PHARMACEUTICAL & BIOTECHNOLOGY

INDUSTRY UPDATE

 

May 2013

 

McIlvaine Company

www.mcilvainecompany.com

 

TABLE OF CONTENTS

 

UNITED STATES

Millstone Completes Move to New Memphis Facility

Grand Valley State University Planning New Biology Building

Cogmedix Expands To Support Laser-Based Medical Devices

Selah Genomics Establishes Second Clinical Genomics Center

Pennsylvania State University Millennium Science Complex

Biogenics Research Chamber to Expand

World’s Tallest Children’s Hospital

Catalent Opens Madison Bio-CoE

Harlan Labs Expands North American Facilities

Altman Clinical and Translational Research Institute

Clinical and Translational Research Building, University of Florida

University of Washington (UW) Medicine Research Complex, Seattle

BioOutsource Opens New Facility in Cambridge, MA

Wayne State Opens Cleanroom Lab for R&D

Monsanto Plans Expansion in Chesterfield

Altman Clinical and Translational Research Institute, California

Albert Sherman Center Opens

Chicago Plans Biotech Commercialization Center

Novo Nordisk Opens New U.S. Headquarters

Final Phase at BioTechnology Research Park

Baxter Evaluates Biomanufacturing at New Minnesota Plant

Bayer CropScience Begins Work on New R&D facility in Tennessee

Biosearch Technologies Relocated

EMD Serono Expands

Injectronics Adding Presses for Medical Molding

Biosearch Moves into New Facility

Baylor Breaks Ground on Medical Center

Constantia Flexibles Expands South Carolina Facility

NAMSA Expands Lab Capacity in Irvine, CA

Bristol-Myers Plans $250M Expansion

CoreRx Plans Expansion

Pall to Open Life Sciences Centre of Excellence in Portsmouth, UK

Dr. Reddy’s to Relocate Headquarters and Establish R&D Center in Princeton, NJ

Regeneron Expands

ScieGen Pharmaceuticals to Build in Suffolk

Swedish/Edmonds Opens Cancer Center

REST OF WORLD

Flextronics Opens Milan Design Facility

Plainfield Precision Completes ISO Class 7 and 8 Cleanroom

Bosch Delivers Syringe-Filling Line to Drug Contractor in Italy

Jacobs Receives Contract from Sanofi Pasteur for Aguila II Project

Penn Pharma Produces in New Contained Manufacturing Plant

ADC Bio Opens Technical Service Lab

Novo Nordisk Plans Plant Conversion

DSM Opens Australian Government Backed Biologics Facility

Nypro Invests in Device Manufacturing Facility in Ireland

RPC to Open New Cleanroom

B. Braun Opens Expanded Production Site in Hungary

UK to Award $124M for Synthetic Biology Centers

Vertellus Completes Upgrades for API Production

PRA Opens New Wales Facility

MedPharm Opens Topical Testing Lab

Redx Pharma Houses New Venture in Alderley Park

South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia

Fujifilm Diosynth Biotechnologies Commissions New Cell Banking Facility

Eisai to Establish New Parenteral Facility in China

B Braun Invests in Brazil

Merck Opens New Manufacturing Facility in China

GE Healthcare Awarded Contract to Design Biopharmaceutical Facility in Brazil

New Anti-Infectives Company Formed

OnCore Manufacturing Expands in Tijuana

Vetter South Ready for cGMP Filling

ATMI and Disposable-Lab Introduce Single-Use Platform for Fill/Finish Operations

Covance's Asia Focus Sees Expansion in Singapore Services

Pall to Open Life Sciences Center of Excellence

 

 

 

UNITED STATES

 

Millstone Completes Move to New Memphis Facility

Millstone Medical Outsourcing announced that the company successfully completed the move of its Memphis operations to a new facility located in Olive Branch, MS, a suburb of Memphis, TN.  As of January 7, Millstone Medical was fully-operational in the new state-of-the-art facility after a complex two-stage moving approach that required validation of equipment and processes and approval from close to 35 customers.  The new facility offers 150,000 square feet of operational space, more than three times the size of the previous facility, for mechanical inspection, world-class loaner kit processing, bone/tissue storage, innovative packaging services, and distribution.   Millstone, outsource partner to the nation's top orthopedic companies, is the fast-growing provider of advanced inspection, clean room packaging, loaner kit processing, and distribution services to medical and dental device manufacturers worldwide.   

 

The expansion to the new facility was precipitated by the growing needs of customers.  In addition to significantly increased space, the new facility provides high-speed data lines for the company's cutting-edge enterprise resource planning (ERP) system; new equipment, including high speed autoclaves, freezers, back-up generators, and racking for storage; and enhanced security systems.  The benefits of the new facility are expected to be additional space for customer expansion as well as the ability for Millstone to enhance capacity, add new capabilities, and offer greater flexibility.  

 

"With professionals from both the Memphis and Fall River locations working round the clock and over weekends, Millstone was able to finish the complicated move without disruption within three days," said Karl Neuberger , Vice President of Memphis Operations of Millstone Medical Outsourcing.  "The additional operational space allows Millstone to expand programs for existing customers and to bring on new customers.  We are tremendously excited about all the possibilities the new facility will deliver for the company and our customers."   

 

Grand Valley State University Planning New Biology Building

Grand Valley State University is planning to build a new biology building in Grand Rapids, Michigan. The project scope includes constructing a 144,000-sq-ft building that will contain classrooms, teaching and research labs, and faculty offices. It will be designed by Fishbeck, Thompson, Carr & Huber, and Pioneer Construction will serve as construction manager.

 

Construction is expected to begin in August 2013 and be completed in 2015. The project has been valued at $55 million.

 

Cogmedix Expands To Support Laser-Based Medical Devices

Cogmedix has recently expanded its medical device contract manufacturing facility to add an additional 8,500 ft2. The expansion includes a 400 ft2, Class 10,000 cleanroom with laminar flow hoods for additional sub environment particle control.

 

The increase in space is accommodating growth in medical device manufacturing, servicing, warehousing, and order fulfillment. There has been a growing demand for manufacturing capabilities to support laser-based medical devices and dental devices.

 

Cogmedix focuses on complex electro-mechanical devices; assembling, testing, and packaging a variety of sophisticated electronics, sensors, user interfaces, and high-precision mechanical components. The company is an FDA QSR-compliant, ISO 13485-certified contract manufacturer for medical and clinical devices.

 

A subsidiary of Coghlin Companies Inc., Cogmedix focuses on the production of Class I and Class II medical and clinical devices for the critical care, home healthcare, emergency room, and industrial laboratories markets. The company is located in West Boylston, Mass.

 

Selah Genomics Establishes Second Clinical Genomics Center

Columbia, SC-based Selah Genomics has formed a new clinical genomics center at the University of South Carolina’s Innovista research campus. The company is a clinical diagnostic specialist supporting healthcare providers and the pharmaceutical industry with molecular and genomic diagnostic services.

 

“Our new clinical genomics center at Innovista is already actively engaged with several pharmaceutical customers,” said Michael Bolick, Selah’s CEO. “Our team is now transferring our quality management practices from our other facilities to Columbia [SC] and we plan to file for CLIA registration for this new facility in the spring. These efforts also strengthen our ability to serve USC researchers and other clients worldwide.”

 

“With research and technology at the forefront of genomics, our partnership [with Selah] will help clinicians throughout South Carolina improve health outcomes for patients,” added Harris Pastides, president of the University of South Carolina.

 

According to Bolick, Selah Genomics growth has been supported by investments from Nexus Medical Partners and SCRA Technology Ventures’ Stage 2 Affiliate.

 

Pennsylvania State University Millennium Science Complex

Aware that new technologies and scientific breakthroughs are increasingly resulting from research that takes place at the boundaries between disciplines, the Pennsylvania State University (Penn State) decided to integrate the Life Sciences department together with the Materials Sciences and Engineering department in a new construction project that would significantly expand the resources available to both.

 

The resulting building, designed by Rafael Viñoly Architects, is a 291,500 ft2 facility called the Millennium Science Complex. The building is located within Penn State’s main campus in University Park, Pa.  The complex features include:

 

        10,000 ft2 of Class 100 and Class 1,000 cleanrooms, materials science characterization laboratories, and imaging research facilities. It also houses 30 biosafety cabinets and 66 fume hoods.
 

        Innovations in massing, planning, and structural design, such as a 154-ft. cantilever, to protect sensitive underground labs from vibration and acoustic interference.
 

        A conjoined mechanical penthouse that allows for system redundancies and efficiencies to be shared with Life Sciences and Materials Sciences wings of the building.
 

        8,400 net ft2 of structurally isolated "quiet" laboratories for imaging and materials science built as independent structures shielded from vibration and electromagnetism, and located beneath the open garden space.
 

        Sustainable design strategies include 60,000 ft2 of green roof, storm water recycling, heat recovery wheels to recycle air and absorb energy, and deep-set windows with fritted glass to reduce heat in summer and admit light in winter.

 

Teams of MRI faculty from across the campus combine their expertise in materials science, chemistry, biology, engineering, physics, and advanced computation to understand and control the properties of matter, the fabrication of devices, and the performance of engineering systems. MRI is centralizing its core user facilities in the Millennium Science Complex. The Materials Characterization Laboratory is a state-of-the-art facility for the synthesis, measurement, and characterization of traditional and advanced material. The Penn State Nanofabrication Facility (Nanofab) is a founding member of the National Nanotechnology Infrastructure Network (NNIN), and provides an array of sophisticated instruments for micro- and nanofabrication.

 

The enclosure system consists primarily of precast concrete cladding panels embedded with a one-inch thick brick veneer. In addition to their contextual appearance, the precast concrete panels also help dampen potential vibrations within the building cantilever by providing mass at the perimeter.

 

The most vibration-sensitive labs have been located below an area of the garden that has a 4-bay clear span without any structural connections between the basement level and the ground, thus limiting vibration transmission into these ultra-critical spaces.

 

In order to minimize the impact of foot- and wheel-borne vibrations from runners, skateboarders, and other light vehicles passing through this area, winding paths were introduced in order to force pedestrians to move slowly across the site. Additionally, the mass of planting soil and rocks also helps to minimize the potential movement and vibrations due to foot-fall.

 

Materials Science Laboratories consist of cleanrooms, quiet laboratories, and high-temperature furnace laboratories in order to support materials research endeavors. Enclosed spaces housing multiple setups, typically fed from overhead carriers, support a wide range of engineering experimental needs. Facilities include:

 

• The Materials Characterization Laboratory which features more than 70 instruments, in the basement (referred to as the quiet labs).

 

• The Nanofabrication Facility which consists of 10,000 ft2 of Class 100/1,000 cleanrooms with 6,500 ft2 of support spaces run by expert technical staff who provide hands-on support and training for, or perform research on behalf of, faculty students and industry researchers. The facility enables "fabrication and characterization of a wide range of devices to support fundamental and applied research in diverse fields spanning electronics to medicine."

 

• The Smart Materials Integration Laboratory, which is designed to allow researchers to "create a new generation of smart integrated components that combine electrical, mechanical, and optical functions ... The laboratory enables the integration and miniaturization of 'smart' materials and the fabrication of components that go beyond conventional semiconductor-based materials."

 

The Millennium Science Complex is designed to the exacting standards of a world-class laboratory for imaging on the atomic level, and that includes stringent cleanroom performance criteria.

 

Cleanrooms are served from the sub-fab level below (except for those labs requiring Class C vibration criteria or higher, where thickened slab-on-grade construction is mandated) and arranged with interstitial chases for flexibility and versatility in the distribution of services.

 

Laminar flow circulation is provided from HEPA-filtered fans above the cleanroom and returned through raised floor plenums and continuous air return slots at the base of demising walls. The sub-fab facility contains systems for treating vented gases, lab wastewater, and used chemicals and further ensures the flexibility and reconfigurability of the cleanroom space above as science and tools continue to develop.

 

For the Penn State Nanofabrication Laboratory (one of the 14 university-member National Nanofabrication Infrastructure Network funded by the National Science Foundation), the new cleanrooms not only provide the opportunity to do hands-on research with some of the world's most sophisticated instruments for the fabrication and characterization of materials at the nano- and micro-scale, but also doubles the space for nano- and micro-scale device fabrication. Over 400 researchers from Penn State, other universities, government labs, and industry are able to take advantage of the expertise and world-class facilities of the Nanofabrication Laboratory, employing a cross-disciplinary expertise in the areas of spectroscopy, biology, chemistry, physics, optics, electrical engineering, and engineering science.

 

Measures to mitigate air-entrainment begin with the physical separation of air intake and air exhaust systems. The building is arranged in such a way that all ventilation air is introduced at the Level 4 façade through storm-proof air intake louvers. Additionally, all exhaust air is projected vertically away from the building via a series of general exhaust and fume hood exhaust fans at the roof level. Each exhaust system connects to a vertical stack at the roof level to increase separation distance between its discharge and the building's air intake louvers. The building's fume hoods are exhausted via high-efficiency "vector" type up-blast exhaust fans that discharge into stacks. These fans are provided with integral bypass sections to allow for constant, high velocity discharge further minimizing the risk of re-entrainment.

 

The building's mechanical systems, including the supply air ventilation systems, general exhaust air systems, fume hood exhaust systems, chilled water pumping systems, and hot water pumping systems, are arranged as an N+1 configuration, allowing for reliable back-up in the event a system component fails or requires routine service.

 

The building is provided throughout with an automatic temperature control system managed by the BMS. Each laboratory is provided with its own thermostat allowing for precise control of the space's thermal environment via variable volume terminal devices with integral hot water reheat coils.

 

The building is provided with chilled water steam services via Penn State University's central campus plant. The chilled water enters the building at grade level and is delivered throughout the building through local pumps equipped with high-efficiency motors. Additionally, high pressure steam is provided to the building via the campus plant.

 

Due to the stepped-form of the building, most of the mechanical equipment on Level 4 is partially located on the cantilevered structure. The air handling units include large fans that together with air flow impart vibration into the rest of the structure down to the foundations. To address these vibrations, the vibration consultant carried out detailed analysis that resulted in modifications to the structure, stringent specifications in the procurement of mechanical equipment, and vibration isolation systems. Detailed vibration analysis, such as empirically validated finite element modeling was undertaken to design the structure and for selecting proper vibration isolation for all mechanical equipment.

 

In order to verify that surrounding environmental conditions would not impact the building with exhaust air from adjacent buildings or that the Millennium Science Complex would exhaust impurities that impacted adjacent facilities, a wind tunnel air-re-entrainment test was undertaken.

 

The most significant feature in minimizing electromagnetic interference and vibration is separation distance. The quiet labs, which contain electromagnetic sensitive equipment, were purposefully built an adequate distance away from sources of interference such as passenger/freight elevators and vehicle travel on the two main roads.

 

The Millennium Science Complex is designed for LEED Silver certification (pending). A large measure of this performance comes from energy-efficient measures, though the most visible element can be seen in the green roofs that cover the stepped building terraces. These green roofs help reduce the heat-island effect and filter pollutants and carbon dioxide from the air surrounding the facility. Other sustainable design strategies include efficient plumbing fixtures and CO2 and O2 monitoring of spaces to optimize conditioning of interior spaces. In addition, sustainably harvested wood was used, more than 90% of construction waste was diverted from disposal at a landfill and at least 10% of materials used in construction were from recycled content and regionally sourced, including the precast concrete enclosure system.

