NanoViricides Inc. reports that construction of its modern R&D Lab and cGMP Clinical Production facility in Shelton, Conn., is nearing completion on schedule. Construction of the cGMP Cleanroom Production Suite is expected to be completed in March 2014, and shortly thereafter the project will enter facility testing and validation phase.

"Our urgency to bring this facility online has increased with the new wave of H7N9 Influenza A infections in China this year," says Eugene Seymour, MD, MPH. "It is now thought that H7N9 bird flu has at least sporadically transmitted from humans to humans. This is the first step before the H7N9 virus gains ability to cause an epidemic, which could become a pandemic if a drug-resistant mutant strain of the virus takes over. Drug resistant H7N9 has already been found in China."

NanoViricides is a development stage company that is creating special purpose nanomaterials for viral therapy. Its nanoviricide class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.

"We believe that the broad-spectrum FluCide should be an excellent treatment for H7N9," says Anil R. Diwan, PhD, President and Chairman. "This FluCide drug candidate was designed to mimic both the bird and human variants of the sialic acid receptors on cells to which the influenza virus binds. FluCide has shown extremely strong activity in animal studies against both Group I and Group II Influenza A viruses. Thus we fully expect it to work against H7N9."

In late March 2013, investigators confirmed that 3 patient deaths in China were due to a novel avian-origin influenza virus, H7N9. Approximately 32% case fatality rate is reported from H7N9 by the European Center for Disease Prevention and Control.

The company reports that its project for enabling clinical scale drug product cGMP capability at the Shelton facility is now nearing completion of construction. After construction is complete, the facility, and particularly the cGMP Cleanroom Suites, will undergo facility testing and validation to ascertain that the facility satisfies the requirements. After validation, NanoViricides plans to occupy the new facility while keeping the current facility active to minimize impact on the multiple nanoviricides drug development projects. The company intends to first start production of FluCide in the cGMP section, set up appropriate cGMP operation for this production, produce multiple batches of FluCide under cGMP conditions, and demonstrate equivalence of the batches produced, in preparation for human clinical trials.

California Provides $40M for Stanford-led Stem Cell Genomics Center

Stanford University has been awarded $40 million from the California Institute for Regenerative Medicine to work with several partners to create a center that will focus on applying genomics approaches and technologies to stem cell science.

Stanford and its collaborators will use the CIRM funding to create the Center of Excellence in Stem Cell Genomics, which will apply genomics in developing better ways to use stem cells in research and treatment, and enhance understanding about diseases like cancer, diabetes, heart disease, and mental health, Stanford said.

The other partners working with the center include the Salk Institute for Biological Studies; the J. Craig Venter Institute; the University of California Santa Cruz; UC San Diego, Scripps Research Institute; and Illumina.

"Bringing together this team to do this kind of work means we will be better able to understand how stem cells change as they grow and become different kinds of cells," CIRM President Alan Trounson said in a statement from the stem cell agency. "That deeper knowledge, [which] you can only get through a genomic analysis of the cells, will help us develop better ways of using these cells to come up with new treatments for deadly diseases."

The funding was approved by CIRM's board, the Independent Citizen's Oversight Committee, which had set aside $40 million two years ago to fund stem cell genomics initiatives and had received several proposals. Although the ICOC was free to fund more than one of these stem cell genomics projects, it ultimately decided to award all of the funds to the Stanford-led

initiative.

According to CIRM, $19 million of the funding for the center will support independent and collaborative projects focused on disease mechanisms and developing new technologies.

The center will be a resource for other stem cell researchers and engage in outside collaborations, but it also will pursue its own projects, such as collecting and characterizing induced pluripotent stem cell lines, using single-cell genomics techniques to understand cellular subpopulations, and building computational tools for analyzing networks that underlie stem cell and genome function.

CIRM, also known as the California Stem Cell Agency, was created in 2004 after voters approved a proposition to provide $3 billion for stem cell research projects and programs at institutes around the state.

The Center of Excellence in Stem Cell Genomics will be led by Co-directors Michael Snyder, chair of genetics at Stanford, and Joseph Ecker, a professor in the plant biology lab at Salk.

Snyder, who also directs Stanford's Center for Genomics and Personalized Medicine, said many of the partners in the project have developed cutting-edge technologies that will be available through the center.

UC Santa Cruz will run the center's data collection and management component, which will handle the large amounts of data these stem cell genomics projects generate.

"Stem cell researchers are collecting large amounts of DNA and RNA sequence data, and data analysis is becoming a bottleneck to discovery," Josh Stuart, a professor of biomolecular engineering in UCSC's Baskin School of Engineering, said in a statement. "We will provide the high-performance infrastructure needed to manage that data."

UCSC added that Stuart will also be working with Trey Ideker at UC San Diego to develop new "machine learning" tools specific for making discoveries in the anticipated stem cell datasets.

NW Bio Prepares for Expansion

Northwest Biotherapeutics has agreed with CMO Cognate Bioservices to begin a large-scale expansion of the manufacturing, storage, handling and distribution of its personalized immune therapies for solid tumor cancers.

NW Bio, a Bethesda, Maryland-based company, says it’s getting a “head start” on the manufacturing of DCVax-L and DCVax-Direct as the regulatory requirements for cell therapy products are more rigorous for commercialization than for Phase III trials.

Linda Powers, CEO of NW Bio., said, “We’ll have topline results by next year and if we meet the endpoint, we’ll submit for product approval.”

She used Denderon as an example of a company that NW Bio has learned from, noting that small biotech companies should not wait to set up the infrastructure necessary to begin commercialization.

As far as the manufacturing process for the two products, Powers mentioned that ten years ago it took five months to manufacture the immunotherapies and now it takes eight days. In addition to the efficiencies, “there’s high purity as well…that’s the dramatically positive results you get if you focus on the practical aspects.”

NW Bio chose Cognate because it’s a sister company with common shareholders, in addition to having a decade-long relationship.

The agreements with Cognate allow NW Bio to begin a scale-up program for expanding clinical programs in the US and Europe, and for any compassionate use programs or other early access or expanded access programs which the company might undertake. They also allow for long-term preparations for potential commercialization and product validation.

“We are excited to enter into a broad program to expand capacity and build large scale infrastructure, systems and operations under these Agreements with Cognate,” commented Les Goldman, Senior VP of business development at NW Bio.

Alexion Pharmaceuticals New Global Headquarters

Alexion Pharmaceuticals started construction on its new global headquarters in June 2013, located at 100 College Street, New Haven, in the state of Connecticut, US.

The new headquarters will include a sophisticated laboratory and an office building. It is expected to be opened in mid-2015. Construction is being sponsored by the city of New Haven, the State of Connecticut, and the US Department of Transportation.

The new building will provide employment for 200 to 300 people by 2017.

Alexion's new headquarters will be located on a 12-storey building with a total floor space of around 500,000ft².

It will include a separate parking garage with 600 to 800 spaces. Existing 400 employees at the old facility in Connecticut will be transferred to the new headquarters upon completion of construction.

The new laboratory at the headquarters will be used for developing life-transforming therapies for patients with severe and life-threatening disorders.

In June 2013, construction began with a ground-breaking ceremony, attended by New Haven Mayor John DeStefano, Governor of Connecticut, Dan Malloy, and other dignitaries of Alexion Pharmaceuticals.

Winstanley Enterprises was awarded a $100m development contract in June 2013. The scope of the contract includes construction of new laboratory and office building for Alexion to accommodate its new headquarters. It also includes refurbishing the College Street bridge, pedestrian and bike improvements, as well as access to the neighboring Air Rights garage.

The total expected investment for the construction of the new headquarters is $140m. Connecticut State government, under its Department of Economic and Community Development (DECD) First Five program, contributes $51m for the project.

The assistance is provided in the form of a ten-year loan of $20m at 1% interest for five years. It will also include around $25m towards industrial sites reinvestment tax credits, and a $6m grant for the laboratory construction and equipment.

Between $16m and $20m will be rebated under loan forgiveness scheme if the promised 200 to 300 permanent jobs are created.

The new headquarters building is being constructed using eco-friendly methods. It is designed to obtain the LEED Silver environmental standard certification.

Alexion Pharmaceuticals is a leading international biopharmaceutical company currently headquartered at Cheshire, US. The company is engaged in innovation, development and commercialization of life-transforming therapeutic products for severe and ultra-rare disorders. It employs around 1,700 people across 50 countries worldwide.

Alexion operates a manufacturing facility located in Rhode Island, and offers the product services to the patients in 50 countries across the world.

SGS Plans Life Science Services laboratory

SGS recently announced plans to open its fifth North American Life Science Services laboratory in Carson, Calif. This investment will establish a Life Science Services GMP/GLP laboratory, with the ability to provide microbiological testing and bioanalytical services. The new facility will encompass 8,000 sq. ft., of which 6,000 sq. ft. will be dedicated laboratory space and remaining space for offices, conference rooms, and client records. The new facility is projected to open early in the third quarter of 2014 and will initially employ seven scientific staff, with room to expand as the demand grows.

