Univ. of Delaware officials are celebrating the school's first new lab in nearly 20 years. The 194,000 sq. ft., $132 million Interdisciplinary Science and Engineering Laboratory building will house teams from the colleges of Engineering, Arts and Sciences, Agriculture and Natural Resources and Earth, Ocean, and Environment, often inside the same shared space.

The building features two wings connected by a catwalk. In one wing there are classrooms and educational labs and the other wing houses professional labs and office space for researchers. Officials hope to attract business to the state by offering access to high-tech labs and equipment, including a 10,000 sq. ft. nanofabrication lab.

The advanced technology, classrooms and individual lab rooms are expected to be a draw for out-of-state talent. The goal of ISE Lab is to provide the flexible teaching spaces, advanced research labs, cutting-edge equipment and collaborative common areas needed to inspire a new generation of science and engineering professionals.

Covance to Expand Central Labs

Covance’s central labs unit has teamed up with NeoGenomics in a second genetics-focused collaboration.

The ‘exclusive alliance’ – details of which were not disclosed – will allow Covance customers to access NeoGenomics pathology and histology (APH) services, which include techniques like immunohistochemistry (IHC), fluorescence in-situ hybridization (FISH) and molecular analysis.

The preclinical contract research organization (CRO) will also set up a services laboratory at NeoGenomics’ facility in Fort Myers, Florida, US, which will help cut timelines according to Paul Kirchgraber, VP of laboratory operations and medical affairs.

“Providing these integrated services through the Covance laboratory co-located within NeoGenomics results in improved turnaround times critical to oncology clinical trials.”

This was echoed by NeoGenomics’ CEO, Douglas VanOort, who said: “Our oncology-focused genetic and molecular testing services are a perfect complement to Covance’s extensive laboratory services and will allow NeoGenomics to rapidly grow its clinical trials business.”

The deal comes hot on the heels of Covance’s agreement with Pathoquest which, like the NeoGenomics collaboration, is focused on using advanced genetic analysis techniques to accelerate and improve product development.

The NeoGenomics deal also follows just a few weeks after Covance CEO Joseph Herring credited the firm’s central business with growth the firm achieved in the third quarter.

The partnership with NeoGenomics – which will also see the firms “expand joint capabilities globally at Covance's central laboratory locations in Shanghai, Geneva, and Singapore” – further underlines that the CRO sees this part of its business as very important.

UCSF, Kaiser Permanente Launch Translational Genomics Ethics Center

The University of California, San Francisco, Kaiser Permanente, and the UC Hastings School of Law will use a $780,000 grant from the National Human Genome Research Institute to create a new center that will focus on the ethical, legal, and social implications of the use of genomics in healthcare.

Kaiser Permanente and UCSF have a history of working together in human genomics research. They have collaborated since 2008 on the Research Program on Genes, Environment, and Health, a biobank of over 200,000 genetic samples from Kaiser Permanente Northern California members that is being used in epidemiological studies of genetic and environmental influences on health and disease.

Their new joint effort, the Center for Transdisciplinary ELSI Research in Translational Genomics (CT2G) is a three-year project. The center will be co-directed by Barbara Koenig, a professor of medical anthropology and bioethics at the UCSF School of Nursing, and Carol Somkin, a research scientist in the Kaiser Permanente Division of Research.

The CT2G will work to create cooperation among a range of stakeholders, including researchers, policymakers, and clinicians from a range of fields and specialties, and it will seek to develop plans for how to educate the next generation of these stakeholders about the ELSI issues involved in genomics and address questions about genomic data privacy.

"A decade after the human genome was fully mapped, figuring out how to translate genomic findings into prevention and clinical care has become a public health priority," Koenig said in a statement.

"How do we take basic scientific findings, like mapping of the human genome, and transform them into applications that can help us better understand the causes of disease, their prevention and treatment?" Koenig asked.

"These new genomic discoveries raise complex ethical and social issues," added Julie Harris-Wai, associate director for the new center and a staff scientist in the Kaiser Permanente Division of Research.

"We have to be able to work across many disciplines to get something that's useful to individuals," Harris-Wai said. "We will identify target areas and work collectively to come up with guidelines and advice for translating genomics information into clinical care."

Boston Research Institutes, Hospitals Launch Clinical Genomics Center

A quartet of Boston-area research centers including Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston Children's Hospital, and the Broad Institute have teamed to create a new clinical cancer genomics center that will be headquartered at Dana-Farber.

Dana-Farber said that the new Joint Center for Cancer Precision Medicine will harness a wide range of scientific resources and clinical capabilities from the partners to treat cancer patients and feed treatment data into research programs. The multiple capabilities these partners will share and use in the new center include DNA sequencing and other tumor molecular profiling tools, pathology, radiology, surgery, computational interpretation, and tumor modeling systems, they said.

"The center is creating a new capability to use these huge resources in sequencing and pathology and making sure the data gets to caregivers to help customize cancer treatment," Dana-Farber President Edward Benz said in a statement.

A core part of the center will be a program to obtain and characterize biopsies from patients during treatment by looking at the tumors' DNA, RNA, and proteins.

The center also will create a computational biology working group that will spread across Dana-Farber, Broad, and Brigham and Women's Hospital and will include biologists, bioinformaticians, and software designers to develop algorithms aimed at interpreting genome sequencing data.

The partners also plan to support a translational innovation lab that will pursue studies on actionable cancer mutations and drug resistance, as well as preclinical studies of targeted drug combinations. In addition, they will work with members of the Profile cancer genetics research study, a project already launched by Dana-Farber and Brigham and Women's that is focused on analyzing tumor DNA and creating a database of relevant mutations.

The CanSeq study, a whole-exome sequencing effort involving Dana-Farber, Brigham and Women's and Broad investigators, will become "an integral part of the new center," as researchers plan to study the value of whole-exome sequencing in cancer treatment, Dana-Farber said. Currently, the CanSeq partners are sequencing the whole exomes of 50 lung and colon cancer patients as part of a pilot phase.

"This center will allow us to be optimally positioned to answer the big questions in cancer genetics, especially as they affect clinical decision-making," said Levi Garraway, an associate professor at Dana-Farber and the new center's director, as well as head of the CanSeq study.

"We seek to understand which genetic and other molecular alterations predict how tumors will respond to targeted drugs, why some patients become resistant to drugs, and what that means about the treatments that should be tried next," he added.

Building Environmental Rooms for a Nobel Prize Winner

Suffolk built environmental rooms as part of the overall construction of the $400 million Albert Sherman Center, a 512,000 square-foot biomedical research and education facility located on the University of Massachusetts Medical School campus in Worcester, Mass.

The facility is the centerpiece of the state’s multi-year life sciences initiative, and will continue to house the research activities of Dr. Craig Mello, who received the Nobel Prize in 2006 for his discovery, along with Andrew Fire, of RNA interference.

The original scope of the Sherman Center included 22 environmental rooms, designed for temperature control covering a full temperature range from 4°C to 37°C. These rooms consisted of 16 environmental rooms measuring approximately 9-ft. 8-in. by 9-ft. 6-in., and six environmental rooms measuring approximately 9-ft. 8-in. by 13-ft. 6-in. The wide operating design range covers both cold room and warm room user applications—from chromatography research to incubation—allowing for optimal flexibility for the future as research needs change with time.

An individual control panel houses an independent high/low temperature alarm system, a dry alarm contact for connection to the BMS system, and a seven-day circular temperature chart recorder.

As the project was being built, the scope was enlarged to include two stability rooms and one drosophila (fruit fly) room. The stability rooms were designed to cover a temperature range of 15°C to 25°C as well as control a relative humidity range from 40% to 70%. The drosophila room was designed for a temperature range of 20°C to 30°C, as well as to control a relative humidity range from 50% to 70%. The total floor area of research quality environmental rooms ultimately came to approximately 2,850 square feet.

Working with the Albert Sherman Center staff and the lab architect, Architectural Resources Cambridge set forth the project design parameters for the environmental rooms, which were manufactured and installed by Harris Environmental Systems, Andover, Mass.

All of the environmental rooms were designed for research and therefore had their mechanical systems sized to handle the dynamics typically associated with high user activity, changing user loads, and life support makeup air for working personnel.

Due to the research quality requirements for these rooms, they were all designed to control a temperature uniformity of +/-1 °C around the operating set point. The relative humidity uniformity was designed for +/-5% around the set point in the rooms where relative humidity control was applicable.

All of the environmental rooms measured 9-ft. 6-in. overall height while maintaining an internal user height of 7-ft. 6-in. above the finished floor to the underneath side of the 18-in. deep conditioning ceiling plenums. The ceiling plenums house much of the conditioning equipment required for maintaining the temperature and humidity performance levels desired. They also house sealed fluorescent light fixtures in sufficient quantities to provide 70 foot candle lighting levels at the working volume within each room area.

The ceiling plenums were constructed using an anodized aluminum T-grid system with open egg crate panels and vinyl faced blank tiles designed for the proper air distribution needed to maintain the desired uniformity levels. The T-grid ceilings allow for easy access to the mechanical equipment located within the plenum space.

