To increase its capabilities for medical device manufacturing, custom injection molder Plastikos Inc. is in the process of adding a third press for its Class 10,000 clean room at its headquarters plant in Erie, PA.

“There is no firm date by when that will be completed, but we are working to integrate that press now,” said president and general manager Philip Katen in a Nov. 7 phone interview.

He said the new 88-ton Arburg Allrounder press will be the second press of that size for the cleanroom, which also has a 66-ton press.

“We are adding it to expand our footprint in medical device manufacturing,” Katen said. “It is part of our evolution to increase the value we bring to our customers.”

In just a short period of time, he said, medical device manufacturing has become a significant contributor to the revenues of the company which was the Plastics News’ Processor of the Year in 2010.

“A few years ago, we had very little revenues from medical—maybe 5 percent—and no clean room,” Katen said.

When the cleanroom—completed in early 2011—was under construction in mid-2010, medical was 10 percent of the company’s revenues. “Today it accounts for 15 percent of our revenues and is approaching 20 percent,” Katen said.

PN’s rankings of injection molders this year listed $16.8 million in sales for the company’s fiscal year that ended Oct. 31, 2011.

“In the next two to three years we see medical approaching or exceeding 25 percent” of the company’s revenues, Katen said. “Three-to-five years from now we’d like it to be at least one-third of our revenues and hopefully we will get it to be 50 percent of our revenues and maybe beyond” after that.

The new press “will increase our capacity significantly and give us the ability to deliver products to customers on shorter lead times,” Katen said. “It will enable us to provide customers with quicker turnarounds.”

The Plastikos president believes the company’s Class 7 cleanroom gives it an advantage in competing for medical applications that require an extra-clean manufacturing environment.

“Our ISO level Class 7 cleanroom is one-quarter of a magnitude cleaner that the ISO-level 8 cleanroom most medical manufacturers have,” he said. “It gives the ability to produce product and inspect product in an even cleaner environment for applications that require an even cleaner [manufacturing] environment.”

He declined to specify any specific product or market segments that the company was targeting. But he said the company currently supplies dental care components, products for eye care, diabetes care, fluid delivery systems — both liquid and air, and surgical applications where precision is required.

“Precision manufacturing and high-end, highly engineered parts with tight tolerances fit our expertise,” he said.

Down the road, an expansion of the clean room or an additional facility for medical manufacturing is a possibility, he said.

“When we would do an expansion would be difficult to specify,” he said. “We have additional capacity at our existing manufacturing facility” because of continuing investments to make operations there “more efficient”—which increases the capability in that plant.

But “depending on how quickly we approach those targets” for medical sales, Katen said, “an expansion into a second facility could be required.”

Agere Expands cGMP Capabilities

Agere Pharmaceuticals, Inc., Bend, Oregon, an oral solubilization-focused contract research and manufacturing organization (CRO/CMO), announced that it has added the capability to support clients entering Phase IIb clinical trials with cGMP manufacturing. The new capacity extends the services to pharmaceutical companies that currently partner with Agere for formulation development to improve oral bioavailability of their BCS II and IV compounds. By expanding cGMP manufacturing services, Agere now offers its clients one-stop-shopping from concept development through manufacturing for advanced clinical trials.

Outsourcing research and development to CROs is a widespread and growing practice for pharmaceutical and biotechnology companies. The trend toward relying on a single service provider for research into clinical trial manufacturing eliminates costs, delays and risks inherent in switching vendors.

“We’ve extended our cGMP spray drying capabilities in response to our clients’ requests to continue with Agere as they enter Phase IIb clinical trials,” commented Marshall Crew, Agere’s President and CEO. “This is a natural progression for us, as expanding services delivers efficiencies to our clients.”

Pharmaceutical companies facing solubility challenges with active pharmaceutical ingredients (APIs) depend on Agere’s expertise and scientific approach to enhance the bioavailability of their drugs. Agere services span formulation design and development into clinical trial drug product manufacturing. All services are offered “à la carte,” allowing companies the flexibility to engage with Agere at any stage in their process. Agere provides all services on a fee-for-service basis, in which Agere assumes no intellectual property (IP) ownership over work done on behalf of the company’s clients.

Eli Lilly Plans Expansion of Plant

John Lechleiter, Chairman, President and CEO of Eli Lilly and Company talked about the insulin cartridge that will be made in the new 80,000-square-foot expansion at the Eli Lilly plant.

Eli Lilly and Co. will expand an insulin plant in Indianapolis as part of a much larger plan to defend its 89-year-old insulin franchise from competitors that will include, for the first time, multiple low-priced generics.

The plan includes making improvements to its insulin manufacturing processes that should allow it to meet doubled demand for its products without significantly expanding the physical size of other plants, said Enrique Conterno, president of Lilly’s diabetes business.

“That is very important for us because it makes us more competitive,” Conterno said.

The $140 million plant addition will be at Lilly’s Kentucky Avenue campus and will enable the company to make pre-filled insulin cartridges in the United States. Lilly currently makes the cartridges only in Italy and France.

The cartridges go into the increasingly popular penlike devices that diabetics use to discretely inject insulin. The traditional method uses a vial and needle.

Indianapolis-based Lilly, with nearly 11,000 employees statewide, announced the plant expansion at the site of the new building, already fenced off and ready for excavators. More than 100 people, many newly hired, will work in the 80,000-square-foot addition when it opens in 2015.

Left unsaid at the public announcement is that Lilly faces growing competitive pressures on its insulin business even as a quickly increasing number of diabetics drive up demand for the product.

“There is an extraordinary amount of pricing pressure on insulin right now, and the coming threat of generics,” said David Kliff, publisher of Diabetic Investor newsletter. “The insulin market is in . . . a state of flux right now.”

It’s a business in which Lilly aims to stay relevant by investments such as the new cartridge plant and an initiative it calls the insulin technical agenda, which will overhaul Lilly’s insulin plants worldwide to introduce more-efficient modes of production that should lower costs of making Lilly insulin.

Insulin makers are racing to cut costs, Kliff said, as insurance plans and government negotiate deals with drug makers who want to make sure their drugs are listed on formularies of covered medicines.

Insulins are particularly prone to price pressures because many competing brands are similar to one another and often interchangeable.

Lilly said sales of its insulins Humulin and Humalog both saw a surprising drop in U.S. sales in the third quarter, largely because they were dropped from a drugstore chain’s national drug formulary. Sales of those products represented about 16 percent of Lilly’s revenue for the quarter.

One hurdle for Lilly is that the changes to the production processes must be approved by the Food and Drug Administration and other drug regulatory bodies.

Kliff said Lilly is not alone in looking to wring costs from insulin production. “Every major insulin company has taken a greater interest in manufacturing processes,” he said. “They want to make it cheaper.”

Key patent expirations on Lilly’s Humalog in 2013 and Sanofi Aventis’ Lantus in 2015, among other brand-name insulins, stand to bring multiple low-priced generic insulins onto the market, putting more price pressure on the brand-name products.

Lilly itself is developing a bioequivalent version of Lantus.

Conterno said 2015 is the year Lilly hopes to start benefitting from the wide-ranging cost-cutting changes it has begun making to insulin manufacturing. Although the cost of the initiative is significant, he said, “I’m very proud of this initiative.

The insulin market is undergoing a shake-up even as the size of the market is growing. The spread of diabetes worldwide is caused by growing sedentary lifestyles, higher rates of obesity and eating habits that favor higher calorie foods.

Nearly 26 million Americans have diabetes, a chronic disease in which the body does not properly produce or use the hormone insulin. As many as a third of American adults could have diabetes by 2050, according to estimates by the Centers for Disease Control.

Meridian Helps Biotech Firm Meet FDA Standards

Frederick biotech firm Meridian Biogroup has completed a four-year project for Baltimore contract research and manufacturing firm Paragon Bioservices so its laboratory equipment and programs meet US Food and Drug Administration regulations.

“Our projects are not like construction projects with a definite end. Some are long-term,” says Thomas Blake, Meridian’s Principal and Co-Founder with Alison Demarest.

Meridian offers validation and compliance services for biotechnology and pharmaceutical companies. These include testing facilities’ utility systems, developing higher-quality programs and providing extra staff for specific tasks.

Meridian’s 37 clients range from large companies like Human Genome Sciences and Osiris Therapeutic to small- and mid-range companies like Paragon Bioservices and startups that want to launch a product and need to comply with FDA regulations. Paragon moved to the University of Maryland, Baltimore BioPark in 2008.

Blake says that for MedImmune, another client, Meridian is engaged in more than 30 new and ongoing projects at the company’s sites in Frederick and Gaithersburg in Maryland, and in Pennsylvania and Liverpool, England. Projects for MedImmune include quality assurance, regulatory affairs and FDA inspection.

Meridian, a privately held company, has been located at the Frederick Innovation Technology Center since its founding in 2007. It has grown from the two co-founders to a staff of 26.

The company was the recipient of the 2012 Incubator of the Year Award in the technology services company category. The Maryland Technology Development Corp. (TEDCO) and the Maryland Department of Business and Economic Development sponsor the annual award.

Cook Medical Opens New Facility in Illinois

Cook Medical has opened a new medical device manufacturing plant in Canton, Ill. The opening ceremony was held on Friday August 31, when Cook Medical President Kem Hawkins joined national and local dignitaries to dedicate the $19 million production plant that will add another 60 high-skilled jobs to the local economy. The new facility joins an existing $20 million Cook factory in Canton that opened two years ago.

“At Cook, we have always believed in reinvesting revenues earned here and abroad in new manufacturing facilities that create jobs for people, while ensuring that the Cook organization continues to grow,” said Hawkins. “Over nearly 50 years, Cook has reinvested more than $1.5 billion dollars in plants across the United States and in key facilities overseas that now employ 10,000 people. And we hope circumstances will allow us to continue that tradition.”