 

The University envisions the Complex—one of just a few specifically developed to integrate the physical and life sciences—as a place which embodies new modes of research "in which experts from many disciplines coordinate their technologies and knowledge in ways that produce exponential advances," generating a positive return on the University’s investments in the Institutes and this new research infrastructure.

 

Biogenics Research Chamber to Expand

Biogenics Research Chamber, an allergy testing facility in San Antonio, Texas, has broken ground on an extension. The 5,400 ft2 facility will house a large allergy exposure chamber, a specialty chamber, and eye examination rooms. The chambers will utilize cleanroom technology with complete electrical back-up by generator. The extension will enhance capacity for simultaneous testing of large numbers of participants, while broadening therapeutic testing capabilities.

 

Biogenics Research Chamber, the only large permanent pollen exposure chamber in the U.S., opened in 2010 in the Medical Center of San Antonio. Projects have included pharmaceutical and vaccine trials and scientific studies elucidating the basic mechanisms and genetics of allergy. The extension, scheduled for completion in January 2014, is engineered to challenge with seasonal pollens as well as year-round allergy-provoking agents including dust mites and cat dander. The specialty chamber is designed for testing of novel agents for non-allergic eye and respiratory conditions.

 

World’s Tallest Children’s Hospital

The Building Team for the 23-story Lurie Children’s Hospital in Chicago implements an integrated BIM/VDC workflow to execute a complex vertical program.

 

The design and construction of the hospital’s 42-foot-high, 60,000-sf mechanical floor was coordinated using BIM/VDC. All MEP subcontractors were co-located with the construction management team during the project in a highly collaborative environment. When clashes or other issues arose, the entire team would gather and come up with a workable solution.

 

Standing on the 10th floor of the sparkling new Ann & Robert H. Lurie Children’s Hospital of Chicago is not exactly a glamorous experience. Compared with walking the hospital’s double-height glass lobby, which features two magical lifesize whale sculptures suspended from the ceiling, or the 11th-floor Crown Sky Garden, with its expansive views of the city and lakefront, the 10th floor seems relatively mundane.

 

But standing there in the 42-foot-high space talking with the Building Team members that led the construction of the 1.25 million-sf, 288-bed project over a six-year period, it’s easy to see that the two-story mechanical floor is among their greatest sources of pride on the project.

 

“This floor alone took 10 people 60 hours a week almost seven months to coordinate,” says Peter Rumpf, LEED AP, Integrated Construction Manager with Mortenson Construction (www.mortenson.com). “The level of complexity and the sheer size of the place really challenged the best builders and VDC/BIM users to the limits.”

 

It’s the perfect example, says Rumpf, of a space that likely could not have been built within the time frame and budget without the use of building information modeling and virtual design and construction coordination. The 60,000-sf mechanical floor required upwards of 12 layers of information—from the structural design to the MEP systems installation to facilities operations considerations—that had to be carefully coordinated in the model.

 

To execute this effort, the joint construction management team of Mortenson Construction and Power Construction established a BIM operations center, where as many as 40 subcontractors and construction team members were co-located during the project. Prior to coordination meetings, each subcontractor loaded its updated model into Navisworks. The construction management team then integrated the subs’ models and ran clash detection. Clashes deemed significant were discussed and resolved by the entire team. Tens of thousands of coordination issues were resolved virtually, according to Rumpf, a 2012 BD+C “40 under 40” honoree.

 

 A 12-story cantilever highlights the building’s structural steel design. Beginning at the 11th floor, the building juts out some 15 feet, offering expanded views of the city and lakefront. Using BIM/VDC coordination, the Building Team was able to erect the steel frame in just nine months.

 

 This months-long process of designing then refining in a highly collaborative 3D environment allowed the team to create a true digital prototype of the mechanical spaces. From that prototype, the subcontractors were able to pull installation points and input them into robotic total stations so they could precisely lay out the work as modeled on the project site.

 

One of the mechanical subcontractors even prefabricated its systems using data from the model to help speed installation and ensure accuracy. All pipe was cut to length and threaded at the firm’s facility nearby and shipped to the site.

 

“They were able to create work kits,” Rumpf explains. “The team installing the mechanical piping, for example, had a pallet of material that included all the pieces required for that portion of the installation, including hanger rods, unistrut clips, pipe, and insulation.”

 

While more common today, this level of coordination was virtually unheard of in 2005-06, when the Lurie Children’s project kicked off. “This job changed the Chicago market in terms of BIM capability, because everybody got over the learning curve,” says Eric Hoffman, a former Mortenson Project Manager who joined the hospital as Administrator of Facility Services soon after construction was completed. “The mechanical floor was the absolute critical path on the project.”

 

The missing piece in most BIM/VDC-driven building projects is operations and maintenance. For legacy facilities like hospitals, schools, and government buildings, the initial cost of construction may only represent 10-15% of the total cost of ownership.

In a 50- or 100-year facility, something as minor as an incorrectly orientated air handler or a poorly placed ventilation fan can lead to decades of inefficiencies, added costs, and potential safety issues for the owner.

 

The mechanical floor is so dense with equipment and infrastructure required to service the hospital, the Building Team had to model nearly every element of the space, down to small pipes and conduit, to ensure efficient and accurate installation.

 

To date, few BIM/VDC projects have involved facilities personnel at a deep level. The Building Team for the Lurie Children’s project was one of the early pioneers in this area. During both the design and preconstruction phases, the design and construction teams met with the operations staff to get a better understanding of their processes and procedures and the type of data required for operating and maintaining the building’s equipment. These meetings led to early design decisions that will allow the operations staff to more efficiently service the facility.

 

“There are numerous opportunities on the front end, looking at the model, to do some facilities-oriented solutions,” says Hoffman. “The designer or engineer may think they need this type of fan, but the facilities person is thinking, ‘To service this piece of equipment, I have to pull it out a certain way and it weighs 150 pounds, so how do I get it out and down safely?’ These are the kinds of exercises the team can do on the front end that can make the difference between 50 years of a bad design or a design that is efficient, easy, and safe.”

 

A prime example at the Lurie Children’s tower is the access pathways designed into the mechanical room that allow the facilities team to service the equipment and perform regular inspections.

 

“See that ladder right there?” Rumpf asked during a tour of the facility, pointing to a small steel ladder bolted to the wall that leads up between two massive ducts. “That’s part of our ‘chutes and ladders’ exercise.” Because the mechanical floor is so dense with equipment and infrastructure, the Building Team had to devise pathways for facilities personnel and fire/life safety inspectors to reach critical areas, such as fire sprinkler heads and smoke dampers.

Rumpf admits that some of the access solutions are not all that elegant, but they’re effective in helping the operations team service the space. For instance, the ladder leads to a smoke damper 40 feet overhead and obscured by layers of ductwork. Every six years, the damper must be inspected to ensure it’s working properly. To reach it, a facilities staffer must climb the ladder, transition across an air-handling unit, open up an access zone inside a 12-foot-wide duct, step into the duct, open a door on the other side of the duct, step out onto a platform, and climb up another ladder.

 

Two-dimensional drawings of the mechanical space proved ineffective in communicating what was required to get all the systems built and installed properly, so the team utilized 3D BIM model views. Views of the coordination model were plotted out and referenced by the mechanical contractors during the build.

 

“It was an extreme challenge for us to fit all the systems together and get them to work together and then layer back how we were going to service this space,” says Rumpf. “I don’t know how it would have been done without 3D BIM coordination. A smoke damper like that may have been ignored in the past.”

 

The team also devised a tie-off system of aircraft cables embedded in the slab above the space that is useful for both construction and O&M. To ensure the safety of the users, the team utilized the model to determine the optimal location of the tie-off points so that a person is no farther than 10 feet from a tie-off point at any given time.

 

Because no two floors in the hospital are the same, measuring and improving the construction progress from floor to floor proved difficult.

 

“It’s not like a hotel, where we can track how long it took to build the first five floors and come up with ways to build the remaining floors faster,” says Rumpf. “We didn’t have the luxury of repetition.”

 

To validate its MEP systems installation processes, the team utilized laser scanners to create a point cloud model of the installed systems. The data was then inputted into Navisworks, where the team could visually inspect the difference between the construction BIM model and the digital representation of reality. By continually measuring the delta between the real world and the digital model, they were able to quickly recognize any disconnects.

 

Rumpf cites the building’s pneumatic tube system as an example: “The person who was creating the model was using shapes and bends that would not allow the containers carrying medical samples and supplies to get from point A to point B in the specified time. The installer knew that to meet the performance specification the tube system could not have too many bends and made the necessary adjustments in the field. As a result, the radiuses in the model were different from those installed. Because of the laser scanning and BIM analysis, we were able to catch this early on and have the installer review and sign off on the altered design before installation drawings were produced.”

 

The two whale sculptures suspended from the lobby ceiling were donated to Lurie Children’s when the project was about 85% complete. To accommodate the massive pieces spatially and structurally, the team laser scanned the whales to determine their size and scale.

 

The Building Team also used laser scanning to capture the geometries of the whale sculptures in the lobby, which were donated by the Shedd Aquarium when construction was 85% complete. The mother and calf were in a half dozen pieces in the basement of the Field Museum. The team placed each piece on tripods, laser scanned them, and then stitched together the scans to create a complete picture of the sculpture. The point cloud information was used to create an accurate digital model, which the architectural and structural teams used to spatially orient and support the whales. The installation required both structural reinforcement and rigging, all while the project was nearing completion.

 

“Could we have done it without the 3D model coordination? Probably,” says Rumpf. “But it would have cost more, and there probably would have been some modifications to the end product. We were able to accomplish this with very few concessions to the design intent, and the schedule was not impacted at all.”

 

PROJECT SUMMARY

Ann & Robert H. Lurie Children’s Hospital of Chicago

Chicago, Ill.

 

Size:  1.25 million sf

 

Construction cost:   (excluding land): $605 million

Completed: June 2012

Floors: 23

 

BUILDING TEAM

Owner: Ann & Robert H. Lurie Children’s Hospital of Chicago

Architects: ZGF Architects LLP; Solomon Cordwell Buenz; Anderson Mikos Architects

Structural engineer: Magnusson Klemencic Associates

MEP engineer: Affiliated Engineers

Construction managers: Mortenson Construction, Power Construction (joint venture)

 

Catalent Opens Madison Bio-CoE

Catalent Pharma Solutions has opened its new biomanufacturing Center of Excellence in Madison, WI. The new facility quadruples current biologics manufacturing capacity and allows the company to extend its offerings as well as enhance the efficiency and output of its GPEx cell line engineering technology and other mammalian cell lines. Catalent has moved its 89 employees to the 100,000-sq.-ft. Madison site, and eventually plans to employ more than 100 people at the site.

 

Also, Catalent has recently acquired an exclusive license to market Redwood Bioscience’s SMARTag precision protein-chemical engineering technology for the development of advanced antibody drug conjugates (ADCs). Redwood’s site-specific protein modification and linker technologies enable the generation of homogenous bioconjugates engineered to enhance potency, safety and stability. Catalent will combine its GPEx cell line expression system with SMARTag for the rapid development of stable, high yielding cell lines, and a broad range of analytical and fill-finish services.

 

The facility is designed for flexible cGMP production from 10L up to 1000L, and non-GMP production up to 250L, and features single-use technologies and unidirectional flow. Manufacturing is supported by integrated analytical, formulation development and viral clearance capabilities, small-scale and large-scale process development labs, and separate microbiology and Quality Control functions.

 

“Our new biomanufacturing Center of Excellence has been specifically designed to meet our customers’ needs through improved delivery of integrated services in the areas of biologic development and manufacturing, and we will be pleased to welcome many of them on site at the official opening,” said Barry Littlejohns, president of Catalent’s Biologics business. “The extensive application of single-use technology greatly reduces the risk of cross contamination and gives us huge flexibility and scale, while our on-site capabilities enable us to provide our customers with solutions for even the most difficult to express proteins.”

 

Harlan Labs Expands North American Facilities

Harlan Laboratories is expanding its specialty research production facilities in Indianapolis and Livermore, CA, doubling the number of isolators for its immunocompromized models. 

 

The environmentally controlled breeding isolators are supported by individual air supply and HEPA filtered air handling to ensure the integrity of the colony within each isolator. The facilities also feature the latest equipment and biosecurity measures including a watering system with automatic flushing to help prevent the unwanted proliferation of organisms, as well as a backup power system.

 

“Our investment in these facilities underscores our commitment to providing the highest quality research models and services to investigators across the globe,” said Joe Meyer, vice president Global Commercial Operations at Harlan Laboratories. “We will continue to expand and enhance our facilities worldwide to meet the needs of the research community in key therapeutic research areas like oncology, immunology and toxicology with consistently dependable research models, diets and supporting services.”

 

Altman Clinical and Translational Research Institute

The University of California and San Diego (UCSD) initiated construction of Altman Clinical and Translational Research Institute (CTRI) building at La Jolla in San Diego, US, in January 2013.

 

The CTRI will provide laboratory and clinical researchers with an environment for collaboration and resource-sharing to better understand and treat diseases such as cancer, arthritis and diabetes.

 

The building is named after Lisa and Steve Altman, who contributed $10m in funding for the construction of the CTRI building in March 2011. The construction is expected to be completed by 2016.

 

The facility will provide employment to about 1,000 people, including about 100 principal investigators. It will be home to biomedical informatics specialists, telemedicine specialists, electronic health record technology specialists, imaging specialists and biomedical engineers.

 

The new facility will be a seven storey building with three floors below ground and four above.

 

The building will have a pentagonal structure, which will be enclosed with a terrace at street level, a courtyard on lower level three, and another terrace on the exterior of the auditorium at level one, which will feature a green theme.

 

The facility will be connected to the Sulpizio Cardiovascular Centre by a pier-supported pedestrian bridge.

 

The new facility will be engaged in research to accelerate the development new technologies, drugs and procedures for patients. It will be equipped with state-of-the-art laboratory equipment and clinical research facilities. It will invite talented people from all disciplines, such as physicians, geneticists, engineers, immunologists and computer scientists, to carry out research and to collaborate cures for specific diseases.

 

The Altman CTRI will also be the new home for the UC San Diego pediatric diabetes research centre.

 

The building will have a total floor space of 359,000ft2. It will include about 189,000ft2 of space for research and core laboratories, 66,000ft2 of space for the dry research, multiple conference rooms, a large lecture hall and other facilities.

 

CTRI administration offices will also be located in the building. Other facilities will include a vivarium, auditorium, and café.

 

The ground breaking for the construction of the CTRI facility was held on 17 January 2013. The preliminary construction works on the site are now underway. The actual construction work is expected to begin April 2013 and is scheduled to be completed in 30 months, by 2016.

 

The building will target to achieve LEED Silver (Leadership in Energy and Environmental Design) certification. It will be constructed in compliance with environmentally-friendly norms and will use zero energy strategies.

 

The new CTRI facility has been designed by Zimmer Gunsul Frasca (ZGF) architects. The construction contract has been awarded to Rudolph and Sletten, who will act as construction manager, with assistance from UC San Diego Facilities Design and Construction.

Rudolph and Sletten has invited bids for 38 subcontract works for the construction of the building.

 

The total estimated investment for the construction of the project is about $269m. It is financed with $10m funding by Steve and Lisa Altman, the San Diego-based philanthropists. The rest of the project costs will be met through external and public funding as part of research funding from the UCSD.

