NantWorks, a US-based pharmaceutical company which intends to bring innovation in to healthcare by using digital technologies, announced it was to setup a new drug manufacturing plant in Vigo County, in the state of Indiana.

The plant will be built on a property which was earlier owned by pharmaceutical company Pfizer. The site is spread over approximately 210 acres at the Vigo County Industrial Park II, which is located about seven miles south of Terre Haute.

NantWorks will commence construction at the site upon obtaining manufacturing process permission from the US Food and Drug Administration (FDA).

The company expects to begin operations at the plant in 2015. The project is expected to create 234 jobs by 2016.

"NantWorks will commence construction at the site upon obtaining manufacturing process permission from the US FDA."With corporate operations based at California, NantWorks is undergoing an expansion.

California-based NantWorks was founded by Patrick Soon-Shiong. He founded two more companies prior to NantWorks, namely injectable drug company APP and biopharma company Abraxis BioScience.

The two companies were sold to fund the expansion of injectable and next generation drug manufacturing facilities.

The expansion taking place in Vigo County is a step towards achieving this objective.

APP was the only reliable supplier of heparin during a supply crisis in the US in 2008. Abraxis BioScience developed the first breast cancer drug based on protein nanoparticle technology.

Pfizer used to produce insulin products at the Terre Haute manufacturing facility. The company intended to use the plant to produce Exubera, an inhaled insulin product.

Pfizer, however, had to cease the marketing of the product in 2007. Operations at the plant were thereafter wound up gradually. The property has been lying idle since the closure.

NantWorks offered to buy the idle property in Vigo County. The sale is expected to be made for just $1, which is, however, subject to the approval of the Redevelopment Commission of the county.

The Vigo County Redevelopment Commission earlier intended to sell the property for $6.5m. The company will rebuild the entire facility at an initial estimated investment of $85.5m.

The new plant in Vigo County will produce injectable and oncological drugs targeted at patients requiring critical care. The drugs will be produced in the form of pre-filled syringes and vials.

The existing facility contains equipment required for insulin production, most of which will not be useful for NantWorks. The company will, therefore, have to install a number of new pieces of equipment.

It currently plans to construct new facilities for drug compounding, aseptic and terminally sterilized drug product filing, lyophilisation, laboratories, product development, process engineering and cleanroom operations.

Construction and financial incentives offered to NantWorks by the IEDC

Construction works on the redevelopment of the manufacturing plant will begin in 2012. The work is expected to take three years to reach its completion.

"The plant will be built on a property which was earlier owned by pharmaceutical company Pfizer."The Indiana Economic Development Corporation (IEDC) has announced several financial incentives for NantWorks to locate the plant in the state. The incentives include up to $2m in tax credits, based on the operational performance of the company. Furthermore, the IEDC will provide $100,000 in training grants.

The IEDC oversees the programs enacted by the General Assembly, related to matters such as tax credits and employee training grants.

Vigo County has also promised to consider additional property tax abatement if requested by the Terre Haute Economic Development Corporation.

The incentives will depend on the number of local jobs created by the project and the capital investment made on the project. NantWorks can claim these incentives only upon completion of the project and creation of jobs. The amount of the incentive will be proportional to the invested capital and the number of jobs created.

Buck Institute Regenerative Medicine Research Center, California

The New Regenerative Medicine Research Center in California was opened on 14 April 2012. It is a biomedical research facility which focuses on how the regeneration of human cells and tissues can be used for treating fatal diseases and conditions, such as Parkinson's, Alzheimer's, strokes and diabetes in older people. It is located in Novato in California, USA.

The Buck Institute for Research on Aging and the California Institute for Regenerative Medicine (CIRM) sponsored the facility.

The Novato facility is the third research facility of the Buck Institute. Its construction started in March 2010 and took nearly two years to reach completion.

The research facility is spread over a 488-acre campus in Novato at a three-storey building, with more than 65,708 square feet of space. It was constructed at a cost of $36.5m.

The facility has 12 laboratories and has the equipment needed for developing treatments for age-related conditions such as Parkinson's, cardiovascular problems, cancer, macular degeneration, strokes and Alzheimer's disease, by focusing the research on various stem cell technologies.

The facility is primarily engaged in researching and developing regenerative medicines, which include naturally stimulating the damaged organs, cells and tissues in the body for healing, to develop cells, organs and tissues in the laboratory and implant them in to the human body, as well as to eliminate the rejection of transplanted organs in the body.

The other medical research which is currently being conducted at the facility includes Parkinson's disease research at the Andersen laboratory, finding causes of breast cancer at the Benz laboratory, plus stem cell therapies research at the Campisi laboratory.

Research is also being conducted on replacing the brain cells lost from Huntington's disease at the Ellerby laboratory and restoring the functions of the brain following strokes at Greenberg laboratory.

The research facility broke ground in March 2010 and was constructed during three phases. In the first phase of construction, earthworks and site grading were completed. In phase II the building's structural construction was completed, while in the third phase finishing and installation works were completed.

Buckle restrained brace frames (BRBF) were used in the construction to allow the building survive during a seismic event.

Travertine limestone from Italy was used for the construction of the façade of the building. More than 250 precast foot panels with thickness of eight inches were attached to the steel.

Three major contractors and 92 subcontractors were hired for the building's construction.

The design for the building was provided by Perkins+Will architecture. Rutherford & Chekene, a structural engineering company, provided the building frame. IM Pei provided the original master plan for the Buck Institute campus.

Phase I construction was awarded to North Bay Construction. A phase II construction contract worth $17m was awarded to a joint venture consisting of Cahill Contractors and Otto Construction. Kitchell Corporation completed the core and shell work in phase II.

CSW/Stuber-Stroeh and the Miller Pacific Engineering Group provided civil engineering and design consulting services for phase II construction. The pre-construction services were provided by Ghilotti Construction.

Kitchell Corporation was the general contractor for phase III construction. Alfa Tech Cambridge provided a HVAC system design for the building.

Peterson Mechanical provided plumbing and low-flow fixtures installation. The electrical systems were provided by Northern Electric and W Bradley Electric (WBE). Alcal-Arcade supplied roofing, waterproofing, insulation and glazing. Shamrock Materials supplied concrete for foundations and decks. The heating and cooling heat pump and thermal recovery systems were provided by ClimaCool. Clark Pacific provided raw stone cutting, polishing and bonding of rocks to concrete.

The original cost of the project was projected to be $41m in 2008, but due to the effective construction methods adopted by the contractor, the actual cost of the project came down to $36.5m. It was financed by the California Institute of Regenerative Medicine (CIRM) with $20.5m, while Buck Institute contributed $16m

Jennie Smoly Caruthers Biotechnology Building Opens in Colorado

University of Colorado's Jennie Smoly Caruthers Biotechnology Building (JSCBB) was opened in April 2012. The new research and teaching facility located at the university's Boulder campus in the US has been built with an investment of $160m.

JSCBB will house 60 faculty members and nearly 500 researchers from various fields, including biology, physics, engineering, chemistry, biochemistry, computer science and medicine.

It will help in fostering innovation and discovery, to help find cures or treatments for illnesses such as cancer, inherited diseases and heart disease, along with the creation of biofuels and tissue engineering.

The bioscience industry in Colorado generates nearly $400m in taxes annually for the state. It employs about 36,000 people across more than 375 companies.

JSCBB includes four wings, which house the Department of Chemical and Biological Engineering, the Division of Biochemistry, the University of Colorado Biofrontiers Institute and the Colorado Center for Biorefining and Biofuels (C2B2).

The main areas of research focus include synthetic tissue engineering to regenerate cartilage for human joints, bioengineering of heart valves and the development of liquid membrane technology to capture carbon dioxide.

Some of the most famous scientists of the Colorado University will be working at the new facility, including Tom Cech, who won the Nobel Prize in chemistry in 1989.

The facility will enable collaboration between biotech companies and academia. Biotech companies will be able to run tests using the state-of-the-art equipment available at the facility. They will be able to understand the various biological processes and improve the design of medicines being developed.

The new building is spread over an area of 336,800 square feet and has been designed based around the concept of research neighborhoods. It consists of a 'main street' corridor, around which several clusters of offices are located. This design fosters cooperation among scientists from various disciplines.

Scientists are currently scattered across various buildings of the university. The facility also features spacious lounge areas, aimed at facilitating interaction between scientists.