The new 60,000-square-foot Canton facility will manufacture polytetrafluoroethylene (commonly known as PTFE) tubing used in a broad variety of the 16,000 different medical devices Cook makes. The highly technical, equipment-driven manufacturing plant is intended to capitalize on the existing mechanical and maintenance knowledge of workers in the Canton area. Some employees formerly worked for the large International Harvester plant that once employed 3,000 people in Canton before it was closed in 1983, raising local unemployment to 17 percent. The city was selected for the new Cook plants because in addition to its ready workforce, it was the boyhood home of the late Cook Group founder Bill Cook, who wanted to help revive his hometown.

As of June 2012, the Canton unemployment rate was at 9.6 percent, 1 percentage point higher than the national rate of unemployment. State officials are hopeful Cook will help lower this number further in the coming months.

Since Cook Canton opened, the local hospital, Graham Hospital, has invested over $40 million in a new clinic and upgrades to their existing facilities. A hospital spokesperson told Medical Product Outsourcing that the expansions were not directly related to the presence of Cook, and that the plans would have gone ahead as planned regardless. However, she did say that the hospital is “grateful for Cook’s presence.”

In addition, a number of new retail stores have opened and local businesses have been able to expand. After years of no new housing permits, the city also has experienced a housing boom with a new 42-unit apartment complex being built along with 16 new home construction permits having been issued.

Cook intends to work toward employing at least 350 people. Parent company Cook Group also has invested more than $15 million in Canton’s downtown square, building a new 32-room boutique hotel and buying and improving a shopping mall and other properties.

Cook Group has also announced plans to expand in Pittsburgh, Pa. Cook MyoSite Inc., a biotechnology company located in Pittsburgh that develops cellular therapies to treat disorders of the body naturally, hopes to expand its workforce to more than double its current size by 2015. The goal for the end of this year is for Cook MyoSite to hire 12-15 new employees.

Founded in 1963, Cook Medical produces a wide range of medical devices. Its headquarters are in Bloomington, Ind., which is also where Cook Group is based.

Xcelience Plans Expansion

Xcelience is shopping for a European distributor after opening a new clinical trial supply facility in the U.S.

Xcelience plans to distribute clinical trial supplies outside the US following the opening of its new facility in Tampa, FL.

President and CEO Derek Hennecke said the acquisition plan is designed to meet client demand in the EU as well as other countries, especially for Phase III packaging.

“As the market has slowly increased after the end of the recession, a lot of the materials are moving into Phase III,” he said. “Some companies may have stopped their earlier trials, but they are continuing with their later phase compounds, and that trend is continuing to grow.”

Hennecke added that demand has come particularly from mid-sized and large companies that are struggling to source “quality” services. He held industry consolidation responsible for the gap in the market.

“On the supply side there has been consolidation of companies in this area and a reduction of the number of the number of choices customers can go to,” he said.

“As the companies get larger it’s typical that offices tend to segment and they are not able to provide the same service as they might have in the past. That gives an entrance for Xcelience to come into that open niche.”

The manufacturing and formulation services provider expects to be granted the right to package materials for EU Phase I-III trials at its new 24,000 sq. ft. facility in Tampa. The plant handles filling, blister packaging and walleting.

UC Berkeley's Energy Biosciences Building Completed

The University of California, Berkeley has completed construction of and opened a new $133 million research building to house its energy and biofuel program and some of its bioengineering department, the university said.

Situated at the northwest side of the UC Berkeley campus, the 113,200 square-foot Energy Biosciences Building will house the Energy Biosciences Institute, including research labs, offices, learning spaces, shared instrumentation, meeting spaces and an auditorium.

Each floor of the new building will contain two eight-bay wet labs, where researchers will engage in a range of research disciplines involving molecular and microbial biology, fermentation, chemical separation, and greenhouse-based studies.

EBI is a public-private partnership between UC Berkeley, The University of Illinois at Urbana-Champaign, Lawrence Berkeley National Laboratory, and funded by BP, that was created to develop solutions to energy challenges and ways to address the impact of fossil fuels on global warming.

These programs include research into feedstock development, biofuel production, biomass depolymerization, and fossil fuel bioprocessing, among others.

The Berkeley Department of Bioengineering is engaged in research areas including computational biology, systems and synthetic biology, cell and tissue engineering, bioinstrumentation, and biomaterials and nanotechnology.

Neurosciences Research Building Plans 2014 Opening

Construction of a new neurosciences research building at Indiana University (IU) was initiated in August 2012, and is scheduled to be completed by 2014. It is being developed jointly by Indiana University School of Medicine and Indiana University Health.

The facility will focus on expanding and strengthening the biomedical and life sciences research capabilities of the university. It will be also used for conducting a wide range of research in fields such as neurotrauma, addiction, epilepsy, dementias and pain.

Following the Indiana General Assembly's approval of the project, the Indiana state budget committee gave approval to the University for going ahead with construction, in April 2011.

"The Indiana state budget committee gave approval to the University for going ahead with construction, in April 2011."The new research building for neurosciences at the Indiana University will have a total floor space of 138,000 square feet.

It will provide enhanced research facilities for neuroscientists from numerous fields, such as psychiatry, neurology, neurosurgery, rehabilitation, radiology and pathology. The aim of the project is to provide patients with the best neurological care.

The facility will be connected to the 270,000 square feet ambulatory care and imaging centre, being built by the IU Health Neuroscience Centre with an estimated investment of more than $100m. The imaging centre is expected to be completed by the end of 2012.

The two facilities together will create a hub of expertise in neurosciences for researchers, doctors, patients and future physicians.

The space in the neurosciences research building will be allocated to interdisciplinary research teams for a flexible research with a disease oriented focus, rather than assigning the space on the basis of traditional academic departments.

"The two facilities together will create a hub of expertise in neurosciences for researchers, doctors, patients and future physicians."The facility will welcome neuroscientists across the world from various disciplines, such as neurology, neurosurgery, psychiatry, rehabilitation, pathology and radiology. The cluster of multi-disciplines in one place will result in bringing fundamental advances in the research against various nervous diseases, such as Alzheimer's, spinal cord injuries, addiction and psychoses.

The research building will provide sophisticated and world class laboratory research spaces and facilities to the IU School of Medicine's scientists, the Stark Neurosciences Research Institute and those from the Institute of Psychiatric Research.

The Institute of Psychiatric Research will be the primary occupant of the building. It focuses on developing treatment for psychiatric disorders such as addictions, schizophrenia, anxiety, mood disorders, autism and Alzheimer's disease.

The Stark Neurosciences Research Institute focuses on applying advances in molecular, genetic and imaging technologies. Part of the institute will be relocated to the new research building. It will initiate collaborative research in the building through shared technical support and centralized analytical facilities. The institute aims to achieve these through flexibility in adapting to changes in programs and funding, and maximizing the performance of scientific instruments.

The neuroscience building at Indiana University broke ground for construction in August 2012. It is expected to be completed by 2014.

The exterior of the building will feature an efficient skin, composed mainly of glass. The interior of the building will be flexible so as to adapt to changes, and will have abundant natural light and other fundamental facilities. The building will follow a theme consistent with the entire neuroscience campus.

The research building was designed by BSA LifeStructures. The structural engineering support for the project is provided by TRC WorldWide Engineering. HKS Maregatti Interiors is the interior designer. Messer Construction was appointed as the general contractor and construction manager for the project.

The total investment for the construction of the facility is estimated at about $53m. The State of Indiana contributes about $43m through the issuance of bonds. The Indiana University and IU School of Medicine are contributing $5m each towards the project.

University at Buffalo Has New Facilities

John and Editha Kapoor Hall is located on the south campus of the University at Buffalo in New York, United States. It houses the School of Pharmacy and Pharmaceutical Sciences of the university. It was built with an investment of $62m and replaces the former Acheson Hall chemistry building on the university campus.

The 147,000 square feet facility will mainly focus on research and development in the pharmaceutical sciences. It will provide education programs to pharmaceutical students, pharmacists and patients.

The location of the hall unites the pharmacy school with other health sciences schools of the university. It will revitalize the south campus of the university, which has been vacant for several years. More than 600 faculty, staff and students will occupy the building.

"It was built with an investment of $62m and replaces the former Acheson Hall chemistry building on the university campus."Construction of the new facility is part of the UB 2020 strategic plan to expand the university and increase its economical impact on the region from $1.7bn to $3.6bn. A major part of this plan is the improvement of the north, south and downtown campuses of the university.

The John and Editha Kapoor Hall is the third major project being undertaken at the university. Other projects include Kaleida Health's Global Vascular Institute, the Clinical and Translational Research Centre and the Biosciences Incubator.

The project marks the first time a school has moved from the north campus in Amherst to the south campus. The university has already upgraded the campus, by adding new roofs, steam tunnels, electric systems, sidewalks and roadways.

It is also planning to renovate the Townsend, Wende and Kimball halls.

The facility is named after the alumni of the university, Dr. John Kapoor, and his wife, Editha Kapoor. Dr. John Kapoor received a scholarship from the university, which allowed him to complete his Ph.D.

In an act of thanks for the university's generosity, Dr. Kapoor made a donation of $10.8m to the School of Pharmacy. About $5m of this donation is being used towards construction of the facility.

The university received another $46m from the State of New York. The remaining project cost was met through funds raised from private donors and other sources.

John and Editha Kapoor hall was designed by architects, The S/L/A/M Collaborative. The architects were asked to transform the Acheson Hall, which has been unoccupied since 1994, into a facility that would support both pharmaceutical education and pharmaceutical research.

"Construction of the new facility is part of the UB 2020 strategic plan to expand the university and increase its economical impact."The facility is spread across four floors. The first and second floors include two lecture halls and two classrooms, a pharmaceutical care learning centre, a patient assessment suite and a model pharmacy. They also include meeting and study areas, computer labs, gathering areas, offices, conference rooms and a coffee shop.

