The company’s customer service and multiple support teams are also located in Franklin.

The company was founded 50 years ago and was originally a regional provider of insulated shipping containers and freezer bricks to the food and seafood industry. In 2002, FDC Packaging was renamed Cold Chain Technologies and established a cGMP compliant, ISTA certified, and ISO maintained facility that has evolved into a center for thermal design and qualification testing. Later in the decade, additional manufacturing facilities were opened in Nashville, TN, Reno, NV and in Europe.

CCT currently designs, qualifies, and manufactures a portfolio of off-the-shelf and customized packaging solutions across a wide range of sizes, multiple temperature ranges and durations. Its products are used in many segments of the life sciences, including commercial manufacturing, clinical trials, specialty pharmacy compliance and direct-to-patient shipments.

Larry Gordon of CCR said, “This is quite a year for CCT. We are thrilled to be celebrating both our 50th anniversary and opening of the Franklin, MA facility. Our growth and leadership position within the industry is due to the ongoing dedication and efforts of our employees. Their desire to excel, to continually learn, and to provide extraordinary service to our customers allows us to partner closely with the world’s leading pharmaceutical and biotech companies in the delivery of life-saving medicines. CCT is well poised to continue to provide our clients with ever-smarter solutions.”

Donald Danforth Plant Science Center Expansion, St. Louis, MO

Cost: $45 million

Size: 79,000 sq. ft.

Project Team: Flad Architects (associate architect), IMEG Corp. (MEP engineering), McCarthy Building Companies Inc. (contractor), SEE Inc. (structural engineer), The Clayton Engineering Company Inc. (civil engineer), Rowan Williams Davies & Irwin Inc. (wind consultant), Crawford, Bunte, Brammeier (traffic consultant)

Description: This laboratory building expansion supports Danforth Plant Science Center’s mission to “improve the human condition through plant science.” New facilities for 100 scientists enable world-class research in plant biology, bioenergy and sustainable agriculture. Christner designed a three-story, 79,000 sq. ft. addition that is linked to the existing building by a new atrium. This three-story space brings together the whole scientific community around dining, coffee and meetings. Highly efficient and flexible open lab “neighborhoods” connect directly to naturally daylit write-up spaces with views of an expansive greenhouse complex.

Visual connectivity between researchers is achieved with careful planning and the use of glass partitions. Similar planning and design concepts achieved transparency from write-up spaces into and through the labs. At the public corridor on the first floor, a glass curtain wall opens to views of the native gardens, connecting science to the natural landscape. Because of the nature of the plant research here, the project transformed its existing manicured suburban landscape to a more native ecosystem.

Central to the creation of a connected scientific community, a public concourse runs parallel to a new garden and prairie, linking the atrium, first floor labs, and auditorium; connecting these spaces with the natural landscape.

The exterior of the lab addition is a precise, simple volume comprised of terracotta and glass acting as a contextual response to the original structure designed by Grimshaw Architects. It features an envelope that integrates its shading into the plane of enclosure. The building volumes are configured to interweave the landscape with the space inside, resulting in a truly connected campus.

Completion Date: 2015

Evotec Expanding and Opening U.S. Headquarters

Evotec AG Global drug discovery and development company Evotec AG celebrated the opening of its U.S. headquarters and expanded facility in Princeton, NJ.

Werner Lanthaler, chief executive officer of Evotec AG and Ryan Brady, the company’s executive vice president business development and head of U.S. operations were joined by Michele Brown, president and chief executive officer of Choose New Jersey, Inc. and Debbie Hart, president and chief executive officer of BioNJ, to cut the ribbon for the new U.S. headquarters.

“Princeton is an ideal location for our U.S. headquarters based on its proximity to many of the world’s leading biopharmaceutical and Pharma companies and universities, as well as its experienced talent pool that has knowledge and expertise in drug discovery,” said Dr. Lanthaler. “Our Princeton location puts us in easy reach of many our alliance and development partners and gives us the opportunity to cultivate new partnerships in the U.S.”

The company currently has more than 1,200 employees worldwide in its headquarters in Hamburg, Germany and in additional operating sites in Abingdon and Manchester, UK; Göttingen and Munich, Germany; Toulouse, France; and in the U.S. in Branford, CT and Watertown, MA.

