The Louisiana Office of Facility Planning and Control is planning to build a new natural-sciences building, at Southern University at New Orleans, to replace a building destroyed by Hurricane Katrina.

The new single-story, 72,833 sq. ft. building will contain laboratories, classrooms, meeting and conference spaces, faculty offices and a 120-seat auditorium. Sizeler Thompson Brown Architects is the designer. The estimated construction cost is $27.7 million.

First Choice to Build Ohio General Hospital

First Choice ER-Adeptus Health is planning to build Ohio General Hospital near the intersection of Gemini Place and Orion Place in Columbus. The three-story, 75,000 sq. ft. building will contain a 24-bed hospital with three operating rooms. Ascension Group Architects is the designer, and Freese Johnson LLC is the general contractor. The project is estimated to be between $10 million and $15 million.

National Bio and Agro-Defense Facility (NBAF) in Final Phase

The U.S. Dept. of Homeland Security has awarded an $834-million contract for the third and final phase of the National Bio and Agro-Defense Facility (NBAF) to the McCarthy Mortensen NBAF Joint Venture. The NBAF consists of six two-story buildings, totaling 630,000 sq. ft. and including a 580,000 sq. ft. main laboratory building, a central utility building and a visitors center. NBAF will be a state-of-the-art biocontainment facility, with level-3 and -4 biosafety and vaccine development facilities.

Avid Bioservices' Expansion

Avid Bioservices' expansion will double existing capacity to service both a $40m backlog and its owner Peregrine, which is hoping to commercialize its breast cancer candidate.

Peregrine Pharmaceuticals saw revenues grow 20% y-o-y, mostly due to its contract manufacturing subsidiary Avid Biosciences which reported total sales of $27m (€25m) for the fiscal year 2015.

Management said there was a committed backlog of $40m from existing customers, much of which will be carried out at a new mammalian cell culture facility in California set to come online in the next few months.

“Last December, we laid out strategic plans to expand our manufacturing capacity to help support the revenue growth of Avid,” said CFO Paul Lytle. “I am excited to say that the new facility is close to being ready for production.

“The core manufacturing suite has been built, the equipment has been installed, and it is now undergoing some final testing to ensure all systems are operating effectively,” he told investors. “We remain on track to commence production in this new facility in the very near future.”

While the investment will service its customers, the facility has also been built in preparation of a commercial launch of Peregrine’s own lead candidate bavituximab, a monoclonal antibody (mAb) set to begin a Phase III study in non-small cell lung cancer (NSCLC) later this year.

The new facility was described as a “pivotal event” in the growth of Avid and potential commercialization of bavituximab by CEO Steve King during the call, who added there would be “a nice mix” between in-house and customer utilization.

Argos Therapeutics Biomanufacturing Facility

Argos Therapeutics initiated the construction of a biomanufacturing facility at Research Triangle Park in Durham, North Carolina (NC), US, in October 2014. The facility will be used for manufacturing personalized immunotherapy product candidates that are used for the treatment of cancer, HIV and other serious illnesses. The facility is expected to be operational by the end of 2018.

The new biomanufacturing facility will have a total floor space of 100,000ft². It will include sophisticated equipment for automated manufacturing of Arcelis-based products. It will initially produce Argos' lead oncology product candidate AGS-003, which is being evaluated in the ADAPT Phase III clinical trials for the treatment of metastatic renal cell carcinoma (mRCC).

The project has created 100 construction jobs, while an additional 230 jobs are will be created in future.

The new facility will use Arcelis^® technology platform for automated manufacturing of personalized immunotherapy product candidates. The technology captures altered and different antigens that are specific to each patient's disease. It can help to get rid of tumor- and disease-induced immunosuppression in cancer and HIV by extracting a durable memory T-cell response without using toxic adjuvants.

The process uses a small tumor or blood sample along with the patient's dendritic cells, which can be collected and optimized after a single leukapheresis procedure. It then uses RNA isolated from the patient´s disease sample to program dendritic cells to target disease antigens. The antigen-loaded dendritic cells are formulated into the patient´s plasma and injected intradermally.

The new biomanufacturing facility construction contract was awarded to Keith Corporation. Invetech was contracted to develop and supply manufacturing systems to support production needs for fully personalized immunotherapies in November 2014. The contractual scope includes offering services, technology and equipment to support the design, development, supply and maintenance of customized manufacturing systems.

In January 2015, Saint-Gobain's Performance Plastics division was contracted to provide design, integrate and scale production of a range of disposables for use in the automated manufacturing of AGS-003.

The total estimated investment for the construction of the biomanufacturing facility is $57m. The state of North Carolina, Durham County, the City of Durham, and the North Carolina Biotechnology Center contributed a total of $9.5m incentives for the project.

The incentive package offered by North Carolina department of commerce is $7.1m, which includes a job development investment grant of $4.5m, education and on-the-job training assistance of $600,000, sales tax exemption on qualifying equipment of $1.8m, and a $200,000 Economic Development Award from the North Carolina Biotechnology Center.

The NC Commerce, the City of Durham and Durham County contributed the rest of the $2.35m incentives package, which includes a cash grant of $1.85m and $500,000 in on-the-job training assistance.