VA Healthcare Center

Scheduled for completion in 2015, the VA Healthcare Center in Kernersville, NC will be centrally located in the Piedmont Triad, serving 150,000 veterans. The design pays special attention to indoor-outdoor connections, which are an important aspect of LEED for Healthcare. Gold certification is anticipated for the facility, which is a collaboration between Lend Lease Healthcare and Perkins Eastman.

Brigham Begins Work on Translational Research And Clinical Facility

Brigham and Women’s Hospital (Boston) has started construction on the 620,000-square-foot Brigham Building for the Future. The translational research and clinical facility will be designed by NBBJ (Boston) and is located on the hospital’s Longwood campus.

Plans call for the 11-story facility to house eight floors of research laboratories, three floors of clinics, an imaging facility, social spaces, and a 400-car garage.

The facility aims to advance patient care by furthering translational research and collocating the researchers and clinicians. Social spaces including touchdown areas, conference rooms, cafés, and a roof garden. Flexible clinical floors will integrate clinicians across multiple sub-specialties to provide multidisciplinary care for patients with complex neurological and musculoskeletal conditions.

Oliver-Tolas Healthcare Packaging Expands

Oliver-Tolas Healthcare Packaging has been seeing a number of specialized requests emerge for flexible packaging. For instance, the company is tracking interest in autoclavable barrier packaging. “There has been a missing link, so we are responding to the need for flexible barrier packaging that can survive high heat and high moisture while eliminating packaging processing steps,” explains Jody Beeck, marketing and product manager.

Oliver-Tolas has just commercialized autoclavable Dispos-a-vent pouches featuring foil laminations with a breathable header strip. After autoclaving sealed pouches, users would simply apply a third seal to remove the header strip for a barrier package, Beeck explains.

Beeck also reports industry interest in compartmentalized pouches to segregate certain items in the package. To meet that need, Oliver-Tolas has investigated ways to perforate Tyvek during inline pouch making. “The challenge is that the perforation process itself is intended to create holes. So we have developed a robust process to eliminate the chance that a hole is misplaced somewhere else in the pouch,” she explains. “We have maximized process control through machinery controls. And we have determined that the perforation process does not introduce any contaminants.”

Finally, Oliver-Tolas continues to see increased interest in manufacturing quality and cleanliness for heightened control over particulates and endotoxins, among other concerns. To support MDMs, the company introduced its Oclean program in early 2013 for identifying cleanliness requirements early during package design phases, says Beeck. “We can identify a product or process available to meet the needed cleanliness level,” she says.

While the medical device manufacturing industry has always been risk averse and therefore has traditionally expected high-quality materials, newer cost pressures may be driving some of the additional scrutiny, says Beeck. “Cost pressures have increased through healthcare reform, so there is heightened pressure on and scrutiny of packaging suppliers. Any contamination equates to more processing on the MDM’s behalf, so they seek to reduce this burden.”

Oliver-Tolas continues to expand its certified cleanroom manufacturing space. The company currently maintains 6000 sq. ft. of cleanrooms at its Grand Rapids facility; 918 sq. ft. currently in Feasterville, PA, with an expansion underway; 1800 sq. ft .at its Suzhou, China, facility; and 1300 sq. ft. at its Venray, Netherlands, facility.

Cangene Wins Anthrax Contracts

Cangene Corp. has been awarded a multiple award indefinite delivery/indefinite quantity contract to potentially provide its Anthrax Immune Globulin Intravenous (AIGIV) to the U.S. Department of Health and Human Services (HHS) for the U.S. government's biodefense program. Cangene's AIGIV, a hyperimmune antibody product specific for Bacillus anthracis bacteria, was first accepted into the U.S. Strategic National Stockpile in 2007.

Under the terms of the five-year contract, Cangene could be awarded delivery orders for the collection and storage of anti-Anthrax human plasma, for the manufacturing of bulk drug substance and AIGIV final drug product. The contract's work statement has a total potential maximum value of approximately $264 million to Cangene.

In conjunction with the contract award, Cangene was awarded the first task/delivery order under the contract. The order is for the collection and storage of anti-Anthrax human plasma sufficient to manufacture 10,000 doses of bulk drug substance or final drug product. This order is expected to generate aggregate revenue of approximately $63 million for Cangene for fiscal years 2014, 2015 and 2016 and is included in the $264 million potential value estimate.

John A. Sedor, president and chief executive officer of Cangene, commented, "We are proud to have been selected by the U.S. government for this important medical countermeasure. This marks our second major biodefense contract this year, with the extension of our VIGIV contract with the Centers for Disease Control and Prevention that we announced earlier this month, underscoring our leadership in biodefense. We appreciate our long-standing relationship with the U.S. Department of Health and Human Services, and look forward to continuing to support its critical biodefense preparedness program."

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201300009I.

AAIPharma Announces Completion of Parenteral Manufacturing Facility Expansion

AAIPharma Services Corp. (“AAIPharma”), a leading global provider of pharmaceutical analytical testing, product development and manufacturing services, announced that it has completed a multi-million dollar expansion of its cGMP parenteral manufacturing facility in Charleston, S.C.

The expansion consisted of three new suites that were designed and built by AES Clean Technology, Inc. and equipped with a Chase-Logeman monoblock FSAS, Lytzen ISO Class 5 depyrogenation oven, BMT Steripro cGMP steam sterilizer, and SP Hull pilot-scale lyophilizer with a complementing production-scale lyophilizer on order, both with ControLyo™ technology.

AAIPharma has effectively doubled the facility’s sterile product development and production capacity and adds state-of-the-art redundancies to its major processing equipment. Final validation activities are underway and the new suites will be fully operational by February 2014. The buildout was engineered to readily accommodate the production-scale lyophilizer upon arrival, which will more than triple the facility’s lyophilization capacity by late 2014.

“Some exciting features of the expansion include low line loss and in-line weight check capabilities, which are extremely important to our clients with high-value active pharmaceutical ingredients (API’s),” said James Fife, senior director of parenteral operations. “In the coming months, the pilot and production-scale SP Hull lyophilizers will be brought online affording seamless lyophilization cycle optimization and scale-up.”

AAIPharma Services Corp. and Cambridge Major Laboratories, Inc. recently merged to form a premier global supplier of comprehensive CMC services, including process chemistry, solid state chemistry, API manufacturing, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid and sterile), packaging and stability services. The merged company is a portfolio company of American Capital, Ltd. (NASDAQ: ACAS).

Oligomerix Relocates Corporate Headquarters

Oligomerix, Inc., a privately held company pioneering the development of disease modifying therapeutics for Alzheimer's disease (AD) and related neurodegenerative disorders, announced the relocation of its corporate headquarters to Valhalla, NY as of January 15, 2014 and expanded lease agreement for additional laboratory space at New York Medical College.

Oligomerix, which is focused on the development of small molecule drugs aimed specifically at inhibiting tau aggregation at the earliest steps of tau self-association into toxic oligomers in neurons, has continued to successfully advance its research, resulting in the need to add staff and expand its office and lab space.

"We're extremely encouraged by the preclinical data we've observed in our lead small molecule program, and are eager to continue our research in this space," stated James Moe, Ph.D., MBA, President and CEO of Oligomerix. "As New York Medical College is already providing space for in vivo mouse studies for our lead compound, we believe the decision to move and expand Oligomerix's corporate headquarters will benefit the company's logistical needs."

Oligomerix recently announced the appointment of James Hendrix, Ph.D., as the company's Senior Director of Chemistry, and plans to potentially recruit up to five employees in 2014.

Cytovance Begins Facility Expansion

Cytovance Biologics, Inc. broke ground on a facility expansion that will house both manufacturing operations and GMP warehousing. The multi-million dollar investment project is being built by Capstone Construction, and is expected to be completed by June 2014.

The company is expanding its capabilities in the areas of microbial, mammalian, and fill finish operations with the addition of a new 1000L microbial fermenter, an automated fill/finish machine, and a 2500L stainless steel bioreactor. The new facility located at 3500 N. Santa Fe, Oklahoma City, OK, will house 20,000 sq.-ft. of climate controlled and monitored GMP warehouse space and 10,000 sq.-ft. of dedicated space for existing and future manufacturing operations. Initially, this cleanroom space will be used for weighing and dispensing activities.

"Our new GMP warehouse will support incoming and outgoing supply chain activities and provide full segregation between incoming, quarantine, and released materials," said Don Wuchterl, senior vice president of Manufacturing Operations. "The additional manufacturing space will provide Cytovance with future expansion space to quickly meet our clients' contract manufacturing requirements."