The specialized temperature controlled labs are modular and can be reconfigured based on the requirements of the scientists and students. They feature high-tech equipment which can be used by scientists and researchers to carry out research in various disciplines.

The labs feature advanced genomic sequencing equipment, which can be used to conduct millions of genetic, chemical and pharmacological tests. X-ray crystallography machines to examine atoms, proteomics machines to analyze protein data and mass spectrometry equipment are also all part of the facility.

The new building has been built to meet LEED Platinum rating standards. The mechanical and electrical systems of the facility incorporate energy saving features.

The project broke ground in September 2009, with the topping out ceremony taking place in November 2010. The building required the use of 975,000 bricks and 10,000 pieces of cut limestone for its construction. The windows of the facility required 3,400 pieces of glass.

The four wings of the facility required 44 miles of piping work. The ductwork running through the building weighs about 338t. The construction phase of the facility created nearly 600 jobs.

The research facility was funded through private donations totaling about $48m. Marvin Caruthers, a professor of the chemistry and biochemistry department at the university, committed $20m towards the project. The facility has been named after his late wife Jennie Smoly Caruthers.

ConocoPhillips provided $1m to the facility and plans to provide another $2.5m in the future. The National Institutes of Health provided $15m through the American Recovery and Reinvestment Act.

Colorado University and the state also provided funds towards the construction of the facility. By 2014, the university plans to raise $75m in funds for the facility.

Robert A.M. Stern Architects and HDR Architects designed the facility. The general contractor for the facility was JE Dunn Rocky Mountain.

SGS Life Science Services Expands Services

SGS, the world's leading inspection, verification, testing and certification company announces the availability of pre-formulation and formulation development services for large and small molecules at its Life Science Services Laboratory in Lincolnshire, IL.

This service portfolio expansion encompasses liquid and lyophilized development services, as well as technology transfer to cGMP manufacturing. Some of the pre-formulation and formulation capabilities include: characterizing physico-chemical properties; improving solubility; developing stability assays; target product profiling; screening buffers, pH, surfactants and stabilizers; container-closure and pre filled syringe compatibility and selection, and ANDA product development.

This expansion of services strategically positions SGS to “rapidly and cost-effectively move a customer’s molecules from development to clinic and maintain our established level of quality control,” according to Richard Bunnell, PhD, General Manger of the Lincolnshire site. “Our services are supported by strong inhouse expertise in analytical and microbiology method development and ICH real-time and accelerated stability studies.”

SGS has recruited two formulation experts to lead the division. Dr. Leu-Fen H. Lin will manage large molecule formulation development, and brings more than 20 years of industrial experience in liquid/solid protein formulation and protein chemistry. Her colleague, Sunil Potdar, is team manager heading small molecule formulation development, drawing upon nine years experience in formulation development in sterile injectables and lyophilized products as well as sterile ophthalmic solutions and technology transfer.

With 19 laboratories offering contract analytical and bioanalytical services, SGS leverages its strong global network to deliver harmonized solutions to large pharmaceutical and biotechnology firms. In addition to testing services for the bio/pharmaceutical market, SGS also provides clinical trial management (Phase I to IV) and services encompassing clinical pharmacology studies, data management, pharmacovigilance and regulatory consultancy.

Fluidigm, Broad Institute Collaborate on Research Center

The Broad Institute, a life sciences research powerhouse, and small Fluidigm Corp. in South San Francisco will launch a research center targeting single-cell genomics.

The center will be housed at the Broad Institute in Cambridge, Ma, and feature a complete suite of Fluidigm single-cell tools and technologies. Ken Livak, Fluidigm’s only senior scientific fellow and an expert in analyzing gene expression data from single cells, will lead the center.

A spokesman for Fluidigm would not disclose the company’s investment in the new center.

“The cell is the fundamental unit of life, and through greater understanding of it, researchers can make breakthroughs in large and important fields, such as cancer diagnosis and therapy, stem cell biology, vaccine development and even the mounting battle against drug-resistant bacteria,” Fluidgm President and CEO Gajus Worthington said in a press release. “We expect this center to inspire, enable and accelerate efforts in the emerging field of single-cell research.”

Single-cell genomics is an increasingly important field, allowing researchers to better study microorganisms and identify microbes.

UWM to Build Freshwater Genomics Lab on Lake Michigan

The University of Wisconsin, Milwaukee plans to build a center near the shores of Lake Michigan that will conduct a range of research projects using genomic sequencing and bioinformatics to focus on life forms in the lake, ecology, and water-related human health concerns.

The Great Lakes Genomics Center is funded with nearly $3.3 million from UWM and from the State of Wisconsin, and a $500,000 grant from the Fund for Lake Michigan. It will have an initial operating budget of around $1 million, said Rebecca Klaper, an associate professor at UWM's School of Freshwater Sciences.

The genomics center will be housed in a new addition to the Great Lakes Wisconsin Aquatic Technology and Environmental Research Institute that will provide a total of 100,000 square feet of new space for an array of research into aquatic ecology and aquaculture. Researchers at the center will work on projects involving water quality, pollutants, pathogens, water treatment, invasive species, public health, and genetic engineering, among other areas.

Around $2 million of the center's funding will go toward setting up a sequencing lab and buying sequencing technologies, and roughly $500,000 will be spent on technologies and staff for a bioinformatics core, said Klaper.

Next-generation sequencing will enable water and aquaculture researchers to use metagenomics approaches to manage ecosystems by measuring biodiversity, monitoring water quality, and measuring the impacts of pollution, climate change, and other stressors, according to a document detailing the project.

Klaper, who will be a key faculty member at the center, said that her research focuses on "using genomic data to determine the potential impact of emerging contaminants, such as nanomaterials and pharmaceuticals on aquatic organisms," and "using genomics to link the impacts of these contaminants among aquatic organisms and humans."

She said the center is currently reviewing which sequencing platform it will use to anchor the genomics lab.

Okay Industries Expands in U.S. and Costa Rica

Responding to continued business growth and the need for increased capacity and additional capabilities, Okay Industries Inc has announced a major expansion in the United States and its entry into the Latin America market. The announcements are being made in conjunction with Okay’s 100th anniversary celebration. Okay is the successor company to B. Jahn Manufacturing Company.

The company is developing a 63,000-sq-ft medical engineering and manufacturing facility to consolidate and grow its medical components business in Berlin, CT. The new facility will complement Okay’s 100,000-sq-ft operation in New Britain, CT. According to the company, the new facility will focus on developing industry-changing innovations to speed the development and manufacture of components used in life-saving medical products.

Almac Installs Uhlmann Blister Line in New U.S. Facility

Almac has acquired a state-of-the-art, high-speed blister line for their new 100,000 sq. ft. U.S. commercial packaging facility in Audubon, PA. The versatile UPS 4 blister line from Uhlmann will process solid oral dose products, providing primary packaging into a range of materials including PVC, PVC/PVDC, Aclar and Alu/Alu.

Complete with an integrated C2206 cartoner, the line will provide a highly efficient packaging solution with an output of up to 12,000 blisters per hour - in a wide range of blister sizes. The line is capable of both multi-product blister processing and online blister printing (both flexographic and digital) addressing the need for enhanced patient compliance, whilst ensuring flexibility of supply, the company said.

For enhancing product compliance, the line will include a Total Quality Control Centre incorporating a checkweigher and integrated print and vision system for auto-rejection of incorrect print /serialization data including 2D codes.

The blister line will complement the full suite of highly flexible and state-of-the-art commercial packaging equipment already installed at the Audubon facility. Supporting high volume marketed products to niche/orphan drug launches, additional key technologies include bottling, walleting and vial labeling/packaging.

Geoff Sloan, VP manufacturing operations, explained that the partnership with Uhlmann was a natural choice: “Uhlmann was able to provide us with a versatile, high-spec blistering line to match our US client requirements for a high quality, flexible commercial packaging solution.”

Ralf Klotz, regional sales manager at Uhlmann, added “the construction and installation of this equipment proved to be a great project. We are looking forward to a long term partnership with Almac as their US Operations continues to grow. The flexibility of this equipment certainly puts Almac in a position as a leader in contract blister packaging”.

ImmunoCellular Brings Second Manufacturing Site for Cancer Vaccine Online

ImmunoCellular Therapeutics (IMUC) says that the transfer of technology from the University of Pennsylvania to a second manufacturing site is complete. Last October, IMUC entered into an arrangement with Progenitor Cell Therapy (PCT) to produce ICT-107, a dendritic cell-based vaccine targeting multiple tumor-associated antigens for glioblastoma (GBM), for IMUC’s Phase II trial.