Evotec established its Princeton office in 2015 and currently employs a team of more than 20 employees. The 20,000-square-foot expanded facility accommodates additional laboratory and office space for its growing operations in New Jersey.

Frontida BioPharm Expands

After receiving a closure letter for its Philadelphia manufacturing site on May 4, 2017 from FDA, Frontida BioPharm launched their operations expansion initiatives. The closure letter was received 8 months after the FDA issued a Warning Letter to Frontida based on an FDA inspection of the site occurring between June 15 and July 17, 2015, prior to Frontida’s purchase and operation of the facility.

The contract development and manufacturing organization (CDMO) operates the Philadelphia, PA site along with a facility in Aurora, IL.

Since acquiring the facilities on June 3, 2016, Frontida retained 155 positions at the existing sites and added more than 65 quality and scientific professionals. With the implementation of quality system improvements across the organization, Frontida says it plans to hire an additional 40-50 personnel in the next 6 months as it begins to launch new products in its Philadelphia and Aurora facilities.

“Philadelphia is a great region for Frontida to build our organization due to its strong talent pool and pharmaceutical research heritage. Over the past 11 months, Frontida has built a strong foundation by providing new leadership, expanding our manufacturing, QC, and R&D work force, and improving operational and quality systems,” said Song Li, chief executive officer, Frontida BioPharm. “We are continuing to expand our capabilities with additional manufacturing and laboratory personnel, equipment, and capital investments. The positive resolution of our regulatory status with the FDA will stimulate Frontida’s expansion and growth, and enable Frontida to better support our partners to bring new products to the market.”

Synthetic Genomics Launches cGMP Suite for Pharmaceutical Quality Manufacturing

Synthetic Genomics and Advaxis announced they have completed development and deployment of the first current good manufacturing practice (cGMP) synthetic biology facility for the production of synthetic DNA constructs. The cGMP suite has been designed to meet cGMP Phase 1 clinical quality and manufacturing requirements mandated by the FDA. The suite will be used to develop synthetic DNA constructs for Advaxis' upcoming Phase 1 clinical trial of ADXS-NEO, a personalized, neoantigen-targeted cancer immunotherapy. At the core of the suite is the BioXp 3200 System, the world's first benchtop automated genomic workstation that customers can purchase in an expandable fashion, combined with proprietary Synthetic Genomics genome synthesis tools to manufacture precision DNA constructs. The facility is based at SGI-DNA, a subsidiary of Synthetic Genomics.

"This cGMP suite marks the first application of Synthetic Genomics' automated DNA synthesis directed to improve patient care, and is a significant step towards moving synthetic biology from the benchtop to the bedside," said Oliver Fetzer, Ph.D., CEO of Synthetic Genomics. "The BioXp System and this first-of-its-kind cGMP suite opens the door to precision medicine, particularly when paired with the innovative technology Advaxis has developed for directing immune response towards cancer specific epitopes."

Advaxis' ADXS-NEO is a customized cancer treatment to stimulate an immune response against unique mutations contained in each individual patient's tumor. It begins with identifying neoepitopes – non-synonymous mutations between a patient's healthy cells and tumor cells. Using exome sequencing, a mutational map of the tumor is developed to select a set of neoepitopes most likely to trigger an immune response targeted at the cancer.

Under strict cGMP process controls, Synthetic Genomics rapidly converts the genetic sequences of these tumor-specific epitopes into synthetic DNA to create plasmid DNA targeting an individual patient's cancer. Advaxis then combines the plasmid DNA with its proprietary delivery system to generate large quantities of protein containing neoepitopes that are taken up by a patient's antigen presenting cells to activate a tumor specific T-cell response.

Cambrex Invests in API Capacity

Cambrex invests to increase pilot scale API capacity at its High Point, NC facility.

Cambrex Corporation, a manufacturer of small molecule innovator and generic active pharmaceutical ingredients (APIs), announced that it is to expand pilot plant capabilities at its High Point, NC facility with the installation of a fourth reactor suite. The $2.4M investment will increase the site’s reactor capacity by around 30 percent.

The new 400 sq. ft. suite, which is being constructed to meet growing business demand, will feature two 2,000 liter reactors and a 0.6 sq. m. Hastelloy filter dryer, and is expected to be fully operational by early 2018.