AMRI Expanding Manufacturing

AMRI says it intends to expand its fill/finish capability and progress its business into higher value technology following the recent all clear at its once troubled Burlington facility.

In November 2013, Albany Molecular Research Inc (AMRI) received a US Food and Drug Administration (FDA) close-out letter for its Burlington, Massachusetts facility, ending years of sanctions after sterile manufacturing violations ended in a 2010 Warning Letter .

Now AMRI, through its new CEO William Marth, wants to use this “pivotal milestone” - as site manager Christian Phillips described it at the time – to increase both its fill/finish capabilities in the face of rising demand, and grow the CMO business further.

Marth told investors at the JP Morgan Healthcare Conference last week since the lifting of the Warning Letter, the fill/finish business is growing at a great rate, and is an area AMRI wants to expand.

“The demand for Fill & Finish is really tremendous now in the US. It was unfortunate that we had a warning letter,” he said, especially as other manufacturers had also received such warnings. “Since we’ve had that warning letter lifted the demand for our product in Burlington has grown at a great rate.”

However, though Burlington is good for Phase I- III material and small commercial fill/finish, AMRI is looking to grow the Phase III capability and commercial capability both organically and inorganically in order to mature the site, Marth said.

Fill/finish expansion at Burlington would be used as a springboard to focus on the firm’s other manufacturing services, Marth – who took over from founder and CEO for the past 22 years Thomas D’Ambra in September - continued. He said: “As pharma beings to look more and more at outsourcing, we believe we can extend that business both into patches, potentially DPIs, some oral solid dose other areas.

“Now we are not looking necessarily to go head-to-head against Catalent, head-to-head against Patheon, but what we think we can do is add our CMO business on the higher value high technology products.”

Marth also spoke of expanding AMRI’s API manufacturing business, which, through its facilities in Rensselaer, India and Holywell, UK, mostly produces branded drug ingredients.

“We can take that business and direct it more towards the generic markets as well,” he told the room, adding AMRI is looking to increase its approximate $127m share of a $14bn market.

“We’ve looked at a variety of areas in APIs that we think we can excel in, cytotoxic, steroid, peptides, and controlled substances. These are areas that we will look to focus on probably on in both an organic and inorganic basis.”

Marth, who began his career at generics maker Teva, recently recruited George Svokos – also from Teva – as General Manager of the API business, in order to “lead the charge” in focusing on generics, whilst another key hire - Vijay Batra as Managing Director of AMRI India – will also support this project.

SGS to Open First Bioanalytic Laboratory in North America

SGS will open its first bioanalytic laboratory in North America, hoping to capitalize on the growing Californian biotechnology market.

Pharmaceutical analysis firms are experiencing increasing demand, Ferdinand Dabu, marketing director of life science services at SGS, said.

“According to a soon-to-be-released PharmSource Market Study, indicators show the contract testing market is growing at a rate of 7-10%,” said Dabu.

Driving this change, he said, are both cost-cutting measures by pharmaceutical firms, and the escalation of biopharmaceuticals:

“Factors such as more companies striving to reduce costs, their focus on core competencies, and the growth of biologics in the pipeline influence this trend.”

The forthcoming facility in Carson, California will be focused on large molecule bioanalysis, including “PK and PD [Pharmacokinetics and Pharmacodynamics] support for preclinical and clinical studies for all clients developing vaccines, or protein/antibody therapeutics,” said Dabu.

“Bioanalysis is key throughout the drug development pipeline assisting in the decision-making process to move a drug candidate along the development program.”

Although the company has never before undertaken bioanalysis in the US, it would draw from its experience in Europe, said the executive VP for life science services.

“This development permits SGS to leverage the bioanalytical testing expertise from the laboratory in Poitiers, France, where SGS has over 700 validated bioanalytics assays to date,” said Anne Hays.

In addition to large molecule analysis the new Carson facility will also be capable of microbiological testing, said the marketing director.

In this field in particular, said Dabu, “proximity [to customers] is key,” as some microbiological samples need to be processed within a 24-hour timeframe.

He pointed to Carson’s location near Los Angeles International Airport, and its short distance from San Diego and San Francisco, both biotechnology hubs, as behind the choice of the new site.

The company hopes to establish a West Coast presence to address the market, added Jeff McDonald, Chief Operating Officer.

The forthcoming facility will comprise 6,000 square feet of lab space and 2,000 square feet for offices, conference rooms, and client records.

It is expected to open in autumn 2014 and employ a staff of seven scientists.

Nanotherapeutics Opts for GE’s Modular Manufacturing

US defense contractor Nanotherapeutics will use a modular biomanufacturing system provided by GE Healthcare at a facility it is building in Alachua, Florida.

Nanotherapeutics announced it had selected GE Healthcare’s Flexfactory platform, explaining that it selected the system after a “competitive tender,” financial details of which were not disclosed.

The tech – which will be used to produce biomedical countermeasures for the US Government when the Advanced Development and Manufacturing (NANO-ADM) Alachua facility is operational in 2015 – consists of single-use manufacturing models that can be connected in a variety of configurations.

GE gained the Flexfactory system when it acquired Xcellerex in 2012. Since then the system has been adopted by a number of biopharmaceutical manufacturers with China based JHL Biotech being the most recent firm to purchase the technology.

Like the JHL deal, the agreement with Nanotherapeutics will also see GE Healthcare provide training and support services for process development.

Countermeasures

Nanotherapeutics' plant was commissioned after the firm was contracted to make by the US Department of Defense (DoD) last year.

At the time the firm said: "The NANO-ADM Center will integrate new biomanufacturing technologies with existing capabilities, enabling the development of both small molecule and biologic products.

"The goal of the contract is to enable faster and more effective development of medical countermeasures designed to protect and treat military populations against chemical, biological, radiological and nuclear attacks and outbreaks of naturally occurring, emerging and genetically engineered infectious diseases.

The centre will include space for vector development, quality control, a development pilot plant, manufacturing core, warehouse, as well as office/administration and utilities.

The new plant, which is costing $122m to build according to Area Development Online, will be operational in mid-2015 and will provide around 200,000 sq.ft. of development and manufacturing space.

Calbiotech Starts Antibody Manufacture

Immunotherapy contractor Calbiotech has started work on a dedicated mAb plant intended to broaden its biopharma service offering.

The company’s spokeswoman said the new facility will produce antibodies for both Calbiotech and outside sponsors, and will also develop recombinant antibodies for assays.

“Our current focus is on developing antibodies and immunoassays for diabetes, bone deficiency, autoimmune and hormone disorders. In addition, we will aim to grow our current line of Mouse/Rat ELISAs using antibodies made in-house,” said Reema Boccia.

The facility will provide immunoassay services to pharmaceutical companies, as well as aiming to discover novel assays.

Calbiotech is “working with research groups from two different universities on separate projects, both of which involve developing an antibody and then using that antibody as a basis for novel biomarkers for research and clinical applications,” said Boccia.

Collaborations have also already started with diagnostic companies in the US and abroad, she said, which wanted new custom immunoassays to expand their market.

Boccia added that the immunotherapy contractor was suited to a move into antibody production because it had the know-how to create the high-quality antibodies vital to making good assays.

“Antibodies are critical materials for making immunoassays, i.e. good antibodies make good assays. To make good antibodies for immunoassays, the antibody developers need knowledge and technologies on producing antibodies and also knowledge and technologies on immunoassays.

Operations at the new plant will be led by Dr. Jimin Wang, who was recently appointed at Calbiotech’s VP of Research and Development.

Calbiotech’s expansion follows the San Diego company’s acquisition of Moduline Systems, an equipment manufacturer, in December 2013, and before that, the veterinary diagnostics division of Meridian Life Sciences.

"Calbiotech's strategic expansion into antibody production will improve efficiencies, enhance assay development and lead to faster innovation, which benefits our customers and the patients they serve," said VP Barka.

Calbiotech VP David Barka said the company expected to debut its first antibodies this year.

DSM Opens Medical Coating Service Plant

DSM, a biomedical materials science and regenerative medicine company, has launched a new facility to offer coating services for its ComfortCoat coating technologies. As partner to medical device makers, DSM offers a full suite of coating application processes, which include coating, testing, packaging, and labeling as well as additional customized processes such as cutting.

The facility’s equipment is operated in an ISO Class 8 cleanroom, and utilizes a Quality Management System that is compliant with ISO 13485 standards. The biomedical practice with its ISO certification is able to meet customer and regulatory requirements applicable to medical devices and related services. DSM coats medical device parts using a dip coating process and offers UV curing to instantly dry coatings, which can help increase production speed, increase yield rates, improve properties such as scratch and solvent resistance, and facilitate superior bonding. DSM’s medical coatings are applied on numerous types of interventional devices in cardiology, urology, and other clinical fields.