Argos Therapeutics is a biopharmaceutical company focused on the development of fully personalized immunotherapies based on Arcelis technology platform for treating cancer and infectious diseases. The most advanced product candidates of the company include AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC), and AGS-004 for the treatment of HIV.

TSO3 of Canada Creates U.S. Sterilization Technology Subsidiary

Canadian sterilization technology company TSO3 has formed a wholly owned subsidiary, TSO3 Corporation, in South Carolina, U.S. to meet the demands of US customers for product, service and education in sterilization processes for medical devices.

The company has leased approximately 6,000ft² (around 600m²) of space in Myrtle Beach, which will house US customer service and clinical education, in addition to acting as a US warehouse and service depot. It is expected to open in August.

TSO3 President and CEO Ric Rumble explained that the company has spent the second quarter of 2015 engaged in developing a formal commercialization process for its Sterizone Sterilization System and together with its sales and service partner, Getinge Infection Control, expects to secure contracts with leading Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs).

'As a result of these efforts, it became clear that it was time to execute our plans to open a U.S. location focused on the education and ongoing service requirements of the US customers,' he said.

'While the foundation and technical expertise of the company is and will remain in Quebec City, establishing a presence in the US, which represents 40 percent of the worldwide market, will allow us to more effectively reach out to and service this high opportunity market.'

The Sterizone VP4 is a dual sterilant, low temperature sterilization system that uses vaporized hydrogen peroxide (H2O2) and ozone. Its single cycle can sterilize a large number and wide range of compatible devices, thereby allowing for a cost effective and error-free sterilization process. TSO3's Dynamic Sterilant Delivery System automatically adjusts the quantity of injected sterilant based on the load composition, weight and temperature. With its 75lb (around 35kg) load capacity and a short cycle time, the Sterizone VP4 Sterilization System can enhance throughput and lower sterilization cost, the company says. The system was cleared for commercialization in the US in December 2014.

Smithsonian Launches Project to Capture Plant Genomic Diversity

The Smithsonian's National Museum of Natural History announced a project to capture the genomic diversity of half the world's living plant genera over a two-year period.

The effort includes the museum's Global Genome Initiative, as well as resources from the US Botanic Garden, the Smithsonian Gardens, the US Department of Agriculture's US National Arboretum, and the Global Genome Biodiversity Network. It comes at a time when the rate of species extinction for all life has been estimated to be up to 100 times higher than normal, the Smithsonian said.

Initially, researchers will gather samples from gardens in the Washington DC area starting with living plant genera within the holdings of the US Botanic Garden, the Smithsonian Gardens, and the US National Arboretum. Field teams will collect plant samples in partner gardens' holdings that originate from across the world, ranging from Hawaii's rainforests to Madagascar's deserts.

Plant tissues will be preserved using the Global Genome Initiative's standardized research-grade genomic sampling protocols and permanently stored in the Smithsonian's biorepository, while the US National Herbarium at the National Museum of Natural History will house a pressed specimen of each plant. The samples will be accessible through the Global Genome Biodiversity Network's data portal.

"Now more than ever, the Smithsonian is dedicated to increasing our knowledge about life on Earth through emerging genomic technologies and capabilities," Smithsonian Interim under Secretary for Science John Kress said in a statement. "Partnering with botanical gardens around the world is an essential step in opening new doors to the hidden benefits that can emerge from the world's plant genomes."

Global Genome Initiative Director Jonathan Coddington said that the collaboration "comes at an urgent time when the scientific community's access to the world's plant genomes — the blueprint of life — is limited due to biodiversity loss and lackluster genomic research infrastructure." He added that the partners are now focused on developing additional collaborations with botanic gardens worldwide "to preserve and unlock the genomic mysteries of plants."

New Kansas State University Bulk Solids Innovation Center

Brookfield Engineering has donated a Powder Flow Tester (PFT) to the new Kansas State University (KSU) Bulk Solids Innovation Center.

This new facility at KSU will be used to study and develop the understanding of bulk solids materials handling, enhancing businesses that use these materials or manufacture the systems that convey, store and dispense them.

The 13,000ft² center features five research laboratories and lecture rooms for hands-on training, education and conferences. This university-level research center is the only one of its kind in North America.

Brookfield's Powder Flow Tester delivers affordable testing for powder flow behavior in gravity discharge from a bin. The PFT provides quick and easy analysis of design parameters for industrial processing equipment.

It is ideal for manufacturers who process powders daily and want to minimize or eliminate the downtime and expense that occur when hoppers fail to discharge.

Customers can use the PFT to perform QC checks on incoming materials, quickly characterize new formulations for flowability and adjust composition to match the flow behavior of established products.

The donation includes the newest version of Powder Flow Pro Software and all accessories for handling powder samples.

Brookfield will also provide the Small Volume Shear Cell, which requires 43cc of powder for formulators who test expensive powders in limited quantities or materials that are difficult or messy to handle.

Genea Biocells Builds Stem-Cell Facility

Australian company, Genea Biocells, will open a facility in San Diego, California for cell and culture-media manufacturing and R&D.

Australian stem cell company Genea Biocells is expanding its operations to the U.S. with the opening of a new facility in San Diego, California. The office and laboratory space in the Torrey Pines Science Park will accommodate the company's cell and culture media manufacturing, research services, and R&D, and is expected to be fully operational by September 2015.