The drosophila room measures approximately 6-ft. by 9-ft., and uses a return air wall plenum for taking air from the floor area and bringing it to the ceiling plenum area for proper temperature and humidity control. The need for the return air wall is based on the small relative size of the room and its higher operation temperature and humidity range. The return air wall plenum and the ceiling plenum associated with the drosophila room are protected with stainless steel screening to separate the flies from coming in contact with the conditioning mechanical equipment. The mechanical systems associated with the environmental rooms utilize a three-pipe, hot gas bypass, direct expansion, and a water cooled refrigeration system designed to operate using R-134A refrigerant. Each room has its own independent refrigeration system, including a water cooled condensing unit, a fan coil unit located within the ceiling plenum of each room area, and interconnecting refrigeration piping. The core of the fan coil unit associated with the drosophila room is coated with an Electro-Fin protective coating to reduce the corrosion associated with the raising and feeding of flies.

The water-cooled refrigeration condensing units are semi-hermetic units stacked three units high and located in small mechanical closets situated close to the individual groups of environmental rooms. The closets contain the electrical service disconnect switches as well as the building supply and return water systems needed for proper equipment operation. These closets are ventilated using the building’s mechanical systems, in order to remove the residual heat buildup associated with the water-cooled refrigeration systems.

The two stability rooms were not designed with the typical ceiling plenums utilized within the other environmental rooms. The stability rooms were designed with external air handlers located adjacent to each room area for temperature and humidity control based on the specific user requirements needed. The conditioned air from the air handlers is ducted to supply diffusers located within the ceiling of each stability room. A return air plenum is located low along one wall within each stability room for collecting the room air and returning it to the air handler for proper air distribution, providing the required uniformity levels needed. The air handlers are also connected to the individual semi hermetic, water-cooled, R-134A refrigeration condensing units located in the mechanical closets.

The balance of the environmental rooms were constructed utilizing 4-in. thick, UL rated, Class 1 foam insulated panels for the walls and roofs and 2-in. thick insulated panels for the floors. The building slabs were depressed 2.5-in. to allow for installation of the insulated floors. Leveling the 2-in. thick insulated floors, in the depressions, up to the height of the surrounding building slabs allowed for a flush transition from the building slabs to the insulated floor level, avoiding the need for entry ramps. Each environmental room has a 36-in. by 78-in. clear opening entry door with a 14-in. by 24-in. dual pane vision panel, self-closing hinges, inside safety release, and a hydraulic door closer.

The insulated wall and roof panels were covered with a 24-gage galvanized steel skin with a white painted anti-microbial factory installed finish on the room interiors. Each environmental room has a clear opening entry door with self-closing hinges, inside safety release, and a hydraulic door closer.

The insulated wall and roof panels were covered with a 24-gage galvanized steel skin with a white painted anti-microbial factory installed finish on the room interiors, while the insulated floors are covered with a 14-gage galvanized steel skin and topped with a chemically-welded sheet vinyl flooring with a 4-in. integral coved base around the inside room perimeters. The exterior finish of the wall and roof panels consist of a standard white polyester painted finish over the galvanized steel skins.

The two stability room structures, which measure approximately 10-in. by 12-ft. 6-in., consist of insulated dry wall construction with vapor barriers located in the walls and ceiling. The dry wall construction was required to accommodate the specific user’s needs and was a viable approach based on the operating parameters of the rooms.

The relative humidity control needed for the drosophila room and the two stability rooms is provided using a combination of ultrasonic humidifiers, electric steam generators, desiccant dehumidifiers, and latent stripping coils, depending on the performance needed. These devices are installed immediately above or adjacent to each specific room area.

Each room has its own individual control panel located adjacent to the entry door associated with each room area. The control cabinets are NEMA-1, lockable, steel enclosures provided with a white powder coated painted finish. These control panels house the control systems needed for both temperature and humidity, an independent high/low temperature alarm system, a dry alarm contact for connection to the BMS system, and a seven-day, 10-in. circular temperature chart recorder.

The controllers and alarms are accessible through a lockable transparent acrylic cover located in the face of the control panel, offering secure easy access to these devices for making operation adjustments without exposing the user to the electrical wiring inside the panel.

The wide range environmental rooms utilize Honeywell UDC-3200 PID controllers for temperature control, while the drosophila room and the stability rooms utilize an Automation Direct PLC control system with a 6-in. color touch screen for controlling both the temperature and humidity levels in each area. The PLC systems offer greater flexibility in controlling the multiple systems associated with the temperature and humidity control of these areas without the need of adding additional PID controllers for each function.

Particular challenges that arose on this project stemmed from the fact that the stability and drosophila rooms were added after the original scope was determined, and so existing rooms needed to be adapted for these new uses. That meant we successfully worked to coordinate mechanical, duct work, and vapor requirements with no change in the overall schedule.

Working together, all of the Albert Sherman Center stakeholders ensured there was an efficient coordination process, working on layout and design well before the start of construction. The entire building was designed using building information modeling (BIM), which meant that all connections were laid out virtually beforehand. In order to hit the Sherman Center’s timeline for completion of the environmental rooms, the entire team mobilized. The design was released in January 2012 and finished in April 2013—a timeline of 16 months that supported the overall schedule of the building.

American Cleanroom Systems Awarded FDA Class 100 Cleanroom Project

American Cleanroom Systems has been awarded a contract to build a suite of Class 100 (ISO5) cleanrooms by the US Food and Drug Administration and for the FDA Winchester Engineering and Analytical Center (WEAC).

The FDA Winchester Engineering and Analytical Center (WEAC) facility located in Winchester, Mass. requires the new cleanrooms to provide space for sterility testing and analysis of medical devices, such as surgical instruments, gloves, and syringes. The sterility of drugs is also analyzed.

The cleanroom suite was designed by American Cleanroom Systems using green design principles. It will incorporate state of the art cleanroom technology such as the American Cleanroom Systems proprietary wash-down wall system and energy saving features such as the patent pending American Cleanroom System ACS2000 cleanroom power saver and monitoring system, LED lighting, and Envirco LEDC MAC10 HEPA fan filter units.

"American Cleanroom Systems was chosen from a select group of competitors for this highly prestigious project." says Charlie Castaneda, American Cleanroom Systems VP of Operations. "We felt this was largely due to our unique and creative approach to the demanding FDA requirements."

Formex Launches Cytotoxic, Potent Handling Suites

Formex, LLC, a provider of small molecule formulation and clinical trial manufacturing, has launched its dedicated suites for R&D and cGMP production capabilities of cytotoxic and potent pharmaceuticals.

"The addition of our cytotoxic and potent handling suites deepens Formex's ability to handle a broader range of active pharmaceutical ingredients (APIs). Specialized handling of cytotoxic and potent compounds is a strategic complement to our existing technologies for bioavailability enhancement and controlled release technologies," said Rudy J. Emmelot, president and chief executive officer of Formex. "Formex is very proud of its 80,000 sq.-ft. facility in Torrey Pines, CA, and we look forward to continually expanding within our facility to offer more capabilities and dedicated services in formulation and cGMP manufacturing to our clients within the biotech, pharmaceutical, and healthcare industries."

Formex has more than 25,000 sq.-ft. of cGMP clinical and commercial manufacturing space, including 17 dedicated cGMP suites. The company has suites qualified and dedicated for cytotoxic and potent compound handling. The Formex facility has more than 40,000 sq.-ft. dedicated to R&D, analytical labs, and cGMP ICH Stability storage with temperature controlled cGMP warehouses.

UC San Diego Getting Stem Cell Center for Drug Development

South Dakota philanthropist T. Denny Sanford has committed $100 million to create a California stem cell clinical center to speed research into new drugs and therapies.

Officials at the University of California, San Diego, said the Sanford Stem Cell Clinical Center is intended to accelerate development of drugs and therapies derived from human stem cell research through clinical trials and patient therapies.

It will integrate the operations of four locations: the UC San Diego Jacobs Medical Center and a nearby proposed clinical space, both scheduled to open in 2016; the UC San Diego Center for Advanced Laboratory Medicine; and the Sanford Consortium for Regenerative Medicine.

Pradeep K. Khosla, chancellor of UC San Diego, said the center will advance the region's reputation as an international, collaborative hub for stem cell research.

The center's clinical trials with patients will help leverage stem cell research being conducted by scientists from UC San Diego, Sanford-Burnham Medical Research Institute, Salk Institute for Biological Studies and The Scripps Research Institute, among others.

The grant for the stem cell center is the second-largest donation received by the university in its 53-year history.

Sanford has donated more than $1 billion to causes, primarily health related. Many of his projects are in his native South Dakota, where the 77-year-old philanthropist lives.

Sanford is a former Sioux Falls businessman and banker who made much of his fortune in the credit card industry. Most of his donations, about $700 million, have gone to the Sanford Health system based in Sioux Falls. He has pledged to give all his money away. He said he still has close to $1 billion.

Bend Expands

Capsugel's purchase of Bend will strengthen partnership, says DowBend Research is expanding its commercial spray-dried dispersion (SDD) manufacturing with capital from new owners Capsugel in order to offer unique integrated capabilities, the firm says.

