The Rostock, Germany-based orthopedics company is investing approximately $4.5 million to lease, renovate and equip a 17,520-square-foot facility in Columbia City’s Blue River Industrial Park. The facility, the company’s first location outside of Germany, is enabling DOT to fill a gap in the supply chain to its North American clients. The new facility will create up to 20 new, high-wage jobs by 2016, according to the Indiana Economic Development Corporation.

DOT currently employs more than 290 full-time associates in Germany. It already has begun hiring engineers and technicians at its Columbia City location, which opened in November 2013.

“DOT offers valuable surface treatment services to the orthopedic and medical industry in Indiana and the United States. Although business relations with U.S. customers are already well established, the generation of further growth needs direct market presence,” said Hans Eifeler, managing director of DOT. “DOT chose to establish its North American operations in Indiana primarily because the world’s leading orthopedic companies are located here. In addition, Indiana has a positive, welcoming business climate for foreign investors.”

Founded in 1992, DOT develops and supplies medical coating treatment technology for implants and instruments for the orthopedics industry under the name DOTImplantSource. In addition, under the name DOTbiomaterials the company develops and manufactures regenerative medicine products for the dental and orthopedic industries. DOT also maintains a research and development team for the improvement of existing coatings and developing new coatings.

The Indiana Economic Development Corporation offered DOT America up to $50,000 in training grants based on the company's job creation plans. These incentives are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives. Columbia City will consider additional property tax abatement at the request the Whitley County Economic Development Corporation.

DOT is the third German company in recent weeks to announce plans to add jobs and invest in the Hoosier State. NORRES, a German industrial hose manufacturer, announced plans to base its North American operations in South Bend and German extrusion manufacturer Jäger Group made plans to expand its subsidiary, Jaeger-Unitek Sealing Solutions.

State University of New York Adds Biosafety Level 3 Laboratory

The state University of New York at Stony Brook is planning to build an Animal Biosafety Level 3 Laboratory. The project entails constructing a single-story, 15,186 sq. ft. building that will contain three ABSL-3 laboratories, an insectary, an animal imaging suite, support areas for animal feeding and bedding and locker rooms. E.W. Howell has been selected as the general contractor. The project is valued at $16.2 million.

NeoStem Acquires California Stem Cell Manufacturing Facility

Cell therapy developer NeoStem has agreed to acquire California Stem Cell in a deal worth up to $124M, and includes CSC’s manufacturing facility in Irvine, CA.

The deal will allow CSC to initiate plans to begin a pivotal Phase III trial of Melapuldencel-T, an autologous melanoma initiating stem cell immune-based therapy intended to treat malignant melanoma.

Neostem PCT - the company’s contract manufacturing arm, which previously made Denderon’s Provenge – “is a leader in cell therapy manufacturing and provides deep expertise and capabilities to its clients including NeoStem’s internal programs.

"For efficient and cost effective manufacturing at all stages of development, including late stage products, PCT’s focus on innovation and engineering will be incredibly valuable to advance Melapuldencel-T,” said Neostem spokesman Eric Powers.

We can leverage the space and expertise in Irvine to do additional manufacturing and/or development work on behalf of our clients and internal programs alike,” he added.

Since 2005, CSC has developed ways to scale up high-purity human stem cells and their derivatives. CSC has been focused on the application of these cells in developing therapies such as Melapuldencel–T, which was approved to enter a Phase III clinical trial by the US FDA with a Special Protocol Assessment (SPA), as well as fast track and orphan drug designations for metastatic melanoma.

NeoStem CEO Robin Smith said the trial will cost about $25m.

“We continue to lead the industry in the development of novel proprietary cellular therapies, and adding CSC’s advanced immunotherapy technologies to our existing development pipeline and cGMP compliant cell therapy manufacturing facilities (PCT) brings us closer to our goal of delivering transformative cell based therapies,” Smith added.

This platform technology used to develop Melapuldencel-T may also be expanded into other indications, such as hepatocellular carcinoma and other immune responsive tumor types.