The third and fourth floors form the main research hub of the school. They include educational labs, specialized pharmaceutical research labs, classrooms, conference rooms, lounges and offices.

The pharmaceutical research labs have facilities for sample processing, analytical research, molecular genetics, microbiology, bioinformatics, tissue culture, liquid chromatography-mass spectrometry and protein therapeutics.

They can also be used to process BSL3 cultures and radioactive samples. They have a semi-open design, which encourages collaboration between the researchers and reduces infrastructure by centralizing common facilities.

The former Acheson Hall was demolished to allow for the construction of the new facility. The demolition was completed in the summer of 2009. Groundbreaking for the new facility took place in September 2009. Construction was completed in May 2012 with the School of Pharmacy and Pharmaceutical Sciences moving into the facility.

The new facility has been designed with several environmentally sustainable features to gain LEED silver certification. The building materials resulting from the demolition of the Acheson Hall were reused for the construction. Certified woods and low emitting materials have been included in the building.

To improve the energy efficiency of the facility, water efficient plumbing, enhanced room temperature controls and air handling systems have been used. The design of the building allows natural daylight throughout the interiors.

SteriPack to Begin Operations in the United States

SteriPack is preparing to open its new ISO 13485 certified facility in Lakeland, FL, marking the debut of its U.S. medical packaging converting operations. The facility is also currently able to accommodate contract packaging and manufacturing services and is expandable to include future contract engineering and testing services, which the company offers at locations in Europe and Asia.

“SteriPack has been exploring several options in the United States for the past three years to find the ideal situation and location,” said Tony Paolino, president, SteriPack USA, in a statement. “The facility is a ‘first-in-class’ operation and draws on the nearly 20 years of experience that SteriPack has manufacturing converted products and providing contract manufacturing services in a Class 7 and 8 cleanroom.”

Gary Leonard, formerly SteriPack’s technical manager in Ireland, has moved to oversee operations as vice president of operations.

SteriPack USA has dedicated an initial 11,000 sq. ft. of the new 40,000 sq. ft. building to an ISO Class 8/Class 100,000 cleanroom housing a pouch-manufacturing machine for making a variety pouches including chevron-style pouches. The brand new bag line will manufacture the company’s SteriBag as well as standard header bags. The high-speed, high-throughput machinery runs multiple webs and can produce several sizes using film, foil, paper, and Tyvek. The facility will also operate a four-color flexographic printing press that can produce rollstock and die-cut lids.

“We are seeing increased interest in replacing header bags with our lower-cost alternative, the SteriBag,” Paolino told PMP News, which visited the facility in August. “Using uncoated Tyvek and polyethylene, the SteriBag can save users up to 15%,” he told PMP News earlier this year.

The equipment—and SteriPack USA’s quality system—mirror those used in its other facilities to offer customers consistency. “We maintain continuity from facility to facility to support customers around the world. If validation work is completed in one SteriPack location, it can easily support and extend to our other locations,” Paolino said.

Cleanroom operations are supported by technical supporting teams in adjoining clean room offices so that they are close enough to collaborate with operations quickly, explains Paolino. This approach follows the concept SteriPack has instituted at its other locations.

Windows line the perimeter of the cleanroom, allowing facility visitors to view production operations.

Raw materials will be held under controlled conditions, accessible through air-locked doors and offering Class 100,000 areas when required.

Roncelli MPS Begins Renovation of Harper University Hospital in Detroit.

Michigan Roncelli MPS has started work on the renovation of Harper University Hospital in Detroit. The project involves the renovation of the surgical services department and the pathology lab, a total of 55,000 sq. ft. of space. Roncelli MPS is a joint venture made up of Roncelli Inc. and the MPS Group. The renovation is expected to be completed in fall 2013. The construction cost has been estimated at $30 million.

Capsugel Expands Capabilities

Capsugel has expanded its Licaps liquid fill capsule line with a new facility in the US.

The firm can now produce gelatin shells for hot melt or low viscosity liquids under its Licaps brand, which traditionally produces hard capsules. New manufacturing technology was also added to the company's existing production lines in France and Japan.

Speaking at this year's AAPS in Chicago, senior VP of research and development (R&D) Keith Hutchison, said the idea is to address customers' solubility problems.

He said the product is particularly important "where innovation is needed, and certainly in new molecules where you need some pretty innovative ways to overcome the solubility problems."

As for the future of the tech, Hutchison sees dry powders, pellets and other forms as a target.

"The range of applications is very broad, so along the horizon we will see its application in a wider range of products," he said.

New Celerion Facilities to Receive Full Accreditation

Celerion, the premier provider of innovative early stage drug development solutions, is pleased to announce that it has been awarded full accreditation by the Association for the Accreditation Human Research Protection Programs (AAHRPP). Celerion's clinical facilities in the USA; Lincoln NE; Neptune NJ; and Phoenix AZ, have achieved this significant milestone.

AAHRPP is an independent, non-profit accrediting body that uses a voluntary, peer-driven, educational model to ensure that Human Research Protection Programs (HRPPs) meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence--through policies, procedures, and practices--of their commitment to scientifically and ethically sound research and to continuous improvement.

To meet the full requirements for AAHRPP accreditation, Celerion reviewed all internal procedures and processes to ensure extensive safeguards were in place at every level of clinical research. Throughout the organization our teams evaluated their respective areas of responsibility, and reviewed policies, processes, and Standard Operating Procedures (SOPs). This ensured the highest levels of standards were adhered to, well documented and even more critical, translated into practice.

"The approval of AAHRPP certification continues to demonstrate the leadership role Celerion has taken to reach the highest standards and protections for human participants. By voluntarily undergoing the accreditation process, Celerion has committed to participants in our clinical studies that rigorous standards will be applied to ensure their safety and rights are strictly adhered to," said Susan Thornton, Ph.D., President and CEO at Celerion. "This accreditation also highlights our commitment to increased quality and transparency in conducting ethically sound research for our clients."

"I am pleased that Celerion is setting an example and raising the bar for research protections among CROs. With AAHRPP accreditation, Celerion now offers a level of quality assurance that distinguishes it among CROs and boosts its appeal to research clients," said Marjorie A. Speers, Ph.D., AAHRPP President and CEO. "Our hope is that Celerion's decision has a ripple effect across the research enterprise and that other CROs follow its lead."

This accreditation places Celerion alongside a leading pharmaceutical company as well as Institutional Review Boards (IRBs), universities and hospitals to ensure we all collaborate in working with the highest standards in clinical research.

Rollprint Announces New Cleanroom

Rollprint Packaging Products, Inc. is announcing the construction of a 6,000 sq. ft. clean room for the production of sterile medical packaging pouches. T

The ISO Class 8 cleanroom will utilize Rollprint’s innovative material offerings. This vertical integration allows Rollprint to cost-effectively control the quality of the material being used in the cleanroom and assures best-in-class status.

“We started preparing for this two years ago with investments in vision systems, web cleaners and other equipment and procedures to minimize particulates in our film converting area. We wanted to properly address upstream criteria before taking the next step,” said Dwane Hahn, vice president of sales and marketing, Rollprint.

By definition, a cleanroom environment has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified size. ISO Class 8 cleanroom certification dictates the following maximum concentration limits for airborne particulate (particles/m3) according to ISO 14644-1: 3,520,000 at 0.5 µm; 832,000 at 1 µm, and 29,300 at 5 µm.

The upgraded capability has been driven by customer demand for domestic supply that has been produced in a clean room environment. Pharmaceutical, medical device and diagnostic/life science manufacturers are constantly looking for ways to reduce the number of contaminants that come in contact with their products.

“There is a big difference between ‘cleanroom environments’ that some manufacturers claim they have, and actual cleanroom certification. In a few months time, we expect to be able to announce to the industry that we have met the rigorous certification criteria and are producing pouches in our cleanroom,” Hahn explained.

The cleanroom will house five production lines capable of producing a variety of pouch structures for which Rollprint is known. This includes header bags, chevron, vented, three-side weld seals, corner peels, etc.

“Many of the packaging structures used today for pharma and medical device applications—such as film and foil header pouches, coextruded, peelable heat-seal films and silicon oxide/aluminum oxide composites—were first introduced to the industry by Rollprint. The new cleanroom capability builds on that legacy,” said Hahn.

REST OF WORLD

Phillips-Medisize Completes Czech Expansion

Hudson, Wis.-based Phillips-Medisize Corp. has completed its 10,000 square foot expansion to their facility in the Czech Republic. The expansion provides more cleanroom production space while increasing the facility’s total footprint to enhance existing capabilities.

In the new space, Phillips-Medisize now has plastic and liquid injection molding, as well as catheter extrusion and full finished device assembly capabilities in Class 7 and 8 cleanrooms. The facility is U.S. Food and Drug Administration-registered and ISO13485 certified.

“We are very excited about the completion of this expansion,” said Matt Jennings, president and CEO of Phillips-Medisize. “Our Czech facility is an important part of our strategy of providing state-of-the-art medical facilities, equipped with the latest technologies, to our customers in regions around the world.”

According to the company, the expansion was driven by business success, which has also led the company to increase staffing at the Czech facility by more than 60 percent. The now 138-strong staff handles product manufacturing for Phillips-Medisize customers in Europe and North America.

Phillips-Medisize is an outsource provider of design and manufacturing services to the medical device and diagnostics, drug delivery, and commercial markets.

Camfil Farr Opens Tech Center in Sweden

Camfil Farr has inaugurated one of the largest R&D centers in the world for the development of air filters, clean air solutions and filter production technology.

The new 2,500m² (26,900 sq. ft.) Tech Centre is located 70km south of Stockholm, Sweden in the Baltic coastal town of Trosa.