Technology was transferred from the University of Pennsylvania to the second manufacturing site at PCT’s Mountain View, CA, facility. Qualification runs demonstrated equivalent processes and the ability to produce ICT-107 at multiple locations. This will allow for significantly increased production and will mitigate site-specific risks by spreading the manufacturing process to multiple locations, IMUC points out. It will also allow more patients to be treated each week.

PCT’s California facility may also be used to support a Phase III trial as well as the commercialization of ICT-107. “We are pleased to bring our second manufacturing site online, which will increase our ability to produce ICT-107,” says Manish Singh, Ph.D., president and CEO of IMUC. “We continue to focus on enrolling and dosing patients efficiently." IMUC has enlisted 166 patients in its ongoing Phase II study of ICT-107 in GBM. The trial expects to enroll about 200 patients in order to treat 102 patients with HLA-A1/A2 immunological subtypes.

In the Phase I study of ICT-107 in GBM, 16 newly diagnosed patients who received the vaccine in addition to standard-of-care treatment of surgery, radiation, and chemotherapy demonstrated two-year overall survival of 80% and a three-year overall survival of 55%. These figures compare favorably to the current 26% two-year overall survival and 16% three-year overall survival based on the historical standard-of-care treatment alone, IMUC points out.

The median overall survival was 38.4 months compared to the current 14.6 months for the historical standard-of-care treatment. The study achieved a median progression free survival (PFS) of 16.9 months, while the historic median PFS is 6.9 months. Six out of the 16 (37.6%) newly diagnosed patients who received ICT-107 in the Phase I trial continued to show no tumor recurrence at the last analysis, with three of these patients (18.8%) remaining disease-free for more than four years and the other three patients going more than three years disease-free.

Plumbers Union to Build Glens Falls Cleanroom Training Center

The first lot in Tech Meadows has been sold.

The latest place geared toward training people how to work in a computer chip manufacturing “cleanroom” will be built by a construction union in Glens Falls.

Local No. 773 of the United Association of Plumbers and Steamfitters will build a "cleanroom" training center and office building at the business park, recently renamed Tech Meadows Campus.

Construction bids are expected to be awarded in mid-May, and the training center will be ready for occupancy by March 2013.

The project will be financed by the 475-member plumbers and steamfitters union and Glens Falls National Bank.

The 17,500-square-foot facility will include classrooms, and a cleanroom for training.

"We plan on putting a shovel in the ground by next June, maybe as soon as April," said Larry Bulman, the union's business manager, at the Greater Glens Falls Local Development Corp. meeting.

The union signed an agreement to buy a 5-acre lot at the corner of Luzerne and Veterans roads from the LDC for $210,000.

"This is an exciting day for Glens Falls," said Mayor John "Jack" Diamond.

Proceeds from the sale will go back into the LDC fund for use as needed on future development initiatives, Diamond said.

Bulman said the facility will be a "state-of-the-art" training center, teaching skills workers need to construct buildings in a high-tech era.

"Like all businesses, the industry is changing daily," he said.

The center will have 30 welding booths, more than four times as many as at the union's current training center on Bluebird Road in South Glens Falls, which will close when the new complex opens around November 2012.

The complex will also be used for other types of employment training not offered locally now, said Glens Falls Economic Development Director Edward Bartholomew.

"This facility's going to be used for more than just the pipefitters," he said.

Glens Falls Industrial Development Agency Chairwoman Judith Calogero said the training center will be a catalyst for additional development at Tech Meadows, which has an additional seven lots for sale.

Bulman said the building is still being designed, but it is supposed to mirror the appearance of the new Tribune Media Services building on Media Drive in Queensbury, but on a smaller scale.

The office building will have a main floor with a loft above for records storage.

The training center will be one floor with a high roof that will make it appear from the outside to be a two-story building, Bulman said.

California Pacific Medical Center Gets Approval

The proposed $2.5 billion California Pacific Medical Center project cleared a major hurdle when San Francisco’s Planning Commission approved its final environmental impact report. Requested exemptions to city planning codes also passed. The center aims to build and renovate five facilities across San Francisco including a new 555-bed hospital on Cathedral Hill. The facility’s Davies campus would be renovated as a four-story neuroscience institute.

Abbott Increases Biologics Capacity

Abbott is expanding its contract bio-manufacturing capabilities. The company recently qualified and launched a manufacturing suite in Worcester, MA containing 2 x 500 L single-use bioreactors. According to the company, this additional early phase cGMP capacity capitalizes on disposable technologies to optimize production value in terms of process flexibility and efficient change over.

Abbott has also introduced a new chemically defined media, which, according to the company, has demonstrated titer improvements by as much as 30% compared to prior generation media.

Provista Opens GLP Lab

Provista Diagnostics, a provider of oncology-based diagnostic tests and clinical laboratory services, has opened a 13,611-sq.-ft. laboratory. The newly remodeled facility, located in Scottsdale, AZ will house the Provista Dx Reference Laboratory, a CLIA accredited laboratory that is also GLP compliant.

Provista develops and commercializes proprietary blood-based diagnostic tests for early oncology-related disease state recognition and detection purposes. Through the Provista Dx Reference Laboratory, the company will offer a wide range of clinical diagnostic services, in addition to contract research and biopharma testing to clients throughout the U.S. According to Provista, the new Laboratory, which is secured on a long-term lease, is both larger and superior to the site that it currently utilizes and provides a platform for further expansion of the services that can be offered. The new facility, which is both CLIA-accredited and GLP capable, is licensed in 45 states to perform human clinical testing and will offer a comprehensive menu of testing services, including custom projects.

"The move to this state-of-the-art facility clearly demonstrates the level of commitment that Provista is making to our customers and to the level of recent investments made in the company," said Dr. David Reese, President and CEO of Provista Diagnostics, Inc.

With the opening of the new facility, Provista has hired Dr. Sherri Borman, Ph.D., HCLD/CC as its Clinical Laboratory Director. Dr. Borman will be responsible for all clinical laboratory functions in the Provista Dx Reference Laboratory, including quality control, methodologies and certification. She is board certified both as a High-complexity Clinical Laboratory Director (HCLD) and a Clinical Consultant (CC) through the American Board of Bioanalysis (ABB) along with a Technical Supervisor (TS) board certification in Embryology, Andrology and Endocrinology.

Protea Opens Bioanalytical Services Facility

Protea Biosciences Group has opened a 10,000-sq.-ft. laboratory services facility in Morgantown, WV. The new laboratory features Protea's recently-acquired Synapt(R) G2-S high definition mass spectrometer from Waters Corporation, which will interface with Protea's proprietary LAESI DP-1000 Direct Ionization System to provide state-of-the-art biomolecular profiling services, according to a Protea statement.

Alessandro Baldi, Protea's vice president and general manager, remarked, "The combination of the Waters' Synapt G-2 high definition mass spectrometer and our LAESI DP-1000 provides our customers an unparalleled level of discovery opportunities. We are offering pharmaceutical companies the ability to reach new frontiers in medicine. With this new lab and our cutting edge LAESI technology, we have built the capacity to support scientists focused on a more accurate understanding of the biological mechanisms and molecules involved in disease. The addition of LAESI-based services gives us the opportunity to perform direct ionization and 2D-3D mapping of biological samples at ambient temperature and pressure, without the need for time consuming sample preparation. Using LAESI at our new facility will increase our overall biomolecular profiling throughput and empower researchers with data that was previously unimaginable."

Protea's LAESI (Laser Ablation Electrospray) technology allows for 2- and 3-dimensional distribution profiles of molecules in biological samples for unambiguous drug/target interaction studies, as well as the study of bio-dynamics directly from living cell cultures. The Synapt G2-S from Waters combines ion mobility separation with high resolution mass spectrometry for identification of unknown compounds and molecular quantitation in complex biological samples.

Protea's bioanalytical services laboratory provides biopharmaceutical companies the expertise to examine biomolecules using GLP-validated methodologies as well as innovative methods such as LAESI to accelerate the discovery process, reduce time to market, and provide more accurate and reliable information throughout the drug development process.