"DSM's coatings business leverages our deep and wide expertise in medical device materials manufacturing and design," says Dr. Hinke Malda, Director of Medical Coatings, DSM Biomedical. "Launching an in-house medical coating service means we can add further strategic value to our work with partners and customers through full-service support from coating selection to delivering fully coated device parts."

DSM is located in Exton, Pa.

Univ. of Tenn. Converting Dorm to Science and Lab Space

The Univ. of Tennessee, Knoxville announced that work has begun on turning the vacant Sophronia Strong Hall into a large and modern science class and lab facility. The two-year, $114 million project marks the first big step in addressing the university’s need for general class and laboratory space.

The new nine-story, 268,000 sq. ft. building, designed by Perkins+Will, will be home to the anthropology and earth and planetary sciences departments and also provide critical instruction and lab space for the general biology and chemistry departments. Work began on reassignment of utilities and asbestos abatement this week.

Strong Hall was built in 1925 and served as a women’s residence hall until 2008. The renovation and expansion project will preserve 20,000 sq. ft. of the original structure, including the building’s distinctive front arches. The front stone wall and footbridge across Cumberland Avenue also will be preserved. The project also includes the restoration of a small Queen Anne style gardener’s cottage on the north corner of the site.

The state included $75 million for Strong Hall in this year’s capital budget. The university will fund the remaining cost as part of the funding formula for new higher education facilities.

The facility will feature an open and flexible lab design and collaborative learning and research spaces. It also will be energy efficient and sustainable and built to meet LEED Silver standards.

The university updated its master plan in 2011, and the process identified a deficit in general classroom, lab and research space. The Tennessee Higher Education Commission’s standard space formula estimated the campus needed 870,000 more gross square feet of space just to serve its current enrollment. The master plan set several large class and laboratory facilities as top building priorities for the campus to help meet this standard.

As Strong Hall construction begins, the design process is continuing on a new classroom and lab facility along Thirteenth Street and Cumberland Avenue. The 220,000 sq. ft. building will be built next to the Jesse Harris Building and house research labs, a vivarium, classrooms and faculty offices.

Univ. of Oregon, Lewis Integrative Science Laboratory Building, Portland

The new building is home to research clusters centered around interdisciplinary and integrative research missions; its purpose is to create new synergies across diverse academic disciplines by literally uniting the sciences. The majority of the building is devoted to studying the brain and its functions, specifically cognitive neuroscience, systems neuroscience and genetics research.

The building also houses the Support Network for Research and Innovation in Solar Energy (SuNRISE), a program working to advance solar technology, and the Center for Sustainable Materials Chemistry, a part of UO's pioneering green chemistry program. The overarching goal of the design was to support the premise of science as an open, collaborative process rather than an isolated exercise conducted behind closed doors. The underlying goal was to set a new standard for sustainable design at the university by weaving sustainability into every aspect of the building; the building is now the first LEED Platinum campus building at the university. The building extracts waste heat from a utility tunnel below the site and uses the heat to control temperature in labs and office spaces. The entire building uses 62% less energy than conventionally designed buildings of similar size and function, with 17% of that savings coming from the reuse of waste heat. Other innovative strategies include variable flow chemical fume hoods equipped with automatic sashes that close when not in use, reclaiming reverse osmosis treated water from a neighboring zebrafish research facility for flushing all urinals and toilets and an expansive atrium skylight providing natural illumination for the entire atrium space and neighboring offices.

Other highlighted sustainable features include:

Bamboo, a rapidly renewable building material, is the predominant wood finish material, used throughout the atrium and in the lab spaces.
Local building materials are utilized whenever possible.
Operable windows with a built-in occupant notification system: red and green lights notify users when opening windows is appropriate.
28 rooftop solar panels provide domestic hot water.
Heat recovery captures and re-uses waste heat from lab exhaust.
A green wall concealing much of the north side of the mechanical penthouse.
Waste heat from the utility tunnel below the building is recovered with an air-to-water heat pump and serves the lab re-heat requirements.
Chilled beams and radiators, along with demand-control ventilation serves office and dry lab spaces.
Exterior solar shading and interior light shelves.
Daylight sensors and occupancy sensors control electric lighting.
Climate-appropriate landscaping requiring minimal maintenance.
Preservation of two existing oak trees on site, which included raised pathways to protect new and existing roots.
Stormwater planters treat all water on site.
Completion date: July 2013

Project team:

HDR, Portland, OR (architect, ME);

THA Architecture, Portland, OR (architect);

Lease Crutcher Lewis, Seattle, WA (construction);

BHE Engineers, Eugene, OR (civil engineer);

Catena Engineers, Portland, OR (structural engineer);

BHE Engineers, Eugene, OR (electrical engineer);

Glumac, Portland, OR (energy, commissioning)

SGS Opens Facility in California

SGS will open its first bioanalytic laboratory in North America, hoping to capitalize on the growing Californian biotechnology market.

Pharmaceutical analysis firms are experiencing increasing demand, said Ferdinand Dabu, marketing director of life science services at SGS. “According to a soon-to-be-released PharmSource Market Study, indicators show the contract testing market is growing at a rate of 7-10%,” said Dabu. Driving this change, he said, are both cost-cutting measures by pharmaceutical firms, and the escalation of biopharmaceuticals: “Factors such as more companies striving to reduce costs, their focus on core competencies, and the growth of biologics in the pipeline influence this trend.”

“Bioanalysis is key throughout the drug development pipeline assisting in the decision-making process to move a drug candidate along the development program.”

Although the company has never before undertaken bioanalysis in the US, it would draw from its experience in Europe, said the executive VP for life science services.

In addition to large molecule analysis the new Carson facility will also be capable of microbiological testing, said the marketing director.

In this field in particular, said Dabu, “proximity [to customers] is key,” as some microbiological samples need to be processed within a 24-hour timeframe. He pointed to Carson’s location near Los Angeles International Airport, and its short distance from San Diego and San Francisco, both biotechnology hubs, as behind the choice of the new site.

The company hopes to establish a West Coast presence to address the market, added Jeff McDonald, Chief Operating Officer.

The forthcoming facility will comprise 6,000 square feet of lab space and 2,000 square feet for offices, conference rooms, and client records.

It is expected to open in autumn 2014 and employ a staff of seven scientists.

REST OF WORLD

Merck Spending $55M on Production Facility

Pharmaceutical, chemical, and life science company Merck KGaA has broken ground on a new production facility for its Allergopharma unit in Reinbek, Germany. The new facility, which is estimated to cost nearly $55 million, will be used, among other things, to expand production to serve new markets such as China. In the two-story building, which will be constructed on the current Allergopharma premises, products for the diagnosis and treatment of type 1 allergies such as hay fever or allergic asthma are to be manufactured under ultrapure, sterile conditions. Completion of the building is scheduled for 2016.

"We want to fully exploit the potential of our business, whether in Emerging Markets or in rapidly growing and highly promising areas such as the global allergy market," says Stefan Oschmann, Merck KGaA’s Executive Board member with responsibility for Pharmaceuticals, including the Allergopharma unit. "By offering a highly competitive product range, we want to continue to tap the global allergy market."

The new building will have a surface area of more than 19,000 ft2 and will contain cleanrooms for production, as well as plant engineering technology and offer space for further laboratory use as well as a visitors’ foyer. Initially, around 40 people will work in the new building.

"With this investment, which is largest in the history of Allergopharma, we are setting an important milestone to expand the Allergy business internationally and to secure the future of the Reinbek site," says Uta Kemmerich-Keil, CEO of Allergopharma.

Ireland Opens First Human Use Stem Cell Manufacturing Facility

The Centre for Cell Manufacturing Ireland at NUI Galway is the first ever facility on the island of Ireland to receive a license from the Irish Medicines Board to manufacture culture-expanded stem cells for human use. This facility in Galway, opened by Minister Seán Sherlock, positions Ireland as a global player in the regenerative medicine field and is a significant development for the med tech sector as a whole.

In addition to stem cell manufacture, Centre for Cell Manufacturing Ireland is offering a custom advanced therapeutic medicinal product manufacturing service to industry, and also a cleanroom leasing service to Irish SMEs who often have difficulty in procuring cleanroom space.

There are many human diseases which have either inadequate or no effective treatments, and since 2004 researchers based at the Regenerative Medicine Institute (REMEDI) in NUI Galway have been working to develop new therapies to impact many different areas of unmet medical need.

To develop any new human therapy, the treatment must first be tested for safety and effectiveness in a series of rigorous clinical trials. Over the past number of years REMEDI has developed the Centre for Cell Manufacturing Ireland which is a custom-built facility designed to expand stem cells for use in human clinical trials. Now that it has been successfully accredited, the Centre for Cell Manufacturing Ireland plans to supply stem cells for use in clinical trials following regulatory approval arising from pre-clinical data generated at REMEDI.