The centre develops products with the latest laboratory and research equipment to meet a growing global need for air filtration solutions that safeguard health, satisfy stricter energy efficiency and sustainability standards, and meet emerging requirements for high-tech filtration using nanofibre technology. The latter includes researching new polymer technology for developing new and more effective filter material, including hybrid media. Air filtration experts at the centre also analyze air quality and the impact it has on human health and production processes.

Anders Freyschuss, managing director of Camfil Sweden and Anders Sundvik, Camfil Farr’s vice president for R&D hosted the opening ceremony in Trosa in late October. Per Westerberg, speaker of the Swedish Riksdag, inaugurated the centre.

Camfil Farr’s Road Show trailer was also on location in the town for the event. This travelling mobile lab and exhibition has been touring Europe to spread knowledge about the importance of filtration and filters, and the benefits for IAQ and health, which is all in line with the company’s vision to make clean air a human right.

Our philosophy has been to use innovation to develop air filters that are more energy-efficient

At the Tech Centre there are six fully equipped labs, including a molecular lab for filtration systems to eliminate airborne molecular contamination (AMC); a gas turbine and air pollution control lab for turbine filters and dust collection solutions; a process development workshop to design proprietary filter production equipment; two particle labs for comfort and HEPA filter research; and an indoor air quality (IAQ) lab equipped with scanning electron microscope and energy dispersive spectrometry equipment to assess filter performance and air quality. Other facilities include complete test benches, wind tunnels and mobile test systems for comfort air, gas turbine and molecular filtration applications.

The new Tech Centre is one of a number of initiatives from Camfil Farr that aim to enhance the Group’s R&D capabilities globally. As the largest of four R&D units in the Group, the Trosa Tech Centre is the hub of the company’s global R&D network, which employs approximately 60 filtration experts and lab technicians at facilities in France, Germany, Sweden, India, Malaysia, China, Canada and the US. This network ensures that the product portfolio is steadily maintained, improved and advanced across all Camfil Farr business areas. It also drives the development of innovative filters and solutions.

‘R&D on this scale maximizes value for customers,’ said Sundvik. ‘We collaborate and exchange our experience all over the world between research units. We develop the filter solutions and even design the process to make them.

‘Our philosophy for the past 50 years has been to use innovation and entrepreneurship to develop air filters that are more energy-efficient, greener and better for manufacturing processes, and for the health, life quality and well-being of people.’

BASF Opens Centre in China

BASF inaugurated its first R&D centre in China. The ‘innovation campus’ at the firm’s local headquarters in Pudong, Shanghai was set up at a cost of €55m ($m) and will eventually employ a workforce of 2,500 people.

Initially, research will focus on sustainable materials, such as ‘biobased’ polymers for home and personal care applications, as well as waterproofing technologies, energy efficient lighting and shoe components.

UK Pledges $16M for Center to Boost Synthetic Biology Business

As part of a new push to ramp up the UK's synthetic biology business sector, the UK government plans to provide £10 million ($16 million) over five years to fund the creation of a center that will accelerate development of new synthetic biology technologies toward commercialization.

The Biotechnology and Biological Sciences Research Council (BBSRC) said that it wants proposals from institutions interested in founding an Innovation and Knowledge Centre (IKC) in Synthetic Biology that will support and develop new businesses in this industry.

The creation of an IKC Centre in Synthetic Biology is a central part of the UK Roadmap for Synthetic Biology, a long-term strategic plan unveiled this summer that aims to boost and coordinate investments in a fledgling field that the government eyes as a significant growth area.

"Synthetic biology is still at an early stage of development, but its potential is widely considered to be very high. It is a platform and translational technology linking a broad range of foundational science with an extensive range of possible applications," BBSRC said.

The roadmap report, commissioned by the Department for Business Innovation and Skills, cited an analysis by BCC Research that concluded that the global synthetic biology market will grow from $1.6 billion in 2011 to $10.8 billion by 2016.

"Synthetic Biology has the ability to revolutionize major industries in bioenergy and biotechnology in the UK," Minister for Universities and Science David Willetts said in a statement when the roadmap was released. "If we develop this exciting area to its full potential there are fantastic opportunities in sectors such as biofuel and medical care that are largely untapped."

The roadmap advised that an IKC in Synthetic Biology would help commercialize new technologies and integrate academic and business efforts.

The IKCs are aimed at accelerating the commercial exploitation of emerging fields by creating "early-stage critical mass, allowing businesses from different sectors to develop and exploit the technology," and by providing these companies access to scientific, technological, and market expertise and to lab facilities and technologies, according to the call announcing the funding.

The IKC in Synthetic Biology must possess or have direct access to core capabilities in synthetic biology; a shared environment to enhance collaboration; facilities and equipment that are necessary for conducting synthetic biology projects; flexible capabilities in companion and enabling technologies; market analysis and development capabilities; and professional management capabilities for handling internal and external intellectual property assets.

Along with BBSRC, the funding program will be supported by the Engineering and Physical Sciences Research Council and the Technology Strategy Board.

Manchester Cancer Research Center Plans New Building

The UK government has invested £12.8 million ($20.4 million) to build a new facility that will house the Manchester Cancer Research Centre (MCRC), a research partnership between the University of Manchester, The Christie NHS Foundation Trust, and Cancer Research UK, according to the University.

The new funding will cover part of the costs of the £38 million, multi-partner project, which will be located in Withington and will be home to a range of collaborative research projects aimed at translating lab discoveries into personalized cancer medicine. It also will help fund the purchase of specialized equipment.

The award was provided by the Higher Education Funding Council for England (HEFCE) under the UK Research Partnership Investment Fund (UKRPIF).

The research at the MCRC will focus on using studies of tumor biology to inform development of new cancer treatments and will include basic lab research, clinical trials, and patient care in five areas, including radiation therapy, lung cancer, women’s cancers, melanoma, and hematological oncology.

The MCRC already is engaged in a wide array of cancer research projects, many of which use 'omics-based approaches to study cancer biology, prevention, risk assessment, and new treatments.

Among its many research groups are the Breast Cancer Risk and Detection Group, which is studying more than 800 families with BRCA1/2 mutations to develop new ways to predict the risk associated with these mutations, and the Molecular Cancer Group, which is engaged in a number of research approaches, including genetic analysis, aimed understanding relationships between gene expression, cell cycle, and tumor development.

The MCRC bid for UKRPIF funding was made possible with additional funding from a range of businesses, charities, and philanthropists, including AstraZeneca, the Wolfson Foundation, and the Oglesby Charitable Trust.

AstraZeneca’s New Manufacturing Facility, Taizhou, China

AstraZeneca began construction on a new manufacturing facility at Taizhou in Jiangsu province of China in January 2012. The facility will manufacture intravenous and oral solid medicines for the Chinese market. It is expected to be completed by the end of 2013.

The new plant is located at China Medical City (CMC) in Taizhou city. CMC is the national-level hi-tech development zone, which is sanctioned and sponsored by the State Food and Drug Administration (SFDA), Ministry of Science and Technology, Ministry of Health, Jiangsu Provincial Government and State Administration of Traditional Chinese Medicine. It focuses on the biomedical field.

The project, which was announced in October 2011, is the single largest investment made by AstraZeneca to date. It involves an estimated investment of $230 millio and is expected to create about 600 jobs.

"The facility will manufacture intravenous and oral solid medicines for the Chinese market."The plant will enable the company to meet increasing demand for its products in China. It will also expand the availability of its products to about 900 million people in the urban and rural communities, which traditionally had limited access to established medicines.

The company will adopt a multi-channel approach for selling its products in rural areas. It plans to establish an inbound and outbound call centre for reaching out to healthcare professionals.

The new facility will free up some capacity at the company's existing manufacturing facility located in Wuxi, which can be utilized for developing new products in future. It will also enable the company to produce more affordable new medicines for Chinese patients.

The facility will help AstraZeneca to deliver innovative drugs to the Chinese healthcare market. It will produce AstraZeneca's own branded generics as well as the generic brand of drugs of other companies.

The AstraZeneca manufacturing facility at CMC is situated in a 9.2ha site, with a built-up area of about 51,000m² (548,959ft²) and two main production areas. The two key production areas will include a sterile dry powder filling centre for injectable cephalosporin products, and an oral solid-dosage products centre.

The fit-out of the production areas will be completed in two phases.

Cockram was awarded with a contract to provide procurement and construction management services for the plant. The scope of the contract includes offering construction services for two years with a 40-member professional construction crew.

Astra Zeneca is a global biopharmaceutical company headquartered in London. It produces innovative medicines for millions of people across the world with its operations spread over 100 countries.

"The project, which was announced in October 2011, is the single largest investment made by AstraZeneca to date."AstraZeneca established its presence in China in 1993. It currently has more than 5,000 staff working in China and Hong Kong facilities. The main drugs manufactured by the company in China include Losec, Betaloc, Plendil, Nexium, Crestor, Symbicort, and Iressa.

In December 2011, AstraZeneca acquired Guangdong BeiKang Pharmaceutical Company, a Chinese generics manufacturing company, to enter the Chinese market for injectable medicines used to treat infections.

The pharmaceutical market of China grew from $10 billion in 2004 to more than $41 billion in 2010. It is expected to cross over $100 billion by 2015. AstraZeneca's expansion in the country bodes well given the high growth potential of the country for pharmaceuticals business.

AstraZeneca established its initial presence in China in 1993.
The new facility will manufacture medicines for the Chinese market.
Astra Zeneca is a global biopharmaceutical business company.

Takeda Pharmaceutical Manufacturing Plant, Yaroslavl, Russian Federation

Takeda Pharmaceutical completed construction of a new manufacturing facility at Yaroslavl in Russia in September 2012. The new plant is located 280km away from Russia's capital city Moscow. The first shipments from the plant are expected in 2014.