The new site will house over $2 million worth of equipment, including robotics and instrumentation for high-throughput/high-content screening, all of which is instrumental to the company's chemical biology approach and the research services it provides. Genea Biocells' vice-presidents of chemistry and of business development are already based in the US; the company will retain a small team of scientists in Sydney, primarily for the derivation and banking of new human pluripotent stem cell lines.

"The new facility not only places us directly into our main market, the USA, but also in the midst of one of the largest biotechnology clusters in the world," Genea Biocells general manager, Uli Schmidt, said in a press release. "Being in California also offers a new range of funding opportunities that we will explore to support our R&D programs on neuromuscular diseases."

Bristol-Myers Squibb Makes Changes in R&D Locations and Focus

Bristol-Myers Squibb plans to open a new research site in Cambridge, Massachusetts in addition to the ongoing expansion of the company’s R&D Discovery site in the San Francisco Bay Area, the company announced on June 25, 2015. The new facility in Cambridge is expected to open in 2018. The ongoing site expansion in the San Francisco Bay Area adds 61,000 ft2 of laboratory and office space at the Woodside Technology Park life-science campus and is expected to be completed in 2016. Consistent with evolution of the R&D organization’s strategic focus, which was previously announced in 2013, the company also announced its plans to discontinue discovery research efforts in virology. This decision does not impact the company’s promising ongoing clinical development program in virology, nor does it impact the company’s marketed products in virology, according to the press release.

“In addition to investments in central New Jersey, our new location in Cambridge and our expanding presence in the San Francisco Bay Area positions the company and our scientists in the heart of vibrant ecosystems of world class science, innovation, and business opportunities, which offer ideal environments for fostering external collaboration,” said Francis Cuss, executive vice-president and chief scientific officer at Bristol-Myers Squibb. “Ultimately, our goal is to continue to accelerate the translation of scientific knowledge and insights into the next wave of potentially transformational medicines for patients with serious diseases.”

R&D Sites

In Cambridge, Bristol-Myers Squibb scientists will focus on the company’s ongoing discovery efforts in genetically defined diseases, molecular discovery technologies, and discovery platform chemistry. In addition to relocating up to 200 employees from its Wallingford, Connecticut and Waltham, Massachusetts sites, and a limited number from its central New Jersey locations, the company expects to recruit scientists from the Cambridge area. As part of this transition, the Waltham site is expected to close in early 2018. The existing site in Wallingford will also close in early 2018 with up to 500 employees relocating to a new location in Connecticut. Bristol-Myers Squibb and Alexandria Real Estate Equities have a signed letter of intent for the Cambridge location and expect to sign a lease in the near future.

The Woodside Technology Park life-science campus in the San Francisco Bay Area serves as Bristol-Myers Squibb’s Discovery hub for researching breakthrough cancer immunotherapies. With additional square footage leased, Bristol-Myers Squibb will fully occupy two of the three buildings at the campus totaling 194,100 ft2 and will provide additional capacity to conduct biologics drug discovery research. In addition to relocating approximately 40 Bristol-Myers Squibb scientists from its Seattle, Washington site, the company will also recruit scientists from the Bay Area.

Consistent with the evolution of the company’s R&D strategic focus, which was announced in 2013, the Discovery organization will discontinue its research efforts in virology. This includes early research in hepatitis B (HBV) and HIV. Approximately 100 Discovery positions will be eliminated as a result of these changes.

The decision to discontinue Discovery research in virology does not impact the company’s ongoing development programs in virology, which includes the HIV attachment inhibitor BMS-663068, the HIV maturation inhibitor BMS-955176, beclabuvir, and the anti-PD-L1 compound BMS-936559, or the company’s marketed virology medicines, including Baraclude (entecavir), Reyataz (atazanavir)/Evotaz (atazanavir and cobicistat), Sustiva (efavirenz), Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate), Daklinza (daclatasvir), and Sunvepra (asunaprevir). Bristol-Myers Squibb also remains committed to the registration and commercialization of Daklinza around the world, the company said in the press release. Bristol-Myers Squibb’s Discovery organization will continue to focus on research in immuno-oncology as well as heart failure, fibrosis, genetically defined diseases, and immunoscience.

REST OF WORLD

Cell Therapy Manufacturing Center to be built in UK

The Cell Therapy Catapult, which is focused on the development of the United Kingdom cell therapy industry to increase the nation's health and wealth, has chosen to build its £55m ($86 million) manufacturing center in Stevenage, UK. The UK Cell Therapy Manufacturing Centre, which is expected to open in 2017, will be managed by the Cell Therapy Catapult and will be used for manufacture of late-phase clinical trial and commercial supply of advanced therapeutic medicinal products including cell and gene therapies.

Its position on the Stevenage Bioscience Catalyst campus will provide additional inward investment from global companies, as well as support biotech and life-sciences companies based in the UK. The large-scale manufacturing facility is expected to create up to 150 jobs. “We’re excited to be making this announcement, which demonstrates the investment the UK government is making to advance the industry into becoming a world leader in advanced therapy development and commercialization," said Keith Thompson, CEO of the Cell Therapy Catapult, in a press release. "This facility will complement the existing UK capability, enabling companies to operate at the scale needed for Phase III clinical trials, and we look forward to working with global scientific and medical communities to assist in their research into products that have the potential to address many unmet medical needs.”