Situated in Oregon, US, Bend’s facilities will benefit from $20m (€15m) of investment from parent company Capsugel as part of an expansion in its SDD services and GMP set to be completed mid-2015.

“While there are several companies in the industry with standalone development or manufacturing,” said CEO Rod Ray Bend has “sensed the need for a single company to provide customers with an integrated set of capabilities spanning early development, clinical manufacturing, commercial manufacturing, and deep IP and experience.”

This need, Ray continued, has been on the up since Bend ended its exclusive drug delivery development partnership with Pfizer in 2008 , with many of the SDD formulation projects Bend has undertaken for its clients’ compounds in the last few years “nearing late stage clinical development and will soon require commercial manufacturing capacity.”

The facility expansion will see new commercial lines added as well as two new high-capacity pharmaceutical spray dryers (PSD) spray dryer process trains, used for scale-up, quality-by-design studies (QbD), and the production of appropriate toxicology study supplies.

With the acquisition of Bend and drug delivery firm Encap back in March , Amit Patel, Sr. VP & President of Capsugel’s DFS unit, said the business unit “now has enhanced strategic clarity and significant business momentum,” hinting at further purchases.

AMRI cGMP Manufacturing Sterile Fill and Finish Facility, United States of America

Albany Molecular Research (AMRI) operates a cGMP manufacturing sterile fill and finish facility in Burlington, Massachusetts, US. Originally owned by Hyaluron, the facility was acquired by AMRI on 17 June 2010 for $27m.

The facility offers a full range of services from preclinical through commercial scale production of liquid-filled parenterals, biologics and medical devices in vials, syringes and other custom containers.

The facility is ISO 9001 and 13485 certified, and is FDA inspected for drug and medical device. It was approved by the Italian Medicines Agency (AIFA) on 3 February 2011 for the production of octreotide, a commercial drug. The approval was granted following a successful AIFA audit of the facility during the last quarter of 2010.

The facility spans 60,000ft² with dedicated space for manufacturing, clean rooms, laboratories and administrative activities. Three fill lines have been installed across three aseptic fill suites. The first aseptic fill suite houses the lyophilisation unit and the INOVA VFVM-3031 vial filler.

The line has a single star wheel set up and operates at a capacity of up to 75,000 vials per batch with vials ranging between 2ml and 100ml. It performs automated filling and capping and offers a three-fill needle format including pre-gas purge, product fill and post-fill headspace. It also has a unique suction stopper placement, inline class 100 capping area and an online automated inspection facility. Other specifications of the line include a low hold-up volume of up to 30ml.

Lyophilisation is performed in a BOC Edwards Lyomax 3 lyophilisation unit. The unit is designed with a programmable recipe automation that offers repeatability of multiple lots. It can perform lyophilisation for up to 12,000 vials per batch. The unit has six product shelves totaling 36ft² in area with a shelf inter distance of either 69mm or 140mm.

Three removable trays perform lyophilisation for vials ranging up to 250ml in size. Lead / lag circulating pumps for shelves and condenser and redundant systems for compressors and vacuum pumps have also been installed.

The second and the third aseptic fill suites accommodate two syringe filling lines. An INOVA H3-5V commercial scale syringe filler is installed within the second aseptic suite. The line can fill 100,000 syringes a day (or batch), each syringe measuring between 0.5ml and 5ml in size. It has been designed for Bubble-Free Filling, online vacuum filling and online vacuum stoppering. The line works on a 3/5 head filler positive displacement system.

The INOVA SV-122 syringe filler is installed within the third aseptic fill suite. The line is custom designed to fill 0.5ml to 20ml syringes at a capacity of 50,000 syringes a day or batch. It features a disposable product pathway and works on a 1/2 head filler positive displacement system. It functions at a fill precision of ±0.03ml with an option of variable depth stoppering and features a low hold-up volume of up to 30ml.

Custom container filling capabilities within the facility include small volume fills up to 1l in screw-top bottles and mini vials.

The facility undertakes all aspects of formulation / filling / finishing of drugs from the preclinical phase to the commercial phase of development. It offers syringe, vial and custom container filling services, lyophilisation services and stability optimization services (SOS) for both small molecule drug products as well as biological drugs.

The facility uses online vacuum filling and online vacuum stoppering method for pre-filled syringes for low-viscosity liquids.

For oxygen-sensitive compounds including proteins, epinephrine and others, where the solution stability is negatively impacted by the dissolved oxygen, a unique patented technology developed by Hyaluronis is used. Known as Bubble-Free Filling, the technology ensures sterility by reducing the movement of stopper and creating an environment that is unfavorable for the growth of aerobic micro-organisms.

Neuroscience Building, University of Miami, USA

The University of Miami began construction of a new neuroscience facility at the Coral Gables campus in April 2012. It is located adjacent to the Cox Science Centre at the University campus.

The new facility is currently under construction and is expected to be ready by the end of 2013. It will provide great collaboration for scientists in the field to discover the neurological processes and related diseases, upon completion.

The new neuroscience building will be located in a three-story building with a total floor space of 37,700ft². It will be used as a centre for interdisciplinary research on neurological imaging and health research. It will have ample space for research laboratories, offices, a vivarium and an MRI suite.

The facility will enable the scientists from biology and psychology departments of the university to collaborate with the Miller School of Medicine. Scientists, clinicians and engineers will work together on fundamental aspects of brain function at the new facility.

The building will include a transformational facility and also provide training programs for neuroscientists and health psychologists. The laboratory will be used for diagnosing and treating myriad neurological diseases.

The neuroscience building is installed with advanced functional magnetic resonance imaging equipment. It has a human functional magnetic resonance imaging (fMRI) scanner. It was hoisted into place and positioned within a specially shielded room on the first level of the building.

"It will have ample space for research laboratories, offices, a vivarium and an MRI suite."

The latest in molecular imaging is installed at the second floor of the building. The floor will also include a photon-based microscope for observing living proteins at work, plus a variety of cutting-edge microscopes for the research.

The advanced laboratory equipment will enable neuroscientists to study how molecular changes in the nervous system relate to behavior.

The equipment will enable scientists to analyze molecular patterns in the nervous system to predict successful treatment of neurological diseases.

The research programs in the facility will be equipped to study model systems in animals. The studies on animals can be correlated with human behavior to find functional changes in different regions of the brain. The laboratories will be equipped with sophisticated systems to track the nerve cell activity and make real time connections to human behavior in order to study the brain.

The neuroscience building at the University of Miami broke ground for construction in April 2012. It is scheduled to be completed and become operational by the end of 2013.

The pre-construction and construction services contract for neuroscience facility was awarded to Arellano Construction, a subsidiary of Obrascon Huarte Lain.

Tropic Mechanical was awarded with a $5m worth contract to provide state-of-the-art laboratory at the neuroscience facility. The work was completed in March 2013.

The building is being constructed in compliance with LEED Silver green-building standards. It is designed to be environmentally sustainable.

The National Institutes of Health (NIH) contributed $14.8m grant under the American Recovery and Reinvestment Act for the construction of the neuroscience building in February 2010.

NanoViricides cGMP Production Plant, Shelton, Connecticut

NanoViricides initiated construction of a new clinical scale cGMP production plant in August 2013 at the industrial-commercial zone on the Route 8 Corridor in Shelton city, Connecticut, US.

The new facility is expected to be ready for manufacturing in early 2014. It will be engaged in the production of active pharmaceutical ingredients (APIs). NanoViricides will invest $20m for the construction of the facility.

Inno-Haven, a privately-owned company controlled by the president of NanoViricides, was engaged for the construction of the new cGMP and R&D project.

A 4.2 acre facility with 18,000ft² building located at the industrial-commercial zone in Shelton was purchased for the project in August 2011. NanoViricides will lease the cGMP facility to Inno-Haven.

The new cGMP facility will be constructed by renovating the existing 18,000ft² building. New research labs, offices and a cGMP pharmaceutical manufacturing suite with cleanrooms will be built at the site.

The facility will be used for the production of NanoViricides' drug substances for clinical trials using cGMP processes. The substances will be supplied to a third party for final processing and labeling.

They will also be used for performing the necessary investigational new drug (IND) enabling studies for the anti-influenza drug candidates for beginning human clinical studies in future.

The plant construction broke ground in August 2013. The demolition of the old facility at Shelton was completed in July 2013.

The design, engineering and architecture contract for the facility was awarded to Id3A in January 2013. The scope of the contract included providing overall facility architecture, with the integration of a separately constructed Clean Room Suite for cGMP production. The design was completed by the end of June 2013.

MPH Engineering was appointed as the project manager and engineering consultant for the construction of the facility.

The new facility will have a cleanroom suite, the design and development of which was awarded to AES Clean Technology (AES) in January 2013.

The modular cleanroom technology by AES provides speedier, cleaner and more qualitative and repeatable performance.

The contractual scope will include providing the cleanroom with Class 100 laminar hoods, chemical fume hoods and Class 1,000 and Class 10,000 work areas. It will also include providing entry airlock and egress systems.

The facility will be engaged in manufacturing drugs against a number of viral diseases, such as H1N1 swine flu, H5N1 bird flu, seasonal influenza, HIV, oral and genital herpes.