The announcement coincides with plans for the first clinical trial using CCMI-manufactured stem cells which is being funded by the Health Research Board and Science Foundation Ireland. It will investigate the safety of using mesenchymal stem cells (MSCs) isolated from bone marrow for the treatment of critical limb ischemia, a common complication associated with diabetes and which can often result in limb amputation. MSCs must be grown in the laboratory to generate sufficient quantities following their isolation from the bone marrow of adult donors.

President of NUI Galway Dr. Jim Browne says, “Developing Galway’s role as med tech hub of global standing, the Centre for Cell Manufacturing Ireland captures NUI Galway’s commitment to bring bold ideas to life. Innovation can bridge the gap between patient and provider and meet the needs of industry and the wider society in a balanced way.”

Minister of State for Research and Innovation Seán Sherlock says, “The Centre for Cell Manufacturing Ireland is clear evidence of the potential benefits offered by this Government’s substantial investment in applied research. Stem cell technology, developed in the first instance to help patients with diseases such as diabetes, arthritis, heart disease and critical limb ischemia, can also create sustainable growth and jobs in Ireland’s smart economy by making researchers’ visions a reality. The facility will play a key role in ensuring REMEDI’s continued success in EU funding initiatives, in particular Horizon 2020.”

The Minister adds that the Government, through SFI, will work to ensure that Ireland maximizes its participation in the Horizon 2020 program.

“The presence of this facility in Ireland positions us well to develop new therapies for a broad array of clinical problems which do not have effective treatments today,” says Professor Tim O’Brien, Director of the Centre for Cell Manufacturing Ireland. “It will also allow us to translate discoveries from the basic stem cell research program led by Professor Frank Barry at the Science Foundation Ireland-funded REMEDI to the clinic and to be competitive for grant funding under the Horizon 2020 program of the EU.”

Patheon to Invest in UK Facility

Increasing demand for HPAPIs has driven Patheon to invest in its Milton Park, UK manufacturing facility, the company says.

Patheon, a leading provider of contract development and commercial manufacturing services to the global pharmaceutical industry, will specialize in high potency at the company’s Milton Park facility in the UK. The investment in early development capabilities in Europe means expanded capacity for handling highly potent compounds in the early pharmaceutical development phases at the Milton Park facility and then feeding into the later stage and commercialization capabilities at a site in Bourgoin, France.

Patheon is investing £600,000 ($1m) into the UK facility, upgrading it to add instrumented compression, automated encapsulation and coating capabilities in order to offer its clients a “choice of capabilities not previously available that are linked to a network of larger scale sites that are also located in EU,” according to Milton Park General manager Mike Mencer.

The investment is being driven by an increasing demand for Early Development needs for highly potent active pharmaceutical ingredients HPAPIs (as well as lower potency ones).

“Within the industry, the HPAPIs market is estimated to grow by 8.4% from 2009 to 2015 versus 6.3% in previous years,” he said, “and is comprised of both small molecule and biologics.”

He continued: “Because Patheon is seen as the leader in contracted pharmaceutical development services, it made sense to invest in additional capabilities to support the market demands.

“We see an increase in the demand for highly potent products, both those in development and those that are approved and being commercially produced, across all sectors of the Pharma industry.”

Another factor that plays into the expanded capacity for high potency at Milton Park is the new disposable technology, which allows customers greater flexibility, especially those with highly potent compounds.

Marvin Faber, senior director, corporate environmental health and safety, will give a presentation at the HPAPI World Congress in Munich, Germany, which will take place on 26-27 February. His presentation is titled 'Effective Highly Potent Compound Handling in CMOs and will discuss how Patheon effectively and safely handles highly potent compounds. The HPAPI World Congress is Europe’s leading event for high-potency API development and manufacturing.

'HPAPIs form 10% of the overall market and are continuing to grow with a large number of discoveries for these compounds being made in Europe. Patheon is currently developing more than 400 high potency projects across the globe,' said Faber. 'We continue to invest in our capabilities to handle high potency products and have significant resources to ensure contained, fast, efficient manufacturing on both a commercial and development scale. Disposable technologies have been a very effective tool for us when handling high-potency products on a development scale.'

The expansion - expected to lead to the creation of at least 8-10 new highly skilled and technical jobs, according to Mencer – comes almost exactly a year since Patheon last invested in the site.

That investment was for new drug delivery technologies including hot melt extrusion and spray-drying at the Oxfordshire site and was announced last February for an undisclosed but “modest” upgrade cost.

Patheon joins a growing list of manufacturers investing in HPAPI capabilities in Europe, with other examples including Evonik, Novasep and Aesica .

Covance Opens First EU Nutritional Chemistry and Food Safety Lab

Covance is to open its first nutritional chemistry and food safety laboratory in Europe to be closer to customers.

The 10,000 square foot lab will form part of its existing facility in Harrogate, England, which includes 56,000 m2 (602,560 sq. ft. ) of laboratory space and more than 1,000 employees.

In the first year of operation, 25 positions are expected to be added and more than 100 roles within the first five years of operation.

The firm has not set a specific date for a grand opening but is aiming to complete renovations, recruitment and validations, including ISO accreditation, before the end of the year.

Brad Riemenapp, VP and general manager, nutritional chemistry and food safety (NCFS) said the lab will be the first for the NCFS business in Europe. “We have four nutritional and food safety sites globally, three in the US and one in Singapore,” he said. “There are two main reasons, one, we work with a number of clients in the EU already and they used to ship samples to the US and this will give us a local presence. “The second reason is the world continues to get smaller in respect to food and existing customers in the US were asking us to move into the EU.”

Riemenapp said the labs specialism fell into two buckets, nutritional labeling and food contamination testing. “The demand is from less and less contaminants allowed in food, the detection levels are lower so the product is safer and free of contaminants.

“The big demands coming our way are underlined by the human population expecting high standards on the food they eat and the regulations are getting more stringent, so there is a higher requirement of testing in nutrition for healthy and safe food.”

He said the laboratory will offer high resolution mass spectrometry, high performance liquid chromatography and gas chromatography.

The lab will complement existing Madison, Wisconsin, Battle Creek, Michigan, Greenfield, Indiana and Singapore facilities.

A £575,000 ($975,000) grant from the Leeds City Region Local Enterprise Partnership Business Growth Program, through the Government's Regional Growth Fund, will help fund contaminant testing research.

Roger Marsh, chair of the Leeds city region local enterprise partnership, said: “The expertise and intelligence behind this new research into nutritional health and food testing puts the Leeds City Region on the map and enhances our reputation as a great place to do business.”

Aesica Containment Facility, United Kingdom

Aesica, a supplier of active pharmaceutical ingredients, opened a new High Capacity Manufacturing facility at its Queenborough site in September 2013.

The facility was constructed with an investment of £30m, as part of an expansion plan announced in July 2012.

The new facility covers an area of 10,000m2 (107,600 sq. ft.). It produces solid dose medication products for treating Type 2 diabetes in adults.

It started production in November 2013. It implements Buck®Valve split butterfly valve technology for contained transfer of potent powders.

Located in Isle of Sheppey, Kent, England, the Queenborough facility was acquired by Aescia from Abbott Laboratories in September 2007.

The deal, which included a five-year supply agreement with Abott Laboratories, tripled the workforce of the company, boosted capacity and took Aesica into secondary manufacturing.

The Queenborough facility received the US Food and Drug Administration (FDA) approval in 2012.

The new high-potency facility houses multiple suites for granulation, tabletting and blister packing. All the suites are equipped with appropriate heating, ventilating, and air conditioning (HVAC) and cleaning facilities. To avoid any occurrence of cross-contamination, the facility has a segregated unit constructed at a distance from the remaining facilities of the company.

The company says that the design and construction of the purpose-built facility is in conformance with environmental requirements. The new facility is equipped with security systems that ensure the production of Schedule II controlled drugs including opiates.

The multi-purpose Queenborough facility is designed in compliance with ISO14001 standards. It is equipped with a range of capabilities including production of solid dosage forms, anaesthetics, and controlled medicines and packaging facilities that accommodate blister packs, sachets and bottles.

The facility has increased the company's formulation and packaging capacity of liquid and solid dosage forms. Its construction was started in August 2010 and completed in November 2011. Aesica invested €3m ($4.6m) on the construction.

The new facility allowed Aesica to expand its formulation offering in the growing market for contract manufacturing of high-potency drugs.

The Queenborough facility is equipped with a range of technologies including high shear granulation, low shear granulation, fluid bed drying, tray drying, blending, compression, bi-layer compression, tabletting with B&D tooling, film coating, liquid manufacturing, blister packaging, solid bottle filling, liquid bottle filling, sachet filling and capsule filling. Other technologies include those for control release, alcohol-based liquids and device assembly.