OSO Bio Invests In Aseptic Filling Suite

OSO BioPharmaceuticals Manufacturing LLC, Albuquerque is investing more than $5 million in equipment and infrastructural improvements that include a new Grade A aseptic filling suite for liquid, suspension and lyophilized products.

The rolling diaphragm pump-filling suite, manufactured by Bosch, comes equipped with optional rotary piston and peristaltic pumps. According to the company, it will function at 115% of the previous line’s capacity, increasing the speed and efficiency to deliver drug products to clients.

The new line has the ability to conduct non-destructive online weight tests for greater precision and yield, and its restricted access barrier system, according to the company, minimizes risk of cross-contamination and diminishes potential occupational exposure.

“This state-of-the-art filling suite represents a substantial investment in the future – the future of OsoBio, as well as the futures of the pharmaceutical clients we serve,” said Milton Boyer, president. “It allows OsoBio to manufacture drugs in a better, smarter and faster manner, while ensuring high-quality product and the safety of patients and employees alike. This is an exciting new addition to OsoBio’s facility.”

The new line produces sterile liquid, suspension and lyophilized formulations in vial sizes ranging from 2cc to 100cc. The Bosch equipment includes: an RRU 3084/44 high-performance container washing machine, an HQL 4480S drying and sterilization tunnel, an FLC 3080 filling and closing machine, a GLT 4040 tray loader, and a TRL1030 tray loader. The new filling suite is expected to be fully validated and operational by late August.

New U.S. Service for Precision Cleaning

U.S.-based MOGAS Industries Inc., Houston, TX has set up a new division, Momentum Services, that will be responsible for industrial customers requiring precision cleaning of equipment for stringent service.

It has cleanrooms that are ISO Class 7 (Class 10,000) certified and are 100% focused on precision cleaning. For example, cleaning equipment for oxygen service is an important step prior to installing into a serious application. Having impurities, especially hydrocarbons, in an oxygen-enriched system can cause unacceptable product purity issues or present a dangerous combustion hazard. It is critical to properly clean components for oxygen systems to eliminate the potential for such issues.

Sam Furman, VP of Operations said: “Unlike other cleanrooms in this region, Momentum Services will have the capability of handling heavy components with our 2, 3 and 5 ton cranes. We currently have over 3,000 ft2 of clean environment with more than 1,400 ft2 of that footprint dedicated to procedural cleaning, assembly and packaging. Also of great interest is Momentum Services’ uncommon ability to adapt to a variety of shapes and sizes from small to large and from standard shapes to unusual configurations. This includes everything from valves, piping, tubing, fittings and other industrial equipment.”

Furman added, “Our service technicians will prepare, clean and verify each component according to strict customer specifications and relevant industry standards. After each item is thoroughly cleaned, they will be bagged, labeled and fully documented.”

The ability to clean components locally will have a great impact on the delivery schedules of customers within the greater Houston area, says the company.

Promega Growing

Bill Linton, chairman and chief executive of Promega Corp., has guided the Fitchburg company he founded in 1978 to become a force in the global biotechnology industry and a hub for the Madison area’s biotech cluster.

If you scratch the surface of many of the biotechnology companies in the Madison area, chances are you will find some connection with Promega Corp. — scientists who cut their teeth there and went on to found or lead other biotechs in the market.

For more than 30 years, Promega, led by founder and chief executive Bill Linton, has grown and flourished in the fields of Fitchburg, nurturing biotech studies, encouraging worldwide discussion of biotech ethics issues and serving as a training ground for future biotech leaders as its own business has developed worldwide.

Selling 2,500 products used by scientists, researchers and life science and pharmaceutical companies, Promega has 1,200 employees, including nearly 700 here, and topped $300 million in sales in 2011. One of its machines, the Maxwell 16 purification machine used for forensic analysis, has been on network TV, on the CBS program "CSI: Miami."

Now, Promega is expanding, embarking on one of the biggest construction projects in the Madison area this year. The $120 million project will add a manufacturing building at the Fitchburg campus that will open Promega to a new tier of potential business and add as many as 150 local jobs over the next three to five years.

Burgess was one of the first investors and remains a shareholder in Promega, which was first incorporated as Biotec Corp. The name was changed as the word biotech was becoming more generic.

"Promega began operations at a very prodigious time, at the dawn of the biotechnology industry," said Ralph Kauten, chairman and CEO of Quintessence Biosciences, who held various finance and administrative positions at Promega from 1979 to 1992. The focus of biotechnology research then was on DNA, deoxyribonucleic acid, as the key to genetic instructions and finding ways to manipulate DNA.

"The company recognized that tools used by DNA researchers were not readily available and because of this, researchers were required to produce the tools needed to conduct the research. It would be similar to observing the site of home construction and seeing carpenters produce their own nails," Kauten said.

So, Promega determined to make those tools available, rapidly and at a reasonable price, Kauten said.

That has remained its strength. "Nothing we make is used in any form of treatment or diagnostic outcome. But we make components, some key ingredients, for the biotech industry," Linton said.

The company is known for its DNA fingerprinting technology, discovered by a British scientist, licensed from University of Utah research, and further developed by Promega. The Fitchburg company is one of two main U.S. providers of kits that identify a person's genetic fingerprint, used, for example, to help identify victims of the Sept. 11, 2001, World Trade Center attacks.

Its DNA products also check for pathogens in food and water.

Another specialty of Promega's stems from bioluminescence, the ability of fireflies to light up. Promega learned how to modify molecules to produce light with different wave lengths and intensities, used by scientists as markers to see how a cell changes in response to various interactions.

"Nature taught us how to start," said the 64-year-old Linton. "Nature is our greatest teacher."

Promega already has several buildings along Woods Hollow Road and East Cheryl Parkway, including its research and development building; the prairie-style Agora, with offices and retreat space; and the BioPharmaceutical Technology Center, which houses manufacturing, conferences and an art gallery.

The new building, scheduled for completion in June 2013, will be two stories with a penthouse to house utilities. It will provide 260,000 square feet of space, with 210,000 square feet of that for manufacturing and the rest for conference rooms, a cafeteria and workout space.

"It's going to help us move further into the diagnostics market," said Jennifer Romanin, director of invitro diagnostics operations, who is overseeing the project.

It will provide room for a second bottling line for Promega's products and it will meet U.S. Food and Drug Administration requirements for cleanrooms, packaging and training, Linton said.

In many cases, it will make the same products that Promega currently manufactures but under more stringent guidelines required by the company's customers for products they have to submit for the FDA's approval, he said.

The company could have put the new building in San Luis Obispo or Sunnyvale, Calif., or in Shanghai, China, which already house some of Promega's manufacturing operations. Instead, it chose Fitchburg.

"China offers big incentives," said Linton. In fact, the company recently bought a second building in Shanghai and plans to double employment there to 100 within three years.

"But there is so much personal expertise in the Madison area. We love the Madison area," he said.

A big part of Promega's success, Linton and others say, is its staff.

"You have to have good people with good ideas. It's really about building staff — bringing in really talented people who share the vision," Linton said.

"Over the years, Promega has gotten some really excellent people," Burgess agreed. "I do think it's been a major training ground for many people who have gone on to either start companies or hold high positions in other companies."

Attention to detail has been another of Promega's strengths, Kauten said, including making sure its products are high quality and customers receive clear instructions on how to use them.

"Providing support for use of Promega products has always been a hallmark of the business model," Kauten said.

Linton also has made it a comfortable work environment for employees, said Tom Still, president of the Wisconsin Technology Council.

Promega was one of the first local tech companies to have its own day care center — it helps subsidize the Woods Hollow Children's Center — and offers a cafeteria and yoga space. "It's not just the folks out in Mountain View, Calif." who do that, said Still, referring to Google.

Linton is "an entrepreneur who's just really made it work," Still said.

IPharma Services Opens New Technology Center

AAIPharma Services Corp. has opened a 40,000-sq.-ft. Technology Center on its Wilmington, NC campus as part of a $15 million expansion program. The center provides for additional growth and the company plans to add scientific, technical and manufacturing jobs.

“We’ve designed this world-class Technology Center as an adaptable laboratory concept that gives us the flexibility to meet our clients’ increasingly diverse needs,” said Patrick Walsh, chief executive officer of AAIPharma. “We remain committed to investing in our employees, infrastructure and our region as we project continued and sustainable business growth.”