The pharmaceutical plant was built at a cost of about €75 million ($97.4 million). It will be used to manufacture actovegin, cardimagnyl and calcium tablets for the Russian medical market.

The new plant has a built-up area of 24,000 square meters (258,334 square feet). It will manufacture about 90 million sterile ampoules and more than two billion tablets in a year. It will initially provide employment to more than 200 qualified technical staff and managers.

The plant will engage in both liquid and solid production technologies. The liquid manufacturing will involve processes such as solution preparation, filling, washing of ampoules, inspection and packaging. The solid production processes will include granulation through compression, weighing, coating, mixing and packaging.

"Takeda acquired Nycomed, a Switzerland-based pharmaceutical company for about $13 billion (€9.6 billion) in 2011."The general construction contract of the plant was awarded to PharmaGroup, a Russian engineering company that offers full range of services for pharmaceutical and medical industry.

The plant broke ground for construction in June 2010 and by March 2011 the roof construction was completed. The final stages of construction were completed in September 2012.

PharmaGroup completed the plant's construction within the stipulated time and according to the local and international GMP standards. It has also strictly adhered to the latest safety and environmental standards.

Takeda is the largest pharmaceutical company of Japan. It has head offices located in Chuo-ku, Osaka, and also in the capital city of Tokyo. It manufactures and markets drugs in 100 countries. The company has 17 in-house production plants, which are located across 14 countries. Additionally it has three production bases located in Asia, which are run through joint ventures.

Takeda acquired Nycomed, a Switzerland-based pharmaceutical company for about $13 billion (€9.6 billion) in 2011. The acquisition allowed Takeda to enter the Russian market, which contributed for $15m worth of pharmaceutical sales in 2011. The growth in pharmaceutical sales further cemented the company's plans to enter into Russian market.

With the completion of the new facility at Yaroslavl in Russia, Takeda could make its direct presence in the Russian pharmaceutical market. It is the only major pharmaceutical company that has invested hugely to establish a manufacturing facility in Russia. It intends to tap the Russian market by producing blood substitute actovegin, heart attack preventive drug cardiomagnyl, aspirin and over-the-counter calcium tablets.

The new plant at Yaroslavl will also consolidate production for the Russian market by avoiding import duties from sites in Austria, Germany and Norway.

Russia has the 11th biggest pharmaceutical market in the world with sales having passed $14.7bn in 2011. Takeda is well established in the Russian market, with the company's sales growth expected to reach 11 percent a year by 2016.

"It will be used to manufacture actovegin, cardimagnyl and calcium tablets for the Russian medical market."The future pharmaceutical market in Russia is expected to change, with the government deciding to alter the coverage scheme with effect from 2016.

Third-party reimbursement is rare in Russia, which made it a major market for branded generics. The market for the new drugs is expected to grow however with the change in government's coverage scheme, as it will be imperative for the companies to have sales and marketing infrastructure in place to produce both established and innovative products. The new drugs must undergo clinical trials in Russia for receiving a national license.

GSK, Teva and AstraZeneca are also planning to enter into the Russian pharmaceutical market by establishing manufacturing facilities there.

The plant was the first API plant built by Takeda outside Japan and complements the pharmaceutical finishing plant located in Bray, County Wicklow, Ireland.

KwaZulu-Natal Research Institute for Tuberculosis and HIV, Durban, South Africa

KwaZulu-Natal Research Institute for Tuberculosis and HIV (K-RITH) is located in Durban, South Africa. K-RITH was founded in 2008 by the Howard Hughes Medical Institute (HHMI) and the University of KwaZulu-Natal (UKZN). It is part of the UKZN's Nelson R. Mandela School of Medicine campus.

The facility will carry out research on tuberculosis (TB) and HIV with the aim of developing innovative treatments for controlling these diseases. It was built with an investment of $40m.

Groundbreaking for the state-of-the-art facility took place in July 2011. Its construction took more than a year to complete. It was officially inaugurated in October 2012.

"The facility will carry out research on tuberculosis (TB) and HIV with the aim of developing innovative treatments for controlling these diseases."HIV cases reported in South Africa are the highest in the world, at 5.7 million. Nearly 15 percent of the HIV cases are reported in the KwaZulu-Natal Province. Incidence of TB in HIV patients has also increased in the region, with nearly 295 cases reported per 100,000 people.

The new research facility is located in the heart of this HIV/TB affected region, enabling the institute to provide advanced laboratory facilities to the local population.

The institute will include six to nine large scientific research groups focusing on five areas of research. These include development of efficient diagnostic tests for TB, identification of drug-resistant strains of TB, and analyzing immune responses to TB. The research groups will also analyze the recurrent TB infections in HIV-infected patients and develop targeted treatments.

K-RITH has partnered with the Max Planck Society to set up two research groups at the facility. It has also tied-up with several institutions in Africa, North America, Europe, and Asia to further expand its research.

HHMI will provide $75m to K-RITH over 10 years for carrying out research. The Technology Innovation Agency has also made financial commitments to the institute's activities.

The facility covers 4,000m² (40,000ft²) spread over nine levels. A large glass atrium connects the facility with the Nelson R. Mandela School, and the Doris Duke Medical Research Institute.

The institute has dedicated research centers for microbiology, immunology, pharmacology, high-throughput biology, and clinical protocol development. Three laboratories at the facility have Bio-containment level 3 (BSL3) laboratory modules.

"The institute will include six to nine large scientific research groups focusing on five areas of research."The entire seventh floor of the building is dedicated to BSL3 laboratory modules occupying 600m² (6,000ft²). These modules will be used for safe handling of HIV and the bacteria that cause TB and its strains. The BSL3 laboratory modules feature triple glazed windows.

The containment levels in the BSL 3 laboratories are controlled by Phoenix constant flow / regulating valves. The valves, fitted to the air circulation system in the laboratories and adjacent rooms, control the flow of air and maintain the negative pressure in the zone served.

The building has meeting facilities for large events, which can also be divided into smaller conference rooms. All systems in the facility will be fully recoverable and functional in case of a power outage.

The Centre for the AIDS Program of Research in South Africa (CAPRISA) and LifeLab also have offices in the building.

Sustainably sourced Ukume wood has been used in the construction of the building. A Building Management System (BMS) controls the lighting on all levels of the facility. The lighting is adjusted by the BMS in response to the occupancy levels.

T5 lamp technology is used to for the lighting in the laboratory and office spaces. The technology maintains light-to-power ratio output, thereby ensuring a long lamp life.

Levels two and three of the building feature sensors which switch off the lights in the absence of any occupants.

FGG Architects were the architects for the building. The main contractor was WBHO Construction.

Shionogi Pharmaceutical Research Facility, Osaka, Japan

Shionogi & Co's new pharmaceutical research facility is located in Toyonaka City in Osaka, Japan. The new facility was opened in August 2011. It is equipped with drug discovery research laboratories and laboratory equipment, as well as information technology capabilities.

The new facility was built with an investment of about ¥18.9 billion ($247 million). It will serve as the main research facility for Shionogi. With the construction of the facility, Shionogi has integrated drug discovery research operations into the Shionogi Pharmaceutical Research Centre (SPRC). These operations were earlier dispersed between four other sites in Osaka and Shiga Prefectures. The SPRC will now include the new facility and the existing three sites in Osaka.

The aim of establishing the SPRC is to achieve leading research productivity in drug discovery. The SPRC integrates different drug research functions of the company, such as basic to exploratory research, synthetic and early-stage formulation research, into a single location.

“With the construction of the facility, Shionogi has integrated drug discovery research operations into the Shionogi Pharmaceutical Research Centre."The research facility covers an area of 34,627.97m² (372,597 sq. ft.) spread over five stories. The built-up area of the research centre is about 9,800m² (105,448 sq. ft.) and it has a total floor space of about 43,000m² (472,680 sq. ft.). Operations at the new facility began in mid-August 2011.

Each floor of the facility provides space for about 160 researchers. The state-of-the-art drug discovery laboratories of the facility are equipped with sophisticated laboratory equipment.

The design of the new facility specifically stimulates creativity and supports innovation by increasing communication and mutual collaboration among the researchers. A wellhole space located in the building conveys a feeling of unity among the researchers. The facility also includes several meeting areas and relaxation corners.

The new facility provides support for maximum creativity and high productivity for drug discovery research functions.

The research facility features modern and sophisticated drug discovery equipment. It includes a 25l mini plant reactor system, which enables the researchers to perform medium-scale synthesis of candidate compounds. It also has a high-content screening system that provides high-throughput screening of compounds against novel drug targets.

The safety aspect was given top priority during the designing of the biochemistry laboratories, which are arranged functionally with respect to the measuring instruments.

The facility is located in the same premises as Shionogi's developmental research laboratories. Ground breaking for the facility took place in September 2008. Construction was completed in July 2011. It was constructed using quake-absorbing materials, steel and reinforced concrete.

"The facility is located in the same premises as Shionogi's developmental research laboratories."The facility was built according to environmentally friendly standards. The environment-friendly triple skin structure of the facility reduces about 40% of the heat load from outside. The facility was adopted as a model project of housing and buildings for promoting carbon emission reduction by Ministry of Land, Infrastructure, Transport and Tourism in 2009.

Takenaka Corporation was responsible for design and construction of the facility.

Osaka-based Shionogi & Co is a leading pharmaceutical research company. It has over 5,277 employees and its core areas of activity involve research and development, production, and marketing activities, with a focus on prescription drugs, OTC drug and diagnostics. The company's operations are spread over Europe and North America.

Shionogi built the new drug research facility to upgrade its research capabilities and improve its global competitiveness. Through the facility, Shionogi will focus on tapping unmet medical needs by deploying various technologies such as small molecule drug discovery. It will continuously supply innovative pharmaceuticals to the patients in Japan and the world.