“This expansion will facilitate the scheduling of cGMP campaigns for our customers and assist in meeting clinical deadlines,” commented Brian Swierenga, VP, Operations and Site Director for Cambrex High Point. He added, “In addition, with the new filter dryer we will be able to run small scale batches to demonstrate their feasibility for scale-up.”

In a second investment at the High Point site, Cambrex is to upgrade its analytical chromatography data systems for QC and analytical R & D to new, Empower 3 software. Empower will be introduced in Q3 and Q4 of 2017 and will bring enhanced capability, integrity and compliance to the site’s analytical systems, in line with the increasingly stringent demands of the FDA and EMA among other agencies.

Cambrex acquired the 35,000sq. ft. High Point site, formerly PharmaCore, Inc., in October 2016. At the North Carolina facility, Cambrex produces complex APIs and intermediates requiring multi-step synthetic processes in batch sizes from milligrams to 100kg to support clinical trials from Phase I to Phase III. The site is licensed with the U.S. Drug Enforcement.

Administration (DEA) to manufacture Schedule II to Schedule V controlled substances. The acquisition enhances Cambrex’s portfolio of small molecule API services and complements its large scale, multi-purpose manufacturing facilities in the U.S. and Europe.

Brammer Invests in Gene Therapy Facility

Brammer Bio says its commercial-scale gene therapy manufacturing facility in Cambridge, Massachusetts, US, will open in the second half of 2017.

The contract development and manufacturing organization (CDMO) said the site offers process development, clinical phase, and current Good Manufacturing Practices (cGMP) services for cell and gene therapies.

“We are delighted to add an experienced commercial biologics team and facilities to help meet the needs of this transformative industry,” said Mark Bamforth, CEO of Brammer.

Brammer has completed a Type-C meeting with the US Food and Drug Administration (FDA) to assess the plans for the Massachusetts-based site. A Type-C meeting regards the development and review of drugs or biological drug products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

A Site Master File will be submitted later this year to support Brammer’s clients’ product applications.

The site originally housed Biogen’s clinical and commercial biologics manufacturing facility.

Brammer purchased it along with Biogen’s distribution center in Somerville, Massachusetts, on January 1, 2017.

The Somerville site offers Brammer nearby storage and distribution capabilities.

The announcement follows Brammer’s 2016 plans to renovate its 50,000 square-foot facility in Lexington, Massachusetts, to cater for late stage and commercial therapy supply.

Brammer’s facilities now offer 230,000 square feet of development, distribution and cGMP manufacturing capabilities across Florida and Massachusetts, US.

Aptar Pharma Expands in U.S.

Aptar Pharma has acquired 20% of the US-based company, Kali Care, less than two months after inaugurating its first facility outside of France.

Aptar Pharma and Kali Care have entered into a partnership to address the challenge of monitoring adherence in ophthalmic clinical trials. As part of the agreement, Aptar Pharma has acquired a 20% minority ownership in the Silicon Valley-based technology company.

The partnership combines Aptar Pharma’s ophthalmic device knowledge with Kali Care’s digital monitoring system for ophthalmic medications, which enables clinicians to collect real-time compliance data.

The partnership is the latest in several steps taken by the drug delivery solutions provider to further expand its device and service offerings.

At the end of March, Aptar Pharma inaugurated its Congers, NY site expansion where the company will manufacture injectable elastomeric components for the pharmaceutical industry.

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

Alex Theodorakis, President of Aptar Pharma North America, said the goal from the start was to expand outside of France in order to better serve markets across the Atlantic.

“It made the most sense to go to the US first,” he said, adding, “[the US] is certainly the biggest most valuable pharmaceutical market in the world. For us to really make an impact and grow significantly we needed to start with the US and put in place a manufacturing operation here.”

However, Theodorakis said it’s always a challenge expanding internationally, especially for the first time.

“But we have strong know-how and technical expertise in France,” he explained. “This is not just an America project for us, but a global project for the company.”

The site gives Aptar local expertise that can respond directly to customers “in the same time zone, same language, and the same culture,” said Theodorakis. “We will leverage that to grow the business.”

KCR Moves to Boston

The full-service contract research organization (CRO) is moving to a new office in Boston, MA, which will serve at its fourth "hub," joining Berlin, Warsaw, and Kiev locations.