It will also produce drugs against viral eye diseases, such as herpes keratitis, as well as Hepatitis C, rabies, dengue fever and Ebola virus.

The product portfolio will include FluCide, DengueCide and anti-flu drug candidates NV-INF-1 and NV-INF-2, in oral and injectable versions.

NanoViricides is a development-stage nano-biopharmaceutical company based in the US. It discovers, develops and commercializes therapeutics for viral infections. It produces a class of drugs designed specifically to attack and eradicate surrounding virus particles.

NanoViricides also reached an agreement with Public Health in England (PHE) and the Lovelace Respiratory Research Institute (LRRI) in US to perform and carry out further testing on FluCide drug candidate against additional influenza viruses including H7N9.

Medicago cGMP Vaccine Facility

Canada-based pharmaceutical company Medicago broke ground for the construction of a new influenza vaccine production plant in October 2010. The new facility is located at the Research Triangle Park, North Carolina, and will serve as the company's US headquarters. Construction was completed in September 2011.

Medicago is involved in the production of vaccines for the prevention of pandemic and seasonal flu. The company's vaccines are still at the clinical stage. The current project was built with an estimated investment of $42m.

Medicago USA partnered with NC Bioscience Organization of North Carolina to see that its facilities are in compliance with federal, state and local public policies.

Medicago operates a cGMP production facility with a Biosafety Level 2 greenhouse and an extraction and purification unit in Quebec. It also operates a 13,000ft² rented facility in Quebec, including a 2,500ft² area for purification purposes and the remaining space for storage and office use.

The Medicago cGMP vaccine facility spans 97,000ft² and includes a 27,000ft² fully automated greenhouse unit and an extraction and purification unit.

The greenhouse unit will is a large, cost-effective and scalable facility built in accordance with cGMP standards.

The facility has a targeted production of ten million doses of vaccines per month. It will produce 40 million doses of seasonal flu vaccine or 120 million doses of pandemic flu vaccine annually. The main advantage of the facility is its capability of producing vaccines in a quicker manner.

Medicago aims to produce vaccines in a faster way in order to avoid an H1N1 outbreak similar to the one experienced in 2009. The new Durham facility will produce vaccines for the prevention of influenza using the virus-like particle technique instead of the traditional egg-based or cell production techniques.

The vaccines will be developed from a new strain of Australian tobacco plant Nicotiana benthamiana, which will be grown in the greenhouse area. The leaves of this plant are more delicate and sensitive to infectious pathogens.

A protein will be isolated from the flu virus and its gene later injected into bacteria. These bacteria are then injected into the tobacco plant, which leads to the production of flu proteins. These proteins are extracted, purified and then used as vaccines.

The Australian-strain tobacco plants can germinate within five weeks. Robotic technology will move the plants all over the greenhouse.

Proficia technology is another technology Medicago will employ for producing vaccines at the facility. Living plants are used in this technique to produce the vaccines in a quicker way.

KBR's Building Group was awarded a $19 million contract to build the new vaccine facility in November 2010 by Alexandria Real Estate Equities. AREE, a real estate firm that deals with biological industries, leased the land for Medicago's new facility.

The construction was handled from KBR's Raleigh office.

The project was partly financed by the Defense Advanced Research Projects Agency (DARPA) and AREE. DARPA provided $21m for the project in August 2010. The funding was a federal grant given as part of the Accelerated Manufacturing of Pharmaceuticals program for encouraging quicker (less than three months) production processes of H1N1 vaccines.

Medicago contributed $7.5m and Alexandria Real Estate Equities contributed $13.5m towards the project.

Phillips-Medisize Completes Facility Expansion

Phillips-Medisize Corp. has completed the facility expansion at its metal injection molding (MIM) plant on the company’s Menomonie, Wis., medical campus. This addition, according to company officials, was driven by new business in the medical device and commercial segments.

This capacity expansion focuses on metal injection molding business, which provides customers with complex, precision-shaped parts (150 grams or less in weight). The addition will increase the facility’s continuous debind and sintering furnace capability.

“The metal injection molding capability offers our customers a unique, cost-effective solution by providing complex shapes, superior strength, and dimensional precision in a scalable manufacturing model,” said Matt Jennings, Phillips-Medisize's president and CEO. “We have seen increased interest from our medical device customers to help them design for MIM in surgical device applications as they look for ways to reduce costs and improve quality versus machined parts. The facility’s expansion will bring much needed capacity to continue providing the highest level of satisfaction to our both our growing medical and commercial customers.”

Hudson, Wis.-based Phillips-Medisize provides design and manufacturing services to the medical device and diagnostics, drug delivery and commercial markets. The company has annual sales of more than $500 million with 75 percent of the total revenue coming from drug delivery, medical device and diagnostic products. The company employs more than 3,100 people in 19 locations throughout the United States, Europe, Mexico and China. The company also has design centers in Wisconsin, California, and the Netherlands.

Repligen Expands Facility

Repligen Corp. has completed a 9,000-sq.-ft. expansion of its manufacturing facilities at its Waltham, MA headquarters to meet growth in demand for its bioprocessing products and to ensure that the quality, capacity and support needs of its customers continue to be met.

A dedicated production suite more than doubles capacity for the Company's OPUS line of pre-packed chromatography columns, with cleanrooms built to ISO 7 specifications providing an appropriately controlled environment to satisfy the GMP standards of the company's biopharma customers.

"This expansion will enable us to meet the critical needs of our customers for quality and timely delivery," said Walter C. Herlihy, Ph.D., president and chief executive officer of Repligen. "The new cleanroom suite enables us to produce OPUS columns under the highest quality standard demanded by biopharmaceutical manufacturers."

The facility expansion also triples warehouse space and includes dedicated purification and fermentation laboratories for optimization of existing manufacturing processes, new product development and applications support. An additional 17,000 sq. ft. is reserved for future expansion of the same facility.

Repligen also has manufacturing facilities in Lund, Sweden.

ACell Expands Manufacturing Plant in Indiana

Columbia, Md.-based ACell Inc. has broken ground on an expansion of its Duncan Park, Lafayette, Ind. manufacturing operations. The expansion includes $6 million in equipment, 50 new jobs on top of its current employment of 70, and 14,000 square feet of new space, bringing its facility size to 42,000 square feet by spring.

Duncan Park developer INOK Investments LLC is spending another $3 million to construct the ACell addition and a new stand-alone building in the 79-acre park.

ACell was founded in 1999 by physician Alan Spievack, who has since died. The company develops and manufactures regenerative medicine products that are used to repair and remodel damaged tissue. It opened its Lafayette operations, the company’s only other site, in May 2006, in a 2,500 square-foot-facility in Duncan Park, and has increased its space incrementally since then.

ACell uses tissue from the bladder of a pig, removes cells rich in protein and creates an extracellular matrix that is similar to the human body, said Rodney Bosley, president of ACell.

“When you put our material into the body, instead of the body wanting to heal the scar, our proteins in the material invite the body’s own stem cells into the site, and those stem cells help the body heal naturally,” Bosley said.

ACell’s MatriStem ECM medical devices are designed to maintain and support a healing environment through constructive remodeling and are available in particle and sheet forms for the treatment of acute wounds and various surgical procedures.

Minnetronix Announces Expansion

Minnetronix, a leading medical device design, manufacturing and IP innovation services firm, is excited to announce the expansion of its corporate headquarters in St. Paul, Minn. bringing the firm’s total space to just over 120,000 sq. ft.

The addition of a 65,000 sq. ft. facility represents the third expansion within seven years to accommodate the company’s growth. This expansion allows Minnetronix to continue to increase its offerings and to enhance its presence and impact in the local community and medical device marketplace.

Focusing 100 percent on the medical device and life science industries, Minnetronix helps customers extend and strengthen their ability to develop and deliver medical technology to the marketplace with award-winning design, engineering and manufacturing services.

Most recently, Minnetronix introduced its IP technology portfolio as a solution to unmet customer needs. Such examples of the firm IP portfolio include the MinnetronixÂ^® Cognitaâ„¢ wireless monitoring system, wireless energy transmission technology (TETS) for Congestive Heart Failure, and the recent acquisition of Neurofluidics. By identifying and pursuing unique solutions to various challenges facing the operational and clinical markets, Minnetronix continues to create a rapidly developing services and technology portfolio that benefits its design and manufacturing customers, as well as patients.

According to Minnetronix CEO Rich Nazarian, Minnetronix has experienced substantial growth over the past five years and we are poised for much more. Successfully partnering with our customers to deliver innovative medical technology to patients around the world has resulted in substantial business growth. This allows us to support the continued expansion of our facility, enhancing our offerings to customers in a positive and dynamic environment for our team.

The expanded facility opened in early September.

Novum Opens Facility in Fargo, ND

Novum Pharmaceutical Research Services has opened a new clinical facility in Fargo, North Dakota.

The CRO offers Phase I-IV clinical trials and the new site will add early phase research services as well as strengthen Novum’s network and accommodate future growth.

“Fargo represents the perfect opportunity for Novum and our clients, providing us with added capacity, committed study participants, and a strong local team of clinical and scientific talent,” CEO Christopher Chamberlain said.