The high potency facility allows Aesica to develop Schedule II controlled substances, potent active pharmaceutical ingredients (API) and intermediates that are classified as Category 3 by Safebridge Consultants, Liverpool UK.

“The facility boosts Aesica's the production capacity of Schedule II compounds. Aesica began production of Schedule II compounds in 2009 after the approval of its Cramlington, Northumberland facility. Compounds categorized as high potent are effective in treating a range of diseases at low doses.

The compounds, however, have to be produced in an environment equipped with appropriate safety measures.

The Queenborough facility specializes in the production of drugs containing APIs that require special handling needs including high potent medicines or controlled substances.

It also manufactures a range of formulated products including anti-infectives, cardiovasculars, anti-virals, anaesthetics, anti-inflammatories, haematinics and hormones.

The products are manufactured in solid dosage forms, liquid dosage forms, anaesthetics and potent drugs. The facility can additionally perform packaging in bottles, blister packs and sachets.

The facility can operate at an annual wet granulation capacity of more than 500t, including low shear, high shear and fluid bed drying. Annual tablet production capacity including single, bilayer and film coating is more than 2bn.

The facility can additionally manufacture 1.5m liters of liquid at non-critical temperatures and up to 300,000l of liquid at critical temperatures every year. Blister packaging capacity of the facility is 90m packs per annum.

The facility can also pack 15m bottles of solids including tablets and granules and 14m bottle packs of liquids every year.

Acino Manufacturing Plant, Miesbach, Germany

Acino opened a new pharmaceutical manufacturing plant in Miesbach, Germany, in August 2012. The plant, owned and managed by Acino Holding, produces commercial quantities of transdermal rivastigmine patches.

Acino received EU approval for the rivastigmine patch for the treatment of mild to moderate forms of Alzheimer dementia in March 2013. The patch was launched in the German market in partnership with Betapharm in April 2013.

Acino also received the U.S. Food and Drug Administration (FDA) approval for manufacturing the transdermal rivastigmine product at Miesbach facility in September 2013.

The new facility was constructed with an investment of approximately €20m ($25.06m) and created employment for 40 highly skilled professionals.

The new facility at Miesbach features laboratories and modern storage spaces well-equipped with sophisticated pharmaceutical manufacturing equipment. It is currently the second biggest manufacturer of transdermal patches in Europe.

The new plant began operations at the end of 2012 and has enough space to carry out future expansions. The current production capacity of 37 million patches per year is planned to be doubled or tripled in the coming years.

Acino also plans to roll-out rivastigmine patches in other markets and supply license takers with the finished product.

The plant manufactures transdermal patches by employing better dosage forms compared to the oral delivery system. The patches manufacturing method primarily involves mixing and weighing of all ingredients as liquid drug-containing adhesive solution.

The drug-in-adhesive layer is created by coating, drying and lamination of liquid mass and the laminate is then sliced into daughter rolls. The patch forms are punched and each patch is then sealed into pouches.

PhC PharmaConsult, a subsidiary of i+o Industrieplanung + Organisation, was contracted for the design, site supervision and qualification of the facility. The construction was completed on time and within the budget with the coordination of project management, integrated building design and logistics of i+o.

Acino is a leading pharmaceutical company headquartered at Aesch, Basle, Switzerland. The company employs approximately 788 people across 80 countries worldwide. It is engaged in the development and manufacturing of generic and innovative pharmaceuticals by utilizing advanced and patented drug delivery technologies.

The company focuses on the development of sophisticated oral dosage forms with modified release of the active ingredient, transdermal therapeutic patches and biodegradable, subcutaneous implants. It generated annual revenues of €143m ($187m) in the first half of 2013.

Provence Technologies Builds New Headquarters

Provence Technologies, a specialist fine chemistry research group, and its subsidiary Provepharm, developers of pharmaceutical applications, announced an investment of €4 million to build their new 1,600-m. (17,223-sq.-ft.) head office in Marseille, France, tripling their footprint from their current space, which houses 30 employees. The increased floor space means that staff numbers at the group can expand up to three-fold in the medium term, to sustain strong growth in the business (Provepharm has expanded by 2,000 percent in five years).

“The new facilities mean that we can continue with our in-house R&D programs,” said Michel Feraud, chairman and CEO of Provence Technologies Group. “I would like to acknowledge the involvement of all our staff and the support provided by our partners. They have really helped the group to reach the next level of development.” The investment will also fund the launch of a specialist incubator for the healthcare sector, which the company called “something of a rare step for an SME.”

UK Invests $66M in Three New Synthetic Biology Centers

The UK government is providing £40 million ($65.8 million) to fund three new synthetic biology research centers that will serve as key components of a national strategy to ramp up research and industry capabilities in this field.

The funding will support a network of collaborative, multidisciplinary research centers; one in Bristol, another in Nottingham, and a third that is a partnership between researchers in Cambridge and Norwich.

The five-year investment was provided by the Biotechnology and Biological Sciences Research Council and the Engineering and Physical Sciences Research Council, BBSRC said.

These centers will pursue their own research programs, develop new technologies, and support the synthetic biology culture in the UK by providing resources such as equipment, researchers, and technical staff.

"Synthetic biology has the potential to drive economic growth but still remains relatively untapped and these new centers will ensure that the UK is at the forefront when it comes to commercializing these new technologies," Minster for Universities and Science David Willetts said in a statement.

The Bristol Centre for Synthetic Biology at the University of Bristol will receive £14 million to support development of new techniques, technologies, and reagents that will make building biologically based produces easier, faster, and cheaper, BBSRC said. These products may include vaccines, antibiotics, red blood cell-based drug delivery systems, and environmental remediation tools.

The Synthetic Biology Research Centre Nottingham at the University of Nottingham will receive £14.3 million. This center will focus on engineering microorganisms for use in manufacturing alternative fuels.

The OpenPlant Synthetic Biology Research Centre at the University of Cambridge and the John Innes Centre was awarded £12 million to develop open technologies for use in plant synthetic biology. The initiative will establish internationally linked DNA registries for sharing information about plant parts that will be useful in engineering new traits in plants.

Launching the network of collaborative centers is a core part of the UK's Synthetic Biology Roadmap program, which launched in 2012 after the government identified this area as a field with excellent potential for spurring new industries and innovations in healthcare, agriculture, and manufacturing.

Under the roadmap plan, the UK recently invested £10 million in a fund to support startup businesses seeking to commercialize synthetic biology technologies, and marked another £3.8 million for a competitive grant program to support industry-led efforts to develop new synthetic biology tools.

New Military Hospital for UAE

The Abu Dhabi Command of Military Works selected LEO A DALY to design its new 300-bed, 1.25-million-square-feet Zayed Military Hospital campus that will serve all branches of the United Arab Emirates Armed Forces. The design includes a 260-bed medical/surgical hospital, a 40-bed psychiatric hospital, a women’s services building, security facilities, a mosque and a utility plant.

LEO A DALY, design architect and engineer, and its local partner, AE7, architect and engineer of record, collaborated to create the concept design for the new hospital, which replaces a 45-year old military hospital located in downtown Abu Dhabi.

“It is a privilege and honor to work with the Abu Dhabi Command of Military Works to design the flagship military healthcare facility for the United Arab Emirates,” said Leo A. Daly III, FAIA, RIBA, FRAIA, Chairman and CEO of LEO A DALY. “As we endeavor to complete LEO A DALY’s largest ever international healthcare project, we are looking forward to bringing the latest in patient and staff-centered design to the Middle East.”

With final completion anticipated in 2016, Zayed Military Hospital will serve as a teaching hospital with a focus on specialties including cardiology, orthopedics, pediatrics and burn care. It will support and share services with the future Maliha Military Hospital, located to the north in Sharjah, U.A.E., which is currently under construction and expected to open in 2014.

The picturesque design is inspired by the canyons — “wadis” in Arabic — that meander informally through the lowlands of the regional landscape. The dry wadis’ dramatic rock formations, which are transformed and eroded over time by mountain floods, display the effects of one of nature’s most powerful and life-giving forces — water.

The hospital building is positioned on the high point of the site, which in many cultures is symbolic as a destination for nurturing and healing. Each building’s design replicates the curvature of canyon walls, while roadways and paths wind and converge like water would during rainstorms.

Future expansions to the medical campus will include additional residential accommodations, parking structures, a separate utility plant, a hotel for visiting families, rehabilitation and long-term care facilities and onsite recreational facilities.

The LEO A DALY design team is employing advanced building information modeling techniques to coordinate team tasks, visually represent data, program the geometry of the buildings, perform daylighting analysis, create models of the building materials and select locations for mechanical and electrical systems throughout the facility design.