KCR CEO, Mike Jagielski, said the decision to move offices was an easy one to make, “Boston is where money and research meet on the East coast,” he said. “KCR needs to be part of the East Coast R&D hub.”

The facility will be offering “the full KCR Trial Execution service spectrum,” Jagielski explained, beginning with clinical operations, project management, and data management.

The CRO has seen the greatest demand from biotech in Phase I (oncology), Phase II, and Phase III, “supporting US biotech with the execution of trials between Europe and US,” Jagielski added.

“We are just glad to be in Boston finally. We’ve worked on US ground for many years now, but this piece was somewhat missing.”

The grand opening was planned for June 2017.

Granules India Confirms U.S. Plant Expansion

Granules India says adding manufacturing capacity at its facility in Virginia, US will create 102 jobs.

The Hyderabad, India based firm announced it would add finished dosage form manufacturing capacity at the facility in Chantilly, Virginia earlier this year.

Granules gave more details of the project, explaining that it will spend $35m (€31m) on the expansion adding that it will create 102 new jobs.

Granules bought the plant from Valeant in 2014.

The firm said it “is conducting research and development to formulate products, and intends to manufacture products in the location as well.”

The expansion is backed by the Virginia Economic Development Partnership, which provides consultative services and funding to companies creating jobs. According to Virginia Business Granules is eligible to receive $750 per job.

The project is the third expansion Granules has announced this year.

In February, it said it will build an API production facility in Bonthapally, Telangana and increase capacity at a plant in Gagillapur where it produces pharmaceutical formulation intermediates (PFIs).

At the time a Granules spokesman told us “existing capacities are not sufficient to meet customer demand” adding the new and expanded facilities will supply both local and international markets.

UTEP Interdisciplinary Research Building (IDRB), Texas

The University of Texas at El Paso (UTEP) has initiated construction of an interdisciplinary research building (IDRB) at 500 West University Avenue in Texas.

The building will support interdisciplinary research teams from colleges across the campus. It will be completed with an estimated investment of $85m.

The designs for the building were unveiled in August 2016, while construction is scheduled to be completed by late 2019.

The research building's north wing will have four floors, while the middle and south wings will have five. The building will be constructed in an area of 2.1 acres.

With a Bhutanese architectural design featuring drought-resistant vegetation, a canyon-like patio will bridge the research facility and an undergraduate learning center. The building will also feature pedestrian paths and elevated walkways.

The research facility will have a total floor space of 158,800ft² including a functional floor space of 90,000ft². The first floor of the building will be partially underground and accommodate core facilities and heavy equipment.

The second floor, known as Main Street, will include a café, a visitor center, galleries to showcase research, meeting rooms, and an 80-seat auditorium. The top three floors of the building will feature wet and dry labs, as well as interdisciplinary research suites.

The IDRB will feature core research facilities including a vivarium, equipment and imaging suites, wet and dry labs, and special laboratory spaces. It will also include meeting rooms and storage offices.

The facility will be used to carry out advanced research and training in a number of disciplines. It will integrate research, teaching spaces, and institutional support, which will accommodate approximately 300 staff.

The research building will create various opportunities for graduate, undergraduate training, and community partners to form new projects.

The research building is being constructed by replacing Burges and Barry buildings in the south-east corner of University Avenue and Sun Bowl Drive within sight of Interstate 10.

Pre-construction work commenced in August 2016, followed by the main work in April 2017.

The scope of construction includes expanding the thermal plant infrastructure, extending electrical and communication duct banks, and other anticipated site improvements.

Houston-based architecture firm Perkins + Will was awarded a contract to provide an exterior design and landscaping plan for the building.

Hensel Phelps was awarded the construction contract in October 2016.

The interdisciplinary research building is estimated to be completed with an investment of $85m. The Texas Legislature will contribute $70m for the project under Tuition Revenue Bonds. The Regents provides $10m from the permanent university fund, and the UTEP will contribute the remaining $5m under the revenue financing system bonds.

Medical Sciences Building (MSB) II, Texas Tech University

Texas Tech University Health Sciences Center El Paso (TTUHSC El Paso) will soon feature a new medical sciences building at its campus in Texas.

Named Medical Sciences Building (MSB) II, the facility will be the third medical sciences building at TTUHSC's Paul L Foster School of Medicine.