 

Clinical and Translational Research Building, University of Florida

The University of Florida started construction of a new clinical and translation research building at its Gainesville campus in Florida in May 2011. The construction of the new facility is expected to be completed by spring 2013.

 

The facility is expected to serve as headquarters for clinical and translational science at the university. The project is being sponsored by University of Florida (UF) and the NIH National Center for Research Resources.

 

The facility will be a hub for expanding research network, which will connect all 16 colleges within the Florida university campus as well as Shands HealthCare and the North Florida / South Georgia Veterans Health System.

 

The design for the new clinical and translational research building was provided by Perkins+Will architects. The facility is being constructed on a 2.57 acre site located in the University of Florida campus.

 

The building will have two wings, which will be connected with a hub on the east side. It will have a two storey glass-walled atrium-lobby at the centre. The building will also feature a garden.

 

The new clinical and translation research building will have a total floor space of 120,000ft², which includes 40,000ft² ageing institute complex in the south wing, and 80,000ft² clinical and translational sciences institute in the north wing.

 

All the clinical research spaces will be located in the ground floor. The administrative, support spaces and offices for staff and researchers will be located respectively in second and third, fourth and fifth floors of the building.

 

The new facility will have a clinical and translational science institute, Institute on Aging, UF clinical research centre and department of health outcomes and policy. It will also have department of biomedical informatics, department of epidemiology, department of biostatistics and geriatric research.

 

The Institute on Aging will be a one-stop facility that will make it easier for mobility-restricted older adults to take part in clinical trials and strengthen connections among existing UF research centers including the Claude D. Pepper Older Americans Independence Center, the CTSI and the Cognitive Aging and Memory Clinical Translational Research Program. It will also include a geriatric medicine multispecialty clinic.

 

The facility will also have an array of other research departments, as well as sophisticated conference, training and reception areas.

 

The new clinical and translational research building broke ground for construction in May 2011. The building was topped out in May 2012. It is expected to be opened in spring 2013.

 

The building was designed by Perkins + Will architects. The building construction contract was awarded to Skanska. Mechanical and electrical engineering support was provided by Moses and Associates.

 

Other key contractors involved in the construction of the building are AEI, SEG, Siebein and Associates, Brame Architects, Williams-Scotsman and Brentwood Company.

The estimated investment for the construction of the building is $45m. It was financed with $15m under the American Recovery and Reinvestment Act of 2009 by the NIH National Center for Research Resources. The University of Florida contributed $30m for the construction of the 80,000ft² facility.

 

The new building is being constructed with environmentally sustainable features. It is aimed to achieve LEED platinum certification. The building will have solar panels and systems. It will use rainwater for flushing toilets and irrigation. The designers increased the thickness of glass in the facility to keep out the noise of a power plant situated adjacent to the facility.

 

University of Washington (UW) Medicine Research Complex, Seattle

The new medical research complex at University of Washington (UW) School of Medicine in South Lake, Seattle was completed in March 2013. The new facility will house many of the university's biomedical research laboratories. It is expected to receive certifications by spring 2013.

 

The construction was primarily sponsored by UW School of Medicine, Vulcan Real Estate and the National Development Council.

 

The new phase three research centre has a total floor space of about 330,000ft2, in a seven storey building. The research complex is surrounded with beautiful landscape and features a tree-lined sidewalk. It has two spacious seminar rooms with videoconferencing capabilities and also features 266 parking spaces located in two bays.

 

The third phase has laboratories for kidney research, vision sciences, rheumatology, immunology and infectious disease investigations. The scientists at the new facility will focus on a number of medical conditions, including multiple sclerosis, blindness, malaria, lupus and renal failure.

The new facility will be engaged in developing life-changing therapies and medical breakthroughs that will positively impact the health of future generations. The facility can accommodate between 1,000 and 1,200 researchers and support staff.

 

The construction of the research complex was completed in three phases. The total floor space of the medical research complex in all the three phases is about 800,000ft2.

The design and planning for the construction of the research complex began in September 2003. The facility broke ground for construction in 2004. The first phase of construction was completed in January 2005. It included a total floor space of 215,000ft2.

 

The facilities constructed in the first phase included laboratories intended to carry out research in microbiology, biomarkers, biologic imaging, cancer vaccines, heart regeneration, inflammation and proteomics.

 

The second phase of construction began in 2006 and was completed in 2008. It included 170,000ft2 laboratory building and 86,000ft2 office building.

 

The research facilities opened at the complex during the second phase included biology, therapeutic delivery systems, neurobiology, genetics, and regenerative medicine. The research facilities are specifically focused on diseases such as Parkinson's and Alzheimer's, diabetes, hearing loss, strokes, heart regeneration, liver diseases, and bone and joint regeneration and repair.

 

The Board of Regents approved the third phase of the medical research complex's construction in April 2010. The third phase broke ground in July 2011 and was completed in March 2013.

The building design and architectural support was provided by Perkins+Will. The landscape design was provided by Gustafson Guthrie Nichol (GGN). The construction contract for the building was awarded to Sellen Construction.

 

The structural engineer for the second phase of construction was Magnusson Klemencic Associates. The electrical and mechanical engineer was Affiliated Engineers NW. The civil engineer for the second phase was Coughlin Porter Lundeen.

 

The first phase of construction was sponsored by philanthropy funding from Jeffrey H Brotman. The second phase of construction was contributed by Tom and Sue Ellison, Lynn and Mike Garvey, the Oki Foundation, Quellos, Safeco and the Orin Smith Family Foundation.

The total investment on the third phase of the medical research complex construction was $165m. The construction cost of the building was $113m. The National Development Council sponsored the third phase.

 

BioOutsource Opens New Facility in Cambridge, MA

BioOutsource, a provider of contract testing services to the biopharmaceutical industry, has opened a new facility in Cambridge, Massachusetts, its first in the U.S.

 

The Glasgow, Scotland-headquartered firm plans to draw on its experience of providing biosimilar characterization assays to its European customers to provide similar services throughout North America.

 

‘We have opened this new office in response to increasing demand from across the North American market for our market-leading BioAnalytical services, and particularly in the field of biological biosimilar characterization,’ said BioOutsource’s CEO Gerry MacKay.

 

‘Our US office will facilitate engagement with North American customers for our off-the-shelf biosimilar biological characterization assays, for example for Humira, Enbrel, Rituxan, Herceptin, Remicade, and Avastin.’

 

The office is located at the Cambridge Innovation Center, near the Massachusetts Institute of Technology campus and home to a number of growing life sciences and venture capital firms.

 

MacKay added: ‘We see the North American market as an essential strategic element of our global expansion plans. We remain committed not only to growing our business in North America but also in nurturing our relationships with our existing North American clients.’

 

Wayne State Opens Cleanroom Lab for R&D

Wayne State University in Detroit, Michigan will increase and diversify microtechnology research at its multimillion dollar Nano Fabrication Core Facility by opening its cleanroom lab to researchers, students, and companies throughout the region.

 

Wayne State University in Detroit has announced an initiative to increase and diversify microtechnology research at its multimillion dollar Nano Fabrication Core Facility (nFab). The cleanroom lab, which was originally built to focus on automotive applications, has been home to a broader set of nanotechnology research and development by WSU faculty and students. WSU has re-launched the lab and opened it to researchers, students, and companies throughout the region, who would otherwise not have access to the rare microfabrication environment, with a valuation exceeding approximately $12 million.

 

“The lab initially focused on the automotive industry but has widened its scope to include biosensors, targeted drug delivery and medical devices,” says nFab Director and WSU Department of Chemistry Professor David Coleman. “Microfabrication is now used in many research fields, from biological micro-electromechanical systems to nano-electrochemechanical systems and from flat-panel displays to solar cells and more. There’s really no limit to how this lab can assist researchers looking to discover and create new things.”

 

The nFab lab, located in the College of Engineering, was originally established in 2002 thanks to a major contribution from Delphi. Its mission is to create devices that benefit humanity. The lab provides researchers with three distinct microfabrication services: deposition (the addition of materials), lithography (the defining of materials), and etching (the removal of materials). Cutting-edge processes and equipment include a high-temperature furnace, low pressure chemical vapor deposition (LPCVD), E-beam evaporator, sputtering, photolithography, isotropic wet or dry etching, anisotropic wet or dry etching, and metal lift-off.

 

Associate Professor of Electrical and Computer Engineering Yong Xu has developed a technology that opens new possibilities for health care and medical applications of electronic devices. Xu’s flexible electronics technology could result in retinal processors that cause less tissue irritation and more comfortable wearable health-monitoring devices, balloon catheters, stents, and more.

 

Xu is only one of Wayne State’s many expert faculty members utilizing the lab. College of Engineering Assistant Professor of Electrical and Computer Engineering, Amar Basu is working on a variety of projects, including one involving environmental sensors for preventing invasive species in the Great Lakes. Assistant Professor of Electrical and Computer Engineering Mark Ming-Cheng hopes to create a robust, chronic neural prosthesis using high-capacity graphene electrodes and biodegradable silicon support to treat a variety of neurological illnesses. Assistant Professor of Chemistry, Parastoo Hashemi’s work developing new micro-electrochemical electrodes for neurological research may have significant implications for those battling depression and other mental disorders. And Assistant Professor of Physics Zhixian Zhou is investigating the correlation of transport properties with edge structure in suspended graphene nanoribbon field effect transistors, which could have possible applications in touch screens, solar cells, fast transistors, gas sensors, and lightweight, high-strength materials.

 

A wide variety of researchers from universities and companies across Michigan and the U.S. have already begun to take advantage of the state-of-the-art technologies and services available. Graduate and undergraduate programs in engineering, physics, and more can hold specialized classes in nFab to provide an introduction to the unique technologies involved. Researchers from the Karmanos Cancer Institute, H2Scan, General Motors, and Argonne National Laboratories have used the lab’s equipment and services to create new technologies

 

Monsanto Plans Expansion in Chesterfield

Monsanto Co. plans to spend more than $400 million to expand the Chesterfield Village Research Center, 700 Chesterfield Parkway.

 

The expansion, which includes 36 greenhouses, 250 labs and plant growth chambers, is expected to create 675 new jobs. In one of the biggest corporate expansions the St. Louis region has seen in years, Monsanto said that it would add 675 jobs and invest more than $400 million at its research facility in Chesterfield, Missouri.

 

Construction is scheduled to begin in August and continue for three years.

 

State and local incentives will total up to $53.5 million, including tax credits contingent on new job creation.

 

The research center, built by Monsanto, opened in 1984. After Monsanto's merger in 2000 with Pharmacia & Upjohn Inc., the center was owned by Pharmacia, then Pfizer.

 

Monsanto, which became an independent company in 2002, reacquired the center in 2010.

 

“This is a tremendous investment in the future of agricultural research and development in the state we proudly call home,” said Jerry Steiner, Monsanto’s executive vice president for sustainability and corporate affairs. “This gives our researchers what they need to get farmers the tools they need so that we all — 9 billion of us in a few decades — will be able to get the food we need.”

 

The company plans to add 400,000 square feet of lab space, greenhouses and high-tech plant growth chambers at the research center, which it originally built in 1984 and reacquired from Pfizer in 2010. Construction is scheduled to begin in August.

 

The investment, as well as the creation of hundreds of high-paying jobs in the St. Louis region, will help cement Missouri’s place in the burgeoning plant-science industry, said Gov. Jay Nixon.

 

“It’s a worldwide kind of announcement from an iconic company,” Nixon said. “It really amplifies St. Louis’ footprint in the industry.”

 

The company will also draw sizable state and local incentives for the expansion.

 

Monsanto will be eligible for $22 million in Missouri Quality Jobs tax credits if it creates all 675 promised jobs, and the Missouri Development Finance Board is considering a request for $9.5 million in Build Missouri bonds.

 

The company has also emphasized its emerging “biologicals” platform, which centers on topical seed treatment products that could potentially control viruses, kill insects and provide more weed control.

 

Monsanto has also stressed growth in new parts of the world, particularly in Brazil and Argentina, as well as in Eastern Europe. The company is preparing to launch a new glyphosate-tolerant bean in Brazil — the first product developed specifically for an international market.

 

Altman Clinical and Translational Research Institute, California

The University of California and San Diego (UCSD) initiated construction of Altman Clinical and Translational Research Institute (CTRI) building at La Jolla in San Diego, US, in January 2013.

 

The CTRI will provide laboratory and clinical researchers with an environment for collaboration and resource-sharing to better understand and treat diseases such as cancer, arthritis and diabetes.

 

The building is named after Lisa and Steve Altman, who contributed $10m in funding for the construction of the CTRI building in March 2011. The construction is expected to be completed by 2016.

 

The facility will provide employment to about 1,000 people, including about 100 principal investigators. It will be home to biomedical informatics specialists, telemedicine specialists, electronic health record technology specialists, imaging specialists and biomedical engineers.

 

The new facility will be a seven storey building with three floors below ground and four above.

 

The building will have a pentagonal structure, which will be enclosed with a terrace at street level, a courtyard on lower level three, and another terrace on the exterior of the auditorium at level one, which will feature a green theme.

 

The facility will be connected to the Sulpizio Cardiovascular Centre by a pier-supported pedestrian bridge.

 

The new facility will be engaged in research to accelerate the development new technologies, drugs and procedures for patients. It will be equipped with state-of-the-art laboratory equipment and clinical research facilities. It will invite talented people from all disciplines, such as physicians, geneticists, engineers, immunologists and computer scientists, to carry out research and to collaborate cures for specific diseases.

 

The Altman CTRI will also be the new home for the UC San Diego pediatric diabetes research centre.

 

The building will have a total floor space of 359,000ft2. It will include about 189,000ft2 of space for research and core laboratories, 66,000ft2 of space for the dry research, multiple conference rooms, a large lecture hall and other facilities.

 

CTRI administration offices will also be located in the building. Other facilities will include a vivarium, auditorium, and café.

 

The ground breaking for the construction of the CTRI facility was held on 17 January 2013. The preliminary construction works on the site are now underway. The actual construction work is expected to begin April 2013 and is scheduled to be completed in 30 months, by 2016.

 

The building will target to achieve LEED Silver (Leadership in Energy and Environmental Design) certification. It will be constructed in compliance with environmentally-friendly norms and will use zero energy strategies.

 

The new CTRI facility has been designed by Zimmer Gunsul Frasca (ZGF) architects. The construction contract has been awarded to Rudolph and Sletten, who will act as construction manager, with assistance from UC San Diego Facilities Design and Construction.

 

Rudolph and Sletten has invited bids for 38 subcontract works for the construction of the building.

 

The total estimated investment for the construction of the project is about $269m. It is financed with $10m funding by Steve and Lisa Altman, the San Diego-based philanthropists. The rest of the project costs will be met through external and public funding as part of research funding from the UCSD.

 

Albert Sherman Center Opens

The University of Massachusetts Medical School (UMMS), the US, expanded its research and curriculum teaching capabilities with the opening of the new Albert Sherman Center in January 2013.

 

Chicago Plans Biotech Commercialization Center

Chicago Mayor Rahm Emanuel disclosed plans for a downtown biopharma center designed to assist startups and house companies—an announcement coinciding with industry leaders gathering in the Windy City for the Biotechnology Industry Organization (BIO) 2013 International Convention.