Takeda Launches New Subsidiary in Peru

Takeda Pharmaceuticals International GmbH ("Takeda") announced further expansion of its presence in Latin America with the launch of a wholly-owned subsidiary in Peru. Takeda Peru S.R.L. will be headquartered in Lima and will be responsible for the sales and marketing of Takeda's products in Peru.

Takeda is building a leading position in Latin America. It has a direct presence in Brazil, Mexico, Argentina, Venezuela, Colombia, Ecuador and now Peru, and is looking at opportunities to further expand its footprint in the region. According to IMS Market Prognosis, pharmaceutical sales in those countries totaled US$60 billion in 2012 and are expected to grow at a compound annual rate of 12.5%* between 2013 and 2017. Takeda plans to outgrow the market over the same period.

Peru is a dynamic and growing market, driven by government investment and strong mining industries. It is estimated that the country's GDP totaled US$ 200 billion in 2012 while pharmaceutical sales amounted to US$1.5 billion and are expected to continue to grow by 8% during 2013*.

In line with Takeda's emerging markets strategy, Takeda Peru is building a product portfolio based on the medical needs of the population, focusing on gastroenterology, cardiology, metabolism, oncology and respiratory diseases. The company will initially focus on Zurcal (pantoprazole), Riopan (Magaldrate + Dimeticone) Faktu (Policresulen, Cinchocaine hydrochloride), and its gynaecology product, Albothyl (Policresulen), which Takeda repatriated following the Nycomed acquisition.

Takeda plans to leverage its Peru sales platform with a steady stream of product launches from its existing portfolio and R&D pipeline.

Julio Cesar Acevedo Orrego has been appointed country manager for Peru. He joins the organization from Takeda Colombia, where he has built up and headed the Takeda Sales and Marketing organization following the acquisition of Farmacol Laboratories. He will lead the start-up team which will grow steadily as the company expands its portfolio and enters new therapeutic areas.

"The launch of our subsidiary in Peru reinforces Takeda's position in Latin America and will enable us to meet the diverse healthcare needs of the population. We have an established product portfolio, which will give us a strong starting point and we look forward to launching our novel medicines into the market," said Norbert Oppitz, Senior Vice President, Latin America, at Takeda. "This investment further demonstrates our commitment to Latin America and its growth potential."

GE Healthcare Life Sciences Opens Technology Laboratory

GE Healthcare Life Sciences, a global provider of tools, technologies and services for life science research and for the manufacturing of biopharmaceuticals, announced the opening of a Technology Laboratory at Stevenage Bioscience Catalyst, the UK’s first open innovation bioscience campus. The GE Healthcare Life Sciences Technology Laboratory, which is equipped with the company’s latest tools and technologies for drug discovery, protein science, and bioprocessing research, was officially opened by Sir William Castell, Chairman of the Wellcome Trust.

Staffed by technical specialists, the new 1000 sq. ft. laboratory will allow GE Healthcare’s UK and European customers to evaluate the company’s technologies as well as benefit from the advanced technical training facilities. The facility will also be open to researchers who are based at Stevenage Bioscience Catalyst, and makes GE Healthcare a significant new part of the open innovation network at the Stevenage campus. This use of GE technologies in an active multi-disciplinary scientific environment will help the company drive the development of new innovations and technologies for life sciences research.

Co-located with GlaxoSmithKline on the Stevenage campus, SBC is a joint venture between the Department of Business, Innovation & Skills, GlaxoSmithKline, the Wellcome Trust and the Technology Strategy Board.

Highlighting the significance of the new laboratory, Dr. Martino Picardo, CEO Stevenage Bioscience Catalyst said, “The opening of the GE Healthcare Life Sciences Technology Laboratory here at Stevenage Bioscience Catalyst is an exciting development for us, providing a state-of-the-art facility for use by our tenants, partners and GE. We are delighted to welcome the company, with its expertise in technology development and commitment to open innovation, to the fast-growing Stevenage campus, and believe the new facility is a great boost to our interest in cell technologies.”

The new laboratory will house a wide range of technologies, including Xcellerex™ tools for biomanufacturing, Wave™ for cell culture, IN Cell 6000 for high content cell analysis, AKTA™ Avant for protein purification and Biacore™ for protein interaction studies.

New KUBio Modular Biopharmaceutical Factory for JHL Biotech

GE Healthcare Life Sciences, a business unit of GE Healthcare (NYSE: GE), and JHL Biotech, a provider of biopharmaceutical process development and manufacturing services, announced that a KUBio™ modular biopharmaceutical factory will be built in China for JHL Biotech. The site for the new factory, which will be fully operational beginning early 2015, is the Biolake Science Park in Wuhan, China.

“In realizing our vision of making world-class biopharmaceuticals affordable and accessible to all patients, KUBio was the natural choice. Utilizing manufacturing innovations was always a key part of our strategy and GE Healthcare’s KUBio delivers the technologies we want, with the technical support and training we need.”

Worldwide demand for biopharmaceuticals, such as antibodies for the treatment of cancer and a new generation of innovative vaccines, is increasing dramatically. KUBio is a new approach to readily establish biopharmaceutical manufacturing capacity by delivering customers a fully functional, ready-to-run bioprocessing facility in 14-18 months, which is significantly shorter than constructing a traditional facility. Pre-designed to meet cGMP requirements, KUBio helps manufacturers, such as JHL Biotech, respond to local healthcare needs and support global customers in bringing life-saving treatments to market more quickly.

GE Healthcare’s innovative turnkey approach will involve the assembly at the JHL Biotech site in Wuhan, China of pre-made modules equipped with GE Healthcare’s world-class technologies for the start-to-finish manufacture of biopharmaceuticals. In addition to GE project-managing the build, members of its experienced Shanghai Fast Trak team will be deployed to validate the equipment and provide training for JHL Biotech staff. After completion, the JHL Biotech KUBio facility will have a floor space of approximately 2,400m² (25,824 sq. ft. ) and will contain a number of 2,000L single-use bioreactors.

Olivier Loeillot, General Manager of Enterprise Solutions, GE Healthcare Life Sciences, commented, “The decision of JHL Biotech’s highly experienced team to select KUBio as the basis of its commercial cGMP biopharmaceutical manufacturing capabilities in China is a fantastic endorsement of our complete, turnkey approach. We look forward to working with them to bring the facility online to serve the fast-moving biopharmaceutical industry. A diverse range of customers, including governments and pharmaceutical companies, are continuing to recognize the breadth, depth, simplicity and flexibility of what we offer with KUBio.“

Racho Jordanov, Co-founder, President and CEO of JHL Biotech, added, “In realizing our vision of making world-class biopharmaceuticals affordable and accessible to all patients, KUBio was the natural choice. Utilizing manufacturing innovations was always a key part of our strategy and GE Healthcare’s KUBio delivers the technologies we want, with the technical support and training we need.”

KUBio is the latest addition to GE Healthcare’s broad offering of world-class tools, technologies and services for the biopharmaceutical manufacturing industry, allowing customers to benefit from a wide range of solutions that can be tailored to meet specific needs, from pilot to commercial scale. KUBio aligns with GE’s healthymagination initiative which focuses on reducing cost, increasing access and improving quality in healthcare.

Sanofi and Transgene Start Construction of New Bioproduction Platform in France

French pharmaceutical firms Sanofi and Transgene have started the construction of the manufacturing platform dedicated to the production of viral vectors such as TG4010, a subcutaneously administered cancer vaccine based on Co-X-Gene Technology.

Being built on the Genzyme Polyclonals site in Lyon, France, the new production unit will cost €10m over two years, with each company financing half the cost.

The new unit will be dedicated to production of viral vectors via a broad range of technologies, including mammalian cell culture up to 1m³ using single use bioreactors, combining the excellence of Genzyme, Sanofi-pasteur and Transgene in Lyon area.

Under the deal, Sanofi will provide to Transgene its know-how in bioproduction and experience in launching biologics.

Transgene chairman and chief executive officer Philippe Archinard said: "Our decision to invest now reflects the increasing confidence in our program, including our cancer immunotherapy candidate, TG4010, for which we recently announced topline preliminary data from a clinical study in non-small cell lung cancer."

Through the Genzyme Polyclonals site for the manufacturing and the CEPIA organization (Commercial & External Partnership Industrial Affairs) for all commercial aspects, Sanofi will act as Transgene's contract manufacturing organization (CMO) and Transgene will be the preferred customer of the platform through 2028.

Following completion, the production unit will be Sanofi's exclusive property that will help it produce a new breakthrough class of APIs (Viral vectors).

Transgene's MUC1 targeted cancer immunotherapy TG4010 uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination.

It is currently under development for the treatment of metastatic non-small cell lung cancer.

Retrofit for Wilton Centre Laboratories

Wilton Centre Laboratories needed to reduce energy demand without compromising on operator safety.