Hans Keirstead, CEO of CSC added, “We believe NeoStem’s and PCT’s deep expertise in scaled manufacturing, regulatory, and clinical development will advance our programs significantly.”

American Empire Manufacturing Adds Cleanroom

American Empire Manufacturing has doubled the size of its Illinois-based manufacturing facility to better meet the increased demand for their services amongst companies operating within the healthcare, dental, veterinary, and cosmetic industries.

According to the firms' Chief Operations Officer, Joseph Trznadel, the 10,000 ft2 clean suite in Waukegan allows American Empire Manufacturing to integrate additional liquid filling lines, a prototype lab, and three labeling machines which will take approximately 30-60 days to get operational.

In addition to new machinery and process controls, the cGMP/cGDP compliant facility has already been outfitted with energy efficient T-8 lighting, epoxy finish floors, and an ISO 8/Class 100,000 cleanroom. By year's end, the company hopes to have the facilities ISO 13485 certified.

Trznadel says, "The expansion of the manufacturing operation clearly makes a statement that American Empire Manufacturing is back on track after the company was saved from financial ruin and neglect in April of 2013. It also crystallizes and confirms that all of our painstaking planning, hard work, vision, and strategy are well aligned with our customers and their needs."

Trznadel may also consider adding a second cleanroom of equal size to further enhance AEM’s filling capabilities and position the organization for future growth.

Qiagen Consolidates Invests in Maryland Facilities

Qiagen announced changes to its Maryland operations with the consolidation of three facilities into two and a $10 million investment into the businesses

As part of the changes, Qiagen will shutter its Gaithersburg manufacturing facility and move it to the company's Germantown site, which will manufacture some of Qiagen's highest volume diagnostics assays, including the digene HC2 HPV Test for cervical cancer prevention.

The Germantown site recently passed a US Food and Drug Administration pre-approval inspection without any observations that were deemed objectionable or in violation of FDA requirements. Qiagen added that it plans to move the manufacturing of its QuantiFeron-TB Gold test for latent tuberculosis to Germantown, as well.

Consolidation of the Gaithersburg and Germantown sites is expected to occur by early 2015, Qiagen said.

During the past three years, Qiagen's Frederick facility has also expanded, the firm said, and will remain focused on the R&D and manufacturing of molecular testing products for life sciences research and other applications.

Qiagen currently employs about 550 workers in Maryland, and a spokesperson for the firm said that no layoffs are planned as a result of the consolidation.

"Combining three Maryland sites into two will strengthen our presence by bringing Qiagen's people together to encourage closer collaboration," Qiagen Senior VP of Operations Douglas Liu said in a statement. "At Germantown, we are creating a global focus on molecular diagnostics for disease prevention, including women's health and tuberculosis, by placing our R&D teams on the same campus with marketing and manufacturing for those products."

He added that along with the $10 million investment announced today, Qiagen had previously invested $40 million into its Maryland facilities during the past two years.

"This upgrade will prepare us for expected growth in the coming years, including moving additional support to Maryland for several rapidly growing product lines," Liu said.

NIH Opens New Research Facility

The National Institutes of Health (NIH) held a scientific symposium and a dedication ceremony March 31 to April 1, 2014, to celebrate the completion of the John Edward Porter Neuroscience Research Center. This state-of-the-art facility brings together neuroscientists from 10 institutes and centers across the NIH in an effort to spur new advances in our understanding of the nervous system in health and disease.

As one of the largest neuroscience research centers in the world, the Porter Neuroscience Research Center has 500,000 sq. ft. of open lab space and offices, shared resources and facilities and other design elements meant to foster collaborations among scientists.

The Porter Neuroscience Research Center is made up of two buildings connected by a glass atrium. Construction on the first building began in 2001 and was completed in 2004. This phase was completed by Rafael Viñoly Architects, which designed the full master plan for the 600,000-sq. ft. facility, along with concept design and construction administration for phase one of the project. The second phase of the center, designed by Perkins+Will, was built with a number of environmentally friendly design features such as solar cells, geothermal energy system and energy-efficient lighting, which make the facility 25% more energy efficient than a conventional lab building

WORLD

Phillips-Medisize's China Facility Begins Production

Phillips-Medisize Corp. reports that its facility in Suzhou, China, has begun full-scale production of a finished injector pen.