The Cell Therapy Catapult is part of a family of Catapults, which are not-for profit, independent centers that connect businesses with the UK's research and academic communities. “This is an exciting development for the Cell Therapy Catapult and an important next step in the establishment of the UK as a global manufacturing center for the cell therapy industry," said Iain Gray, chief executive of Innovate UK. "The choice of Stevenage follows a rigorous selection process to ensure the right location for this important facility. The new center is a further endorsement by the Government of the Catapult model following the Hauser review and recommendations that were published last month."

The Cell Therapy Catapult also launched its Advisory Panel, comprising 15 academic and industry leaders, the group announced in a Dec. 18, 2014. The panel's initial meeting discussed a range of topics, including anticipated trends in cell therapy over the next decade, the development of the UK Cell Therapy Manufacturing Centre, and optimizing academic engagement.

Shantha Constructs Insulin Facility in India

Shantha, a Sanofi Company, began construction of an insulin manufacturing facility near Hyderabad, India, the company announced in a Jan. 29, 2015 press release. The facility is located in Muppireddipalli, in the state of Telangana, and will help address local and international demand. Sanofi's existing plant for its Insuman branded product is in Frankfurt, Germany. Sanofi will invest INR 460 crores (nearly 75 million USD) in the facility in India, and the site should be fully operational by 2019.

“I am delighted that Sanofi has decided to manufacture Insuman insulin in Telangana state, so that it helps the 65 million diabetics in India have better access to affordable insulin," said Honourable Chief Minister Shri K Chandrashekar Rao, according to the press release. "We are shortly going to launch a new industrial policy that will fast track projects and make Telangana one of the most favored destinations, for investments, in the world.”

“Laying the foundation stone for the Insuman insulin manufacturing site is an important milestone in our journey, at Shantha, to improve public health in India," said Harish Iyer, CEO of Shantha Biotechnics, in the press release. "For the first time, we will be able to manufacture insulin, in cartridges, here. The new high technology facility will benefit from our existing biotechnology production expertise. This state-of-the-art facility will have the capability to ramp up manufacturing volumes to 60 million Insuman cartridges per year, within two to three years of commercial manufacturing.”

Astra Zeneca, OSD Facility Design, China

PM Group is currently providing engineering design and procurement services for the Phase III repurposing of the AstraZeneca OSD facility design in Taizhou. This is an existing (64,560 sq. ft.)6,000 sq. m. sterile fill finish facility which AstraZeneca intends to redevelop as an OSD manufacturing facility.

We have been supporting this project from the very early stages, providing engineering design for the concept, basic and detailed process design phases. Currently, the project is in the construction phase, where we are providing procurement of process equipment, construction support and commissioning and qualification services.

The project involves a phased development commencing with the capacity of 500 million tablets per year and increasing to 1 billion tablets per year in the near future. The site is intended to be fully operational by the end of 2016.

Genzyme, Bulk Biologics Manufacturing Development, Belgium
In Geel, Belgium, PM Group was responsible for the design and construction management of a new cell culture and purification facility for Genzyme BVBA (a Sanofi Company).

The new €250m facility was developed to support the long-term growth of Myozyme^® and Lumizyme®, medications for the treatment of Pompe disease. The 23,000 sq.meters

(247,480 sq. ft.) building effectively doubles the manufacturing capacity of the Geel site and includes 8,000 liters of production capacity, a complete purification installation and capacity for future expansion.

PM Group Scope of Services:

· Project Management

· Feasibility Studies

· Concept Design

· Preliminary Engineering

· Permitting

· Detailed Architectural and Engineering Design

· Contract and Equipment Procurement

· Construction Management

Previously, PM Group had successfully delivered EPCMC services for several expansions and upgrades at the site, but this was by far the largest single investment at the Geel facility.

Pfizer to Close Mumbai Manufacturing Facility

With no active production at the plant since 2013, the company said it would shutter its Mumbai, India-based facility in mid-September, according to a Bombay Stock Exchange filing.

“The decision to close the Plant is based on an assessment of its long term viability and its ability to achieve the needed production,” Pfizer said. “There has practically been no production activity at this plant since 2013, and the closure will not impact the supply of any of the company's medicines to patients.”

All of Pfizers' employees at the 50-year-old plant were offered a voluntary retirement scheme last year, and 132 out of 212 took the option. The company said the remaining workers continue to receive full wages despite the plant’s inactivity.

The closure comes as Pfizer’s recent acquisition of Hospira brings along with it an injectables plant in the Andhra Pradesh region of India, which earlier this month got the go-ahead from the FDA to begin commercial production.

Quotient Clinical Expands Pharma Capacity

Quotient Clinical is expanding its pharmaceutical sciences capabilities, doubling capacity through the acquisition of a second GMP manufacturing facility and the construction of new formulation development and pharmaceutical analysis labs.

The new labs, based within the company’s Nottingham facility, will provide formulation development services with a footprint of approximately 8,000 sq.-ft. The new GMP manufacturing facility, located in the MediCity innovation hub in Nottingham, has a footprint of 3,000 sq.-ft. and comprises eight multipurpose suites for the manufacture of drug products on a large scale, with the necessary containment controls to handle high potency molecules. The facility is scheduled to become operational later in 2015 following an MHRA inspection.