The new building is being constructed as part of TTUHSC EL Paso's master plan to expand research capabilities to address major diseases. The facility will double research capacity and enable the development of basic and translational biomedical research.

With new laboratory facilities, the center will focus on interconnected research programs that develop better medicines for major diseases.

Construction was initiated in May 2017 and is anticipated to be completed by 2019. The economic impact of the project over ten years is estimated to be approximately $1bn.

The MSB II will be a five-story research building with an area of 219,900ft². The building will house a variety of facilities including research labs, classrooms, teaching spaces, and staff / faculty offices.

Its first floor will cover an area of 9,200ft² and will feature a teaching auditorium.

With a capacity to accommodate 500 people, the auditorium will also feature a dining and food services area, which will be under the supervision of outside vendors. Other facilities will include a library, a reflection room, classrooms of various sizes, study rooms for students, and administration offices.

The remaining floors of the building, including the second, third, fourth, and fifth stories, will be exclusively utilized for complex research purposes. The floors will feature research laboratories, offices, and administration spaces.

Vivarium facilities are also planned, alongside an expansion of utility infrastructure and other supporting spaces.

MBS II is being constructed on a 5.1-acre site, which features landscaping, hardscape, a loading dock, and equipment yard areas.

The exteriors of the building will resemble architecture of Spanish Renaissance, which incorporates ornate columns, red-tiled roofs, and colossal archways. Other materials used for the exterior palette include bricks, glazing, stuccos, clay tiles, and thermoplastic polyolefin (TPO) roof systems.

Total investment for the project is estimated at $83m. Of this, $75m was approved by the 84th Texas Legislature in 2015, under House Bill 100. The remaining $8m will be funded by TTUHSC El Paso.

The new medical sciences building was designed by Perkins+Will, an architecture firm based in Houston.

The construction contract for the project was awarded to Sundt Construction, which is involved in building the facilities and expanding utility infrastructure, creating additional parking, and improving the surrounding landscape.

Joining Paul L. Foster School of Medicine, Graduate School of Biomedical Sciences, and the Gayle Greve Hunt School of Nursing, TTUHSC El Paso is the fourth university facility to offer education, research, and patient care services.

In the research arena, the university has four Centers of Emphasis in cancer, infectious diseases, neurosciences, and diabetes.

The university's healthcare division includes student-run clinics in some of the county's poorest neighborhoods and a network of Texas Tech physicians of El Paso outpatient offices located at various locations in the city.

Located in the second biggest bi-national metropolitan area on the US-Mexico border, the university leads the nation in border health initiatives making it a desirable place to learn, perform research, and treat patients.

Recro Gainesville Expands Manufacturing Capabilities

Recro Gainesville expands manufacturing capabilities with new tableting equipment and growing development team.

Recro Gainesville, LLC, a wholly-owned subsidiary of Recro Pharma, Inc., has expanded its capabilities by adding a new tablet manufacturing suite and growing its development team. An FDA- and DEA-approved leading provider of solid oral dose manufacturing services for the pharmaceutical industry, Recro specializes in extended release and controlled substances.

“As long-term leaders in the development of extended release technology, we pride ourselves in meeting our clients’ exact standards,” said Scott Rizzo, general manager. “By expanding our equipment line and adding nearly a dozen more scientists to our team, we are able to offer yet more services to meet our clients’ needs.”

Specializing in formulation, reformulation, analytical method development, manufacturing and packaging and logistics services, Recro is one of only a few contract manufacturing and development organizations capable of taking delayed release, sustained release or combination release products from development to commercialization.

The company’s new suite includes a state-of-the-art tablet press, the Fette FE 55, and a new film coater, the Bohle BTC-100.

“Our new tablet press will enable us to compress single- and bi-layer tablets at commercial speeds,” Rizzo said. “The new equipment further demonstrates our commitment to remain a leader in the solid dose manufacturing world.”

Grace Expands Fine Chemicals Development and Production

Grace has expanded its current Good Manufacturing Practice (cGMP) development and production capabilities with the opening of a cGMP- compliant Kilo Suite at its Albany, Oregon facility.

The new kilo lab can produce advanced intermediates of high quality, consistency, and control.