The company did not release the name of its customer, but claims it is "a leader in the development and manufacturing of delivery systems for drug self-administration."

The pens produced in the company’s China facility are for use in China and other Asian markets. The full ramp-up of the project represents the cornerstone of the company’s recently announced “China for China” strategy, meaning that products designed and manufactured in China will serve that region and not be shipped elsewhere such as the United States or Europe. The project, which started in 2011, included a global engineering team led from Europe, which has successfully transferred this product into production. The program features molds built in Europe and China and an automated on-line scalable process, which produces a finished injector pen

Matt Jennings, President and CEO of Phillips-Medisize Corp. said: “The start of production signifies the successful execution of our China for China strategy. The global Phillips-Medisize team is very excited about the attainment of this milestone, as it validates our fully-integrated capabilities for customers that desire products designed specifically for the China/Asia market and manufactured in a Chinese facility, all with state-of-the-art western medical quality systems and procedures.“

Phillips-Medisize China is located in the Suzhou Industrial Park and is ISO 13485 certified and China Food and Drug Administration registered. In addition to medical device, disposable diagnostics components, and drug-delivery device manufacturing, The company plans to open a design development center in Suzhou later this year. Other investments in the facility planned for 2014 include expanded office space, added molding capacity, and upgrades to mold repair and maintenance capabilities.

Hudson, Wisc.-based Phillips-Medisize is a global outsource provider of design and manufacturing services to the medical device and diagnostics, drug delivery, and commercial markets.

In addition to facilities in Wisconsin and California, the company has locations in China, Mexico, Switzerland, the Netherlands, Finland, Ireland and the Czech Republic.

Novartis Opens Singapore Ophthalmic Plant

Novartis subsidiary Alcon has opened the doors to its new $160m facility in Singapore for the manufacture of ophthalmic drugs.

Construction began on the plant in Tuas, Singapore in 2009 with Alcon – fully acquired by Novartis in 2010 – investing approximately S$200m ($160m) into the 330,000sq ft site in order to manufacture ophthalmic pharmaceutical products for the Asian market.

According to Novartis, the facility will manufacture the drugs Systane, Travatan, Patanol, Tobradex and Vigamox, amongst other ophthalmic products. "As the second largest division of Novartis, Alcon is the global leader in eye care, providing innovative products that enhance quality of life by helping people worldwide see better," the firm told us.

Alcon has 20 manufacturing plants worldwide with the Tuas plant becoming a second plant in Singapore for the firm, the first focused on contact lens manufacturing

For the company overall Singapore has become a key location with Novartis currently building a $500m cell-culture based manufacturing facility next door to a solid dose plant.

Shepherd Engineering Services Wins Contract at University of Cambridge

Shepherd Engineering Services (SES), headquartered in York, UK, has been appointed by Morgan Sindall and the University of Cambridge to deliver mechanical and electrical services as part of a £40m chemical engineering and biotechnology facility (CEB).

The contract, which is said to be worth about £12m, includes: high efficiency specialist ventilation systems, laboratory gases, process cooling, steam, RO water, a building and energy management system, photovoltaics, security and lighting services.

The CEB centre build, designed by architect BDP, follows the merger of the university’s Department of Chemical Engineering and the Institute of Biotechnology, and will bring its teaching and research departments under one roof on the site to the west of Cambridge. The new building will become the focus for the university’s activities in sensors and diagnostics research as well as reaction engineering.

The engineering services work for the facility, which will house biotech labs, cleanrooms, optics and imaging labs, a magnetic resonance research centre, materials and processes labs and an undergraduate teaching laboratory, begins this month, with project completion scheduled for summer 2015.