TriLink BioTechnologies to Build cGMP Facility

TriLink BioTechnologies (TriLink) has signed an agreement with American Cleanroom Systems (ACS) and Kelchlin Construction to build a 2,000ft2 pharmaceutical cGMP production suite within its facility in San Diego, CA.

The manufacturing facility will contain nine labs and will be equipped to manufacture and process mRNA, long RNA, aptamers, oligonucleotides, small molecules and nucleoside triphosphates. The project is scheduled to be completed in the first quarter of 2014.

'Building a pharmaceutical cGMP production facility is the next logical step in expanding our quality system,' said Richard Hogrefe, CEO of TriLink. 'Soon we will be able to support our customers at every stage from research to clinical trials and commercialization.

'ACS offered the quality and experience we were seeking and we're confident they are the right contractor to help us meet these goals.'

Founded in 1996, TriLink is a privately held firm employing approximately 50 people.

ACS, based in Orange County, California, builds ISO4-8 class cleanrooms for the pharmaceutical and medical device industry.

Arrayit Adds Cleanrooms

Life sciences and diagnostics company Arrayit Corp. has signed a seven-year commercial lease for its new corporate headquarters in Sunnyvale, Calif. The new facility features 15,000 ft2 of modern industrial space including Class 100 cleanrooms, demonstration laboratories, and manufacturing and shipping facilities.

Arrayit is a microarray technology leader that sells its discovery platform to researchers and clinical laboratories worldwide to empower exploration of the human genome, presymptomatic disease diagnostics, and the development of safer and more effective pharmaceuticals.

REST OF WORLD

GlaxoSmithKline to Invest in Montrose Plant

GlaxoSmithKline is expected to unveil another significant investment in Scotland that will result in the company creating more jobs in Montrose.

Finance Minister John Swinney will announce details of the investment at the company's plant in the Angus town along with senior executives from GSK.

The investment is another vote of confidence in the company's Scottish operations 18 months after GSK announced plans to invest pound(s)100 million increasing capacity and creating around 100 jobs at its plants at Montrose and Irvine in North Ayrshire.

"It's another sign of our continuing commitment to the plants and the people that we have here. We think they play a very important role and we're going to give them more things to do," said chief financial officer Simon Dingemans in an exclusive interview.

He added: "We expect both plants to be playing a very important role for many years to come."

The company employs 270 people at Montrose making ingredients for respiratory medicines and vaccines. The 400 workers at Irvine produce ingredients for antibiotics.

Mr. Dingemans did not give details of the latest investment but confirmed it is "significant".

He said Montrose had beaten off competition from plants in Europe and in emerging markets to be selected for the investment.

"The Scottish plants can deliver cost competitive products that we can sell around the world," he said.

The company has decided to retake control of a range of functions that it had outsourced, possibly overseas.

"We have been investing to allow us to insource," explained Mr. Dingemans. "We like doing that because it gives us better control over production. That way we can concentrate all our activities in one place which gives us scale benefits and cost advantages, which in the pharmaceutical industry are increasingly important."

Some of the pound(s)100m funding committed last year was used to develop a new facility at Montrose which has taken over vaccine production work that had been performed by suppliers around the world.

Regarding the latest decision, Mr. Dingemans said: "What is significant about it is beyond the money it will bring some more jobs but it will also bring some more capabilities. We are bringing to Montrose another bit of activity that had been previously elsewhere in the company and elsewhere in our supply network."

The Scottish plants supply ingredients used in key areas of GSK's product portfolio.

Asked how a vote for Scotland to become independent in the referendum next September might affect the company's view, he said: "That's really a question for the people of Scotland.

"We will continue to invest where we see expertise and skills that can contribute to the company's strategy and its overall objectives and so far Scotland has made a significant contribution."

The company has sanctioned two big investment programs in spite of uncertainty about Scotland's future status.

Mr. Dingemans praised the Scottish Government and development agencies for their support.

He also praised the UK Government for implementing measures such as the Patent Box, under which firms get tax relief on intellectual property developed in the UK. "The UK has engaged with us as a company and the pharmaceutical industry collectively in terms of the Patent Box, which was one of the motivations bringing more investment into the UK."

Mr. Dingemans said tax changes could influence the company's decision making. But GSK would not consider moving its head office to somewhere like Ireland for tax reasons. "We are absolutely committed to the UK; we think it's a great place to operate," said Mr. Dingemans.

He added: "The key to a sustainable structure is to have your activities and your substance in the same place."

The London-based company employs 15,000 people in the UK.

Almost three years after joining GSK from Goldman Sachs, Mr. Dingemans said he was pleased with the progress the company has been making.

It has been developing more products and increasing its presence in emerging markets while trying to boost efficiency.

He noted GSK has won US regulatory clearance for four important new drugs in recent months, including the Breo respiratory medicine.

Sellas Life Sciences in Investment Deal with Fochon Pharma

Sellas Life Sciences, a pharmaceutical firm with operations in Switzerland and Greece, has signed a four-year €400m cooperation agreement with China’s Fochon Pharma, a division of Fosun Pharma Group, to develop and sell two novel molecules for treating Type II diabetes and lung cancer.

Under the agreement, Sellas will acquire the worldwide rights, outside China, to sell the resulting medicines, having organized and funded the clinical trials, some in Greece.

Fochon, which discovered the molecules, will keep sales rights in China and will receive a 10% sales royalty.

'It is estimated that if the results of the studies are positive, these treatments may become available within an approximate five-year time horizon worldwide,' said Sellas.

The signing ceremony in Athens was attended by Fochon Pharma CEO Dr Weibo Wang, Sellas CEO Dr Angelos Stergiou, the Chinese ambassador to Greece and the Greek Development and Competitiveness Vice Minister Notis Mitarachis.

Dr Stergiou said the deal would 'promote the exchange of specialized scientific knowledge and innovative research activity' between Greece and China. He claimed the market for diabetes and lung cancer is worth €50bn.

Merck Serono's New Plant in China

Merck Serono has announced plans to build an $80m plant for the production of diabetes and cardiovascular drugs in China.

The new plant - located in the Nantong in the Northeast of the country - will produce Merck Serono's antidiabetic Glucophage, the hypertension drug Concor and the hyperthyroidism treatment Euthyrox for the local market in a project expected to be completed in 2016.

All three products are included in the latest version of China's essential drugs list (EDL), which restricts the prices of certain pharmaceuticals deemed vital by the country's government and controls the bulk purchase of pharmaceuticals by provincial authorities.

The drugs' inclusion on the EDL was acknowledged by Merck Serono CEO Belén Garijo, who said: “We are proud to be one of the first multinational companies investing in a local site focused on the manufacturing of medicines referenced in China’s essential drug list. By bringing high-quality medicines made in China to a broader population in full alignment with the Chinese government’s goal to increase access to quality products.”

Some observers - including Frost & Sullivan healthcare analysts Zhong Hongyue - suggest this is the main motivation for the new plant. Hongyue told Chinese news website Global Times that: "Local production of the drugs could help Merck to lower its costs."

But, this may only be part of the picture. When completed the facility will be the second largest Merck Serono facility anywhere in the world, indicating the importance firm places on the Chinese pharmaceutical market.

This idea was undelined by Allan Gabor, General Manager and Managing Director of Merck Serono in China who said: “With our research center, our development capabilities, our commercial presence and this new manufacturing facility, we are building for the future in China by investing across our value chain.”

Over the past five years, Merck Serono said, it opened a research center in Beijing focused on biomarker research, including pharmacogenomics and bioanalytics; strengthened development capabilities across more than 400 key clinical study sites, recruiting more than 10,000 patients for trials across China; increased its commercial presence to improve service to patients and healthcare providers; and launched several collaborations with top-tier academic and medical institutions, as well as businesses.

Other units of Merck KGaA have advanced biopharma activity in China through the Merck Millipore Biopharmaceutical Technical and Training Centre, and a soon-to-be-opened liquid crystals manufacturing facility, both in Shanghai.

Construction of the facility is expected to commence in 2014, with completion scheduled for 2016 and start of commercial production in 2017.

Following completion, the new facility, which will cover an area of 40,000m² with a possible 20,000m² (215,200 sq. ft.) extension, will be responsible for the bulk production and packaging of the company's leading brands.

Merck Serono is a Switzerland-based biopharmaceutical division of Merck and is focused in the discovery, development, manufacturing and marketing prescription medicines of both chemical and biological origin in specialist indications.

Investment in UK Facility for AZ

AstraZeneca says it would never outsource the manufacture of Zoladex after announcing plans to invest £120m ($190m) in a fifth production facility for the blockbuster cancer drug.

In the 26 years of Zoladex manufacture, AstraZeneca’s Macclesfield, UK, facility has been home to four plants used exclusively in its manufacture. Two have been retired and two are still in operation, but the Pharma Giant announced it was investing £120m into a fifth facility after receiving planning approval in September.

Site manager Tony Broughton was able to confirm to in-Pharmatechnologist.com the new 6,668m2 (71,748 sq. ft.) plant would be used solely for Zoladex and would be a “replacement asset,” allowing one of the current facilities in Macclesfield to retire.