 

The planned Bioscience & Pharmaceutical Industry Commercialization and Innovation Center will be filled in part by the city-based biotech consortium Chicago Innovation Mentors and its partners, which include Northwestern University, the University of Chicago, University of Illinois, Rehabilitation Institute of Chicago, Argonne laboratories, and iBIO Institute's PROPEL Center, which assists life-sci startups. iBIO Institute was created in 2003 by the Illinois Biotechnology Industry Organization (iBIO) to draw business support for life-sci education and business startup programs.

 

While the center is envisioned primarily for startups, the city said it will also allow for downtown offices by biopharma giants. Several of them are either based in suburbs of Chicago, such as Abbott Laboratories and its new prescription-drug spinoff AbbVie; or have U.S. headquarters in the region, such as Japanese drug developers Astellas Pharma and Takeda Pharmaceutical.

 

No big-name biopharmas have yet surfaced as planning to move into the facility. Instead, the center has received commitments for space by Diagnostic Photonics, a cancer diagnostics startup; medical device maker Novian Health; healthcare IT company Pervasive Health; and the biotech research services business Shamrock Structures.

 

Also lacking in center plans, for now, is a precise location, though a leader for the project’s development effort has emerged: Jeffrey Aronin, founder, chairman and CEO of Paragon Pharmaceuticals, an investment firm that creates, builds, and manages pharmaceutical companies; and a board member of the not-for-profit economic development organization World Business Chicago, which is chaired by Mayor Emanuel.

 

“This important project furthers my vision to strengthen Chicago’s place as the hub of the bioscience industry by partnering with leading companies, universities and venture capital firms to promote large and small businesses in the city,” the mayor said. “I look forward to working with all members of the biotech community to make the City of Chicago the best place to innovate and commercialize these technologies.”

 

The biotech center will be based loosely on 1871, an existing co-working center for digital startups launched last year and based at Chicago’s Merchandise Mart.

 

The new center joins other recently announced projects to promote Chicago as a life-sci hub.

 

Northwestern Medicine—a consortium of Northwestern University Feinberg School of Medicine, Northwestern Medical Faculty Foundation, and Northwestern Memorial HealthCare—announced plans in January to build a $1 billion, 1.2 million-square-foot biomedical research facility in Chicago’s Streeterville neighborhood.

 

Also, the University of Chicago has expanded its biotech presence in recent years, while the University of Illinois has spent more than a decade growing the Illinois Medical District, which includes 560 acres of medical research facilities, labs, biotech business incubator, raw development area, universities, and more than 40 healthcare related facilities.

 

Novo Nordisk Opens New U.S. Headquarters

Advancing its commitment to patients and New Jersey, Novo Nordisk unveiled its new U.S. headquarters.

 

Located in Mercer County in Plainsboro, N.J., the building is the result of a $225 million redevelopment project, which utilized an existing structure and sustainable materials to limit environmental impact. The public and private sectors collaborated on this redevelopment project, which created over 500 union construction jobs.

 

"Becoming a leading healthcare company requires not only the best people in the field, but a work environment that fosters collaboration," said Jurek Gruhn, president of Novo Nordisk's U.S. business. "Our new home provides our employees with the physical space and resources to fuel our continued commitment to provide the best possible solutions for diabetes patients in the United States."

 

The company said the redeveloped building was designed to promote innovation, teamwork, and employee wellness. Features include a cafeteria, a one-mile scenic walking path, and special quiet focus areas where employees can work effectively. The redesigned headquarters showcases Novo Nordisk's dedication to its internal culture and commitment to employees' personal growth--values that have earned the company recognition on the Fortune "100 Best Companies to Work For" and the NJBiz "Best Places to Work in New Jersey" lists in 2013.

 

Utilizing recycled and locally-sourced materials, the new U.S. headquarters is consistent with Novo Nordisk's Triple Bottom Line (TBL) approach to business. The LEED Silver certified campus is fully powered by renewable energy from wind, solar, and hydro sources a feature that is expected to lead to a 30 percent reduction in energy costs.

 

Reflecting Novo Nordisk's expectations for continued growth in the U.S., the company's initial plans are to occupy 75 percent of the building's total capacity, leaving room for future expansion.

 

Headquartered in Denmark, Novo Nordisk is a global healthcare company, focusing on diabetes care.

 

Final Phase at BioTechnology Research Park

Development has begun on the third phase of BioTech 8, a six-story tower within the 34-acre Virginia BioTechnology Research Park in downtown Richmond, Virginia. The project will complete this $100 million three-building complex totaling 276,000 square foot and including a four-story, 485-space parking deck.

 

This facility is an expansion for Health Diagnostic Laboratories, Inc., a CLIA-certified and CAP-accredited laboratory, health management and bioscience company, offering a comprehensive test menu of risk factors and biomarkers for cardiovascular disease, diabetes and related diseases.

 

The Phase III BioTech 8 expansion for HDL will take total development at the Virginia BioTechnology Research Park to more than 1.25 million sq. ft. HDL's growth combined with the BioTech Park's unique mix of over 60 public and private bioscience companies, including three publicly traded firms, contribute to this park's success in attracting companies globally.

 

The Lingerfelt Companies Principal Ryan Lingerfelt said, "Since partnering with HDL in 2009, development has been fast paced with the third phase six-story tower scheduled for completion spring 2014. Lingerfelt is pleased to assist HDL in their expansion by developing all three of their buildings within the BioTechnology Research Park totaling 276,000 sq. ft. and a $100 million investment. HDL is a significant complement to our growing health care development portfolio. We have enjoyed partnering with such a high-quality and successful company."

 

Baxter Evaluates Biomanufacturing at New Minnesota Plant

Baxter says it is evaluating a number of options at its newly acquired Minnesota facility, though biosimilars will be the main focus.

 

The news comes following Baxter International’s Q1 FY2013 results, which fell in line with the company’s guidance. Revenue for the quarter stood at $552m (€424m), just short of the same period last year which was partially due to several acquisitions in the quarter, one of which was the $10m purchase of an antibody manufacturing facility in Brooklyn Park, Minnesota from biotech company Genmab.

 

The deal, which was finalized earlier this year, has added a 215, 000 sq. ft. facility to Baxter’s biologics manufacturing offering and though spokesperson John O’Malley said that “the facility is designed to produce monoclonal antibodies,” - as was the case with the previous two owners, Genmab and PDL - he continued to say “it could produce other recombinant proteins using a cell-culture process.”

 

According to Minnesota publication the Star Tribune, Baxter intends to spend a further $300m on the site though O’Malley said Baxter has for now “not made any specific decisions with regard to future plans and [is] simply evaluating a number of options for the facility based on [its] pipeline”.

 

He added: “Future decisions on additional investments will be made over time to expand on the technical capabilities of the site and equip the site for biosimilar production.”

 

Back in February, Baxter invested $77m into its cytotoxic manufacturing plant in Halle, Germany citing a demand for biologics outsourcing as biopharma companies move away from in-house production.

 

This is certainly the strategy of Genmab who - through spokesperson Rachel Graveson - told Outsourcing-Pharma.com that the firm sold Brooklyn Park as “at is not part of Genmab's current strategy to own manufacturing capacity.”

 

The company, who now only use contract manufacturing organizations (CMOs), also said that they had “around 400 enquiries about the facility and about 20 CDAs [Confidential Disclosure Agreements] signed before the final sale to Baxter was completed.”

 

Such interest only goes to support the recent wave of CMO biologics activity. Within the last fortnight both Catalent and Cytovance have invested in the field, and can be added to a growing list of CMOs offering biomanufacturing services, which includes Lonza , Piramel and Novasep.

 

Bayer CropScience Begins Work on New R&D facility in Tennessee

Bayer CropScience LP has started construction work on its new $17 million research and development (R&D) facility in Memphis, Tennessee.

 

Located at Agricenter International in Memphis, the 40,000 square feet greenhouse will feature 40,000 square feet of growing space as well as a spacious headhouse and open office area. The facility is scheduled for completion in early 2014.

 

The new R&D facility is part of the greater Bayer CropScience's commitment to invest €7 billion ($9.15 billion) in R&D as well as an expansion of production capacities and seed processing facilities globally between 2011 and 2016.

 

The greenhouse will have a reduced footprint, which means less materials and an approximate 40% reduction annually in natural gas and electricity consumption. Additionally, the facility will include hands-free plumbing fixtures and high efficiency lights with longer lasting ballasts.

 

According to Bayer CropScience, the Memphis site supports all of its cotton brands, including Stoneville and FiberMax. All cotton trait introgression work for North America is done in Memphis, which also provides trait introgression support for Bayer CropScience cotton seed business development in South America.

 

Biosearch Technologies Relocated

Biosearch Technologies has relocated its GMP manufacturing process to a new 30,000-square-foot production facility in Novato, Calif., allowing the company to expand processes and controls relevant to medical device and molecular diagnostic customers, it said. The company also achieved ISO 13485:2003 certification.

 

EMD Serono Expands

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany announced the continued expansion of the company's presence in the United States, resulting in an estimated 20% increase in EMD Serono's employee base from last July to the end of 2014.

 

"The US represents one of the fastest growing markets for our company," said Annalisa Jenkins, Head of Global Drug Development and Medical. "Strengthening our presence in the US is central to our ability to deliver innovation and value to our patients and customers. By expanding our footprint within the Boston life sciences cluster of technology and talent, we significantly enhance our competitive position in the US and globally."

 

The expansion will primarily take place at the site in Billerica, Massachusetts, which is being renamed the "EMD Serono Research & Development Institute." The renaming reflects the full scope of work that will take place in Billerica, from early stage drug discovery research through to clinical development and medical, and reinforces EMD Serono's commitment to discover and bring to market new treatments in key therapeutic areas.

 

In recent years, EMD Serono has invested more than $75 million in a new state-of-the-art research facility in Massachusetts. The expansion of the company's drug development organization in the US marketplace is another strong signal of EMD Serono's commitment to be closer to customers and ensure a stronger scientific and commercial profile in this critical pharmaceutical market.

James Hoyes, President of EMD Serono, added: "The Greater Boston area remains one of the top locations for state-of-the-art drug development. Here we can attract and retain best-in-class talent in the biopharma and life sciences industry. We are confident that by increasing hiring in the US, we can continue to foster innovation and a culture anchored in new possibilities."

 

EMD Serono has further bolstered its US presence with recent strategic appointments of leadership within global functional areas residing at either its Rockland or Billerica sites, including the heads of three global Research and Early Development platforms; Immuno-Oncology, Immunology and Neurology. Additionally, the heads of global business franchises, including the head of the business franchise NDD, and various other strategic leaders within the global operations, global medical teams, global development and other global group functions are now based in the US. The presence of these leadership roles in a strategic region such as the US is one signal of the overall commitment to growth of the EMD Serono global pharmaceutical footprint.

 

The company's growth in the Boston area will support the advancement of its pipeline and an ability to build partnerships with academia and the biotech sector, while enhancing access to talent across the R&D continuum. The company is ongoing in building its expertise in the area of oncology, immuno-oncology and immunology, in addition to further strengthening its solid market position in the therapeutic area of multiple sclerosis. Globally, the pharma division of Merck KGaA, Darmstadt, Germany has four R&D hubs, in Boston, MA; Darmstadt, Germany; Beijing, China; and Tokyo, Japan.

 

Injectronics Adding Presses for Medical Molding

Injectronics Corp. is purchasing three Arburg 88-ton injection molding machines for the Class 8 cleanroom at its headquarters in Clinton, Mass.

 

The presses will be used for the company's growing diagnostic disposables business, and Injectronics plans to integrate one of the presses into a fully automatic manufacturing and assembly cell. The company also plans to add two additional machines — with 200 and 300 tons of clamping force, respectively — in the next six months.

 

Injectronics Corp. is a medical device manufacturer with subject matter expertise in injection molding, contract manufacturing, thermoformed packaging, sterile packaging, and 3PL logistics. Injectronics' facilities in Massachusetts offer redundancy and risk management opportunities while providing automated production cells utilizing vision and packaging solutions supporting high volume injection molding in multiple ISO Class 8 cleanrooms.

 

Biosearch Moves into New Facility

Biosearch Technologies Inc., a developer and manufacturer of GMP-grade oligonucleotides, has relocated its GMP manufacturing process into a new, GMP production facility in Novato, Calif. The 30,000 ft2 facility was developed to further expand processes and controls relevant to medical device and molecular diagnostic customers.

 

"The GMP production facility is designed to incorporate the environmental and access controls, linear production flow, and cleanroom processes critical for the controlled manufacture of highly-qualified diagnostic components, reagents, and kits," says Ron Cook, President and CEO of Biosearch Technologies. "Our new facility allows us to continue to support our diagnostic customers in a manner fully compliant with customer and regulatory requirements. This advanced facility also introduces pharmaceutical-scale lyophilization capabilities allowing for state-of-the-art processing of molecular diagnostic assays in large scale single batches and all format types."

 

In addition to the relocation to the new GMP production facility, Biosearch has successfully completed certification to ISO 13485:2003., which confirms that Biosearch has developed, implemented, and maintains a Quality Management System able to meet the stringent requirements of medical device and molecular diagnostic manufacturing.

 

Biosearch's products include fluorophores (CAL Fluor, Quasar, and Pulsar dyes) and dark quenchers (Black Hole Quencher dyes) to be included in custom-synthesized probe formats for real-time, quantitative PCR, Stellaris RNA FISH, and other genomic-based applications. The company is licensed by the State of California Department of Public Health Food and Drug Branch as a medical device manufacturer – its markets include pharmaceutical, in vitro diagnostics, biotechnology, ag/bio, environmental and food testing, public health, and biodefence sectors.

 

Baylor Breaks Ground on Medical Center

Baylor Health Care System is breaking ground on the new 299,000 ft2 location for Baylor Medical Center at Waxahachie, Texas. The new campus will be constructed in accordance with Leadership in Energy and Environmental Design (LEED) certification guidelines.

 

Health care system officials anticipate completion of the estimated $175.5 million hospital in the fall of 2014. The new hospital is initially designed to accommodate 129 beds with future growth capabilities and will include a six-story hospital bed tower.  It will also be the 100th anniversary since the hospital originally opened in 1914. Physician practices will be located in an adjacent medical office building, which is estimated to be completed prior to the opening of the hospital.

 

The new campus will be the home to Baylor Charles A. Sammons Cancer Center at Waxahachie, allowing patients to receive cancer treatment close to home.  Additionally, the increased space will accommodate expanded service lines such as Women’s Services which will include Labor and Delivery.

 

Baylor Health Care System is a not-for-profit, faith-based supporting organization providing services to a network of acute care hospitals and related health care entities that provide patient care, medical education, research, and community service.

 

Constantia Flexibles Expands South Carolina Facility

Constantia Flexibles – a global corporation that develops, manufactures and supplies flexible packaging solutions for the pharmaceutical, healthcare, food and beverage markets – has announced plans to invest $12 million to expand its main U.S. manufacturing facility in Blythewood, South Carolina.  Slated for completion in autumn of this year, the project will add 15,000 square feet of factory floor space to house several new pieces of packaging equipment and more than a dozen new employees.

 

The Blythewood facility manufactures custom packaging for the pharmaceutical and food industries, including packaging foils for blister packages, child-resistant packaging, and lids for portion controlled containers.  The factory also houses equipment used for laminating, coating, rotogravure printing and slitting services.

 

The construction project marks the third of its kind for Constantia Flexibles’ South Carolina facility, which opened in 1997 and underwent expansions in 2001 and 2005. 