This contract follows a number of other project wins across the science and research sectors for SES, including work on a new research laboratory for the Pirbright Institute centre of excellence for research into viral diseases of livestock in Surrey, which was completed earlier this year.

As part of its ongoing commitment to engaging the local community and supporting the local economy on all of its sites in the UK, SES will be providing a number of local apprenticeships in Cambridge through the Training and Apprenticeships in Construction (TrAC) initiative.

Kyowa Hakko Kirin Completes Biopharmaceutical API Facility

Japanese pharmaceutical company Kyowa Hakko Kirin has completed construction of a GMP biopharmaceutical API manufacturing facility at its Takasaki plant in an investment of approximately JPY6bn (€43m; US$59m).

The 3,892m2 (41,893 sq. ft.) four-storey HA4 facility contains one of the largest bioreactors for recombinant animal cells (12,000L) in Japan, as well as a purification facility with a large column.

The company says the new bioreactor will enable it to offer large scale and stable manufacturing of high-quality pharmaceutical ingredients.

Operations will commence at the new facility in the first half of 2016.

Neuland Laboratories Opens New Facility in Hyderabad for API Corporation

Neuland Laboratories, a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), intermediates and contract manufacturing services, has opened a new manufacturing facility at its existing complex in Pashamylaram, Hyderabad, India.

As a subsidiary for Mitsubishi Chemical Holdings Group, APIC manufactures APIs, intermediates, investigational new drugs, fine chemicals and reagents. This is the first facility that APIC has built outside of Japan.

The plant has been built as part of the company's collaboration agreed last year with Tokyo-based API Corporation (APIC), a healthcare unit of Mitsubishi Chemical Holdings Group that produces APIs, intermediates and investigational new drugs, along with fine chemicals and reagents. The new manufacturing facility in India is APIC's first outside Japan.

APIC helped fund the facility, which Neuland is dedicating to production for APIC's customers in Japan.

'This facility will benefit our growing customer base by rapidly increasing our capacity to deliver high quality, competitively-priced APIs and intermediates in partnership with Neuland,' said Kiyoshi Kondo, President and CEO of APIC.

D R Rao, Chairman and Managing Director of Neuland Labs, added that the partnership would raise Neuland’s profile as a quality supplier of APIs and intermediates to the Japanese market

Bosch Packaging Technology Opens Pharmaceutical Laboratory

The opening of the pharma laboratory was celebrated during an international symposium on solid pharmaceuticals.

Bosch Packaging Technology, a leading supplier of process and packaging technology, held its Pharma Solid Symposium in Schopfheim, Germany, on 19-20 February 2014 which gave occasion for the opening of its new pharmaceutical laboratory.

The international conference offered industry experts an opportunity to learn about current trends and developments in the manufacturing and processing of solid dosage forms.

'We can look back on two exciting and successful days, during which top class speakers provided our international guests with up-to-date industry knowledge,” explained general manager Martin Gross. 'In addition, our diversified program provided sufficient room for personal exchange, as well as the chance to get to know our site in Schopfheim better.'

On the first day Gross and his guests inaugurated the new laboratory during a tour of the site. The new facility combines the pharmaceutical portfolio focus areas of the German Bosch Packaging Technology sites Schopfheim and Waiblingen with the British site Knowsley in one centre of competence. 'We have consistently expanded our laboratory over the past years. Now we offer our customers the appropriate services and machines for all stages – from development to production of their solid pharmaceuticals,' Gross explained.

Ten machines from the Hüttlin and Manesty product portfolio, as well as from the site in Waiblingen, are available for tests in an area of more than 300m2 (3229 sq. ft.) . The wide range of equipment covers all process steps in the production of solid dosage forms: from mixing, drying, granulating and coating of fine particles and pellets to pressing and coating of tablets and filling of capsules.

A compact and modular machine jointly developed by Huettlin and Manesty combines several process steps in a small space

Bosch Packaging Technology’s pharmaceutical laboratory concept enables customers to test machines and formulations on-site. Bosch experts are on hand to support them during the entire development process of their pharmaceuticals, right through to the start of production and beyond.