The new facility will also serve as the foundation for Shionogi's growth over the next 10 to 20 years. Shionogi's research is targeted on three main areas, which include metabolic syndrome, pain, and infectious diseases. The research facility will provide the company with top-class global research capabilities to focus on these areas.

Shionogi pharmaceutical research facility is located in Japan.
Shionogi is based in Osaka, Japan.
The Shionogi research facility includes drug discovery laboratories.

Heraeus Opens New Facility in Singapore

Heraeus Medical Components, headquartered in Hanau, Germany, has opened a new Singapore facility. The location will support the expansion of the company’s Medical Components Division, and is focused on research and development and materials and components for the medical device industry. With this new facility, Heraeus now has 20 manufacturing facilities in Asia, a burgeoning market for medical devices.

“Heraeus has a long tradition of being close to our customers and there has been a strong movement in the last few years by our major cardiac rhythm management customers to relocate their medical device manufacturing to Southeast Asia,” said Nicolas Guggenheim, president of the Medical Components Division. “With the strong Asian investment in local startups, a strong base of new Asian medical device companies is growing in the region, which makes for a powerful mix of companies and innovation. Being the first phase of Heraeus Medical Components’ Asian operations strategy, Singapore is uniquely positioned as a premier high-tech hub providing access to a very technical and well-educated workforce that can support our development efforts. Singapore’s ideal location situated between Malaysia and Indonesia provides both Heraeus and our customers with nearby lower cost manufacturing and production options.”

“The division is also very fortunate to be able to leverage the existing Heraeus Singapore infrastructure, which includes one of the world’s largest bonding wire facilities and that has already received approval by many of our top medical customers,” noted Mark Kempf, executive vice president of Global Business Lines for Heraeus Medical Components. “With strong guidance and support from the Singapore government Heraeus Medical Components was able to quickly and efficiently ramp up our new development and production center.”

Kempf also has been named Singapore General Manager and has relocated to Singapore.

Heraeus Medical Components specializes in precious metals, sensors, biomaterials, medical products, dental products, quartz glass, and specialty light sources. Heraeus Medical Components’ U.S. headquarters are in St. Paul, Minn.

Novartis to Start Construction of New Facility in Singapore

Novartis announced the construction of a new state-of-the-art biotechnology production site in Singapore with an investment valued at over US$500 million. The new facility will focus on drug substance manufacturing based on cell culture technology. It will be co-located with the pharmaceutical production site based in Tuas, Singapore. In the future, Singapore is expected to be a technological competence center for both biotechnology and pharmaceutical manufacturing at Novartis.

"This investment further strengthens our strategy to establish key strategic sites based on technological competencies. Singapore will be strengthened through a new state-of-the-art facility for biotechnology which is a growing segment of our business", said Joseph Jimenez, CEO of Novartis. "We have chosen Singapore as strategic supply point as it offers a wide range of advantages due to its strong local biomedical presence and knowledge, skilled labor as well as proximity to growth markets in Asia."

The investment decision underlines the long-term strategy of Novartis to establish a worldwide manufacturing network of technology centers of excellence. The groundbreaking for the new production site is scheduled for the first quarter of 2013 while the new facility is expected to be fully operational by the end of 2016. The site will be designed to operate in a flexible manner to handle small and large scale volumes. It is planned to support both clinical and commercial production of potential new products that include monoclonal antibodies for use in helping patients with diseases in autoimmune, respiratory and oncology indications. The biologics pipeline currently accounts for 25 percent of the clinical pharmaceutical research pipeline with a trend for future growth.

Novartis has several operations in Singapore, including the Novartis Institute for Tropical Diseases (NITD), the Novartis Asia-Pacific head offices and two production facilities for Alcon as well as one pharmaceutical manufacturing site.

Boehringer Ingelheim Invests in Plant

German drugmaker Boehringer Ingelheim (BI) plans to double production capacity at its inhaler plant.

The firm said it will spend €85 million ($110.4 million) to expand its manufacturing plant in Dortmund, Germany – creating 100 new jobs – and explained that the facility is currently operating at full capacity. The plan is to be able to make 44 million Respimat inhalers a year by 2015.

BI board member Wolfram Carius said: "We expect that the Respimat business will continue its strong growth. For this reason, Boehringer Ingelheim is now laying the symbolic foundation stone to expand production capacity for the Respimat Soft Inhaler at the Dortmund facility.

“In future, we will continue to meet the increasing demand, while at the same time fulfilling our claim to provide patients with innovative medications" he continued.

The money will be spent on new cleanrooms and production machines and that the additional production capacity will be used to manufacture the firm’s own products rather than for those of third parties.

BI claims about growing demand fit with its most recent financial statement - released in August - when it said that Spiriva and Combivent helped group sales increase by 6.8 per cent to €7.1 billion ($9.3 billion).

BI’s respiratory products are based on its ‘soft mist’ technology, which generates a mist using mechanical means rather than chemical propellants. The firm acquired the platform and the Dortmund plant when it bought microtechnology specialist STEAG microparts in 2004.

STEAG – since renamed BI microParts – continues to operate the Dortmund site, employing a workforce of around 450 people.

The manufacturing investment is the second BI has made in as many years. In 2010 the firm announced that it has spent around €70m to expand production capacity at the site, again citing demand for its Respimat products.

Charles River Laboratories to Expand in China

Charles River Laboratories International, Inc. announced that it has entered into an agreement to acquire 75 percent ownership of Vital River, a provider of research models and related services in China. Through this acquisition, Charles River will provide high-quality research models and associated services to the emerging China market for drug discovery and development. The acquisition is expected to close in the first quarter of 2013, subject to customary closing conditions, including Chinese regulatory approvals.

James C. Foster, Chairman, President, and Chief Executive Officer of Charles River Laboratories, commented, “We expect demand for research models in China to significantly increase over the next several years as drug development initiatives in academia, government and biopharmaceutical companies expand. Through our acquisition of Vital River, Charles River intends to set the standards for research models in China, the third-largest pharmaceutical market in the world, and play a leading role in this emerging opportunity.”

For the last ten years, Vital River has been a licensee for production and distribution of Charles River research models in China, with sites which reflect Charles River facility design.

Charles River expects to acquire the 75 percent ownership of Vital River for approximately $27 million, subject to certain closing adjustments. The transaction is expected to add more than 1 percent to 2013 total net sales on a full-year basis and be slightly accretive to 2013 earnings per share. When the acquisition is completed, Vital River will be majority owned and controlled by Charles River. The agreement provides an option for Charles River to acquire the remaining 25 percent of Vital River at a later date.

Novasep Invests in Plant for Pharmaceuticals

The investment of €30 million allows Novasep to build the largest chromatography plant for the production of a large volume commercial API’s in Mourenx, France.

The plant will be built on Novasep's existing Mourenx site in France and will be operational and validated within 18 months. Both the development of an advanced purification process and the plant expansion within the challenging timescale are results of the sharp increase in the projected demand for a large volume, highly purified API.

The €30 million investment follows two other significant global investments in 2012. The first is the opening of a new 2,000m² (21,521 sq. ft.) facility in Shanghai, China and the second is a €three million investment to expand the Highly Potent API (HPAPI) manufacturing capabilities at the facility in Le Mans, France.

Novasep has pioneered continuous chromatography for pharmaceutical manufacturing for more than 20 years. Its SMB and Varicol(R) continuous chromatography technologies are currently used for commercial scale production of several chiral APIs. The new plant, designed by a Novasep in-house engineering team, will include Varicol(R) systems with 1,200 mm diameter columns operated at up to 70 bars, the largest ever built in the pharmaceutical industry. The plant will enable the production of a highly purified API from a complex mixture. The systems will also integrate sophisticated solvent recovery systems for the recycling of 99.9 percent of solvents, resulting in both a very cost-effective and environmentally friendly process.

"Demand for Novasep's advanced, purification-based manufacturing capabilities in the life science industries continues to increase as drugs in development and reaching the market become more complex and specific. This necessitates our third, and largest global plant expansion in 2012," said Patrick Glaser, President and CEO of Novasep. "This successful project, the world's largest chromatography plant in the pharmaceutical industry, demonstrates the validity of the Novasep strategy which is based on the combination of synthesis, biosynthesis and purification. We thank our institutional partners for their active support and our shareholders for their strong involvement to enable this transforming project."

Beyond Novasep's commitment, the €30 million investment has been made possible through financial and/or logistic support by the following partners: the association of local authorities of Lacq, the General Council of Pyrénées Atlantiques, the Regional Council of Aquitaine, the Economic Development Bureau, DIRECCTE Aquitaine, the Prefecture of Pyrénées Atlantiques, the Total Group, and OSEO, France's innovation partner. The plant will leverage the SOBEGI platform's utility supply.

Standards Firm Opens Lab for Food Safety in India

TÜV India, a subsidiary of the German TÜV Nord, has opened the doors to a new laboratory that will test agricultural and processed food materials in Pune.

Dr Guido Rettig, chairman of the parent company’s board, was present at the opening of the state-of-the-art laboratory and offices, and said that they will house some of the most advanced analytical equipment in the world. He also announced the launch in 2013 of a centre of excellence for food safety at the 20,000sq-ft facility.

TÜV’s Indian operation already provides services to several thousand customers across the wider subcontinent, but according to Rettig, the new centre will also help local exporters access worldwide markets through testing, certification and training services. Last year, it contributed €1.4 billion to TÜV's turnover—corresponding to almost one-sixth of overall operations.

Referring to “the advent of Indian food safety revolution” Rettig vowed to support the local industry and regulators to improve standards.

In spite of being one of the world’s largest food producers, India presently processes only between 3-4 percent of the world’s food production, wasting much of it due to the lack of adequate infrastructure like cold-storage and supply logistics.