Mark Egerton, chief executive officer Quotient Clinical said, “This expansion is in direct response to the increasing demand for our Translational Pharmaceutics services. Our approach of integrating formulation development, real-time GMP manufacturing and clinical testing is proving an attractive option to reduce development timelines and associated costs.”

Almac opens Clinical Trial Supply Facility in Singapore

Almac has successfully completed the Health Sciences Authority (HSA) inspection of its new Asia Pacific headquarters in Singapore, having met standards of safety, quality and efficacy for GMP certification.

The newly opened facility expands Almac’s suite of clinical trial primary and secondary packaging, distribution, technology and consultation solutions offered in the region. The Singapore facility has full-service equipment including primary packaging rooms, secondary packaging areas, frozen storage, label control room, a Just-in-Time (JIT) labeling suite and non-GMP storage area.

“Asia Pacific is a vital region for us, as currently 23 percent of global clinical trials for new pharmaceutical products are being conducted here. By basing our regional headquarters and operations in Singapore, we are better equipped to support our Asia-based clients in their own time zone and languages,” said Dr. Robert Dunlop, president and managing director of Almac’s Clinical Services business unit. “With the opening of our new Singapore facility, we are directly supporting studies run by regional and global pharmaceutical firms by providing critical manufacturing, packaging, supply chain management and Interactive Response Technology (IRT) support services in Asia Pacific.

Aptuit Expands

CDMO (contract development and manufacturing organization) Aptuit is investing in additional scale and capabilities at its Italian site to augment its 1600L scale API capability and to add a commercial GMP license.

The expansions are centered on formulation development, analytics and clinical manufacturing to serve Phase III clients and those looking toward commercialization. The company’s integrated CMC (chemistry, manufacturing and controls) solutions, which are currently used by many of the top 20 pharma companies, will now be able to produce commercial APIs as well as capsules and tablets at batch sizes in the range of millions, which should be sufficient for Phase III and commercial purposes.

Aptuit is also adding lab scale nanomilling, hot melt extrusion, and spray drying capacity equipment including SEDDS/SMEDDS (Self-microemulsifying drug delivery system) technology.

The company’s solid-state chemistry and analytical functions across its Italy site will also benefit from XRPD (X-Ray Powder Diffraction), new surface area equipment and Z Potential/Dynamic Light Scattering as well as two new HPLC (high performance liquid chromatography) systems.

Johnathan Goldman, CEO of Aptuit, explained that the company is seeing a shift in industry where clients are beginning to prefer “this under-one-roof solution, rather than having to get API and drug product from multiple places” and companies.

“We didn’t choose to go into this market, it came to us via existing customers,” Goldman said, noting that customer demand was the driver of the expansions, which also added an unspecified number of new employees to the Italian facility.

“We have now received many requests to support programs to Phase III and beyond NDA (new drug application) filing to product launch. The expansion of capacity, numerous capital investments and adding GMP license is part of our strategy to leverage our core competency of integrated early Phase CMC to fully integrated CMC at commercial scale. We will deliver these services from our fully integrated CMC facilities in Verona, Italy, and Oxford, UK,” he added.

Goldman also said the company is expecting to finalize “a couple of acquisitions” in the coming months, though confidentiality issues stopped him from elaborating more.

The EU launched Program at Six Facilities for Nanomedicines

The European Nanomedicine Characterization Laboratory (EU-NCL) launched, with the goal of speeding up nanomedicine candidates’ path to clinical trials and approvals, for the “benefit of patients and the European pharmaceutical industry.”

An analytical facility set up within the Particles-Biology Interactions unit of Swiss Federal Laboratories for Materials Science and Technology in Switzerland is the first of six planned sites which will offer access to existing characterization services to public and private drug developers.

The project will be funded over the next four years by the EU program Horizon 2020, and by institutions in nine countries:

· CEA-Tech in Leti and Liten, France;

· Joint Research Centre of the European Commission in Ispra, Italy;

· European Research Services GmbH in Münster, Germany;

· Leidos Biomedical Research, Inc. in Frederick, USA;

· Trinity College in Dublin, Ireland;

· SINTEF in Oslo, Norway;

· University of Liverpool in the UK;

· Empa, the Swiss Federal Laboratories for Materials Science and Technology in St. Gallen, Switzerland;

· Westfälische Wilhelms-Universität (WWU) and Gesellschaft für Bioanalytik, in Münster, Germany.

The partnering institutions will provide a “trans-disciplinary testing infrastructure,” said the coordinators, covering preclinical characterization assays (physical, chemical, in vitro and in vivo biological testing), to help nanomedicine researchers understand the drugs’ biodistribution, metabolism, pharmacokinetics, safety profiles and immunological effects.

The organizers said EU-NCL will also foster use of standard operating procedures (SOPs), benchmark materials and quality management for the preclinical characterization of medicinal nano-products.

“Yet another objective is to promote intersectoral and interdisciplinary communication among key drivers of innovation, especially between developers and regulatory agencies,” they said.

The information will be accessible to “all organizations developing candidate nanomedicines prior to their submission to regulatory agencies to get approval for clinical trials and, later on, for marketing authorization.”