The drug is used to treat patients with prostate cancer by administering a subcutaneous injection of a solid state depot that dissolves in the body over three months, Broughton said, and thus the manufacture is a “difficult, complex, multi-stage process which - though refined over the years - is still fairly manual.”

The product’s uniqueness is partly due to such difficulty in manufacturing, and therefore he added: it is “not a product we would take a risk with by outsourcing.”

Zoladex is a top seller for AstraZeneca with sales of $1.09bn for 2012, according to the firm’s annual report , and is approved in 120 countries for the treatment of prostate cancer, breast cancer and certain benign gynecological disorders.

Although key patents have expired, Broughton told us global sales were growing due to growth from emerging markets. Regarding a generic version, “one company tried and failed,” he said, and therefore sustained sales were a key factor to this facility investment.

Construction commences in the next few weeks and the facility is set to be completed by 2016.

According to Broughton, AstraZeneca's Macclesfield site and a facility owned by bioanalysis company Waters will form part of a renewed interest in biosciences in the region dubbed a “Northwestern Science Corridor” by a Councilor representing Cheshire East.

This will be propped by the AstraZeneca site at Alderley Park which the company announced earlier this year was to cease R&D operations as part of a restructure that would affect up to 2,500 jobs.

AstraZeneca will keep a presence in Alderley Park with approximately 700 staff on site, Broughton added.

GSK Plans New Indian Plant

GSK has announced plans for a new manufacturing plant to "bring more medicines to the people of India" weeks after revealing that some drug wholesalers in the country have stopped buying its products.

The UK firm’s Indian unit - GSK Pharmaceuticals – announced its intention to spend £85m ($137m) on the new anti-inflammatory and digestive system drug plant, explaining that – while it has not yet selected a site – a location in Bangalore is the front runner.

GSK said it will build the plant in collaboration with local design and construction firms and added that the facility will house continuous manufacturing technology, automated manufacturing systems, warehouse capacity and a packaging unit.

The firm also predicted that, when fully operational in 2017, the facility will make eight billion tablets and one billion drug capsules a year for the local market and employ a manufacturing staff of around 250 people.

GSK did not say what prompted its decision to invest in the new plant, other than that it is “part of its continued commitment to ensuring access to medicines for people in the country” and did not respond to requests for additional information.

Pfizer to Close Manufacturing Plant in Puerto Rico

Pfizer Inc. says it will close one of its three manufacturing plants in Puerto Rico by 2017.

The world's largest drug maker says the manufacturing of products at its plant in the north coastal city of Barceloneta will be moved elsewhere. The company says the closure is linked to the loss of patent exclusivity and improved manufacturing efficiency.

Pfizer employs nearly 2,700 people at its three manufacturing plants and commercial offices on the Caribbean island.

The announcement comes less than a week after Merck announced it would stop active ingredient production at its plant in Barceloneta, a Puerto Rican city that was once considered a pharmaceutical hub.

Dechra Pharmaceuticals Manufacturing to Expand

Dechra Pharmaceuticals Manufacturing, the manufacturing business of Dechra Pharmaceuticals, based in Skipton, North Yorkshire, has initiated a significant investment program to realize a major expansion of its liquids, creams and ointments (LCO) department, with the aim of creating a globally cGMP compliant, state-of-the-art facility.

The expansion will include refurbishment of the existing building fabric, improved utilities and significant process equipment procurement. The new equipment will provide a major increase in manufacturing capability and capacity, estimated at five times the current level.

'Following our earlier FDA approval for solid dose production, and the recent refurbishment of our injections suite, focus is now moving to the LCO Department and a major expansion of this area will be carried out in the first half of 2014,' said Mike Annice, Managing Director of Dechra Pharmaceuticals Manufacturing.

'This is another step to DPM becoming a global supplier of pharmaceutical products.'

Genea Biomed Chooses Discovery Park for UK Base

Discovery Park, one of Europe’s leading science and technology parks has announced the arrival of Genea Biomedx, the Australian IVF technologies company to its site.

Launched by world-leading fertility group Genea earlier this year, Genea Biomedx is developing practical, accessible, precise technology to improve IVF lab outcomes. The company will move into its new building later this year and plans to recruit around 30 new staff for the facility at Discovery Park in Sandwich, which will take the total number of people employed on the site to more than 1,400.

Discovery Park is in discussions with three other science-focused organizations who between them would bring a further 300 jobs to the site.

'We have been negotiating with Genea Biomedx for some time and have fought hard to secure the tenancy in the face of stiff competition from other science parks in the UK,' said Discovery Park Chairman Trevor Cartner. 'We are naturally delighted to be able to welcome the team and welcome the research jobs that will be created.

We are really building momentum now but it’s crucial that we keep moving forward if we are to achieve our long term goals for the site

We have enjoyed tremendous support from Dover District and Kent County Councils as well from other stakeholders including Locate in Kent, Sandwich Town Council, Sandwich Chamber of Commerce and our neighbors in Thanet. We have been made to feel hugely welcome in Sandwich and we are committed to creating a world class science community surrounded by a new mixed use development.'

Genea Biomedx Commercial Director Kim Giliam said establishing a presence at Discovery Park was a natural fit for the Australian company. 'When it became obvious Genea Biomedx needed a home in the Northern Hemisphere, we developed a list of must haves, including proximity to the Channel crossing and world class facilities. Discovery Park ticked all of our boxes and more,' Giliam said.

In addition to Genea Biomedx, Discovery Park has also recently welcomed two other science-focused tenants to Discovery Park: Osmovian and AlgaeCytes.

Osmovian, a specialist outsourcing provider and consultancy for the life sciences sector, moved its head office from Leeds to Discovery Park and plans to make the park the primary location for its operations as the company grows. The company was keen to be part of the growing life sciences hub at the Kent business park.

Mark Campbell, Managing Director, Osmovian, said: 'The opportunities to work in the same location as so many other life science focused companies was a huge draw. The ability to network and work closely with other companies and offer our services is a great advantage to us. I am very impressed with the ambitions of Discovery Park Ltd, and its desire to make the site a world leading science park is certainly a draw for companies such as ours. Also the benefits of it being an enterprise zone are very attractive to a growing company.'

Currently employing five staff, the company’s future plans include the expansion of its services and to take on more staff at Discovery Park.

'We have plans to launch the Pharma Outsourcing Consortium in the very near future, specifically focused on the needs of small and emerging biopharmaceutical companies,' Campbell continued. 'This will provide members with networking opportunities with other companies in their position to share and gain knowledge, as well as tools and processes to increase their outsourcing effectiveness. In addition, it will engage with contract service providers on a collective basis and thus increase the overall leverage of individual member companies.

'With this move to Discovery Park, Osmovian gains an office identity that reflects our strong commitment to supporting early stage biopharmaceutical companies and accommodates our future growth plans.'

Boosting the scientific expertise on site is AlgaeCytes, a company focused on developing and commercializing algae-derived bioactive ingredients, in particular Omega 3 oils and proteins, for the nutraceutical, cosmetics and pharmaceutical markets.

The company founders were originally based in Canterbury with their research and development operations based abroad, and the team regularly traveled to the Czech Republic to conduct R&D for the business. After reaching a critical stage where the company needed to scale up production, they decided to bring AlgaeCytes back to the UK.

Both Oxford and Cambridge were considered as suitable locations and Discovery Park was highlighted as a potential site that was still in development. Following a brief spell at Kent Enterprise Hub, which the company quickly outgrew, Discovery Park was ready for business and the firm moved its entire offices to its state-of-the-art laboratories.

Naz Bashir, Chief Operating Officer, AlgaeCytes, said: 'There were a number of factors that influenced our decision to move to Discovery Park. The quality of the lab space and buildings on site, both regional and national transport links, the quality of workforce and the excellent location were a big attraction.

'The team at Discovery Park were also fantastic and clearly shared our vision, as well as having a great vision of their own - to grow the park into a renowned site with a variety of science, clean technology and other businesses to become a real innovation site.'

AlgaeCytes originally heard about Discovery Park through local news stories and also from inward investment agency Locate in Kent, which is a big supporter of the Park.

'Although we did consider science parks in the north east and north west, when we looked at all aspects, Discovery Park was top of the list,' Bashir continued. 'We were also successful in securing funding through the Regional Growth Fund so the move to Sandwich quickly became a reality and we are now really taking off.'

The science firm, which employs 10 people, is launching its first algae pilot plant where it will produce samples for new food and pharmaceutical clients, which forms the basis of a scaling up program leading to commercial production in 2014/2015.

'We are very excited about the opening of the pilot plant and as part of our future development we are looking forward to supplying high quality products and to building on our vision to grow the company. Kent has a lot going for it and we would encourage other businesses to consider moving to Discovery Park,' added Bashir.

Since taking over in August 2012, Discovery Park Ltd has created almost 700 new jobs with a target of 1,000 by the end of the year

Suir Pharma Ireland

Suir Pharma is an independent contract manufacturing organization working with many established pharmaceutical companies worldwide

Suir Pharma (formerly Stada AG manufacturing site) is well known as an established manufacturer of generic medicines for more than 40 years working to the highest Quality standards. We supply various markets across Europe and the United States.