The solution involved:

Upgrade supply units with control and filtration upgrades
Retrofit Variable Air Volume (VAV) to the existing fume cupboards
Install pressure controllers to each laboratory
Initiate fume cupboard diversity into each laboratory
Strip out all the primary extract fans and upgrade secondary fans with VSDs
Installation of energy monitoring units to verify savings and act as MM&T capability

This led to an energy savings delivered: 3,400 MWh

Energy cost savings: £205,000

Emissions reduction: 1,700 tonnes CO₂

EECO2 phased upgrades over three years, carried out complete system redesign, scope and bid proposal on client's behalf, including laboratory user interface and programming. Provided project management for contractors, delivered to budget, on time with zero incidents.

Rexam Opens Extension at French Nasal Pump Plant

Rexam has completed its extension of a French plant that manufactures the nasal spray pump product, Advancia.

Advancia is a drug delivery device that modulates accurate and consistent doses of a drug, even when the pump has not been used for several weeks, a Rexam spokesman said.

The product is set to be manufactured at Rexam’s Le Tréport facility in Normandy, France, following the completion and inauguration of a €20m ($27m) expansion yesterday that sees a new unit measuring 3,750 m² (40,350 sq. ft.), including a new 2,900 m² (31,204 sq. ft.) clean room added to the site, plus additional space to house maintenance workshops and a new metrology department.

“The new year brings the arrival of the equipment we need to manufacture next generation products in the new facility,” said Stéphane Thiaudière, Plant Manager.

As well as the Advancia pump, the site makes other spray pumps and valves for export to more than one hundred countries.

Calbiotech Builds Antibody Manufacturing Facility

Immunotherapy contractor Calbiotech has started work on a dedicated mAb plant intended to broaden its biopharma service offering.

The company’s spokeswoman said the new facility will produce antibodies for both Calbiotech and outside sponsors, and will also develop recombinant antibodies for assays.

The facility will provide immunoassay services to pharmaceutical companies, as well as aiming to discover novel assays.

Collaborations have also already started with diagnostic companies in the US and abroad, she said, which wanted new custom immunoassays to expand their market.

Boccia added that the immunotherapy contractor was suited to a move into antibody production because it had the know-how to create the high-quality antibodies vital to making good assays.

Operations at the new plant will be led by Dr. Jimin Wang, who was recently appointed at Calbiotech’s VP of Research and Development.

Calbiotech VP David Barka said the company expected to debut its first antibodies this year.

DSM Biologics Expands in Australian

Royal DSM has confirmed that its biologics manufacturing operations and new Australian facility will be part of the business merged with Patheon in its agreement with JLL.

In November last year DSM announced that it will combine its pharmaceutical products business (DPP) with contract manufacturing organization Patheon, bringing to an end several years of efforts to find a partner for the underperforming division.

Earlier DSM spokesman Herman Betten said that DSM Biologics – which is part of the firm’s pharmaceutical unit – will be part of the new combined company and that the recently opened biomanufacturing facility in Brisbane would be included.

The plant, which has been operational since June last year, was constructed in partnership with the Australian Institute for Bioengineering and Nanotechnology (AIBN).

Betten also said that the official name of the combined firm – which is currently being referred to as NewCo – will be revealed when the deal is completed.

DSM’s plans for DPP also featured in the Dutch firm’s results released. The business is now listed as a discontinued operation.

The firm said that: “DSM Pharmaceutical Products delivered an improved performance in the quarter, with good volume growth and higher prices being reflected also in good EBITDA growth.

“This performance will support a good start for the value-creating venture with JLL Partners.”

Vetter Invests in New Filling Lines

Vetter, a leading contract development and manufacturing organization (CDMO) for pre-filled application systems, had another growth year in 2013. As evidenced by a growing demand for customer projects in clinical phases and commercial aseptic manufacturing, the CDMO increased sales by more than 10 percent. Currently the company employs around 3,300 people at its German and US facilities. This sustained, positive development by the company was made possible as a result of its high quality and safety standards, as well as investments made across the company's facilities for process optimization.

With an increase in market demand, Vetter responded by strengthening and reinforcing its position as a strategic partner for both the development phase and commercial manufacturing of parenteral drugs. These actions included the increase in its capacities and service portfolio in production sites in Germany and the U.S. The company is planning the implementation of three new filling lines and is also making investments in innovative technologies. Vetter will also continue to optimize its quality management and processes in manufacturing and logistics to support pharmaceutical and biotech companies in meeting market requirements of quality and safety.

Still another reason for the strong growth is the newly launched customer projects at Vetter's Chicago site. Here the company supports its customers in process development and manufacturing of clinical trials during product development. Once the clinical development phases are completed, the product is transferred to the German facilities for commercial production and market supply.

"Increasingly, our customers rely on our expertise and more than 35 years of experience in aseptic filling of injection systems," says Vetter managing director Peter Soelkner. "Next to a reliable production for continuous market supply, we also supported our customers with their complex development projects with our Development Service both in Chicago and Ravensburg."

Biomedical Science Park to be Built in East Midlands, UK

The former AstraZeneca facility on the outskirts of Loughborough, UK is being redeveloped.

Loughborough is the location for a new 70-acre science and technology park, which is being developed on a former AstraZeneca pharmaceutical research and development site.

Jayplas acquired the site in 2012 for an undisclosed sum and the creation of Charnwood Biomedical Campus has already begun.

The Campus will provide 450,000 sq. ft. of multi-purpose, specialist laboratories and equipment, stability cabinets, a pilot plant, offices, warehousing and car parking for up to 1,500 vehicles.

Created on the former AstraZeneca site, which the company vacated in 2010, with the loss of 1,200 jobs, the Campus will build on the location’s 43-year history by creating an innovative and collaborative environment for both established and start-up businesses.

In recent years the Campus has benefited from investment of approximately £400m, including the construction of a £42m safety assessment laboratory in 1996; a £31m process R&D plant in 1998; a £34m pharmaceutical and analytical laboratory facility in 1999; £17m on general infrastructure; a £45m pharmaceutical development facility in 2001; an £11m clinical building; and a £16m biology building in 2006.

Charnwood's owners expect the Campus to attract tenants from a number of sectors including pharmaceuticals, life sciences, healthcare, new technology, R&D, academia and the public sector, creating opportunities to bring jobs back to Loughborough and the East Midlands.

The Campus will attract tenant businesses from new start-ups to established enterprises

Previous R&D activities on the site served to establish Loughborough as a global leader in pharmaceutical R&D excellence. Its legacy and heritage includes an extensive portfolio of marketed drugs and formulations used around the world.

Dominic Young, Director at Charnwood Biomedical Campus, who is leading the site’s redevelopment, commented: 'The Campus will attract tenant businesses from new start-ups to established enterprises that are looking to grow and develop in a dedicated and relevant environment. It will be the ideal location for businesses across a range of sectors including pharma, biotech, academia and government organizations. We have been overwhelmed by the interest so far and negotiations are in the advanced stages with a number of potential tenants.'

The masterplan builds on the existing facilities at the park and further investment and expansion will be made as it grows, he added.

In addition, demolition of some of the old buildings and laboratories will make way for new landscaped areas and facilities that will be available to the wider local Loughborough community, including sport and recreational areas, a cafe with catering facilities, a nursery, and conference and meeting room facilities.

Nicky Morgan, MP for Loughborough and Economic Secretary to the Treasury, said: 'I know many people in Loughborough and nearby have a connection with the former AstraZeneca site and most of us want to see it regenerated and reoccupied. I am delighted that Jayplas is really pushing forward with its plans for the Charnwood Biomedical Campus and deserves lots of credit for first taking on the site, and now working very hard to attract new tenants. This Campus offers a great opportunity for the Loughborough economy and our reputation as a great place to base your business. It is also perfectly located at the heart of the Midlands, supported by the region’s excellent air, rail and road links.'

Chilean University Testing Accredited

A department of the Universidad de Santiago has been certified to run scientific tests in chemistry and microbiology.

The Food Science and Technology Research Center was accredited as a laboratory for the maximum period of four years by the National Institute for Standardization.

Juan Manuel Zolezzi, president of Universidad de Santiago , said the Food Science and Technology Research Center’s (CECTA, Spanish acronym) accreditation by the National Institute for Standardization (INN, Spanish acronym), backs the lab and the university.

“The commitment of our University to science, technology and innovation is faithfully reflected in this laboratory; this is why we are interested in continuing to make this type of organization stronger and we expect this to attract researchers from the University and other institutions,” he said

Claudio Martínez, director of CECTA, described the accreditation as a milestone in the history of the center.

“This decision recognizes our very professional way of working and it open doors for us to undertake more complex projects, together with companies, exporting ones mainly, which we were not able to access before.

“For example now, we can have access to other types of certification, through SAG (Agricultural and Livestock Service) or Sernapesca (Fishing National Service), which are agencies that require previous accreditations.”

McIlvaine Company

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