EU-NCL says it is prepared to adapt to the needs of national medicines agencies to help bring drugs to market. It is partnered with the US National Cancer Institute’s Nanotechnology Characterization Laboratory (US-NCL) for “faster international harmonization of analytical protocols.”

The lab is also closely connected to national pharma regulators and the European Medicines Agency “to continuously adapt its analytical services to requests of regulators.”

“EU-NCL is designed, organized and operated according to the highest EU regulatory and quality standards,” said the lab.

Scott McNeil, Director of US-NCL, said the American institute was excited to be part of the cooperative transatlantic project:

“We hope this collaboration will help standardize regulatory requirements for clinical evaluation and marketing of nanomedicines internationally. This venture holds great promise for using nanotechnologies to overcome cancer and other major diseases around the world.”

Pfizer Opens Chile-Based Precision Medicine Center

Pfizer officially opened the new Center of Excellence in Precision Medicine (CEPM) on July 8 in Santiago, Chile.

Precision medicine is a form of healthcare where disease treatments are customized for individual patients based on their genetic profile.

CEPM’s goal is to create and validate new technology platforms that can precisely diagnose cancer through genomic sequencing without resorting to invasive procedures.

Investigating lung cancer will be CEPM’s first endeavor.

“Non-small cell lung cancer, which we will be analyzing at CEPM during its initial phase, has a high incidence in Chile and the region. In Chile, it is estimated that there are between 1,800 and 2,100 cases a year,” said Sylvia Varela, president of Pfizer Oncology in Latin America, in a statement.

Thermo Fisher Scientific, CEPM’s technology partner, will give CEPM access to its ION personal genome machine (PGM), a genetic sequencer, to kick-start the research process.

President of Thermo Fisher Scientific Latin America Roberto Mendes noted the Ion PGM was chosen for this endeavor because “it is a revolutionary DNA sequencer that uses next-generation sequencing technology to perform full analysis.”

The official announcement didn’t specify as to what the timeline would be for this research, but it assured all studies conducted at CEPM would meet the standards required by international regulatory agencies.

Expansion of Boehringer Ingelheim Research Institute of Molecular Pathology (IMP)

The construction of a new research premises for the Research Institute of Molecular Pathology (IMP) began in March 2015 at the Vienna Biocenter in the third district of Vienna, Austria's capital city.

The project is fully sponsored by Boehringer Ingelheim, which will invest €50m ($54.53m) for the construction. The new building, which will be completed by the end of 2016, is expected to be a leading research institute in molecular biology on a global scale.

The IMP building will have a total floor space of 15,000ft². It will have gross built area of 14,945m² and gross built volume of 66,854m³. It will accommodate 250 researchers from 35 nations and be provided with sophisticated laboratories and office space.

The building will include a five-story atrium under which the office and laboratory areas will be arranged. It will house a spacious lecture hall, server room, a workshop and a cafeteria.

A smooth glass façade will stretch up the atrium from the ground to the fourth floor. The façade will be transparent in the open areas. A bridge will be used to connect it with the neighboring building, so that the entire infrastructure will be used.

The facility will open up new possibilities to further develop Vienna Biocenter in future. It will bring about improvements in infrastructure, flexibility and new communication opportunities to achieve scientific results.

The facility will be used to carry out research in cell and molecular biology, neurobiology, disease mechanisms and computational biology. It will be used for the discovery of fundamental molecular and cellular mechanisms underlying complex biological phenomena.

It will focus on carrying out research on neural circuits in drosophila auditory perception and memory in the neocortex, spatio-temporal specificity of miRNA function, and stem cell commitment in haematopoiesis circuit mechanics of emotions in the limbic system.

The research topics will include symmetry breaking during cell polarization, learning and memory in drosophila, in addition to the molecular basis of migration, and molecular machines and mechanisms of protein quality control and antibody diversification.

Other areas of research focus will include systems biology of regulatory motifs and networks, molecular mechanisms of kinetochore function, mitosis and chromosome biology, and finding and probing cancer drug targets using advanced in-vivo RNAi.

The contract to design the new IMP building was awarded to ATP architects engineers, an Austrian-based company. The building construction contract was awarded to PORR, which is also an Austrian company.

The IMP building will be constructed using building information modeling (BIM) and will comply with environmentally friendly methods. It will have a resource-saving energy concept, which will facilitate the recycling of most of the energy used in the building.

Hospira's Vizag Plant Begins Sterile Production

Hospira has begun commercial production at a sterile injectable plant in Vizag, India hit with several 483 forms after the U.S. FDA deemed the site ‘acceptable’.

The 1.1m sq. foot Visakhapatnam facility (known as the Vizag plant) in the Andhra Pradesh region of India has been delayed in commencing production by a number of Form 483s from the U.S. Food and Drug Administration (FDA).

But in an SEC filing last week Hospira announced its response to the latest 483 – which contained 14 observations relating to an inspection in February this year – had resulted in the Agency deeming the plant “acceptable for the manufacture of finished dosage drugs”.

“As a result of this action, the Company may receive U.S. product approvals from this facility in the future,” the filing continued. “Hospira responded to the Form 483 on March 18, 2015, and submitted additional support documentation on May 29, 2015. The inspection was found to be acceptable following the FDA’s review of the company’s responses and support documentation.