Both the facilities and the resources of our site strategically position Suir Pharma to provide a high quality, cost effective contract manufacturing solution for your company.

Our site consists of two manufacturing units. The antibiotic (AB) plant is a dedicated beta-lactam (Penicillin) production plant. It is self-contained with facilities to support the entire production process. The plant is 3,800m2 (40,888 sq. ft.) in total floor space. The AB plant can produce antibiotics in the form of film coated tablets, hard gelatine capsules and powders for reconstitution. Packaging formats vary from PE bottles; glass bottles; PVC/ ALU and bulk drum delivery. Running a two shift cycle, the AB plant has the capacity to produce 700 million tablets/capsules and 4m bottles of powder for reconstitution.

The second manufacturing unit, known as the main plant, is the larger facility with a production area of 4,000m2 (43,040 sq. ft.). Similar to the AB plant, it is self-contained incorporating the entire production process. In addition, the main plant is equipped to store controlled drugs. There are two high security vaults and security systems throughout the plant to monitor the production and handling of controlled drugs.

We currently employ over 170 people on the site having already conducted a rationalization program after the change of ownership.

As the site is in possession of a clinical trial license, there is a dedicated suite for trial work which includes granulation, drying, compression and coating equipment.

As evidenced from the above description of facilities, Suir Pharma Ireland can offer a full service in product development, manufacturing, packaging, analytics, and clinical trial services. A recently implemented SAP ERP system allows for a seamless flow of information from raw materials to distribution stages increasing the efficiency of our service.

WuXi AppTec installs First 2000L Disposable Bioreactor

WuXi PharmaTech has expanded its cell culture capacity with the installation of two 2000L disposable bioreactors at its plant in Shanghai, China. The bioreactors are now ready for cGMP manufacturing.

WuXi AppTec, the firm's operating subsidiary, opened its state-of-the-art cGMP biologics manufacturing facility with two cell culture suites containing 500L and 1000L disposable bioreactors in October 2012.

As a result of this new expansion, the firm claims to operate the largest biologics facility with disposable bioreactors in China, and the largest disposable bioreactor in the world. The facility has passed GMP audits from global clients and an audit by former US FDA biologics inspectors.

The firm is now poised to support Phase III clinical manufacturing and initial commercial launch for therapeutic antibody and recombinant protein drugs.

WuXi AppTec says it has completed the first run in the 2000L disposable bioreactors using an NS0 mouse myeloma cell line for Taiwanese firm TaiMed Biologics' ibalizumab, a novel CD4 entry inhibitor for the treatment of HIV/AIDS infection.

'Successful completion of our biologics facility expansion and the subsequent 2000L run mark important milestones in WuXi AppTec's mission of building first-class biologics manufacturing capabilities in China,' said Ge Li, Chairman and Chief Executive.

'Although there is overcapacity in biologics manufacturing facilities globally, our biologics manufacturing facility is the only one in China that meets global cGMP standards. Through this expansion, we can quickly address increasing market demand for high-quality and cost-effective manufacturing of biologics.

'The first 2000L run also showcases our solid development and scale-up capabilities in mammalian cell culture. We continue to invest to build our integrated open-access biologics discovery, development, and manufacturing platform to serve our global clients and to play a pivotal role as the gateway for introducing biologics into the Chinese market.'

Lilly Plans Insulin Manufacturing Investment

Eli Lilly and Co. plans to spend $715 million to bulk up its manufacturing in a key product line, insulin production.

The company said it will spend $350 million to expand its insulin cartridge manufacturing in China, another $120 million for a similar improvement in France and $245 million to boost manufacturing capacity in Puerto Rico and Indianapolis.

"Insulin is a cornerstone of diabetes treatment and its use will only continue to increase given the rising number of people with diabetes around the world," Lilly Diabetes president Enrique Conterno said in a statement.

Lilly opened a research and development center last year in China, where the disease's prevalence has ballooned in recent years.

People with the diabetes have trouble breaking down carbohydrates, because their bodies have become resistant to the protein insulin, which is critical to digesting sugars. Over time, diabetics are at higher risk for heart attacks, kidney problems, blindness and other serious complications.

Lilly, which makes the antidepressant Cymbalta, counts the insulins Humalog and Humulin among its best-selling drugs.

AstraZeneca to Invest in New Manufacturing Facility

AstraZeneca announced plans to invest $190 million in a new facility at its global manufacturing site in Macclesfield, UK, to continue production of Zoladex, an injectable treatment for patients with prostate cancer. The investment secures 300 existing Zoladex jobs at the site and will create over 200 temporary jobs during the construction and commissioning phase between now and early 2017.

Zoladex has been manufactured at AstraZeneca’s Macclesfield plant for over 25 years, supplying the medicine to more than one hundred markets around the world. It continues to be an important asset in AstraZeneca’s oncology portfolio and is currently the company’s fifth largest selling brand with annual sales in the region of $1 billion.

David Smith, Executive Vice-President, Operations at AstraZeneca said: “Zoladex is one of AstraZeneca’s leading cancer drugs, supplied to patients across the globe. This new facility will support the continued production of this important medicine in the UK. Having considered a number of options globally, we believe it is the right choice to build the new facility in Macclesfield, which has been home to Zoladex manufacturing - and the expertise that goes along with it - for many years. This investment is a further signal of our long term commitment to the UK, and to the North West.”

As a sterile subcutaneous injectable product, Zoladex is manufactured under highly specialized conditions, following a complex, multistage formulation process. This requires a range of high-specification equipment in a controlled operating environment to ensure aseptic production. The continued global demand for Zoladex, particularly in Japan and emerging markets including China and Russia, has resulted in the decision to invest in replacing some of the existing facilities where the medicine is currently produced at the Macclesfield site.

The building of the new facility will begin in 2013 and is due to be completed by 2016. Products manufactured in the new facility will begin to be supplied to markets in 2017.

Almac Invests to Accelerate Formulation Development Services

Almac expands its pharmaceutical development service offering with an investment in excess of $10m.

In Jan 2013, Almac completed the doubling of their pharmaceutical development service capabilities with the opening of a new dedicated non-GMP facility together with 2 analytical laboratories at their UK headquarters.

The new non-GMP formulation development facility offers clients greater flexibility and speed in formulation and process development, creating an environment where development work can be progressed quickly and then easily transferred to the existing GMP development facility located on the same Almac UK campus.

Although the new facility is dedicated to non-GMP work, it mirrors all the technical capabilities of Almac’s existing GMP pharmaceutical development facility, including high levels of control over environmental conditions as well as extending current capabilities in processing potent compounds with low OELs.

In parallel to the new non-GMP facility, Almac has doubled its analytical capacity with new analytical laboratories for processing the large sample sets which result from non-GMP process development work for clients who seek to better understand their processes in line with the principles of QbD.

Additionally, in response to increased client demand for preclinical and early phase clinical GMP supply, Almac have further enhanced their pharmaceutical development offering with an investment in additional Xcelodose® technology.

Similar to our existing technology this additional Xcelodose^® unit comes complete with an Xcelohood^® providing the capability to dose potent API directly into capsules.

“Almac is continually assessing and investing in solutions to accelerate the manufacturing of our client’s clinical supplies, while ensuring quality at all times. The investments this year in the new non-GMP facility and Xcelodose equipment strengthens Almac’s position as an integrated service provider in the pharmaceutical development sector.” said John McQuaid, VP Technical Operations.

Brenntag Facility Opens in Spain

Chemical distribution company Brenntag has inaugurated a new facility in Granollers, Spain, dedicated to the food, pharmaceutical, and cosmetics industry. The new facility offers specialized storage vessels, mixing and blending facilities, an application laboratory as well as a White Room for the packaging of pharmaceutical products within a controlled atmosphere. The specialized storage vessels consists of six stainless steel and nine fiber tanks with a total storing capacity of over 1,200 ft³ and can hold different products like glucose, monopropylene glycol, fructose dilution, and citric acid dilution.

“Two mixers for tailor-made blendings and formulations together with an application laboratory in which quality controls of these blends can be checked on site are only one of many advantages for our customers offered by the new facility. With our specialized technical sales force and its state-of-the art technology, Granollers is a true center of excellence,” says Frédéric Pierre, Regional Manager, Brenntag South Europe.

Designed to serve the South Europe region, the facility close to Barcelona is ideally located for Spanish food companies exporting overseas due to the harbor proximity.

Brenntag expects the site to be certified with the ISO 22000 certification, a special certification for food safety, within the remainder of the year. The facility is already certified with ISO 9000:2000 and ISO 14001. The company is headquartered in Mülheim an der Ruhr, Germany.

Smiths Medical Opens Facility in the Czech Republic

United Kingdom-based medical device manufacturer Smiths Medical has initiated the first phase of a new production unit in the Prerov region of the Czech Republic.

The company moved into the 29,500-square-foot manufacturing and assembly facility at the CTPark industrial zone in Hranice in July 2013 and the leased unit was officially opened in September.

Smiths Medical will turn out a range of high-tech products at the plant, primarily single-use medical devices to support breathing and for drug delivery. The facility includes state-of-the-art cleanroom facilities.