The Technology Center has flexible workstations to accommodate changing requirements for developing and testing pharmaceutical and biopharmaceutical products. The center houses analytical, microbiology, preformulation and mass spectrometry experts, as well as new UPLC, HPLC, GC-MS, and LC-MS-MS systems. According to the company, project documentation will become virtually paperless with the rollout of an electronic laboratory notebook system, maximizing internal analytical processes and providing clients with real-time accessibility to their project deliverables.

The company expects all Wilmington lab operations to be consolidated into the new location by June and also plans to expand its manufacturing centers in Charleston, SC, and Wilmington, NC.

AAIPharma Services Corp. is a leading provider of contract services that encompass the entire process of pharmaceutical drug development from discovery through commercialization. The company’s wide array of capabilities includes analytical chemistry, formulation development,

material testing services, microbiology, and clinical and commercial contract manufacturing and packaging. AAIPharma Services serves more than 500 clients around the globe. It is headquartered in Wilmington, N.C. For more information on the company, visit www.aaipharma.com.

3M Expands Manufacturing Capability

3M Drug Delivery Systems announces the expansion of the pressurized metered dose inhaler (pMDI) fill line at its facility in Northridge, Calif., significantly extending the company’s manufacturing capability. The addition of the pressure fill line complements the existing state-of-the-art cold fill line in the facility and enhances 3M Drug Delivery Systems’ inhalation manufacturing services for customers. With the expansion, 3M Northridge can manufacture new and marketed pressure filled pMDI products for its customers on a global scale, solidifying 3M Drug Delivery Systems’ “start-to-finish” reputation as a single-source provider for the development and commercialization of the pMDI. Additionally, the company has established a Qualified Person (QP) release route to Europe.

“This expansion reflects our continued growth,” said Louise Righton, global divisional marketing manager for 3M Drug Delivery Systems. “Customers are responding enthusiastically to our manufacturing expertise, which capitalizes on Lean Six Sigma methodology to drive efficiency.”

Since creating the first metered dose inhaler 50 years ago, 3M Drug Delivery Systems has continued to lead in the development of new technologies and manufacturing services for inhaled drug delivery. 3M Drug Delivery Systems currently has four strategically located pMDI filling sites and the company has experience manufacturing products for distribution in more than 60 countries worldwide.

In the early stages of product development, 3M Drug Delivery Systems offers formulation screening and optimization for both solutions and suspensions, including particle engineering to improve dosing performance. The company also offers an array of pMDI components such as valves and canisters that can be customized to fit customers’ needs, as well as actuators and dose counters, which improve the patient experience.

Fort Bliss Plans Cutting-Edge Hospital

Few hospital designs are subjected to the rigors of wind-tunnel testing. And none create all the power they need from heat produced deep inside the Earth.

Those unique features are expected to make the new Beaumont Army Medical Center a place that soothes the senses, officials said -- promoting healing on an instinctual level and creating minimal environmental impact.

The $966-million complex, with four central buildings, is being designed and built from scratch and will promote cutting-edge health-care delivery after its scheduled 2016 opening, said Col. Dennis D. Doyle, Beaumont's commander.

"This is the single largest federally funded facility in El Paso's history that will capstone Fort Bliss' unprecedented expansion," said U.S. Rep. Silvestre Reyes, D-Texas, who worked to get funding for the project. "This new Army medical center will provide Fort Bliss soldiers and their family members with the finest facilities in the nation for medical care."

Construction of roads, water, electrical and sewer systems will soon begin on a 272-acre site located on the southwest corner of Loop 375 and Spur 601. The new 1.13 million-square-foot hospital on East Fort Bliss will offer medical services similar to those offered at the current hospital, Beaumont Army Medical Center, which opened its doors in 1972.

This hospital promises to be unlike any other on the planet.

It will meet or exceed emerging requirements for a state-of-the-art medical facility such as computer and equipment connections supporting an enormous data flow, and operating rooms with screens, hanging from wall-mounted arms, that allow viewing of all types of information.

Nursing stations will be "decentralized," placed in room clusters that allow quick and personalized responses. Medical staff will have computer access to electronic records at each of those stations, eliminating the need to run around the hospital looking for paper files. They also will be able to watch patients' vital signs on monitors.

Designing from scratch allows departments to be located close to others that interact regularly, such as the trauma unit and radiology, where X-rays are produced, said Maj.

Patient rooms will have remotes that allow temperature and lighting adjustments and control of a monitor that can be used to order meals or conduct teleconferences with physicians or family members. Family areas will have seating that converts to beds and space for some measure of privacy.

"Having your family with you, the evidence suggests, you get better faster," Evans said.

Other design elements will minimize the chances of injury through falls and other accidents, said Maj. Bryan J. Walrath, Southwest region program manager for the Army's Health Facility Planning Agency. Some rooms will be equipped with lifts that ease patients out of bed without straining the staff.

But as patients and family members walk the naturally lit halls, easily finding rooms and garden areas where they can talk in peaceful surroundings, they likely will not be aware of the attention to detail that made it possible.

"Daylight and views of nature help people heal faster," Evans said.

Plentiful windows allow people to locate themselves using outside landmarks such as the Franklin Mountains, instead of wandering through a maze lit by fluorescent tubes.

Wind tunnel tests not only ensure windows will survive El Paso's blasting spring winds, they also ensure hospital entrances are designed to protect people.

The windows will be double- and triple-paned and coated to reflect the sun's heat in the summer but allow penetration in the winter. Alignment of the building will ensure maximum solar heating in the winter. Walls created from hollow bricks will insulate the complex, decreasing the need for air conditioning in summer and heating in winter.

By using those conservation measures, energy demands are minimized, Evans said.

That means a geothermal power plant will have less work to do.

In December, a contractor will drill a 5,500-foot-deep test well to see if the temperature difference is large enough to generate electricity. At the least, geothermal energy can be used to heat the plant, Evans said.

The hospital also will include a water reclamation plant that will clean waste water for irrigation and other non-drinking uses.

With all its advances, the new medical center will be the hub of a new concept for delivering medical care, Doyle said.

All primary care, where doctors and patients make first contact, will be at satellite clinics located in areas where large numbers of soldiers live and work. Beaumont will provide specialized care through referrals from the clinics.

Fort Bliss has added a warrior transition complex for wounded soldiers on the main post. A soldier and family care clinic and a dental clinic were built on Biggs Army Airfield. Other clinics located next to brigade combat team complexes provide convenient access to medical care.

In his "State of the Military" address earlier this month, post commander Maj. Gen. Dana J.H. Pittard said a new community-based clinic will open next year in Northeast El Paso to serve the military population in that area.

"But I won't be satisfied until we have one in the Northeast, the East and West," Pittard said. "And that's so soldiers and their families won't have to come to our post, so they can be in their own communities where they're living, because 70 percent of our families live in El Paso."

The entire venture will mesh with El Paso's grand vision of a Medical Center of the Americas, Evans said. A 50-year plan for the medical center includes local hospitals, universities and Beaumont. It would allow for everything from basic research to production and distribution of new medical devices and drugs.

"Our role is not to compete with private industry," Evans said.

In fact, the post still will rely on El Paso's medical specialists in certain cases, Doyle said, including mental-health and obstetrics and gynecology services.

"We expect that the baby biz will increase and there's an increased capacity at the new Beaumont," Doyle said.

But births tend to spike after soldiers return from deployments, Doyle said, and it is not practical to keep additional physicians on staff who are needed only occasionally.

Nonetheless, Pittard spent a significant part of his speech discussing the medical advances at Fort Bliss, including the fact that two of the clinics are the largest of their kind in the Army.

"I don't want to be bragging, but there's a saying in Texas, 'It ain't bragging if it's true,' " Pittard said.

The new Beaumont will be a $966-million complex. The 272-acre site is on the southwest corner of Loop 375 and Spur 601. It will have four central buildings and will be 1.13 million square feet.

Genzyme Northborough Operations Center

The new Northborough, Massachusetts operations center for Genzyme, which is one of the world's leading biotechnology companies, is in a totally remodeled 211,000-square-foot building. Upon completion, the facility will have offices, a laboratory, and a cGMP warehouse space for shipping and receiving, quality control, cold and high-bay racking storage and packaging operations aimed at achieving LEED certification.