 

“Like previous expansions, the current project reflects Constantia Flexibles’ solid growth in sales, and its leadership as a packaging innovator,” said Steve Godwin, Chief Operating Officer, USA for Constantia Flexibles.  “More room means additional equipment and new employees to build further upon our successes.  We’re excited as well as proud, and we look forward to the expansion’s completion this coming fall.”

 

The current upsizing comes on the heels of a particularly prolific 2012, during which Constantia built upon its established successes by launching several new products.  The company’s new easy-PIESY is an aluminum/PET/aluminum lamination that – due to its absence of paper –requires less heat during the sealing process than traditional paper-back foil structures. No modifications to existing heat-seal lacquer are necessary, nor is additional tooling. The blister lidding’s also offers reduced sealing temperatures, leading to higher productivity and less stress on machines.  Its paper-free design also makes it especially suited to cleanroom environments. 

 

Another recent addition is Dispense Lid, which was developed as a means of dosing tablets, capsules or liquids from plastic bottles in a controlled, more compliant manner. Incorporated into a bottle’s closure, the Dispense Lid features a liner with a small opening that induction seals to high-density polyethylene, polypropylene, and polystyrene bottles. The customized opening feature helps users dispense only the desired number of tablets or capsules, assisting with compliance and minimizing the risk of contamination to remaining product.

 

NAMSA Expands Lab Capacity in Irvine, CA

NAMSA has expanded its microbiology laboratory in Irvine, CA to employ the latest technology for microbiology and sterility assurance testing. Set to open in spring 2013, the new lab space will be used for in vitro toxicology, sterility, and bioburden testing, NAMSA reported in a press release.

 

Increasing capacity by nearly 50%, the expansion will not affect current services, NAMSA reported.

 

“At NAMSA, we believe that everything we do must be in our clients’ best interests. This expansion is one of several examples of that commitment,” said Gina Skolmowski, Corporate Vice President of Operations for NAMSA, in the release. “Through this effort we have optimized our processes to meet increased demand for efficient lot release testing.

 

“The medical device research, regulatory approval and commercialization process is continuously taking longer and costing more, driving the need for efficiencies wherever possible, and we are very focused on helping our clients meet that need,” added Skolmowski.

 

The building is being improved to meet the requirements of silver Leadership in Energy and Environmental Design (LEED) standards developed by the U.S. Green Building Council (USGBC), NAMSA reported.

 

Bristol-Myers Plans $250M Expansion

Bristol-Myers Squibb plans to begin construction on 200,000 square feet of new lab and office space later this year, to be completed in 2015.

 

Bristol-Myers Squibb will pump $250 million into the expansion of its large-scale biologics manufacturing facility in Massachusetts.

 

The New York City-based biopharmaceutical company behind the popular antidepressant drug, Abilify, and a slew of other drugs, said it plans to expand its facility in Devens to introduce biologics development and clinical trial manufacturing capabilities to the company’s Massachusetts operations.

 

Bristol-Myers, which has 400 employees working at its Devens facility, plans to nearly double the number of positions in Devens with an additional 350 jobs. The plan is to construct two new buildings on its 89-acre site in Devens. One building will house BMS’s process development business, which focuses on the early production of investigational biologics medicines. Specifically, it will be used for the manufacturing of new molecules coming out of the early-stage of research and development. A second building will focus on the clinical manufacturing of investigational medicines for use in clinical trials.

 

“These functions really represent a bridge between R&D and manufacturing,” said John Patella, manager of communications for global manufacturing and supply at Bristol-Myers Squibb.

 

In total, the two buildings will add 200,000 square feet of lab and office space to the campus, which currently has six buildings in a 400,000-square-foot complex. Construction on the site is slated for late 2013 with a completion date some time in 2015, according to BMS.

 

In order to roll out the expansion of the two business functions, BMS has leased 30,000 square feet of lab space in Hopkinton so that it can begin the move of its process development functions closer to Devens during the construction.

 

BMS is not shy about its investments. The company, which has net sales of $17.6 billion in 2012 and invested $3.9 billion in research and development in 2012, pumped $750 million into the first major facility in Massachusetts in 2009.

 

While Devens was built to accommodate future expansion and can grow to meet its needs, the next phase of the expansion is designed to facilitate the development and launch of new products with more closely aligned biological and manufacturing capabilities, according to Patella.

 

The news of the expansion is exciting for the state of Massachusetts, said Susan Windham-Bannister, President and CEO of the Massachusetts Life Science Center (MLSC), an organization that is focused on expanding life sciences in the state. Officials at the MLSC said it has been in talks with BMS for months about the expansion.

 

“This is a great example of why life sciences have become top job creators in the state,” Bannister told Mass High Tech. “The real draw for large companies to Massachusetts is our pipeline of early-stage companies. They want a front-row seat and we want to invest in making this a good ecosystem for them to be part of.”

 

Bannister said no upfront incentives were provided to BMS as part of its decision to expand in the Bay Sate. In fact, Bannister said the company has not yet applied for any incentives offered by the state through the Life Sciences Center. Patella, however, said the company plans to apply for MLSC tax incentives program, adding that the Massachusetts Development Finance Agency (MassDevelopment) agreed to provide a partial, incremental abatement would reduce property taxes by 38 percent over a 13-year term. The value of the deal will depend on the assessment of the new construction, but internal estimates pegged it at $5 million over 13 years.

 

Patella would not comment on how quickly it will fill the 350 jobs, but did say that the expansion will create jobs for scientists, engineers, bioprocess operators, quality specialists and other skilled workers.

 

Asked what incentives for which BMS would be eligible, Bannister said she’d have to first look at the application before she could provide that number. “We have a menu of 10 different tax incentives,” she said. “We look at how many jobs they plan to create.” The incentive is also figured based on the number of other companies that apply for incentives and what amount MLSC is authorized to award.

 

The range, however, is on average $20,000 to $25,000 per job. If BMS applies for any incentives, it will need to achieve 70 percent of the targeted job creation in 12 months and will need to retain those jobs for five years. “If they achieve 90 percent of that target in 12 months, they can come back and apply for subsequent incentives,” she said. “It really is for us a pretty strict program.

 

MLSC is excited about the expansion for another reason. At this point, nine of the top 10 biopharmas - including Sanofi, Johnson & Johnson, Astra Zeneca and GSK - have a presence in Massachusetts. The only one missing is Roche, but Bannister said she’s working on getting Roche to have a presence in the Bay State.

 

“The new model of economic development in the innovation economy is yes to provide incentives,” she said, “But more important than anything is to have a pipeline to make them feel like they have to be here.”

 

CoreRx Plans Expansion

CoreRx plans to buy a new manufacturing site. The expansion of CoreRx’s Clearwater, Florida facility will allow for hormone development, clinical trial and commercial manufacturing, and create about 25 new jobs.

 

"The new facility will be outfitted to handle solids manufacturing,” said Todd R. Daviau, Ph.D., president and CEO of CoreRx. “Initially, it will be set up for granulation, blending, encapsulation, coating and packaging… Additional capabilities will be added as our clients’ needs dictate.”

 

The new site will add about 40,000 square feet of additional manufacturing and office space and will contain three suites dedicated to process development and clinical production, to make investigational drugs to support clinical trials. Construction will begin in May and is expected to be complete by the middle of Q4 2013.

 

“We are partnering with one of our clients who has a product approaching Phase 3 with a strong commercial partner showing interest,” Daviau said, noting that more information on the partnerships will be available “in the next few weeks.”

 

The decision to expand the site is based on uptick in the market for such outsourced manufacturing and the development of niche drugs.

 

Market data “is showing a trend in this direction” toward clinical trial and commercial manufacturing, and one of CoreRx’s clients “has expressed a need,” Daviau said.  He added that the expanded site will help the company maintain its focus on “niche commercial products.”

 

Construction of the current manufacturing site was completed last July and the initial success of CoreRx and the increasing abundance of biotechnology knowledge, education and training, as well as the inception of the USF College of Pharmacy, has driven the growth in the Tampa area, the company said in a statement.

 

“This initiative is designed to accelerate the development of new medicines through the closer alignment of our research and development, and manufacturing,” Brian R. McMillan, VP of product development added in a statement.

 

Pall to Open Life Sciences Centre of Excellence in Portsmouth, UK

Pall Corporation, headquartered in Port Washington, New York, is to open a state-of–the-art Life Sciences Centre of Excellence at its new Harbourgate site in Portsmouth, UK, in the middle of the year.

 

The supplier of separation systems and filtration, separation and purification technologies to pharma and biotech companies says the Centre of Excellence (COE) will offer a full suite of capabilities including cell culture, purification, analytical solutions, protein characterization and microbiological tools. It will complement recently announced Life Sciences Centers in the US (Westborough, Massachusetts and Menlo Park, California) as well as investments previously announced in China, Singapore and India.

 

‘The announcement of Pall’s new Portsmouth Centre of Excellence provides another example of our commitment to meeting the diverse needs of our Life Sciences customers across the globe,’ said Yves Baratelli, President, Pall Life Sciences.

 

‘Portsmouth represents an important Life Sciences hub for Pall. By upgrading and expanding our capabilities at the site, we are not only enhancing our ability to service our customers, but also creating a multi-disciplinary and responsive environment in which Pall scientists and engineers can thrive and innovate.’

 

The Portsmouth COE will include a dedicated 4000m2 scientific area with a connected walkway to another recently opened facility that houses an additional 2000m2 for Life Sciences technical support and training, R&D engineering and product management. Manufacturing and test areas will remain at the current Walton Road site in Portsmouth.

 

In addition to customer service support, COE offerings will include the development, testing and validation of products that now form part of Pall’s portfolio.

 

Dr. Reddy’s to Relocate Headquarters and Establish R&D Center in Princeton, NJ

Dr. Reddy’s Laboratories announced plans to relocate their North America Headquarters and establish a R&D Center in Princeton, New Jersey. Dr. Reddy’s, represented by Jones Lang LaSalle, has entered into two lease agreements for a 75,500 square foot office facility and a 31,000 square foot office/lab at 107 College Road East and 303 College Road East respectively with National Business Parks.

 

Dr. Reddy’s anticipates relocation to the office facility at 107 College Road East by the end of the summer of 2013 after the renovations to the facility are completed. The new North America Headquarters will house the Generics, Biologics, PSAI and Proprietary Product businesses as well as the corporate support functions within North America. It is projected to employ 300+ people as the US businesses within Dr. Reddy’s continue to expand in the coming years.

 

The lab facility located at 303 College Road East will undergo a redesign to accommodate Dr. Reddy’s product development and analytical laboratory requirements. Approximately 20,000 square feet of space will be part of the initial phase of redesign. The lab facility is also expected to be completed by late summer to early fall of 2013 and will employ 35 scientists, chemists and support personal.

 

Commenting on the move, GV Prasad, Chairman and CEO, Dr. Reddy’s said, “The relocation will allow Dr. Reddy's to tap into local talent which will be instrumental in our long term growth. This R&D center, along with centers in Cambridge (UK) and Leiden (Netherlands) establishes our presence within some of the leading innovation centers of the world.”

 

Regeneron Expands

Regeneron, a biopharmaceutical company based in New York, has announced plans to expand its corporate headquarters and laboratories in Westchester. This expansion will create more than 400 new highly skilled jobs and further cement Hudson Valley's reputation as an emerging epicenter for biopharmaceutical growth.

 

"Today's announcement further advances New York's reputation as a leader in the biotech industry," commented Governor Andrew M. Cuomo in a press statement. "This administration has had a laser-like focus on creating an environment where companies, such as Regeneron, can grow and invest. The expansion of Regeneron's headquarters and the addition of hundreds of new high-skill jobs is great news for Westchester County and great news for New York."

 

Two new buildings with 300 000 square feet of laboratory and office space will be added to Regeneron's site at the Landmark at Eastview in the Town of Mount Pleasant in Westchester, New York. At present, Regeneron occupies approximately 590 000 square feet of space at this site and is expanding to include another 85 000 square feet of additional space later this year. The expansion will allow the company to accommodate its rapid growth over the last six years, from 682 employees in 2007 to 2 000 today, including more than 1 300 employees in Tarrytown and nearly 600 at its industrial operations and product supply facility in Rensselaer, New York.

 

Last November, Regeneron announced plans to invest nearly $70 million in the expansion of its manufacturing site in Rensselaer and create 300 new jobs in the capital region. The company anticipates that with both the Rensselaer and Tarrytown expansions, there will be more than 700 new jobs in New York. Regeneron stated that it will invest approximately $170 million in capital expansion in New York over the next few years.

 

Regeneron had also considered expanding outside New York before the State stepped in with $8.5 million in tax credits through the Excelsior Jobs Program. Furthermore, the Town of Mount Pleasant Industrial Development Agency offered additional incentives. Construction of the new buildings is expected to begin in late 2013 and to be completed in late 2015.

 

ScieGen Pharmaceuticals to Build in Suffolk

In a decision that will help an emerging pharmaceutical research and development leader expand in Suffolk, the Suffolk County Industrial Development Agency (IDA) approved a cost-saving incentive package for ScieGen Pharmaceuticals, a subsidiary of Bactolac Pharmaceuticals.

 

The company, which specializes in development of low-cost generic prescription drugs, has had one drug approved by the Food & Drug Administration (FDA) and has an additional 23 applications pending.

 

Anticipating that the FDA may approve several drugs before year-end, ScieGen is ramping up to begin manufacturing operations here in Suffolk County.

 

"The company will be purchasing a 79,000 square foot building in Hauppauge for $6.3 million and investing $1.5 million in renovations and another $1.75 million in equipment," said IDA Executive Director Anthony Manetta. "Jobs will run the gamut from entry level maintenance staff to supervisors in research and development, chemists and other STEM-related positions. With a plan to hire 100 new employees at average salaries of $37,000 per year, ScieGen's expanded business will add more than $3.5 million in payroll dollars to the local economy."

 

According to Manetta, the IDA has backed the company with an incentive package that includes a 50% property tax abatement over 10 years totaling $496,573, sales tax exemptions of $86,251, and $42,000 mortgage recording tax savings on a $4 million mortgage, for total projected savings of $624,824 over a 10-year period.

 

Currently, ScieGen operates a 28,000 square foot R&D facility with 55 employees. "ScieGen is the fourth pharmaceutical company to receive Suffolk IDA benefits in less than a year, which suggests an industry sector is emerging. With numerous other states' pitching incentives for relocating, ScieGen had entertained the possibility of moving their manufacturing operation off Long Island," said County Executive Steven Bellone.

 

"However, Suffolk has three things ScieGen values: synergy within the local industry, a quality workforce, and the Suffolk County IDA, which continues to create a pro-business environment to create jobs."

 

In addition to ScieGen, three pharmaceutical companies have received IDA benefits in recent months: A&Z Pharmaceuticals, LNK International, and Biobotanica.

 

"The assistance and support of the Suffolk County IDA will help catapult Sciegen into the competitive arena delivering high quality, low-cost generic prescription pharmaceuticals to the marketplace," said Sciegen Chief Financial Officer Renee Reynolds. In addition, the Suffolk County Department of Labor Business Services Unit will be working with ScieGen to assist with the company's hiring needs. According to Manetta, the Empire State Development Corp is also working with ScieGen through the Excelsior Jobs Program.