The firm, a division of London, England-based global technology group Smiths Group, is investing more than approximately $9 billion on the Czech plant, which is set to employ up to 300. It will be fully operational in the first half of 2014.

Smiths Medical produces a range of high-tech devices used for surgical procedures and hospital care, including equipment for cardiovascular treatment, incubation and in-vitro fertilization.

The company, which had headline revenue of almost $1.3 billion in fiscal 2013, has other European production plants in Germany, Italy and the U.K., with production units in China, Mexico and the United States. The company employs 7,900 worldwide.

Dow, Cambrex Complete Facility

The Dow Chemical Company and Cambrex have completed and opened the operational facility for Dow’s Hydroxypropyl Methylcellulose Acetate Succinate (HPMCAS) for Drug Solubility Enhancement. The facility is an expansion of Cambrex's Karlskoga site, and work began in early 2013.

The facility completion and start of HPMCAS product validation marks a year-long process that began with a solubilization partnership between Dow and Bend Research, announced in October 2012. Starting early 2014, Dow will be able to commercially supply solubility enabling excipients.

“We are proud to have completed this carefully executed expansion in such a short amount of time,” said Bjarne Sandberg, managing director of Cambrex Karlskoga. “This has been a great collaboration with both the Dow and Cambrex teams focused on meeting project goals. This partnership between Dow and Cambrex further demonstrates Cambrex's commitment to finding solutions that allow our clients to meet a market need in a timely manner.”

“We are enthusiastic about commercially bringing the first solution of our Affinisol portfolio to the market,” said Marc van Gerwen, business director for Dow Pharma & Food Solutions. “Working with Cambrex, we were able promptly address the pharmaceutical industry’s most pressing need: advancing poorly soluble APIs to become therapeutically beneficial oral drug products.”

Cobra Biologics Expands Production Capacity

Cobra Biologics has installed a new Thermo Scientific 1000L HyClone Single-Use Bioreactor (SUB) at its center of excellence for mammalian antibody and recombinant protein production. The additional capacity is part of the company’s ongoing expansion plans and follows the signing of a new contract with a longstanding North American customer.

Cobra’s investment plan includes installing SUB technology across all three of its production sites for contract manufacturing services and the supply of commercial antibodies and recombinant proteins.

Peter Coleman, chief executive officer of Cobra Biologics, said, “Antibody and other recombinant protein production has been a strong growth area for our specialized manufacturing site. Cobra’s maxXpress cell line development and comprehensive analytics services are proving to be very attractive to customers. Demand is such that we have the confidence to invest for the future and we see this as just a stepping stone in the expansion of our capabilities at all three Cobra facilities.”

DSM Opens Brisbane Bio-Facility

DSM Pharmaceutical Products has officially opened its cGMP bio-CMO facility in Brisbane, Australia. The facility was built in partnership with Biopharmaceuticals Australia with cooperation from the government of Queensland and the Commonwealth of Australia. The Asia-Pacific region is an important growth area in DSM's strategic development in the biopharma field, according to a company statement.

The facility was designed by an international team of biological scientists and bioengineers, utilizing DSM's 27 years of experience in mammalian cell culture processing to construct a purpose-built, state-of-the-art biomanufacturing facility. The Brisbane facility offers cGMP mammalian cell culture contract manufacturing services from process development through to commercial manufacturing. The Brisbane facility has an output capability of 500kg and has expansion space available for further capacity utilization. In June of this year the Brisbane site was thoroughly assessed by inspectors from TGA (Therapeutic Goods Act). CGMP commercial production is expected to begin in January 2014.

Lukas Utiger, president and chief executive officer of DSM Pharmaceutical Products, commented, "With its flexible design and use of single-use technology, the facility represents the model for the future of biomanufacturing. It represents an important milestone in the development of Australia-based mammalian cell-based manufacturing of biopharmaceuticals, and extends DSM's contribution to the global biotechnology market."

In conjunction with the opening, DSM Pharmaceutical Products has announced a manufacturing agreement with Opthea Pty Ltd of Melbourne, Australia. The contract covers process development and cGMP manufacture by DSM for Opthea's lead molecule, a soluble form of human VEGFR-3 that blocks the activity of both VEGF-C and VEGF-D, which promote blood and lymphatic vessel formation and are involved in the progression of eye diseases.

This project represents an agreement for process development at DSM Biologics’ Groningen, The Netherlands, facility and manufacture at the Brisbane facility. DSM previously announced contracts for the Brisbane site with DecImmune Therapeutics of Cambridge, MA; RECEPTA Biopharma in São Paulo, Brazil; and Paranta Biosciences of Melbourne, Australia.

Fujifilm Diosynth Biotechnologies Opens Facility in the UK

The facility – in Billingham, Teeside – has been providing microbial contract manufacturing services for more than a decade. In April FujiFilm announced its intention to begin mammalian cell-based biopharmaceutical production at the site to gain a “larger slice of the market.”

The now operational manufacturing area houses two Xcellerex single-use bioreactors – one 200L capacity and one 1000L capacity – according to spokeswoman Bridget Hall. The CMO already has experience using the systems.

“We have installed Xcellerex single-use systems at the Billingham site, as this will give us common equipment with our sister site in Research Triangle Park, NC, US.

She added that: “The build quality of the Xcellerex system is taken to be high and is an attractive feature of the system, and allows for flexibility and scale-up across the whole range, as well as ease of expansion.”

Fujifilm plans to add a 2000L capacity bioreactor sometime next year and is likely to choose an Xcellerex system Hall said, explaining that “It would make technical and operational sense to use the same system for 2000L scale-up.”

The site will also have cell line development capabilities for customers according to Hall, who added that: “The services are aimed mainly at clients starting pre-clinical development and as such we are able to offer two CHO based cell lines.”

The new facility also houses a cell banking facility, which has been operational since April this year for commercial reasons as Hall explained.

“The cell banking facility is a small section of the new Mammalian facility it was just completed and operational earlier than the rest of the facility so we could commence business.

“The manufacturing facility contains the cell growth and production suites, including downstream processing and buffer make up and hold areas.”

FDA Gives Go-Ahead to Novasep Manufacturing Sites

Novasep, a provider of manufacturing solutions for life science molecules and fine chemicals, announces that the U.S. Food and Drug Administration has successfully audited two of its European custom manufacturing sites in Le Mans, France and Leverkusen, Germany. FDA investigators audited the two facilities in June and July 2013.

The FDA audit at the Novasep site in Le Mans was a pre-approval inspection for production of paclitaxel, an anticancer parenteral active ingredient for which Novasep is a supplier. The positive outcome of the audit in Le Mans confirms that the company is suited to handle highly potent active pharmaceutical ingredients, in particular paclitaxel. Novasep has held European Certificate of Suitability for paclitaxel since 2011 and an FDA drug master file since 1996.

The Leverkusen facility audit included both a pre-approval inspection of the production of formulated nitroglycerine and an overall cGMP inspection on all products made for the U.S. market.

“The FDA has tightened up its surveillance and audits,” says Michel Spagnol, CEO at Novasep. “Adhering to regulatory requirements is critical, although it is becoming progressively more challenging across the industry. Our teams’ commitment to quality is impressive. I am very pleased with our continued track record in securing FDA inspection approval and the added assurance these successes give our global customers.”

“The two successful FDA inspections demonstrate that Novasep’s custom synthesis facilities are operated under a robust quality management system,” says Jean-Claude Romain, VP of quality at Novasep. “A quality assurance system does not remain static. It constantly evolves due to experience, multiple customer feedback and regulatory inspections. In addition, FDA inspections provide excellent opportunities for further improvement. The successes of the audits not only result from the quality systems Novasep has in place, but also from the day-to-day involvement of each person on the team.”

The Le Mans site produces highly potent cytotoxic pharmaceutical ingredients and registered advanced intermediates, either for commercial purposes or clinical development. The facility has synthesis and chromatography purification suites in contained areas, enabling the handling of highly potent pharmaceutical ingredients with Occupational Exposure Limits below three micrograms/m3 per 8 hours.

The site in Leverkusen, equipped with modernized machinery, has operated chemical syntheses and in particular hazardous chemistries on an industrial scale for 140 years. Novasep holds Drug Master Files for several APIs including nitroglycerin and numerous formulations, as well as a European CEP for nitroglycerin-ethanol solution. Hazardous chemistries enable the design of shorter synthetic routes for producing APIs and advanced intermediates.

Novasep's offering includes process development services, purification equipment and turnkey processes, contract manufacturing services, and complex active molecules to serve pharmaceutical, biopharmaceutical, fine chemical, food, and functional ingredients as well as bio-sourced chemicals and bio-industries.

Cobra Biologics Expands Production Capacity

Brandon Pence, global director of marketing Cell Culture and BioProcessing at Thermo Fisher Scientific, said, “We are delighted to partner with Cobra Biologics in their continued expansion of their commercial operations. The combination of our application-focused design and collaborative approach to working with customers makes the Thermo Scientific Single-Use Bioreactor the system of choice for more than 85 percent of the top biopharma companies. Cobra’s decision to incorporate our industry-proven design will enable the company to confidently provide consistent and high quality manufacturing services to its biotech and biopharma customers.”

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