This new facility promises to be a showpiece for several of HTS New England's premier manufacturers. It features a 1,500 TON Epsilon factory-packaged chilled-water plant and three 39,000 CFM Haakon custom air-handling units. The units have energy-efficient Seibu Giken heat wheels, AcoustiFLO energy-efficient & low-sound fan arrays and Plasticair high plume dilution exhaust nozzles. The majority of the work needed in the new building was HVAC work.

Genzyme has operations in Cambridge, Boston, Waltham, Framingham and Westborough, and the company has said it will move 165 employees to the Northborough location upon completion, with room to add 35 jobs in the future.

GCMI Opens Medical Device Prototyping and Development Facility

The Global Center for Medical Innovation (GCMI) officially opened its doors on April 18, 2012, attracting a large crowd eager to see the Southeast's first comprehensive medical device innovation center.

"GCMI has built and equipped a prototyping design and development facility that will accelerate the commercialization of next-generation medical devices and technology," said GCMI's Executive Director, H. Wayne Hodges. "The Center has the equipment, cleanroom facilities, engineering expertise and partner network needed to help bring ideas from concept to market."

GCMI General Manager Doug Schumer, Ph.D. praised GCMI's role in accelerating medical device commercialization, adding, "To me, the greatest thing GCMI will do is to help bring to life devices that otherwise might never see the light of day. There are many doctors out there with good ideas, but who don't know how to bring that idea to commercial fruition. GCMI will be able to help."

The center brings together core members of the medical device community, including universities, research centers, clinicians, established device and drug companies, investors, and early-stage companies, with the goal of accelerating the commercialization of innovative medical technology.

The Global Center for Medical Innovation (GCMI) is an independent, not-for-profit, full-service product development organization -- the first and only one of its kind in the Southeast. The center helps new-product teams enhance their product development, shorten time to market, and achieve significant cost savings throughout the process. GCMI was one of six winners of a national i6 Challenge focused on driving commercialization and innovation in the U.S. in an effort to move great ideas from the lab to the patient, creating jobs and economic growth. Founding partners are the Georgia Institute of Technology, Georgia Research Alliance, Piedmont Healthcare and Saint Joseph's Translational Research Institute.

USF Plans Heart Research Center with Genomics Focus

The University of South Florida has reeled in $8.9 million in new state and local support to fund the creation of the USF Heart Health Institute, a center that will focus on using genomics and personalized medicine approaches in cardiovascular care.

USF said that Governor Rick Scott has approved $6.9 million in state funding for the initial design of the new institute, and the Hillsborough County Commission has approved $2 million for equipment and space for the facility.

The institute will pursue research seeking to identify people with the highest risk for heart disease, to improve how individual genetics can help guide treatments and dosage, and to develop new therapeutics based on genetics.

"We can put into place the current known genetic signatures, and discover those that are desperately needed, with the formation of this institute at USF Health," Steve Liggett, who will take over the post of vice dean for personalized medicine at USF in June, said in a statement. "This places the State of Florida, and the Tampa Bay Area, as a leader, and not a follower, in the most advanced health care and research in the world."

"We believe that the technology developed here will herald a new day and that USF Health will be able to partner with the best industry and academic partners throughout the world to develop these new personalized and genetic approaches to health," added Stephen K. Klasko, CEO of USF Health and dean of the school's Morsani College of Medicine.

USF Health said that it has now committed a total of $25 million for genomics and personalized medicine, including the purchase of research equipment and the recruitment of Liggett and Leslie Miller as chair of the department of cardiovascular sciences.

USF also said the Heart Health Institute will partner with the American College of Cardiology in a trial that will link a genomic screening test with a clinical database of millions of patients who have cardiovascular disease, and that the ACC has named USF's Health Center for Advanced Medical Learning and Simulation a Center of Excellence in Education and Training.

Another Heart Health Institute partner will include the Florida Pepin Heart Institute at Florida Hospital Tampa, which will collaborate with the institute on research and clinical trials, USF said.

Baxter International to Open Manufacturing Facility

Georgia Governor Nathan Deal announced that Baxter International will locate a new bio-pharmaceutical manufacturing facility near Atlanta as well as plasma centers throughout Georgia that will employ approximately 1,500 people across the state with the potential for hundreds more.

Total investment by the company will exceed $1 billion.

“Baxter’s decision to come to Georgia marks a new era in the growth of our biosciences industry and will have far-reaching impact on our economy,” said Governor Deal. “We are honored to welcome this flagship company to Georgia and proud that our state’s vast resources for the biomedical field will assist the company with the groundbreaking medical advances it is renowned for. Baxter’s commitment to Georgia moves us closer to making Georgia the No. 1 state in which to do business.”

Baxter International will invest more than US$1bn over the next five years to build a new state-of-the-art manufacturing facility in Covington, Georgia, US.

The move is expected to create more than 1,500 jobs to support growth of Baxter’s plasma-based treatments, which include medicines for immune disorders, trauma and other critical conditions.

Construction will begin this year at the new site, which will include operations supporting plasma fractionation, purification, fill-finish and a testing lab.

Commercial production is scheduled to begin in 2018, with the new plasma fractionation facility adding up to three million liters of new capacity annually when fully operational.

The site will also have room to expand to support additional global demand.

In connection with this investment, the company also expects to create more than 200 new positions in Illinois, including jobs associated with expanded filling and finishing capacity at its manufacturing facility in Round Lake, to support production of Flexbumin, a preparation of plasma-based albumin treatment in a flexible container.

LGC Genomics Launches New US Genomics Services Lab

LGC Genomics has launched its new US genomics services lab in Beverly, Mass. The London-based firm provides services including genotyping, DNA extraction, and Sanger and next-generation sequencing.

New Lab Speeds Plant Research

A new laboratory at Washington State University will help breeders more quickly pick out key traits in plants.

The $250,000 phenomics lab measures different attributes of a plant, such as height, chlorophyll in its leaves, how fast the leaves grow and how efficient photosynthesis is or how it changes with light fluctuations, said Michael Kahn, associate director of the WSU Agricultural Research Center. A camera takes photographs that allow researchers to see how plants develop.

The goal is to help breeders screen plants for a superior combination of traits that may be more difficult to find, such as disease resistance.

Some traits can be followed with genetic markers, but genetic screening is expensive and difficult, Kahn said. He hopes to reduce the amount of screening required and save years in the breeding process.

Kahn said research efforts include yield, pest and disease tolerance and crop timing.

Breeders will be able to immediately remove those plants that don't have the desired performance after a genetic cross, said Michael Neff, WSU assistant professor.

Neff said the facility is able to change temperature and growth conditions to anticipate changes in weather patterns.

WSU researchers hope to follow a plant through its life cycle.

"A plant at 10 a.m. is not the same as a plant at 2 p.m.," Kahn said. "We think some of those things that might be able to improve yield would have to do with the differences between a plant at 10 in the morning and 2 in the afternoon."

The lab is primarily working with arabidopsis and camelina right now, and expects to begin looking at grasses and other crops, including wheat, in the next few months.

A USDA grant supports the facility, but will run out in 2013. Kahn hopes to bring in additional funding to operate it.

Australian researchers have used phenomics to develop wheat cultivars with salt tolerance.

Purdue Drug Discovery Lab to Open in 2014

Purdue Univ. will take another step forward as a leader in pharmaceutical development efforts with construction of the new Drug Discovery Building.

The $25 million facility, which is scheduled to open in 2014, was celebrated during an event in the university's Stewart Center.

"Purdue research has been at the forefront of drug discovery, and this building is another step in assuring that we attract top scientists to further our efforts in finding solutions to real-world problems," says Purdue President France Córdova. "Purdue is committed to becoming one of the top destinations for drug discovery."

The Drug Discovery Building will be located in the Purdue Life and Health Sciences Park, located near Harrison and Univ. streets. The new facility will be west of the Agricultural and Biological Engineering Building, with construction scheduled to begin this summer.

"The fact that we will have a building devoted specifically to this scientific endeavor demonstrates that the university is very serious about becoming a pre-eminent site for the discovery and development of new drugs," says Philip Low.

"Our intention is to draw the attention of the world to not only the current quality of research in this field that is taking place at Purdue, but also to our future potential as we expand and enhance our strength in the area."

The facility will partially replace space in the Wetherill Laboratory of Chemistry, where a group led by Low has developed novel treatments for cancer and inflammatory diseases.