The lab includes a wide range of all-glass reactor systems from 15 to 100 liters, an Aurora filter dryer, a walk-in hood, and an integrated air-lock system.

The state-of-the-art R&D scale-up facility is cGMP compliant and equipped to produce multi-kilogram quantities.

Last year, Grace opened a GMP release Quality Control lab in Albany, which enabled the site to validate analytical methods and perform GMP release of starting materials and advanced intermediates.

The Albany site’s operations team has more than 30 years of custom manufacturing experience in multi- step organic, organometallic/chiral chemistry and integrated grams-to-kilos-to-tons production.

Phenomenex Opens Gas Chromatography Research and Manufacturing Facility

Phenomenex, a global researcher and manufacturer of advanced technologies for the separation sciences, has opened a new manufacturing and development facility dedicated to the company's gas chromatography (GC) columns, marketed under the Zebron brand name.

The 15,000sqft facility, which was designed and extensively renovated specifically for Phenomenex, is located in the Sacramento, California (USA) suburb of El Dorado Hills. Prior to the expansion, GC products were manufactured elsewhere in the state, in Sutter Creek.

The new location supports twice the production capacity and enables improved logistics and delivery speeds to the company's global customers.

Phenomenex is currently expanding sales internationally as demand for GC columns grows in North America and Europe, as well as in India and China.

Emmet Welch, Senior Product Development Manager for Phenomenex, said: “We are staffed with scientists and production experts with decades of leadership in every aspect of GC column technology and manufacturing. In fact, many of our current staff have more than 25 years’ experience in column technology development.”

The new facility includes organic synthesis, R&D and analytical labs.

“Detailed and exhaustive planning went into creating an efficient production floor, using lean principles to maximize the use of space while minimizing the movement of people and materials,” said Welch.

“We have also included a centralized piping system that reduces the cost and movement of process gasses.”

“With advanced, automated workflows, this new facility will be capable of supporting significant growth in Phenomenex GC manufacturing and new product development for many years.”

The facility's work environment for employees features a bright, colorful and open design, complete with inspiring, art-filled spaces and an outside athletic center.

Phenomenex founder, Fasha Mahjoor, remarked, “Phenomenex is known for the vibrant colors and pleasing architectural spaces that are the hallmarks of our corporate headquarters.”

“Our people are the reason for our success and it's our goal and responsibility to give them an environment that inspires teamwork and camaraderie and promotes their health and well-being.”

JSR Corporation Invests in CDMO Facilities

JSR Corporation subsidiary KBI Biopharma is expanding its facilities in Durham, North Carolina and Boulder, Colorado, US, to respond to client needs.

“KBI Pharma (KBI) is experiencing strong increases in demand at both our North Carolina and Colorado facilities,” said CEO Tim Kelly.

“Our North Carolina expansion will allow us to respond to the demand for commercial manufacturing for mammalian cell culture products, while our Colorado expansion creates the ability to respond to demand for clinical and commercial manufacturing of low dose microbial products,” he said.

The contract development and manufacturing organization (CDMO) will invest approximately $30m (€26.8m) in the project.

The Durham facility houses cGMP cell culture manufacturing lines for clinical production, and offers process development, analytical and formulation services.

The expansion will include 2 x 2000L single-use bioreactors and downstream purification suites to increase commercial mammalian cell culture manufacturing line capability.

“Increasing our manufacturing capacity and adding commercial production capabilities to our Durham site will enable KBI to win more manufacturing contracts, grow our business, and create value for our employees, corporate partners, and clients,” said Kelly.

Currently, KBI’s Boulder site offers commercial manufacturing capacity for microbial processes at 15000L scale.

The Boulder expansion will incorporate a second complete manufacturing train with 300L scale fermentation capability which leverages single-use technologies.

“This additional, smaller-scale capacity will ensure that KBI can continue to meet the process development and clinical manufacturing needs of its clients, as well as commercial manufacturing needs for low-dose microbial products,” said KBI.

The expansion plans will also create jobs in KBI’s operations, and quality groups to realize the potential of the enlarged capacity, said Kelly.

KBI expects to complete the expansions later this year.

KBI recently acquired a cell therapy manufacturing facility in Texas, and plans to open an analytical services laboratory in Belgium next year.