“As such, there remains tremendous opportunity for India to fulfill its food security requirements,” said Rettig. “There is a huge latent opportunity for India to become one of the major sourcing hubs for its produce and ethnic food items. However, there is a large gap in terms of meeting international standards and expectations.”

According to Anil Rairikar, managing director of TÜV India; “With the implementation of the new Food Safety & Standards Act, India needs the services of accredited, third-party testing laboratories more than ever before.

“Globally, food safety concerns go much beyond routine quality testing, and products are now tested for safety aspects like pesticide residues, toxins, dioxins, and antibiotic and hormone residues, and these require very sophisticated capabilities.”

The new lab has already been approved by NABL, APEDA, FSSAI and AGMARK, and will also shortly be seeking EIC, BIS, FDA AND German QS approvals.

DSM Announces Australian Facility

DSM Pharmaceutical Products, the custom manufacturing and technology business of Royal DSM, announced that it has signed a biologics contract manufacturing agreement with Paranta Biosciences Ltd of Melbourne, Australia.

The contract covers the process development and cGMP manufacture by DSM of Paranta's lead recombinant human protein. This project represents an agreement for DSM with an Australian customer at their Brisbane facility. Paranta Biosciences is an early stage drug development company dedicated to developing and commercializing novel biotherapeutics based on recombinant human follistatin for the treatment of respiratory diseases.

Alexander Wessels, CEO of DSM Pharmaceutical Products, stated, "Working with Paranta is an important milestone for DSM to support the local client base directly from our facility in Australia, expanding our presence in global regions. Our collaboration with Biopharmaceuticals Australia (BPA), the Queensland Government and the Australian Commonwealth Government is already bringing benefits to Australia by providing biopharmaceutical firms local support and manufacturing expertise."

Ross Barrow, CEO of Paranta Biosciences stated, "Follistatin has been shown to have great potential in treating a wide range of inflammatory and fibrotic respiratory diseases, which affect over 300 million people worldwide. Our selection of DSM as Paranta's biologics manufacturing partner is the culmination of an extensive global search process spanning more than nine months. We are looking forward to working with the Groningen and Brisbane groups of DSM Biologics as we continue the development and manufacturing scale-up of what we believe will be a truly exciting biotherapeutic."

Karen King, President of DSM Biologics, the business unit of DSM Pharmaceutical Products operating the Brisbane site, commented "We are proud to announce that Paranta has selected DSM as its manufacturing and development provider. DSM will bring over 25 years of experience, a state-of-the-art facility and an expert team in Brisbane to help drive the success of Paranta's lead project." In addition to an R&D and manufacturing site in Groningen, The Netherlands, DSM is building operations in Brisbane, Australia, with the support of the Governments of Queensland and the Commonwealth. The Brisbane facility is DSM's blueprint for its 'biologics plant of the future' for the production of biopharmaceuticals.

"For Biopharmaceuticals Australia, DSM's signing-up Paranta for the new facility represents a key endorsement of the wisdom of the public sector investment in the project," said CEO, David Hughes. "The Paranta contract is an important step in ensuring that more of the drug development value chain is retained locally." BPA, an industry-development company owned by the Queensland State Government, put together the partnering deal with DSM, and is currently project managing the final stages of the construction of the new state-of-the-art facility in cooperation with DSM Biologics."

Financial terms were not disclosed.

WuXi AppTec Opens Bio-Facility in China

WuXi AppTec has opened its cGMP biologics manufacturing facility in Wuxi, China and hosted its first Global Monoclonal Antibody Summit in conjunction with the opening. The company has invested in growing its capabilities and capacity in biologics in the past few years. The manufacturing facility in Wuxi is the first in China to meet GMP standards of the U.S., EU and China, and uses 100% disposable equipment for biologics drug substance manufacturing.

“The establishment of this cGMP biologics facility has greatly improved WuXi’s services in biologics manufacturing and further showcases our commitment to global clients,” said Dr. Ge Li, chairman and chief executive officer of WuXi AppTec. “WuXi is determined to provide world-class services for anyone conducting research in biologics discovery, development and manufacturing including multinational and Chinese pharmaceutical and biotech companies.”

The company recently announced contracts with Open Monoclonal Technology to use OmniRat to develop human antibodies, a contract with TaiMed Biologics to produce the HIV compound ibalizumab for global Phase II and III trials, and a joint venture with MedImmune to develop MEDI5117, an IL-6 inhibitor for rheumatoid arthritis and autoimmune disorders in China.

Cleanroom Opens at BBIC, Barnsley

A new Class 8 cleanroom has been opened at Barnsley Business and Innovation Centre (BBIC), at Wilthorpe, Barnsley, South Yorkshire, UK, which will help to create a ‘hub’ of health technology businesses.

The venture, thought to be the first shared cleanroom in South Yorkshire, is a partnership between BBIC and Single Use Surgical (SUS), a firm based at BBIC that makes single-use surgical instruments for hospitals around the world.

Shared facilities previously located on site have included an electronics development centre, an e-business centre and post-production editing suite.

The cleanroom is the latest project at BBIC and chief executive Tim Milburn said: “SUS’s involvement is essential in that the company has both the expertise and the quality accreditations to facilitate the Class 8 certification of the cleanroom. We hope that, as well as benefiting SUS, it will also serve as a magnet to attract new businesses to Barnsley.”

The cleanroom, which can be hired out for a daily rate, is aimed at start-up and small companies that make medical, dental, and optical devices, and electronic products.

Staff from SUS will manage the unit and provide training for people who use it.

Milburn said BBIC is seeking to promote and encourage development of innovative technology businesses to generate new jobs and create economic growth in the area.

“Where businesses need help developing specialized facilities we’ve been able to step in and share some of the cost,” he said. SUS is a market leader in supplying single use suction tubes for neurosurgery, and its products are also widely used by ear, nose and throat surgeons. It supplies 75 percent of hospitals around the UK as well as exporting to 20 other countries.

The firm has a turnover of £1.8 million and sells more than 150 different single-use surgical instruments to replace those that are difficult to clean, such as fine suction tubes. SUS designs and develops the instruments and sub-contracts manufacture to approved suppliers.

SUS’s managing director Matthew Tulley said the cleanroom would be a major boost to product development as previously staff had to travel to use a supplier’s cleanroom.

“We use cleanrooms to create and refine our prototypes, often working closely with local surgeons, and that process will now be significantly faster,” he said.

SUS was the first business to sign up to the Genesis initiative run by BBIC. Genesis is now part of the Enterprising Barnsley business support program.

The Genesis program is aimed at high-growth businesses in the first year or two of life and includes intensive business coaching support, technical assistance and business development workshops.

CRC Continues Expansions

Cleanroom Construction has completed a number of successful projects, including this one with Zytronic, a manufacturer of projected capacitive technology touch sensing (PCT) products

Clean Room Construction (CRC), a specialist in the design and build of cleanrooms and containment facilities for science and technology sectors, has continued its successful expansion into the competitive manufacturing sector by winning a contract worth around £1m (€1.26m) million with a global power systems company.

This latest contract involves the design, build and testing of three containment rooms for a company based in Derby and is part of a wider regeneration of an extensive manufacturing facility. One of the containment rooms has been designed without a fixed roof while another incorporates a retractable roof. The rooms will also feature dedicated air handling systems and high volume dust extraction.

“This is the latest in a line of manufacturing sector contracts, working with a prestigious client on a challenging and sensitive project,” said CRC Director Steve Lawton. “Clean Room Construction now has an established foothold in the manufacturing sector due to our experience of delivering tailor-made containment and cleanroom solutions that reliably protect the integrity of complex manufacturing processes.”

The Derby contract follows on from other successful projects, including a £3.7m (€4.67m) project in Cheshire for a pioneering medical technology company. CRC was responsible for the design and build of cleanrooms for the end-to-end woundcare product manufacturing process from polymer manufacture through to final packaging.

Searle Pharma Medication Production Plant, Moscow, Russian Federation

In 2000 Searle Pharma (part of Pharmacia which combined/merged with Pfizer in April 2003) opened a $30m medication production plant in Izvarino, Moscow. The plant's aim was to lower production costs by 50 percent, and produce 300 million tablets and capsules per year.

The factory, which sits alongside a row of half-completed pharmaceutical research facilities owned by Searle's Russian joint-venture partner, RAO Biopreparat, has an approximate 5% share of the Russian market.

Around 75 percent of the Russian pharmaceutical market is still supplied by foreign imports (2007 figure) mostly from France and Germany. The Russian government has put an increased tax on imported pharmaceutical products to encourage foreign companies to invest in, and thus manufacture, products in Russia.

"The plant formed a good base for the establishment of a domestic supply of important medicines at more reasonable prices."Searle's new plant at Izvarino primarily manufactures the most marketable new-generation drugs, namely, cardio-vascular, gastroenteric and antibacterial drugs. It also produces antibacterials, antihypertensives, antivirals, cancer drugs and anti-arthritics. All products are marketed at a price that enables them to be used widely.

The site, which covers 6,500m², was donated by the National Research Center for Molecular Diagnostics and Treatment (VNTSMDL), which is owned by the all-Russian scientific centre of molecular diagnosis and treatment RAO (Biopreparat). Searle Pharma (75%) and Biopreparat (25%) owned the business jointly.

The idea for the venture was first conceived while work was being carried out by the Russia-American Gore-Chernomyrdin intergovernmental commission. The agreement between Searle and Biopreparat was brokered with assistance from the US Agency for International Development (US-AID) and the Russian Ministry of Public Health and Medical Industry.

American companies invested $24 million in the project. Searle invested the largest sum and US-AID contributed $6 million. Equipment for the plant was supplied by companies in Germany, England, Italy, France and the U.S. The major contractor was Domus along with Jacobs Engineering and laboratory equipment was supplied and installed by Intertech (also provided training for personnel).