"We have carefully considered the construction of the building in every detail and have designed it to be very flexible so that it can accommodate multiple research focuses and areas," Low says, adding that the lab space will be conducive to seamless altering. "The new building will be very open inside with continuous space that will extend from one lab into the next. We believe this not only allows for maximum versatility, but it also will promote collaborations more easily and enable sharing of equipment and resources."

The lab design will allow undergraduate and graduate students to observe experiments from outside through glass barriers.

"They'll be able to watch some of the more senior researchers perform experiments without having to knock on a door," Low says.

Purdue researchers that will move into the new facility have not yet been identified, but are expected to originate from myriad disciplines.

"The anticipation is that they will come from multiple schools, multiple departments and multiple buildings," Low says. "There is existing strength at the university in cancer research that is facilitated strongly by the success of the Purdue Center for Cancer Research. I think there may be a focus on this area, but the Drug Discovery Building won't be exclusively committed to that disease."

Purdue will soon commence a search for two researchers in the area of drug discovery to work at the new facility.

"We will go out and find two of the top stars in the country, or even the world, to join us here," Low says. "At the present, we're not restricting ourselves to any field of interest or disease focus. We simply want scientists who are interested in designing and making new drugs, and also in translating these discoveries into the clinic. We also feel we need to include in our mission statement the desire not only to discover new medicines, but also to assure that they benefit the people we serve."

Purdue will combine up to $5 million in funds from gifts and facility and administrative cost recovery with $20 million in bond proceeds to pay for the project.

"It's a very exciting opportunity for the university, and I believe it's going to greatly enhance the ability of the faculty interested in drug discovery to achieve their goals. I think because of this you'll see new spin-off companies develop in the community," Low says. "You'll also see a lot of other outside researchers visit here. This will be a place where researchers will want to come to learn how to do drug discovery."

As part of the event, the university also celebrated plans for Lyles-Porter Hall, a new facility to house Purdue's nationally ranked Department of Speech, Language and Hearing Sciences and medical and health programs that provide students a variety of learning and clinical experiences.

Two New High-Precision Measurement Labs Open

Two new advanced laboratory buildings for high-precision science and measurements have officially opened in Boulder, Colo., providing upgraded facilities to support technology innovation and economic growth as well as the training of future scientists.

Federal, state and local government officials, university leaders, and Nobel laureates were among those attending the April 13, 2012, dedication ceremonies and tours at the new Precision Measurement Laboratory (PML) on the National Institute of Standards and Technology (NIST) campus in Boulder and at the new X-Wing at JILA, a joint venture of NIST and the Univ. of Colorado (CU) Boulder. JILA is located on the CU-Boulder campus.

Both new laboratories tightly control environmental conditions such as vibration and temperature, as is required for cutting-edge research with lasers, atomic clocks, nanotechnology and other areas of study at NIST and JILA. Both new buildings also have capabilities for micro- and nanofabrication of custom research devices. The original NIST-Boulder and JILA laboratories were built in the 1950s and 1960s.

Under Secretary of Commerce for Standards and Technology and NIST Director Patrick Gallagher cut the ribbon to officially open the PML, which will house some of NIST's best-known experiments and technologies, including NIST-F1, the U.S. civilian standard atomic clock.

"This laboratory is at the heart of making sure that NIST Boulder has the capabilities it needs to carry out its critical mission," Gallagher says. "The work that's done here is central to the role of NIST. The work done here on atomic clocks, on voltage standards, on quantum computing, on detectors—this is the essence of NIST's role to define and implement a system of measurement to the benefit of the United States. And it's a mission that is as fresh today as it was in 1901 when this agency was first founded. So I think our best is still to come, and it's exciting to know we'll have a home like this in which to do it."

Stella Fiotes, NIST's chief facilities management officer, noted that planning, design and construction of the PML required six years of sustained leadership and collaboration to ensure completion on time, within the budget, and with a strong safety record. "This beautiful facility provides a dramatic improvement over the existing facilities located on the NIST-Boulder campus," Fiotes says.

At the JILA ceremony on the CU-Boulder campus, Gallagher says the new X-Wing will deepen and refresh NIST's productive partnership with the university. He noted that JILA supports NIST efforts to promote technology transfer by generating new measurement tools and training young innovators who go on to advance measurement science, found high-tech companies and win Nobel prizes.

"JILA started out, frankly, as a unique experiment 50 years ago, a pioneering partnership bringing together federal scientists and university researchers within the same organization," Gallagher says. "It's been an experiment that has had remarkable success, beyond even the original vision of the founders. It's been so successful, in fact, it has served as a model for all other successful university/government partnerships, not just at NIST, but also at a number of other agencies and universities."

JILA/NIST Fellow and Nobel laureate Eric Cornell, who served as master of ceremonies for the X-Wing dedication, noted that JILA had outgrown its original building. "JILA was a victim of its own success. We really needed to expand, we really needed to modernize, we really needed the X-Wing," Cornell says.

New Biotech Building Dedicated at University of Utah

The University of Utah has been recognized for its research and business innovation; now a new high-tech facility could help further that reputation and bring with it financial rewards as well.

Leaders from the Utah Science Technology and Research Initiative will dedicate the James L. Sorenson Molecular Biotechnology Building— a $130 million, 208,000-square-foot research facility where scientists, physicians and engineers will collaborate to create new advances in the biotech field.

"The technology that is developed here is going to be a multidisciplinary … cross-pollination of ideas," said Dinesh Patel, chairman of the USTAR Governing Authority. Located midway between the engineering and medical areas of campus, the new research building will facilitate increased interaction among faculty and student researchers, Patel said.

Eventually, the plan is to have two to three additional buildings complement and expand the university's biotech center, he added.

Financial support for the facility came from $100 million in state bonding and the balance from private donations, including $15 million from the Sorenson Legacy Foundation and $1.25 million from Micron Technology. Construction of the project began in April 2009 and was completed in December 2011. Tenants started moving in last month.

Nanofabrication is the design and manufacture of devices with dimensions measured in nanometers. One nanometer is a millionth of a millimeter — less than the diameter of a human hair. The process is of interest to computer engineers because it could open the door to super-high-density microprocessors and memory chips that could one day store a data bit in a single atom.

Since its inception in 2007, USTAR has helped produce more than 300 invention disclosures and patent filings, along with 44 startup companies or industry partnerships, according to a program statement.

USTAR collaborates with the University of Utah and Utah State University to create world-class research teams in strategic innovation development areas. Highly regarded faculty members, supported by teams of top researchers, lead the teams.

The infrastructure and multidisciplinary nature of the building here and at the counterpart facility at Utah State University allow our research universities to go after bigger research grants, Patel said.

"To successfully win big federal and industry grants takes more complex, collaborative teams of researchers," he said. "The physical and intellectual infrastructure this building represents has already helped the U. of U. win a $20 million advanced materials grant."

The new facility houses the Brain Institute, Nano Institute of Utah, and Department of Bioengineering, according to USTAR spokeman Michael O'Malley.

Thus far, the USTAR program has recruited 32 principle researchers to Utah from such prestigious institutions as Harvard, MIT and UCLA. As of Dec. 2011, the researchers have generated nearly $80 million in grants since 2007, with more than $81 million in research proposals pending, Patel said.

In that time, University of Utah USTAR researchers have generated more than 140 invention disclosures and patent filings, O'Malley said.

"This represents a reservoir of intellectual property and future breakthroughs in health care, engineering, energy and more," he said.

To date, U. researchers have launched or relocated 10 companies, and 10 more commercialization projects are underway. Among the projects currently under investigation is the development of reliable testing to detect pancreatic cancer.

Nano Institute director Marc Porter said his group is working to create the next generation of diagnostic tests using nano technology.

"The kinds of things that we do and people we're talking to are companies that can build kits for these different kinds of diagnostic tests … (creating) the basis for forming new companies or licensing technology," he said.

Eventually, the growth of the new Utah-based companies will result in payment of royalties to USTAR and the university, Patel said, which will help sustain the USTAR program for years to come.

Demolition of BioTech 3 Building to Make Way for Health Diagnostic Laboratory

Lingerfelt Development, headquartered in Richmond, Virginia announces demolition has begun on the BioTech 3 building within the 34-acre Virginia BioTechnology Research Park in downtown Richmond to make way for Phase I and Phase II construction of the BioTech 8 building. Once completed, this three-building headquarters complex for Health Diagnostic Laboratory, Inc. (HDL, Inc.) will total 300,000 square feet and be valued at $100 million.