Colorado State University Renovations

Food Safety Net Services (FSNS) has donated $175,000 to Colorado State University’s (CSU) Department of Animal Sciences.

The donation was in honor of Dr Gary Smith and his late wife, Kay. FSNS has worked on food safety projects with CSU and Dr Smith for more than 20 years.

It will benefit the renovation of the Animal Sciences Building, where CSU has designated the “Food Safety Net Services Microbiology Laboratory” on the second floor.

There will also be a visiting scientist office sponsored by FSNS and Dr Smith in the future called the “Gary C. Smith and Food Safety Net Services Visiting Scientist Office.”

FSNS is a national network of ISO 17025 accredited testing laboratories.

John Bellinger, CEO of FSNS, said: “We know the funds will provide new opportunities for future generations of students as they prepare for careers in the food industry.”

The university is constructing a $15m facility to improve best practices in food safety, meat sciences and animal welfare and has also received backing from JBS.

JBS’ contribution includes $7.5m to build the JBS Global Food Innovation Center and an employee educational programme investment of $5m.

Biosciences Partnership Building, Phoenix, AZ

The University of Arizona (UA) College of Medicine in Phoenix, Arizona, US, broke ground on a new research facility named Biosciences Partnership Building on the Phoenix Biomedical Campus, a major bioresearch and education hub in downtown Phoenix in October 2014.

Construction of the new research building, located immediately north of the UA's existing Health Sciences Education building in Phoenix Biomedical Campus, near 7th Street and Fillmore was completed in early 2017.

The construction was sponsored by the UA and the city of Phoenix. Biomedical research is housed in the building, as well as laboratory facilities to conduct research into partnerships with industries on key medical areas such as neuroscience, cardiovascular and thoracic science.

The project created 500 jobs during construction and currently employs 360 permanent staff.

The facility is the first antibiotic-free and animal-free cell culture media and supplements manufacturing facility in the pharmaceutical industry.

Construction of the biosciences building was approved by the Arizona Legislature's Joint Committee on Capital Review in 2010.

The ten-story, 245,000ft² building expanded research facilities at the UA Medical Campus, while paving the way for innovative therapeutic discoveries to improve lives. The research focuses on neurosciences, healthcare outcomes, cancer and precision medicine.

The research facility provides faculty to teach the next generation of health professionals. It creates employment opportunities in the field of research, while providing opportunities to specialized technicians and other support staff.

Biosciences Partnership Building is part of a larger expansion project underway at the Phoenix Biomedical Campus.

In 2012, the Health Sciences Education Building was opened at the campus and a new 220,000ft² cancer center at Dignity Health St. Joseph's was opened in 2015.

Additionally, the Phoenix Biomedical Campus already houses four health science colleges including the Mel and Enid Zuckerman College of Public Health, and the colleges for nursing and pharmacy.

Arizona State University's School of Nutrition and Health Innovation is located in the Arizona Biomedical Collaborative 1 building. Plans are in place to build another building between the Arizona Biosciences College (ABCI) and Translational Genomics Research Institute.

Total investment for the construction of the Biosciences Partnership Building is $136m. The funding is from the stimulus plan for Economic and Educational Development bonds approved by the Arizona legislature in 2008, for the construction of the Health Sciences Education Building and campus improvements.

California-based CO Architects and Ayers Saint Gross of Phoenix designed the biosciences building. A joint venture of DPR Construction and Sundt Construction are the construction managers for the research building project.

The aim of the state of Arizona and city of Phoenix is to develop PBC as a major biosciences hub and premier academic health center in the region. Once fully developed, the campus creates an economic impact of up to $2bn every year.

Including the Biosciences Partnership Building, the PBC is spread across 28 acres with various bioscience and education projects. Plans are in place for the construction of more than six million square feet of biomedical-related research, academic and clinical facilities.

Phoenix Biomedical campus follows the environmental sustainability policies set by the UA and Northern Arizona University (NAU). An internal team known as PBC Green Team was formed in August 2009 to understand local sustainability practices, define the framework for a campus sustainability plan, periodically assess the sustainability efforts on the campus and suggest improvements and initiatives.

Sustainability initiatives adopted on the campus include recycling of light ballasts, paper, cardboard, glass bottles and aluminum cans, use of sustainability products, energy-efficient fixtures and systems, as well as waste reduction programs.