The plant was the first in Russia to be designed and built in strict compliance with world good manufacturing (GMP) standards and was supposed to help in the reduction of the price of medicines in Russia. The economic crisis in the country occurred just as the plant was being finished. However, the plant formed a good base for the establishment of a domestic supply of important medicines at more reasonable prices, which previously could only be imported.

Searle Pharma, previously one of the world's top five pharmaceutical companies, was a subsidiary of US-based life sciences conglomerate Monsanto. The opening of the facility at Izvarino coincided with a serious downturn in demand for expensive Western pharmaceutical products.

"Around 75 percent of the Russian pharmaceutical market is still supplied by foreign imports (2007 figure) mostly from France and Germany."The 1998 devaluation of the ruble meant that imported goods, including pharmaceutical products, became more expensive for the Russian consumer, whose average expenditure on pharmaceuticals dropped from $15 to $8. This figure was low, compared to the average $220 spent by Americans and $50 spent by Hungarians. The Russian pharmaceutical market has regressed by 60 percent overall.

The flagging ruble meant that foreign exporters were the worst hit by the four-fold rise in healthcare drugs prices in Russia. With government funds too scarce to finance the procurement of free drugs, many suppliers just suspended shipments to Russian consignees.

The plant construction was completed as the economic crisis hit and, although it was thought that actual payback of the initial investment would probably not occur until at least 2010, Searle management believed that the plant gave them flexibility to introduce branded generics to the Russian market, and thus establish a major brand presence. The manufacture of the cheaper generic drugs was a saving grace at the time, actually producing a product that the average Russian could afford.

At the time Searle also offered to be a contract manufacturer for companies wanting to move into the Russian market. Searle, with an important presence in Russia, just had to bide its time until the market recovered. The Russian pharmaceutical market has since increased from $1.5 billion in 2001 to $3.5 billion in 2005 – definitely a trend for recovery.

Cipra Medpro Ltd, Durban, South Africa

Cipla Medpro Pharmaceuticals is listed on the Johannesburg Securities Exchange and is one of South Africa's top ten and fastest-growing pharmaceutical groups.

Formerly known as Enaleni Pharmaceuticals Ltd, the company is a leading supplier of chronic and generic medicine.

The Durban-based manufacturing facility, Cipla Medpro Manufacturing has recently undergone a R195m upgrade to international Pharmaceutical Inspection Co-operation Scheme (PIC/s) compliance, making it one of the first in South Africa to boast this accreditation.

The company acquired 100% of Cipla Medpro Products in 2005 for R1.2 billion and is now integrating Cipla's portfolio into its own operation. Cipla is supplying a great amount of Enaleni's over-the-counter products to be repackaged in India through a 20-year supply contract.

Cipla Medpro reported that sales increased for the first two months of 2007 by 37.5 percent. The company now hopes to obtain a portion of the South African Government's retroviral HIV treatment contract, worth $400m over a two-year period.

In July 2007 new regulations came into force in South Africa from the Medicines Control Council (MCC). The MCC has been working to bring South African companies into compliance with international standards as required by the Pharmaceuticals Inspectorate Cooperation Scheme (PIC/S). The Cipla Medpro facility is the first PIC/S-compliant plant in the country.

The upgrade work was necessary because it was becoming difficult to ensure adherence to the MCC current Good Manufacturing Practice (cGMP) requirements in the old plant, due to ageing equipment.

Because of the enormity of the R125 million (€12 million) upgrade required for the Cipla Medpro plant, just south of Durban in KwaZulu-Natal, it was closed for several months from June 2007 to allow the first phase of the upgrade/expansion to be carried out more quickly.

"The Cipla Medpro facility is the first PIC/S-compliant plant in the country."The plant was able to reopen in September 2007 and obtained its manufacturing license from the MCC, despite phase two work still going on.

Cipla Medpro has worked closely with consultants CTC-Tech who are overseeing the upgrade work, and a number of other world-renowned experts in PIC/S compliance with regards to the new facility and expediting the upgrade.

The work to the 4,000m² (43,040 sq. ft.) plant includes:

A new analytical laboratory
New plant layout
New primary processing equipment
Individual air handling units in every room to control temperature, humidity and airflow
New processes and equipment for tableting, liquids, effervescents and creams
An overall four-fold increase in production capacity
Products

In addition to the company's own portfolio of brands, which includes Bioharmony, Muscle Science (both divested), FirstPharm Pharmaceutical's Hercules and Caivil, Cipla Medpro also manufactures on behalf of other companies such as Reckitt Benckiser (Dettol and Disprin), Pharma Dynamics and Merck Generics.

Bio-Pharma Company, Sigma-Aldrich, Invests in Scotland

St. Louis-based life science company, Sigma-Aldrich, announced in conjunction with Scotland's First Minister, Alex Salmond, plans to expand its operations in Scotland by investing in the development of a new powder manufacturing facility on its Irvine site.

SAFC, a top 10 global fine chemical supplier and manufacturer of specialty chemicals and biologics to the life science and high technology industries, will add to its existing liquid manufacturing capability in Scotland by investing in the development of a new powder manufacturing facility. SAFC's new facility in Irvine is their second powder manufacturing facility, which will support and strengthen SAFC's risk management program, providing an internal back-up supplier for its customers.

The new facility will be used to service customers across Europe and will create 24 new jobs. The project is being supported by a £1.5 million Regional Selective Assistance grant from Scottish Enterprise, the country's economic development organization.

"The liquid facility investment at Irvine was a significant move for SAFC as part of our strategy to support our key European biopharmaceutical accounts," said Gilles Cottier, President at SAFC. "We are delighted to expand on that initial investment and look forward to continued success in Scotland and throughout Europe."

The First Minister and Scottish Enterprise Chief Executive Lena Wilson will meet representatives of the company in Chicago to discuss the company's plans and look at other options to grow its Scottish operations.

First Minister Alex Salmond said: "This is fantastic news for Scotland, for Ayrshire and for Irvine. This expansion to create a new manufacturing facility by SAFC puts Scotland firmly at the center of this US company's European operations and is a clear signal to world-leading companies that we are open for business.

"It is clear that Scotland is a land of major opportunity and we have a long and impressive track record in the chemicals and life sciences sector, developing an environment where ingenuity and innovation can create jobs and wealth. This is the clear message I will be sending out to a number of companies with whom I will be meeting during this trade mission in Chicago."

Lena Wilson, chief executive of Scottish Enterprise, said: "SAFC is a major employer and this latest investment will anchor their operations here in Scotland. The Irvine site is already a strategic part of the company's wider European operations and this latest investment will help to ensure it can continue to meet the needs of its international customer base.

"By working with inward investors like SAFC and its parent company, Sigma-Aldrich Corporation – at the corporate level through Scottish Development International in the US, as well as locally through our teams on the ground in Scotland – we can ensure they grow their presence in Scotland once they're operational with this expansion."

SAFC made a significant multi-million dollar investment to upgrade its liquid handling capabilities at Irvine in 2009, supported by a nearly $260,000 RSA grant from Scottish Enterprise. Scottish Enterprise has also worked with the company through its account management approach since 2009, offering tailored support, including specialist advice from Scottish Enterprise's Scottish Manufacturing Advisory Service to improve efficiency on-site.

Sartorius Opens Production Facility

Sartorius, the Goettingen-based laboratory and pharmaceutical supplier, formally opened its new plant in Guxhagen in northern Hesse for the manufacture of bioreactors. After approximately one year of construction, the new building was officially dedicated in the presence of the prime minister of the state government of Hesse, Volker Bouffier; the mayor of the community of Guxhagen, Edgar Slawik; as well as numerous guests from the local political and business community.

Approximately 18 million Euros were invested in the plant at which Sartorius now manufactures bioreactors and further production equipment for customers in the biopharmaceutical industry. Covering a total area of nearly 100,000 square feet, the new building complex provides space for a high-tech manufacturing hall and offices for around 240 employees. The building owner is Robos GmbH, from which Sartorius has rented the premises in a long-term lease. By opening this new site in Guxhagen, Sartorius has moved from its former bioreactor production facility in Melsungen, Germany, where it had reached maximum capacity limits.

Prime Minister Volker Bouffier stated after a tour of the plant, “By deciding to build a new production facility just a few kilometers away from Melsungen, Sartorius AG has reinforced its close ties with northern Hesse. At the same time, this decision also underscores the advantages of the business location of the State of Hesse, according to him: “We offer companies an excellent infrastructure and intentionally promote the regional economy so that innovative medium-sized companies will invest in and stay with us,” said the Prime Minister.

“The new plant enables us to substantially enhance our manufacturing processes and creates additional capacity for us in view of the rising demand for biopharmaceutical production equipment. As a result, we are optimally prepared for further expansion, especially for single-use bioreactors,” said Joachim Kreuzburg, the CEO and Executive Board Chairman of Sartorius AG.

AqVida Opens New Office in Bavaria

As from October onwards, AqVida, located in Hamburg, will be also present in the south of Germany. With the new office in Bavaria, AqVida further optimizes its production chain.

The crucial indicator for opening the second office was the idea of accompanying the external packaging processes even more closely. In Oberhaching, AqVida is sited right next to its external and independent packaging partner Comphass, to better integrate the last step of production chain in its processes.

"Not only Germany and Europe have high expectations in the packaging of a pharmaceutical product", says Wolfgang Heinze, CEO of AqVida. "Also less regulated markets are increasingly asking for high quality finished products with German appearance." Double-digit growth rates of oncology products also make the decision reasonable for the company economically.

AqVida is a pharmaceutical company focusing on development, registration, and licensing of oncology products. Its portfolio includes Paclitaxel, Oxaliplatin and Docetaxel. The company is based in Hamburg, Bavaria and Hangzhou, China.

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