 

Swedish/Edmonds Opens Cancer Center

Swedish Health Services has opened a new outpatient cancer center at its campus in Edmonds, Wash. The facility includes a cleanroom for mixing the chemotherapy drugs, with negative pressure hoods to remove any fumes present.

 

The center will provide comprehensive medical oncology services to patients through an infusion unit, laboratory, pharmacy, and access to Swedish’s electronic medical record system. As a hospital-based department, patients will also have access to social work, support groups, American Cancer Society navigation and resources, financial counseling, cancer-specific patient education classes, and an education/resource wall.

 

Design-build firm RAD Technology Medical Systems – a specialty modular healthcare contractor – collaborated with design architects Perkins + Will to develop the modular building comprised of 29 factory-built units, which were erected on the site over just two days in December of last year. Skanska USA was responsible for the site development.

 

REST OF WORLD

 

Flextronics Opens Milan Design Facility

Singapore-based electronics manufacturing services provider Flextronics International has opened a new medical design center in Milan, Italy. Called a “design and industrialization center,” the facility is ISO 13485 certified, and is designed to provide expertise for U.S. Food and Drug Administration (FDA) class II and III medical devices, drug delivery services, medical equipment and disposables.

 

Flextronics has assembled a team of approximately 200 advanced medical design engineers to work at the center, which is 53,800 square feet. There is space for expansion of up to 21,500 square feet of engineering labs. The facility has advanced rapid prototyping machines, a new product introduction lab for process development and small-scale assembly in a controlled environment, engineering labs, and a compliance testing metrology area.

 

 “Flextronics is committed to providing our medical customers with the most advanced end-to-end supply chain solutions in the industry,” said Mark Kemp, president of Flextronics Medical. “We are thrilled to celebrate the opening of our Milan Design Center and look forward to providing our medical customers extraordinary design solutions and innovation that will help them to achieve their objectives of product safety, full compliance and innovation.”

 

Flextronics provides design, engineering and manufacturing services to a variety of industries including medical devices. The company’s U.S. headquarters are in San Jose, Calif.

 

Plainfield Precision Completes ISO Class 7 and 8 Cleanroom

Plainfield Precision, operating in the Dominican Republic as Pixley Richards LTD, has completed its first ISO Class 7 and 8 cleanroom. With the completion of the cleanroom, the company looks to serve as a contract manufacturing partner for medical OEMs looking to utilize the strategic infrastructure of the Dominican Republic.

 

"As part of our strategic intent to grow our medical business, the building of a cleanroom was the logical next step for us. We chose to do this in the Dominican Republic because of our commitment and belief that the Dominican Republic offers unique benefits for medical OEMs," says CEO Jonathan Souci.

 

Located in the Zona Franca Free Zone Las Americas in Santo Domingo, Plainfield Precision-Dominican Republic is a custom manufacturing center specializing in precision plastic injection molding and assembly for the medical device industry. The expanded space will be a cleanroom environment for both precision plastic injection molding and assembly. Molding capabilities will range from 110 30-ton to 250-ton machines, and the assembly room is capable of handling multiple contract manufacturing projects at one time. The facility also has a full metrology lab and on-site machine and mold maintenance.

 

Bosch Delivers Syringe-Filling Line to Drug Contractor in Italy

IBSA Farmaceutici Italia, a subsidiary of the Swiss Institute Biochimique S.A., aseptically fills and sterilizes syringes. At its site in Lodi, for instance, IBSA fills 16 million pre-filled syringes with sodium hyaluronate for intra-articular and intradermal use and 2.2 million syringes with solvents for freeze-dried powders. To meet increasing demand for prefilled syringes, IBSA added a new production building featuring Bosch Packaging Technology’s FXS nested syringe filling. The new line will produce Diclofenac, an anti-inflammatory active pharmaceutical ingredient used for muscular and rheumatic treatment; future plans are in place to fill hyaluronic acid for intraarticular and intradermal use.

 

Featuring an ABO 5000 bag opener, an ATO 5000 tub opener, and an open restricted access barrier system (RABS), the FXS line was designed to meet IBSA’s specific requirements. “Bosch designers and technicians showed the best attitude towards the project and were very fast in accepting our specifications,” said Roberto Maglio, Engineering & Maintenance Manager at IBSA, in a press release. “IBSA could draw on Bosch’s expertise and flexibility for the line configuration. Together, we managed to achieve a truly reliable aseptic process.”

 

IBSA can achieve an output of 12,000 syringes per hour with watery products and 6000 syringes per hour with viscous products. “Viscous products are filled and stoppered under vacuum, hence the lower output rate,” Maglio explained.

 

The line features a semi-automatic reject station outside of the aseptic filling zone and permits removal of out-of-specification syringes. Syringes without a stopper or with an incorrect filling weight are rejected via an automatic discharge function and are tracked on screen. Operators can then remove syringes manually to confirm their removal. Correctly closed and filled syringes continue down the line.

 

Controlling contamination was one of IBSA’s critical requirements. Empty sterile syringes contained in tubs are moved from a non-sterile area to the cleanroom area. Syringe sterility must be maintained during this critical transfer and throughout filling and handling. High-precision instruments can detect microbial contamination in real time. “The project was not only about the filling of our syringes; the complete process needed to be taken into account. We had to pay particularly high attention to microbiological contamination issues,” explains Paola Emaldi, responsible for quality assurance at IBSA’s Lodi site.

 

The first series of factory acceptance tests (FAT) were performed at Bosch’s location in Crailsheim, Germany. After only six weeks, the line was shipped to Lodi for testing at the actual place of production, including cleanrooms grade A, B and C. Once at IBSA’s plant in Italy, the line required some changes in configuration. Both the machine shape and the dimensions of critical machine parts were adapted, Bosch reports, to enable a smooth air pathway and material movement to and from the classified areas without contamination. Final tests were conducted and the line prepared for inspection by the Italian authorities. The results confirmed that all improvements had been successfully implemented. “The entire Bosch team was very committed. Clearly, their job not only consisted in the execution of a contract. Everyone involved was continuously seeking to improve processes and to find the best solutions for IBSA,” Roberto Maglio emphasized, adding that this attitude “really came out naturally.”

 

IBSA Farmaceutici Italia offers research and development, clinical development, production, and marketing of proprietary products. It also acts as an interface with the Italian authorities.

 

Jacobs Receives Contract from Sanofi Pasteur for Aguila II Project

Jacobs Engineering Group Inc. announced that it was awarded a contract from Sanofi Pasteur to provide detail engineering services for the expansion and refurbishment of its Flu Vaccine Facility in Ocoyoacac, Mexico.

 

Officials did not disclose the contract value, but noted that this is the second phase of the Aguila Project; the first phase was executed in 2010 by Jacobs’ offices in Lyon, France and Mexico City, Mexico. Jacobs is executing this detail engineering phase of the project from its Mexico operations. The overall goal of the project is to increase plant production capacity.

 

In making the announcement, Jacobs Group Vice President Mike Autrey stated, “We are committed to a long term relationship with Sanofi and we are very pleased to be part of this plant production expansion project. We look forward to continuing to deliver value and technical excellence to Sanofi.”

 

Jacobs is one of the world's largest and most diverse providers of technical, professional, and construction services.

 

Penn Pharma Produces in New Contained Manufacturing Plant

Penn Pharma, a UK bioscience company, has produced the first batch of coated tablets in its new £14.4m contained manufacturing facility in Tredegar, South Wales.

 

The 15,000ft2 plant has been built in less than 12 months for the clinical and commercial manufacture of tablets and capsules and will allow Penn Pharma to build on its expertise in the production and packing of specialist drugs for the worldwide market.

 

Richard Yarwood, Chief Executive of Penn Pharma, said: ‘It is a monumental day for Penn Pharma. In less than one year we have built a world class facility for contained manufacturing and produced our first batch of coated tablets. This gives our customers even greater confidence that Penn Pharma can meet the challenging timelines they require to get their products to market.’

 

Mark Dean-Netscher, Chief Operating Officer at Penn Pharma, added: ‘This success is the result of hard work and determination to get us to this stage in such a short space of time. A facility of this complex nature was a tight build in the timeframe, but we have demonstrated that when Penn Pharma commits to something, we always deliver.’

 

ADC Bio Opens Technical Service Lab

ADC Biotechnology (ADC Bio) has extended its North Wales, UK facility with a new £125,000 Technical Service Laboratory.

 

The lab, located at St Asaph in Denbighshire, will meet growing demand for the company’s R&D services from developers of anti-cancer drugs based on antibody drug conjugates (ADCs), with the clinical pipeline currently including treatments for breast, ovarian, gastric and lung cancers and melanoma.

 

The lab will offer ADC screening, process development and scale-up. It is equipped to manufacture at mg to 10’s of gram scale to toxicology batch scale. This includes materials compatible with in vivo toxicology studies.

 

ADC Bio has hired two more science staff, bringing the technical team up to four people.

 

The laboratory brings together analytical and preparative equipment and skill sets in one integrated space. Capabilities include HPLC, ELISA and gel electrophoresis, along with development and preparative scale chromatography and cross flow/normal flow filtration systems.

 

With dependence on a complex mix of potent compound handling, conventional pharma synthesis and bioprocessing capabilities, the development and production of ADC-based drugs is concentrated across relatively few biopharma and contract manufacturing companies.

 

 ‘The number of ADCs in trials and pre-clinical development has dramatically increased over the past 18 months,’ said ADC Bio’s CEO Charlie Johnson.

 

‘Limited capacity in the ADC space is translating into surging demand for outsourced ADC process and purification development and testing. From fewer than 40 ADCs in trials and pre-clinical development in mid-2010, at least 30 are now in trials with more than 100 in development.’

 

‘Against this background, expanding our R&D lab capacity enables earlier partnering with customer programs, increases our service offer and closely complements our main innovation activity,’ added Johnson.

 

ADC Bio’s original lab will now be dedicated to continuing development of the company’s ‘Lock and Release’ solid phase immobilization technology for high-purity processing.

 

Market momentum for ADCs was underlined in February, when Roche’s Kadcyla (T-DM1) became the second ‘next generation’ ADC to be approved by the US FDA and the first ADC to target HER-positive breast cancer.

 

The combined sales and production services market for ADC drugs is projected to top US$8bn by 2015/16.

 

In January, ADC Bio announced a £600,000 second-round investment and grant package from Finance Wales and a consortium of private investors led by Acceleris.

 

Novo Nordisk Plans Plant Conversion

Novo Nordisk says the $69 investment in its Danish plant will convert capacity ready for its new GLP-1 analogue and is a further commitment to Danish manufacturing.

 

Planned to be operational by the first quarter of 2014, the DK380m plant conversion will, according to the company, create 50 new jobs at the Kalundborg facility, adding to the current workforce of over 2,400 people.

 

In a statement, Per Valstorp, Senior VP of Product Supply said “the Kalundborg investment reaffirms our long-term commitment to creating and maintaining jobs in Denmark.”

 

The Danish drugmaker has previously invested over DK7.5bn ($1.3bn) which manufactures amongst other things active pharmaceutical products (APIs) and finished products for Novo Nordisk’s diabetes drugs.

 

This new investment will convert existing manufacturing capacity ready for future production of the company’s latest GLP-1 analogue, semaglutide, which is currently in Phase III clinical trials.

 

Novo Nordisk already manufacture and market Victoza for the treatment of type 2 diabetes but, if found successful and approved, semaglutide could offer once-weekly alternative for sufferers.

 

DSM Opens Australian Government Backed Biologics Facility

Three years after DSM Biologics – the biomanufacturing wing of Royal DSM – announced it was collaborating with the Australian Government to create the country’s first biotech contract manufacturing facility, the company has announced operations at the 70,000 sq ft plant in Brisbane will commence this June.

 

DSM Biologics’ President Karen King said though “Australia has a vibrant and growing biotech industry with great innovation,” there was “no local manufacturing option” until DSM struck this deal.

 

It had been estimated that up to A$60m ($56m) of business was being outsourced overseas each year and as a remedy to the situation the Government, according to King, engaged “in many activities to incentivize the development of the biotechnology sector in Australia including an attractive R&D tax rebate program.”

One of these incentives led to the funding of the mammalian cell culture facility to which DSM provided only its expertise – the company has been operating for over 25 years from its site in Groningen , The Netherlands – but no capital.

 

King said: “We are pleased to be in a position to serve this substantial industry segment.” She continued, adding that the site was also an important base for the company to offer its services in the region, as “DSM Biologics believes the Asia-Pacific region will continue to grow in importance in the Biologics space.”

 

From the facility in Eastern Australia, DSM will offer its clients services from process development through to cGMP manufacturing at pre-clinical, clinical and commercial stages, including its proprietary XD and Rhobust technologies which has an estimated output capacity of 500kg of product per year.

 

With the completion of this facility, DSM has become the latest company in a trend of CMOs investing and opening biologics capabilities.

 

Cytovance increased its mammalian services in the last few days, and Fujifilm Diosynth has opened a cell banking facility in the UK. Furthermore, Fujifilm said that the mammalian side of the industry was on the up and now accounts for about two thirds to one third microbial in third party biologics manufacturing.

 

This increased growth has also reached DSM. According to King, “DSM Biologics’ client book has continued to grow significantly” and “consists of companies from around the globe and of all sizes and scopes.”

 

Nypro Invests in Device Manufacturing Facility in Ireland

Nypro Healthcare is to establish an additional medical device manufacturing facility in Ireland. A subsidiary of US group Nypro, the company specializes in the development and manufacturing of medical devices for the healthcare sector and will produce advanced respiratory and injectable devices for global healthcare and pharmaceutical customers.

 

The announcement of Nypro’s new facility was welcome news for the Irish market. Located in Bray, Nypro Healthcare is the European Centre of Excellence for the development of medical devices for Nypro.

 

Activities include delivery of proof of concept, initial prototyping, clinical trial support and validation leading to full manufacturing of medical devices for global markets. It uses state-of-the-art injection molding processes and integrated complex automated assembly lines within cleanroom manufacturing environments.

 

RPC to Open New Cleanroom

RPC Group, a UK-headquartered rigid plastic packaging manufacturer, is building a new cleanroom production hall at its RPC Formatec plant in Mellrichstadt, Germany to enable future growth in pharmaceutical products.

 

The 3,000m2 (32,280 sq. ft.) Class D (100,000) cleanroom production hall will include a 1,000m2 (10,760 sq. ft.) controlled area plus a warehouse and logistics.

 

Alfons Boeckmann, Director RPC Bramlage-Wiko Cluster, said the new cleanroom production hall would be completed in the next 6 months and would start manufacturing a pharmaceutical product, which is not yet on the market, in 2014.

 

RPC manufactures rigid plastic packaging using three conversion processes: injection molding (complex designs, high level decoration, high added value), blow molding (re-closable, narrow neck, pourable) and thermoforming (high-volume, low cost, barrier applications). The company’s total turnover was £1.1bn for the half year to 30 September 2012. It employs more than 7,000 people across 50 operations in 18 countries.

 

Pharmaceutical products include blister-, capsule- and reservoir-based dry powder inhalers and pressurized metered dose inhalers (pMDIs), which are manufactured at RPC Formatec.

 

The company has extended its range of inhalation systems with the introduction of the new Twist’n’hale solution for blister-based powders.

 

The Twist’n’hale features a turning wheel on the side of the container. When the cap is opened, the wheel is rotated clockwise in a single movement up to the stop point, which releases the dose. The user then inhales and closes the cap. Usage is monitored via a dose counter and reloading the dispenser is said to be a simple task.