The firm – which is set to be acquired by Pfizer for $17 billion – had also received a 483 with ten observations in the first quarter 2014.

Speaking at the time, CEO Michael Ball said he had expected the plant to come on line by the end of 2014 but then the plant received the second 483 in January.

Hospira’s second sterile manufacturing plant, the Irungattukottai (IKKT) in Chennai, has also had regulatory issues having been subjected to an FDA Warning Letter in 2013 , citing a number of cGMP violations.

Biogen Plans Manufacturing Plant in Switzerland

Biotech company Biogen plans to invest one billion Swiss francs ($1.1bn) in Solothurn, Switzerland to build a new production plant that will create about 400 new jobs beginning in 2019.

The announcement comes as Biogen believes rising demand for its current products, as well as potential demand from developing candidates, creates the need for additional manufacturing capacity.

“Right now we have signed an ‘intent’ to build this facility, but it has not yet been approved by the community in Solothurn,” said Biogen spokeswoman Kate Niazi-Sai. “This announcement is part of our plan to bolster our current drug supply network to meet anticipated future demand for our products.”

The planned facility would support the company’s other manufacturing site in Denmark, as well as its presence in Cambridge, Massachusetts and Research Triangle Park, NC.

Niazi-Sai added that the company has yet to reveal what products will be manufactured at the site or the types of equipment that will be deployed. The company, which has had a presence in Switzerland for a decade, currently employs 300 there.

Biogen’s current products help to treat multiple sclerosis and hemophilia, while its pipeline includes treatments for Alzheimer's and spinal muscular atrophy.

Novasep to Build Integrated ADC Facility

Novasep plans to invest €10 million to build a fully integrated Antibody Drug Conjugate (ADC) facility at its Le Mans site in France. The new facility will complement its current ADC offering with full bio-conjugation services.

The facility, to be built in 2Q16, will provide contract manufacturing in batch sizes from a few milligrams to 600g to ADC drug developers during clinical trial and commercial development phases.

“Combining chemistry and biology is not a given. Novasep is one of the few CMOs able to produce both commercial scale ADCs payloads and monoclonal antibodies,” said Thierry Van Nieuwenhove, president of Novasep’s Synthesis BU. “Customers are now searching for a simplified supply chain to produce their ADC and other bio-conjugate drug substances. By integrating our R&D, analytical and manufacturing services within a single unit, we can give customers flexibility, assurance of supply and continuity in supply chains.”

According to the company, the new ADC facility will be capable of producing ADCs in full compliance with the highest standards in quality and safety.

REACH Separations Expands

REACH Separations plans to double lab space at its headquarters in Nottingham UK and is investing in analytical equipment and purification systems. Growth for purification is being driven by increased demand for chromatography capabilities from the drug discovery, contract research and agrochemical sectors across Europe.

Phil Abbott, technical group director said, “This venture is a major milestone for our organization and essentially enables us to do more of what we’ve already been doing over the last few years, but at even greater speed for even more customers. Our clients typically require purified materials as quickly as possible. Our expanded resource and capacity will allow us to work at increased speed to help reduce screen time and get compounds back to clients even quicker, helping meet tight deadlines.”

The company’s growth has also been bolstered by a strategic alliance with Evotec that provides ongoing purification, analytical and small molecule chromatography in support of Evotec’s pharma and biopharma clients.

Reach supports clients in the fields of chiral, reverse phase and normal phase chromatography from mg scale to in excess of 500g.

BioClinica Expands European Ops

BioClinica, Inc. is opening new and expanded offices in London and Munich that will offer clinical trial services including medical imaging, site training and support, and eClinical product lines.

Together, the London and Munich offices offer a combined space of 1,400 square meters

(15,064 sq. ft.) to support clinical trial services across key therapeutic areas. With a focus on medical imaging, the European offices will have an advanced image analysis center for its network of European radiologists and imaging specialists.

"Our new offices will serve as important hubs that enable efficient delivery of tailored resources to our European and Global clients" said John Hubbard, BioClinica's chief executive officer. "Infrastructure investments and the recruitment of local scientific, medical, and regulatory expertise highlight BioClinica's firm commitment to supporting clinical drug development in Europe."

Colorcon Adds Lab in Beijing

Colorcon has announced that the company opened a new technical service laboratory in Beijing, China on June 25. Located in the Beijing YiZhuang Biomedical Park, the technical center is the company’s second facility in China and 19th worldwide.

Equipped for research-scale solid dose development, the laboratory support the development and commercialization pharmaceutical drug formulations from initial product concept, to pilot scale trials through to final production and registration.

The company established Shanghai Colorcon Coating Technology Limited in 1993 and made additional strategic investments in China in a supply chain and the local manufacture of Opadry film coatings.

GSK to Expand Production in Singapore

GSK will invest £38M (S$77M) in its Quality Road manufacturing plant in Singapore to construct an additional downstream isolation facility for production of amoxicillin, the company announced on June 25, 2015. The addition will increase production by 50% and help the company meet the growing demand for antibiotics in emerging markets, GSK said. The Quality Road enzymatic manufacturing facility is GSK’s sole production site for amoxicillin, the active compound used in the manufacture of antibiotics. The investment marks an important milestone in GSK’s partnership with Singapore’s Economic Development Board (EDB) and is a key element of the GSK–EDB 10-year Singapore Manufacturing Roadmap announced in 2012.