This facility is an expansion project for HDL, Inc., a fast-growing CLIA-certified and CAP accredited clinical laboratory that is adding hundreds of jobs in downtown Richmond.

Phase I encompasses a six-story, 112,000 square-foot wet lab biotechnology building including a two-story parking deck expansion. The parking facilities will be connected by a two-story, fully built-out lab that bridges HDL, Inc.'s existing building and the new Phase I building, scheduled for completion December 2012. In 2013, Phase II will add an additional six-story, 112,000 square-foot tower. Upon completion, both of the six-story towers and HDL, Inc.'s existing building will total 300,000 square feet with a four-story, 485-space parking deck.

Principal Ryan Lingerfelt states, "We are pleased to assist HDL. Inc. with their expansion needs. The timing is right in this development cycle to maximize opportunities of growth markets in the health care sector and also Class A office buildings."

Lingerfelt is no stranger to health-related developments in Virginia having recently completed OthoVirginia building, a $25 million, 70,000 square foot medical facility for West End Orthopaedic Clinic and HCA Virginia's CJW Medical Center; the VCHA & CCNV Healthcare Office Building Headquarters near Innsbrook Corporate Center, a two-story, 25,268 square-foot building; and the 100,000 square foot Bon Secours Heart Institute.

Merck Accelerating Production

Merck was facing a new dilemma: How would they produce much-needed vaccines for both shingles and chicken pox with their current, limited production capacity? They quickly realized that, for the benefit of customers and citizens, they would need to increase their Varicella production capabilities.

Once they realized that production needed to be accelerated, they were immediately faced with other impasses. Mainly, how would they increase their production capacity quickly enough? Within four years, patients were going to require more than double the current Varicella output. In order to meet demand, Merck decided that they would need to design, build and license a facility in less than four years — a feat that, according to the Monte Carlo analysis conducted by Independent Project Analysis (IPA) Inc., had a less than three-percent chance of success, considering its size and schedule.

How did Merck accomplish their ambitious goals? According to Merck’s Brian Morrissey, the plan ran smoothly partly because “the stakeholders, Merck, Jacobs, and the major subcontractors EAS and AdvanceTec worked as peers, as a true team.” Due to this teamwork, “the steep learning curve was handled very well.” He explains that coordinating meetings so that “all parties were in the same location was critical, as was the location of AE/CM and owner in the same office space” throughout the construction process.

Thanks to Merck’s teamwork, innovation and planning, they have been awarded the Facility of the Year Award for Facility Integration for their Vaccine Bulk Manufacturing Facility (VBF) Program of Projects, which is located in Durham, North Carolina.

Merck knew that they would need to speed up the construction process in order to reach their goals. To do this, they utilized a novel concept: To increase the speed of construction, Merck “decoupled” the interior from the exterior, therefore allowing construction to be completed on both the inside and outside, simultaneously.

“This was a not a new concept for Merck,” explains Morrissey. “It was the second time a project was executed using this approach by the Jacobs/Merck team. It was [also] not a novel concept in the industry, but never used at this scale.” Merck took a chance by using the concept at such a large scale, but the gamble definitely paid off, allowing them to save a great deal of time during construction.

The plan involved a substantial amount of overlap. Processes that would usually be carried out in succession, such as basis of design (BOD) and detailed design, were instead carried out in unison at the Merck facility. This strategy saved many hours of labor, leading to an accelerated construction timeline.

Merck’s success was not achieved alone. They organized all of the project’s contributors — Merck, Jacobs, subcontractors and vendors — into an integrated partnership, titled “One Team” jointly led by Merck’s Global Engineering Group and Jacobs’ EPCM team. They credit a great deal of their fast-track success to their integrated-team strategy.

“We relied on input from our major suppliers and subcontractors,” says Morrissey. "We asked them to sometimes work outside of their standard practice, providing partial information to allow parts of the project to proceed, before they had finalized their design. Leveraging their industry and current market knowledge played a major part in the success of the project.” Merck was able to include everyone: the owners, engineers, contractors and vendors, to create a single, integrated project team. Integration was accomplished despite the 50 equipment suppliers and 46 subcontractors that were executing the project.

Because of the strict time constraints, scheduling and coordination complexities, LEAN project delivery was used. The team also optimized the Continuous Quality Verification (CQV) approach. They formed several high-energy, high-impact teams for each of the main areas or production suites of the facility. These “suite teams” were made up of representatives from Technical Operations and Production, and involved support from Maintenance, Quality, Process Engineering, Automation, Validation and/or Commissioning and Construction. Daily tier meetings helped the team stay on track and follow the project’s process.

“I’m the most proud of the fact that we stayed together as a team throughout the challenges of the project,” says Morrissey. “We would have never met the budget or schedule if the “team” devolved into traditional client/CM/subcontract roles. The key personnel from Merck, Jacobs, and major subcontractors were with the project from detailed design until project completion.”

The team was able to cut the industry benchmark schedule down by 40 percent, accomplishing their goals in 24 months from charter to operational qualification for the $315-million, 214,000-square-foot facility.

This was achieved despite the hurdle of losing over one month of work days due to a wet North Carolina winter season, since decoupling the activities made it possible for progress to continue at the off-site fabricators. In fact, one-third of the craft hours were moved off-site. The combined benefits of this original hybrid modular approach cut five months off of the schedule and helped save $43 million in project and business spending.

The project’s success and unique construction approach has made a great impression on the pharmaceutical community. “We have had several tours through the facility with pharmaceutical companies and other industrial companies,” Morrissey says. “We have also conducted two tours through the facility with local ISPE members, and NC State Graduate Class in Construction Management.”

Merck’s vaccine manufacturing facility was constructed to fill an urgent need, but it was not constructed hastily. Through detailed planning, a unique manufacturing approach and expert collaboration, Merck created a facility that is as novel as it is necessary. The world-class facility will provide preventative vaccinations to millions of patients.

Morrissey sums up the reasons why Merck was awarded their FOYA recognition: “The team was recognized for safety, speed of design, speed of construction and speed of delivery for a functioning facility. It has set new benchmarks for project realization for our company and the industry at large. These are achievements by themselves, but together they are truly special.”

Freeze Drying Specialists BTL Announce New Cytotoxic Capability

Biopharma Technology Ltd (BTL) has completed construction of a new stand-alone cleanroom, enabling them to provide freeze drying R&D services for cytotoxic products.

Freeze drying is a complex operation and many drug developers outsource development to contract research organizations specialist in this field. However, few CROs with freeze drying expertise have the ability to handle cytotoxic drugs safety.

Cytotoxic therapies are most commonly used in cancer chemotherapies and work by preventing the growth of cells. However normal cells can also be damaged both in patients and anyone else exposed. Cytotoxics are highly potent which means that from R&D to actual administration there is a need for secure handling.

In R&D, the safe handling of cytotoxic drugs requires measures that are significantly more stringent than standard practice. Cleanroom containment, protective clothing and additional handling procedures are used to protect staff, to prevent product from escaping from the laboratory, and to prevent cross-contamination with any other products that may be under investigation. These factors make it common for cytotoxics to be handled in a separate suite specifically designed for handling them.

Rather than take on the costs of an additional laboratory, many drug developers benefit from partnering with contract research organizations with existing facilities and additional expertise.

Freeze drying is a process used to stabilize high value products including pharmaceuticals. However, freeze drying can be an expensive process.

“When freeze drying cycles are inefficient they become long and costly,” says BTL’s Commercial Director Dr Laura Ciccolini. “This is why many developers choose to partner with an organization specializing in this field. However there are a limited number of companies with this expertise, and few have the capability to handle cytotoxic compounds.”

BTL’s new standalone cytotoxics laboratory has been built to provide both an outsourcing capability to smaller developers, and specific product development expertise to more established enterprises. The suite contains a full range of characterization and analysis equipment as well as a pilot-scale freeze dryer. This enables BTL to offer its full range of freeze drying product and process development services and small scale production runs to customers developing cytotoxic therapies.

Dr Ciccolini says, “BTL are now able to provide a really exceptional combination of world-wide reputation for freeze drying expertise and safe cytotoxic processing.”

NantWorks Pharmaceutical Manufacturing Plant in Indiana

NantWorks, a U.S.-based pharmaceutical company which intends to bring innovation into healthcare by using digital technologies, announced it was to setup a new drug manufacturing plant in Vigo County, in the state of Indiana, in January 2012.