 

RPC said the patented multidose inhaler offers accuracy of dosing and dispersion over a range of flow rates (RSD prototype <8%). It delivers a consistent fine particle fraction (% aerosolized particles <5µ).

 

The Twist’n’hale is suitable for adhesive types of powder blends and a variety of drugs, and can be tailored to different dosing amounts. A choice of decoration options is available to personalize the dispenser for individual medicines.

 

Boeckmann said RPC’s decentralized approach to design means that innovations in each of the markets in which it operates can be transferred into another.

 

The patented Gizmo closure, for example, provides a pressurized bottle cap where all the ingredients are contained and only released when the cap is opened. Boeckmann said such a device could have applications in the pharmaceutical sector where powders need to be mixed with liquids at the patient’s bedside.

 

The Gizmo system comprises a miniature pressurized injection-molded chamber, which operates in combination with various Gizmo closure designs. The chamber is tailored to hold the precise required volume of powdered ingredients. Product integrity for every ingredient is assured.

 

Boeckmann said the company is also looking at the possibility of developing pumps for dispensing wet pharmaceutical products in the future.

 

RPC’s Chief Executive of 24 years, Ron Marsh, is to retire on 1 May. His successor is Pim Vervaat, who has been with the company for 5 years. He said RPC aims to optimize its pan-European thermoforming and injection molding and spread production across its plants, which will mean the closure of operations in Antwerp (Belgium) and Beuningen (The Netherlands).

 

Going forward, he aims to grow the company in new geographical areas through acquisitions, partnerships or joint ventures.

 

‘We aim to build a sustainable and meaningful presence with higher-value products in emerging markets within the next 5 years, but we need to find the right partners and opportunities,’ he said.

 

Higher value-added products, which include inhalers, grew by a CAGR of 15% between 2009/10 and 30 September 2012 and now represent 31% of group turnover.

 

B. Braun Opens Expanded Production Site in Hungary

B. Braun has opened its expanded production site in Gyöngyös, Hungary following the completion of an 18-month building project.

 

The company has doubled the production area and capacity of the plant in a €12.7m investment, which enables 100 million products to be manufactured each year to meet growing demand. Disposable blood-lines, wound drainage systems, catheters and customized infusion sets are now manufactured in the expanded 5,300m2 (57,028 sq. ft.) cleanroom area. The plant covers around 800 product types, with about 98% exported.

 

In addition to the growth in capacity and manufacturing space, more than 100 new employees have been recruited. With a workforce of 755, Gyöngyös is B. Braun Hungary’s largest plant. In total the company employs close to 2,000 people in the country.

 

‘The modern cleanroom has brought processes to the latest standards of technical development and ensures a more efficient production,’ said Jozsef Bognar, Plant Manager of the manufacturing site of B. Braun Medical Hungary.

 

‘Being the second-largest employer in the region, B. Braun is a main contributor to the economy both locally as well as countrywide,’ added Peter Horn, General Manager. ‘In the past 20 years, we have set lasting values in the healthcare system and invested more than €200m in Hungary, which is a clear message in terms of local commitment.’

 

UK to Award $124M for Synthetic Biology Centers

The UK is preparing a program that will use as much as £80 million ($124.4 million) to create a network of multidisciplinary synthetic biology research centers (SBRCs) that will serve as cores for research projects and provide scientists with training and resources.

 

The funding program is a response to the government's Synthetic Biology Roadmap from last year, which recommended that such a network be created to help boost the UK's synthetic biology capabilities.

 

Funded by the Biotechnology and Biological Sciences Research Council and the Engineering and Physical Sciences Research Council, the program will include two funding calls, one in 2013-2014 and another in 2014-2015, said BBSRC. Each funding call will establish up to three SBRCs.

 

The funders plan to award a total of £10 million in capital funding for each of the two phases, and each phase will provide up to an additional £2 million per year to each center for five years.

 

This network of SBRCs will be tasked with creating and sustaining a program of synthetic biology research in strategic areas; creating a collaborative culture and providing a supportive environment and necessary equipment and facilities for multidisciplinary research projects; advancing new research techniques; and boosting the number of postdocs and technical staff that are trained in key areas.

 

The centers will be expected to focus on strategic areas that are relevant to one or more industrial sector, such as the life sciences, medicine and healthcare, energy, agriculture and food, the environment, and diagnostics. They also are expected to "provide the essential equipment and facilities required to enable adoption and uptake of synthetic biology approaches and, where appropriate, make this available to the wider community," said BBSRC.

 

The SBRCs also will bring together researchers working on experimental science with others who are studying the ethical, legal, and social issues related to synthetic biology.

 

The BBSRC said the first of these funding calls is expected to open this June.

 

Vertellus Completes Upgrades for API Production

Vertellus Specialties’ facility in Antwerp, Belgium has completed upgrades for the manufacture of Niacin (nicotinic acid) for pharmaceutical use. For 30 years the plant has produced Niacin USP and Niacinamide for human food applications and agricultural needs. Vertellus upgraded the facility to meet cGMP guidelines for the manufacture of an API and it has been inspected and approved by the U.S. FDA. Major changes include validation of all critical equipment, manufacturing processes, analytical methodology and data collection systems.

 

"We are very excited to broaden our market capabilities to include pharmaceutical use for Niacin," said Bentley Park, president of Vertellus Agriculture & Nutrition Specialties LLC. "Among other applications, Niacin increasingly is used as a critical ingredient in drugs that help improve cardiovascular health by increasing good cholesterol levels. We can now provide another source and more options for pharmaceutical companies making those life-saving drugs."

 

PRA Opens New Wales Facility

PRA has opened its new facility in Swansea, Wales, expanding its Clinical Informatics team with the establishment of a new multi-lingual Help Desk, creating positions in the data coordination, clinical programming, and safety groups. The expansion will create approximately 100 new graduate-level jobs.

 

Steve Powell, PRA executive vice president, Clinical Informatics and Late Phase Services, said, “We are delighted to officially open our expanded location in Swansea. The new site has received substantial funding from the Welsh government, which will mean significant job creation and support for the local economy. We are committed to the growth of our Swansea team and to transforming clinical trials across all phases of drug development; the new building and jobs demonstrates PRA’s commitment to offering a more dynamic service to our customers, both locally and internationally.”

 

MedPharm Opens Topical Testing Lab

MedPharm has opened a new $750,000 GLP laboratory at its UK headquarters in Guildford to support growth of its specialized skin permeation/penetration and in vitro release testing (IVRT) services for topical formulations. The lab is equipped with analytical equipment including HPLC, UPLC and LC-MS/MS. The additional space provides further capacity for in vitro/ex vivo performance and equivalence testing models for topical, ophthalmic, nail, nasal and inhaled drugs/medical devices.

 

The new facility also expands microbiological capacity, increasing output in areas of ex vivo/ in vitro efficacy testing for anti-infectives, as well as the development of new drug formulations for inflammatory skin conditions and the development and testing of novel drug delivery systems.

 

Andrew Muddle, MedPharm’s chief executive officer, said, “All dermatology companies need to find and launch new products. Therefore traditional players in the prescription field are all on acquisition sprees, the latest being the interesting tussle between Valeant and Merz over Obagi. We are also seeing Allergan come back strongly into the dermatology space. Meanwhile Merck Consumer Healthcare, GSK Consumer, Johnson & Johnson and Beiersdorf are all increasingly active in the OTC skin-care market.”

 

Redx Pharma Houses New Venture in Alderley Park

Liverpool-based drug development company Redx Pharma is to open a new research and development facility at Alderley Park in Cheshire, the site being vacated by AstraZeneca’s research team.

 

The new company, called Redx Anti-Infectives, will create 119 science-based jobs at the site to develop drugs that fight resistance to antibiotics and new medicines to tackle viral infections.

 

A particular focus will be on hard-to-treat infections such as MRSA, as well as conditions such as influenza, Hepatitis C and HIV.

 

The company said a further 28 jobs were expected to be created in the supply chain.

 

Redx Anti-Infectives begins operations supported by a grant of £4.7m from the UK Government’s Regional Growth Fund (RGF).

 

The company also recently completed a significant funding round of £6m, brokered by Manchester-based Acceleris Corporate Finance with a combination of commercial partnering revenue and shareholder equity funding.

 

Neil Murray, Chief Executive of Redx Pharma, said the new company would bring ‘fresh thinking and an original approach’ to drug development.

 

‘Whilst our headquarters remain in Liverpool and we have ambitious plans to grow our business and create high value science posts in the city, at the same time we recognize that the facilities at Alderley Park are world class and enable us to move quickly in expanding this key new part of our business. We will be working closely with our colleagues at AstraZeneca, who made a compelling commercial case to attract us to Alderley Park. We look forward to a long and fruitful collaboration,’ he said.

 

Clive Morris, AstraZeneca’s Vice President of Research & Development, said the arrival of Redx to Alderley Park, is ‘an important first step in our ambition to secure a sustainable future for the site’.

 

‘We will continue to seek further opportunities to attract other innovation-driven companies and, wherever possible, build on the existing bioscience expertise and world class facilities available at Alderley Park,’ he said.

 

Redx develops medicines based on existing classes of drugs, structurally modifying them to create new proprietary medicines. Benefits are said to include fewer side effects, greater efficacy and ease of use. The company achieves revenues by entering into licensing agreements with mid-sized and large pharmaceutical partners who undertake further clinical studies with promising new drug compounds.

 

Redx Anti-Infectives is the third business to be created by Redx Pharma, which was founded in 2010. It follows Redx Oncology, which employs 111 people in Liverpool, and Redx Crop Protection, based in Frome, Somerset.

 

South Australian Health and Medical Research Institute (SAHMRI), Adelaide, Australia

The South Australian Health and Medical Research Institute (SAHMRI) is being constructed at North Terrace in Adelaide, the state capital of South Australia. The facility is expected to be ready by the end of 2013. It will be a world class research facility for health and medical research in South Australia. The facility is being sponsored by the South Australia state government and the federal Australian government.

 

"The facility is being sponsored by the South Australia state government and the federal Australian government."The new SAHMRI facility will have a total floor space of 26,000m²

279,760 sq. ft.) in a nine-storey building. It will be integrated with Royal Adelaide Hospital. The new facility will be used for fostering innovation and improvements in health services. It will be a place for carrying out research on themes such as cancer, heart diseases nutrition, metabolism and healthy mothers.

 

It will also enable research on other themes including the mind and brain, immunity, infection and babies and children. It will have sophisticated laboratory space to accommodate about 675 researchers.

 

The South Australian research facility will be provided with state-of-the-art laboratory equipment. It will be incorporated with the Physical Containment (PC) level two laboratory standards set by the Australian Government. It will have both wet and dry laboratory spaces.

 

The SAHMRI facility was designed by Woods Bagot. The building design is inspired by the skin of a pine cone. It features a transparent glass facade made up of triangular structures with glass and diagonal steel beam supports. The façade is designed to allow more natural light into the building.

 

The building also features two atriums inside. The west side atrium includes the entry and bridge links between the laboratories while the east side atrium utilizes an active workplace environment. The design also features glass lifts, wide open spaces, flexible working areas, lofty bridges and a spiral staircase.

 

Construction on the SAHMRI facility was started in February 2010. The concrete works were completed and tree topping ceremony held in August 2012. The building is expected to be ready for opening by the end of 2013.

 

The design and architecture support for the building was provided by an Integrated Design Team led by Woods Bagot. Woods Bagot received collaboration from RFD for lab design, Aurecon for structure design and NDY & Aurecon for services design.

 

The construction contract for the SAHMRI facility was awarded to Hindmarsh Construction. Aconex provided operations and maintenance support during the construction.

 

Shenyang Yuanda Aluminum Industry Engineering, a China-based company, was awarded with a contract to install the diagrid facade to the research facility in March 2013. The company has subcontracted the facade installation work to Samaras Structural Engineers. The facade installation is expected to be completed by June 2013.

 

Norman Disney & Young provided advanced building information modeling to the facility.

 

The Federal Government of Australia contributed $200m funding for the construction of the research facility in April 2009. The state government has contributed $15m for the research facility. The facility is being constructed with ecologically sustainable development (ESD) features. It is expected to achieve the LEED Gold rating. It is designed to provide maximum natural daylight through atriums and glass facade.

 

Fujifilm Diosynth Biotechnologies Commissions New Cell Banking Facility

Fujifilm Diosynth Biotechnologies has commissioned on time its new mammalian cGMP Cell Banking Facility (CBF) at its Billingham, UK site.

 

The new CBF is available to the company’s customers either as part of a larger development and manufacturing program, or as a stand-alone service. It forms the second stage of a major expansion of the company’s mammalian cell culture capabilities at the site, following installation last year of new process development and scale-up capabilities. The asset will support delivery of manufacturing programs for both Fujifilm Diosynth Biotechnologies’ Billingham UK, and Research Triangle Park, North Carolina, USA facilities.

 

The next stage of the company’s expansion will be the commissioning of a new cGMP manufacturing facility, also in Billingham, which is well under construction, and due on-line in early Q4 2013. This manufacturing facility, which will primarily utilize single-use technologies, has been designed with input from regulatory authorities and key customers, to offer high flexibility for meeting customers’ needs and setting new standards. It will initially offer 200L and 1000L single-use bioreactors, with 2000L bioreactors already planned for 2014.

 

Steve Bagshaw, Managing Director, Fujifilm Diosynth Biotechnologies UK, said “I am delighted that we have commissioned the Cell Bank Facility within a year of its commencement, and have already started work on our first customer program. This is the next step in our strategy to grow our services in the CDMO field, becoming a world-class player across both microbial and mammalian cell culture platforms, offering a full life cycle support for our customers”.

 

Eisai to Establish New Parenteral Facility in China

Eisai Co., Ltd. announced that it has decided to establish a new parenteral facility on a lot retained by Eisai’s Chinese subsidiary, Eisai China Inc., at the Suzhou Industrial Park in Suzhou, Jiangsu, China.

 

Eisai currently retains a production facility nearby the site scheduled for construction of the New Plant; the Suzhou Plant operates as a solid preparation production and packaging base that supplies domestic demand in China. Eisai’s decision to establish the New Plant is aimed at constructing a stable supply chain for injection products in China in expectation of future sustained growth in the Chinese pharmaceutical market, particularly a forecasted increase in demand for Methycobal® injection, one of Eisai’s major products in China, as a drug for peripheral neuropathies. The move is also expected to achieve cost reduction at the New Plant through improving production efficiency in the mid-term. Injection products produced at the New Plant going forward will also be considered for supply to emerging countries, including in Asia and Central and South America, with the goal of having the New Plant function as a global supply base.

 

The New Plant will be built on an approximately 132,000 m2 (1,420,329 sq. ft.) lot purchased by Eisai in 2010. The facility will stand two floors aboveground, contain a building area of approximately 2,500 m2 (26,900 sq. ft.), and initially operate as a production line of Methycobal injection. Construction is planned for commencement in the third quarter of fiscal 2013 and completion in the first half of fiscal 2014.

 

Eisai considers Asia as a core region in its business operations and regards China, a country with the third largest market in the world, as a major force in driving its global business growth. Through the establishment of the New Plant, Eisai seeks to make further contributions to patients by strengthening its production capacity in China while also ensuring the stable supply of high-quality products to not only China but also emerging countries in Asia and other regions.