The facility's design is a sustainable approach to the manufacture of amoxicillin and is consistent with GSK’s commitment with the EDB to improve the efficiency of pharmaceutical and fine-chemical manufacture in Singapore. The facility uses enzymatic technology rather than older chemical processes, which reduces carbon footprint by up to 25%. The improved process involves fewer steps under milder conditions and uses less organic solvents, resulting in the elimination of almost 80% of the organic waste associated with the older chemical process, while maintaining product quality standards, says the company.

"This latest investment in sustainable manufacturing and our recent investment announced in October 2014 for a continuous manufacturing facility in Jurong, which produces one of GSK’s key active pharmaceutical ingredients, demonstrates our commitment to ensuring that patients around the world receive the medicines they need and also underscores our shared vision with the EDB to improve the technical capabilities of Singapore’s biomedical science sector," said Roger Connor, president of Global Manufacturing and Supply, said GSK.

"Singapore is a leading global location for best-in-class biopharmaceutical manufacturing," said Yeoh Keat Chuan, managing director of the Singapore EDB. "This project, which is part of the GSK–EDB 10-year manufacturing roadmap, is aligned with Singapore’s vision to become a key site for research, development, and industrialization of cutting edge pharmaceutical manufacturing technologies. This will further enhance the efficiency and competitiveness of Singapore. We are proud to be a partner to GSK in creating the future of pharmaceutical manufacturing."

AstraZeneca Signs JV to Build Manufacturing Facility in Algeria

AstraZeneca has partnered with two Algerian companies, AHT Health and Hasnaoui Finance, to create a joint venture with the aim of building a new $125m manufacturing facility in Algeria.

The plan is for the new facility to formulate AstraZeneca medicines from multiple therapeutic indications, including those covering cardiovascular diseases, gastroenterology, oncology, and diabetes.

AZ will control 49 percent of the JV, as required by Algerian law, with the long term goal of building a facility that can produce a “significant portfolio of innovative medicines," according to Said Habib Bennaceur, AstraZeneca North West Africa President.

AstraZeneca initially set up operations in Algeria in 2007 and now has almost 180 employees there. This latest project is expected to create about 104 direct jobs and 231 indirect jobs, according to the companies.

Other major drug-makers, such as Sanofi, have also set up manufacturing operations in Algeria.

Illumina has New European Headquarters in Cambridge

BioMed Realty Trust announced that Illumina has signed a 20-year lease for a new research building and European headquarters in Cambridge, England.

"This new state-of-the-art European Headquarters will provide enhanced collaboration opportunities for our growing employee base, which is so foundational to Illumina's innovation and success," said Illumina CFO Marc Stapley.

The building will be housed in Granta Park, a scientific research center eight miles away from Cambridge University that is owned, managed, and operated by BioMed Realty Trust. The real estate firm said in a statement that it acquired the land for the Illumina building from the Welding Institute under a long-term ground lease.

Illumina will have the ability to expand the 155,000-square-foot building by 70,000 square feet, BioMed Realty Trust said.

According to a document filed by Illumina with the US Securities and Exchange Commission, the aggregate rent during the initial term of the lease is expected to be approximately £94 million ($148.1 million)

In January, Illumina signed a 15-year lease with BioMed Realty Trust for a 360,000-square-foot campus in Foster City, California.

Apceth has New GMP Cleanrooms

German-based contract manufacturer Apceth has received regulatory approval to use two new GMP cleanrooms for aseptic processing, which will be used for the handling and genetic manipulation of various types of cell and gene therapies.

The expansion will now see the company with manufacturing capacity of 600 m2 (6,456 sq. ft.). The GMP inspection was conducted by the Bavarian State Authorities and the German regulatory agency Paul-Ehrlich-Institute (PEI).

The subject of the inspection was two products, which are now included in Apceth's GMP manufacturing license. The first is Agenmestencel-L, apceth's allogeneic genetically modified mesenchymal stem cells (gmMSCs) for solid cancer. The second product is a genetically modified ATMP (advanced-therapy medicinal product) that Apceth is manufacturing at clinical GMP grade for an unnamed client.

“The expansion will ensure that we remain one step ahead of the manufacturing capacity demands of our current and new clients, as well as for our own therapeutic pipeline,” said Ulrike Verzetnitsch, Apceth CTO and former Director of Production at Baxter and Takeda.

TxCell Opens Cell Therapy Pilot Plant

TxCell will enhance operator training and dedicate more resources to quality monitoring at the cell therapy facility where it halted production.

The French firm temporarily suspended production at its pilot plant in Besancon to eliminate the potential risk that cell therapies made at the site become contaminated by microbes.

COO Miguel Forte said TxCell took the precautionary action after French regulator ANSM (Agence Nationale de Sécurité du Médicament) told it environmental monitoring could be improved.

“Even though no product contamination was identified it was agreed with ANSM to interrupt the production of on-going manufacturing batches and not proceed with new product releases” Forte said, adding that TxCell had been allowed to ship existing product to patients in an ongoing trial.

TxCell has initiated enhanced training for operators and introduced more stringent material sterilisation measures in manufacturing areas according to Forte, who said “more resources are being dedicated to manage the quality system, document and monitoring activities.”

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