 

B Braun Invests in Brazil

The Germany-based B Braun Group, which has operated a Brazilian subsidiary for 45 years, has started construction on a new industrial park in the industrial and business complex Complexo Industrial e Empresarial de São Gonçalo (Ciesg) in the vicinity of Rio de Janeiro. The industrial park, in which the company is investing the equivalent of US$170m, will become B Braun’s biggest industrial site in South America to date.

 

The official groundbreaking ceremony was attended by the Governor of the State of Rio de Janeiro, Sergio Cabral Filho, Minister President of the German State of Hesse, Volker Bouffier, as well as local government officials and company employees.

 

The project, designed by architect Siegbert Zanettini, will be implemented in several phases and will cover a total construction site of 80,000m2 (860,800 sq. ft.) on a plot of 200,000m2 (2,152,000 sq. ft.). The park is located in Guaxindiba, near the BR-101 and RJ-104 freeways, Guanabara Bay and the petrochemical complex Complexo Petroquímico do Rio de Janeiro.

 

The focus of phase one will be the construction of a logistics centre, which will include storage areas for finished products and tanks for storing combustible materials. This will be followed by the construction of an administration centre and a medical device manufacturing plant. The entire project is scheduled for completion in 2017.

 

‘The plant in Ciesgis a major milestone for the Group in Brazil,’ said Otto Philipp Braun, Managing Director of Labóratorios B. Braun in Brazil and member of the B. Braun Management Board, who is responsible for the South American and Iberian Peninsula regions. ‘This new park will enable us to expand our production capacities for the manufacturing of IV administration sets for use in IV therapy. Annual production quantities increased initially from 56 million units to 84 million units and eventually to 112 million units.’

 

The new B Braun industrial park in Brazil was designed according to the principles of lean manufacturing, which aims to optimize production processes in order to cut costs and respond more swiftly to changing market conditions. Safety is another focus, so the park will be built to withstand risks such as fire, flooding, high winds and industrial accidents.

 

‘All facilities are being constructed in line with the sustainable building practices advocated by the Green Building Council. Our aim is to become the first industrial park in the healthcare sector to be awarded the LEED (Leadership in Energy and Environmental Design) gold standard,’ added Otto Philipp Braun.

 

The B Braun Group, which operates in more than 50 countries worldwide, has a comprehensive range of products in Brazil in the areas of IV therapy, volume therapy, anesthesia, enteral and parenteral nutrition, disinfection and hygiene, incontinence care, surgery, dialysis and home care. With 1,600 employees in Brazil and a global workforce of around 47,000, B Braun is one of the world’s leading healthcare suppliers.

 

Merck Opens New Manufacturing Facility in China

Merck, known as MSD outside of the United States and Canada, opened a facility in Hangzhou, China to package Merck medicines for China and the Asia Pacific region. The facility, a nearly $120-million investment by Merck, is located in the Hangzhou Economic and Technology Area (HEDA).

 

Merck also has an R&D Center in Beijing, three manufacturing facilities throughout the country, a marketing and sales organization headquartered in Shanghai, and employs more than 5000 employees in China. The healthcare system in China is growing rapidly, notes the company. In 2011, Merck established its Asia R&D headquarters in Beijing and committed to invest more than $1.5 billion in R&D in China over the next five years.

 

The new 75,000-m2 (807,000 sq. ft.) facility is capable of holding up to 16 high-speed lines to package pharmaceutical tablets and sterile Merck medicines that are used to manage diabetes, cardiovascular, infectious, respiratory, and bone diseases. Packaging capacity is currently estimated at more than 300 million packages annually. Products used in Merck’s clinical studies and in its commercial activities to support future new product launches also will be packaged at the new HEDA plant. The HEDA facility received a cGMP certification in January 2013. The facility was constructed with consideration for the environment; special air, waste, and water-management procedures and systems were built into the facility, notes the company.

 

GE Healthcare Awarded Contract to Design Biopharmaceutical Facility in Brazil

New facility for Bio-Manguinhos will use plant-based protein expression technology.

 

GE Healthcare and iBio Inc. have signed a contract under which GE Healthcare will design a new plant-based multipurpose manufacturing facility for Bio-Manguinhos/Fiocruz in Brazil. The design project is the first contract for the global alliance between GE Healthcare and iBio, which was announced in 2012.

 

The alliance combines iBio’s plant-based manufacturing platform, iBioLaunch with GE Healthcare’s capabilities in process design and biopharmaceutical and vaccine manufacturing technologies. Bio-Manguinhos/Fiocruz is a manufacturer of immunobiologicals for public health needs, primarily to support programs of the Brazilian Ministry of Health. It has invested in the development of bioprocess technologies, such as iBioLaunch, through a codevelopment agreement with iBio and its research and development collaborator the Fraunhofer USA Center for Molecular Biotechnology, which will continue to play a role in advancing iBioLaunch. The iBioLaunch platform is a proprietary technology for the development and production of biologics using transient gene expression in unmodified green plants.

 

New Anti-Infectives Company Formed

Allecra Therapeutics, a new biopharmaceutical company dedicated to the development of novel antibiotics to combat multi drug-resistant bacterial infections, has set up in the established European BioValley Life Sciences cluster with a €15m Series A financing round.

 

The company is based on a strategic partnership between its founders, Orchid Chemicals and Pharmaceuticals Ltd, of Chennai, India, and its lead investors Forbion Capital Partners and Edmond de Rothschild Investment Partners.

 

Bacterial resistance to current antibiotics is widespread and growing exponentially, leading governments, non-governmental agencies and the medical community to call for increased urgency and decisive action. Allecra‘s mission is to develop new treatments that overcome emerging bacterial resistance mechanisms.

 

‘To combat the increasing threat of bacterial resistance the medical community is trying to conserve the use of currently available antibiotics. At the same time, the biopharmaceutical industry is working to find new antibiotics,’ said Allecra CEO Nicholas Benedict. ‘These objectives are complementary activities in the increasingly urgent battle against bacterial resistance.

 

‘Allecra has been formed in order to find new cures for some of the most widespread and hardest to treat resistant infections.’

 

Commenting on this partnership, Orchid’s Chairman and Managing Director K Raghavendra Rao said: ‘We have always believed in building collaborative business models to achieve our vision. This strategic partnership with Allecra is yet another demonstration of how we can create value by harnessing the relative strengths of each company.’

 

OnCore Manufacturing Expands in Tijuana

OnCore Manufacturing Services LLC has opened a brand new facility in Tijuana, Mexico. Located in the Otay-Caliente Industrial Park with capacity for expansion, the 88,000-square-foot facility is scheduled for volume production this month.

 

“We are increasing our existing Tijuana capacity in response to customer demand for a robust, low-cost supply-base that has a short and flexible supply-chain able to service the U.S. market,” said Sajjad Malik, president and CEO of OnCore. “By leveraging the proximity of OnCore’s San Diego (Calif.) facility, the new Tijuana facility provides our customers with a range of highly flexible manufacturing and near-shore fulfillment options. The new site is capable of fulfilling customers’ product manufacturing requirements from board assembly to finished product and includes Lean, ‘focused factory’ production cells for assembly of finished medical devices and industrial instruments.”

 

The increasing desire for near-shoring production is elevating the desire for manufacturing facilities in locations such as Mexico, said Dave Busch, OnCore’s vice president of Business Development and Marketing.

 

“A lot of customers are looking for a low-cost country solution close to the United States,” Busch said. “The total end cost of products—especially larger products like medical devices and instruments—are more expensive now to make in Eastern China and ship than they are to make in Mexico and bring across the border.”

 

In fact, Busch noted, some industry analysts are saying Tijuana is on its way to becoming the largest medical manufacturing center in the world.

 

OnCore does have a manufacturing facility in Suzhou, China, and though it is still buzzing with activity, there has been a shift to manufacturing products in China for China as opposed to products for export.

 

The new Tijuana facility adds “incrementally more capability” to OnCore’s existing facility in the region. Built with the capacity to expand to 175,000 square feet, further expansion could be seen within the next year, Busch said.

 

OnCore is headquartered in San Jose, Calif., and has manufacturing facilities in Springfield and Wilmington, Mass.; Longmont, Colo.; San Marcos, Fremont and San Jose, Calif.; Suzhou, China; and Tijuana, Mexico.

 

Vetter South Ready for cGMP Filling

Vetter’s new filling line at its Ravensburg Vetter South facility in German is fully validated and ready for cGMP filling, after successful media-fill completion.

 

The contract development and manufacturing organization (CDMO) says one customer project is underway, with more in the wings. The line is able to handle mid- to large-volume batch sizes, with a maximum filling speed of 800 pre-sterilized syringes a minute. The line currently fills 1ml standard-format syringes, with additional formats to be added. Featuring novel technologies that enhance safety and maximize API yield, Vetter says exceeds cGMP requirements.

 

Highlights of the new commercial line include minimal human contact to enhance safety, such as fully automated transfer of sterile packed tubs from preparation room to Class A cleanroom and throughout the filling process. The line also takes a novel approach to zonal transition when moving tubs to higher cleanroom classes, the firm says.

 

Restricted Access Barrier Systems (RABS) and novel disinfection techniques are also included plus a special spray disinfection tunnel for bagged tubs, co-developed by Vetter and the equipment manufacturer.

 

Optimized personnel and material flows with a one-way design that minimizes potential for product mix-up and contamination risk.

 

An end-to-end track-and-trace system with integrated scanners and printers, including automated disposal of rejects and sample removal following the filling process

 

Techniques and technology to maximize API yield such as optimized routing that shortens the distances between the compounding area and filling station; 100%, fully automated in-line control of syringe closures using a 3-D scanner prior to filling, to minimize API loss and reduce risk of contamination; and in-line monitoring of filling quantities using an automatic weighing system.

 

Peter Soelkner, Managing Director of Vetter, said: ‘With our launch of the new filling line, Vetter continues to expand its prefilled syringe capabilities due to increased customer demand.

‘Whether our customers require small-batch clinical fills or high-volume commercial fills, we can accommodate their needs.’

 

ATMI and Disposable-Lab Introduce Single-Use Platform for Fill/Finish Operations

ATMI, a global technology company and a leader in single-use process solutions, is offering the first all-single-use cGMP fill/finish platform for pharmaceutical and biopharmaceutical applications through an exclusive agreement with French company Disposable-Lab, a clinical filling services and contract manufacturing organization (CMO).

 

Designed for bioprocess applications from clinical batch to industrial scale, the solution offers aseptic filling from 0.2ml to 100L.

 

The completely disposable system is modeled on traditional manufacturing fill/finish processes, but on a much smaller scale. All of the process equipment used with the fill/finish platform is disposable, including the connectors, vials, baskets and caps. As such, the platform minimizes maintenance costs and provides a smaller footprint than traditional systems. It also delivers timesavings during setup and operation.

 

‘This is the only platform of its kind on the market, and it is an excellent fit for our single-use product portfolio,’ said Mario Philips, Senior Vice President and General Manager of ATMI LifeSciences.

 

 ‘As innovators ourselves, we saw a great deal of potential in Disposable-Lab’s technology. Customers will benefit from having access to the disposable fill/finish platform, as well as from our collaboration. When combined with the mixing system, bioreactor and vessel offers we already have in place, this new addition allows us to provide customers with a truly comprehensive range of single-use technology solutions.’

 

Operation of the system involves decontaminating the non-disposable box in/flushing isolator with hydrogen peroxide. The vial baskets are then manually placed in the preparation isolator before the vials are filled using disposable dispensing needles in the transfer area. Weighing and capping operations are performed in a sterile finishing isolator, where the vials are closed in one step prior to weighing.

 

‘Working with ATMI has allowed us to optimize our complete single-use platform for fill/finish operations and bring it to market with a secure supply chain,’ said Jean-Pascal Zambaux, President of Disposable-Lab, which is located at Technopole Bordeaux Montesquieu in Martillac.

 

ATMI initially engaged with Disposable-Lab in 2008 as a minority investor and later acquired the full rights to its fill/finish platform.

 

Covance's Asia Focus Sees Expansion in Singapore Services

Covance says anticipated future demand across the Asia Pacific region drove the latest expansion of its services in Singapore.

 

The company, which ‘cut the ribbon’ on the 29,000 sq. ft. laboratory expansion, is effectively doubling its genomics offering, as well as adding anatomic pathology and nutritional chemistry capabilities at its site in Singapore, citing current and future growth of drug development in the Asia Pacific region.

 

“For the last 13 years Covance has provided central laboratory testing services in Singapore, where we have seen increasing demand for efficient, high-quality clinical trial data and support,” said Jon Koch - Corporate Vice President and Global General Manager, Central Laboratory Services, Covance.

 

Koch added that on top of continued commitment in the region, the expansion helps to serve “local and multinational customers' R&D needs in key therapeutic areas like oncology and metabolic diseases.”

According to the company, this latest investment in Singapore makes Covance’s facility the largest of its kind on the island state and is part of an overall Asia-Pacific strategy which includes recent developments in Japan and China.

 

Last December Covance received GLP certification from China’s Food and Drug Administration (CFDA – previously known as the SFDA) at its Shanghai early-phase facility, boosting its preclinical service offering in the country, and becoming “the only global CRO with SFDA GLP certification.”

 

Covance also has a grip in the Japanese preclinical market with two sites in Japan, plus collaborations with local firms .

 

Singapore

The island state has, due to its location and national incentives, become a hive of pharma activity and a gateway into the rest of Asia.

 

Singapore has drawn much interest from global manufacturing firms, with Amgen’s recent $200m spend on a new biomanufacturing facility following the lead of Novartis and its $500m investment last November.

 

However, companies have had a mixed reaction to clinical research in Singapore in recent months. Whilst PPD expanded its lab services there in February, Pfizer announced it would shutter its clinical research unit on the island by the end of the year.

 

Pall to Open Life Sciences Center of Excellence

Pall Corp. has confirmed plans for its Life Sciences Center of Excellence at its Harbourgate site in Portsmouth, U.K. The Center of Excellence, which will open in mid-2013, will offer a full suite of capabilities including cell culture, purification, analytical solutions, protein characterization, and microbiological tools.

 

The new Portsmouth COE will include a dedicated 13,100 ft² scientific area with a connected walkway to another recently opened facility that houses an additional 6,500 ft² for life sciences technical support and training, R&D engineering, and product management. Manufacturing and test areas will remain at the current Walton Road site in Portsmouth.

 

This latest COE will complement recently announced centers in the United States (Westborough, Mass. and Menlo Park, Calif.) as well as investments previously announced in China, Singapore, and India.

 

In addition to customer service support, COE offerings will include the development, testing, and validation of a wide range of products that now form part of Pall's portfolio. There also will be a range of scale-up technology on hand for applying standards to match demands for fully representative and rapid drug development.

 

Pall Life Sciences provides products and services to meet the needs of customers discovering, developing, and producing biotech drugs, vaccines, and classic pharmaceuticals. Pall’s membranes and membrane devices optimize detection and sample preparation in the drug research, clinical diagnostics, genomics, and proteomics markets. Pall is a provider of separation systems and single-use filtration and purification technologies to pharmaceutical and biotechnology companies to support faster development of new drugs and vaccines that are safer and require less energy and water to produce. Pall technologies are also used in clinical institutions and the food and beverage industries.

 

 

McIlvaine Company

Northfield, IL 60093-2743

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

E-mail:  editor@mcilvainecompany.com

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