Additional laboratories for trials and feasibility studies are being established at different sites around the world. In the recently opened customer center in Waiblingen, experts assist pharmaceutical manufacturers in familiarizing with Bosch capsule filling machines.

The second day of the symposium focused on lectures and a panel discussion. After the welcome address by Ralf Schmied, director of product area Pharma Solid in Waiblingen, representatives of leading pharmaceutical companies and renowned research institutes reported on new procedures and challenges in the production of solid dosage forms. Speakers included delegates of Hoffmann LaRoche, Capsugel and Excella, as well as the Heinrich Heine University of Düsseldorf, the Johannes Gutenberg University of Mainz,and the Ernst Moritz Arndt University of Greifswald.

The speakers explored a range of new trends and developments in the fields of microdosing, nanoformulation, biopharmaceuticals and containment. The subsequent panel discussion moderated by Dr Martin Opitz, senior market expert from Bosch Packaging Technology provided the opportunity to debate and reflect the presented topics. 'We are very satisfied with the outcome of the Bosch Pharma Solid Symposium 2014,' Opitz emphasized. 'The active participation in the discussions showed how exciting it can be to look upon current topics from different perspectives. Once again, our guests also gave us valuable food for thought.'

UCLA, Chinese Firm to Create Lab Offering MDx, Genetic Tests in China

The University of California, Los Angeles announced an agreement with a Chinese firm creating a new company to offer molecular diagnostic, genetic, and other "sophisticated" tests in China.

UCLA, the UCLA Department of Pathology, and Centre Testing International — which offers product testing, inspection, certification, and consulting services in China — reached the deal to create CTI-Pathology/UCLA Health, a new company that will operate a 25,000-square-foot facility in Shanghai. The lab, which is expected to open in September, will support clinical trials "and enhance medical care" for patients in China with cancer and other illnesses, UCLA said, adding that pathologists from the school will train Chinese lab specialists in interpreting test results.

According to the school, the partnership is the first between a Chinese company and a US academic medical center to create a specialized lab in China. UCLA will manage the lab "to ensure that its operations meet international standards for quality," while CTI is providing funding and marketing expertise. The joint venture was approved in January by the University of California Board of Regents.

"Our collaboration will offer the people of China oncology, pathology, and laboratory medicine services they can trust," CTI President Sangem Hsu said in a statement. "Many of these services are not largely available in China and are needed by physicians and healthcare providers to accurately diagnose and treat their patients."

CTI-Pathology/UCLA Health will be linked electronically and digitally with UCLA and with hospitals, clinics, and other labs throughout China.

"Because pathology has a history of being undervalued in China, the country has a shortage of pathologists trained to diagnose and interpret complex test results in specialized fields of medicine," Scott Binder, senior vice chair of pathology and laboratory medicine at UCLA's Geffen School of Medicine, said in a statement. "Our partnership gives CTI and UCLA the opportunity to save lives by changing that."

UK Cell Therapy Site to Help Biotechnology

Government-backing for a large-scale cell therapy centre is justified because it will help developers navigate the “valley of death” in which many early-phase projects fail says the team planning the new manufacturing hub.

UK Chancellor George Osborne announced that the Government will invest £55m ($90m) in a cell therapy centre to provide developers with a site capable of making sufficient quantities of cell therapies of late-phase trials and commercial production.

Emma Palmer Foster, spokeswoman for management organization Cell Therapy Catapult, said that: “There aren't at present in the UK any manufacturing facilities capable of producing cell therapies in the volumes needed for late-stage clinical trials and the market.

“The Cell Therapy Manufacturing Centre will provide domestic companies with just that, so that they have no need to go overseas to establish a commercial and manufacturing presence. Equally, for US or other international companies seeking a European manufacturing foothold for commercial activities in the region, the Centre will be that place.

This was echoed by BioIndustry Association CEO, Steve Bates, who told us that: “Although the UK's small-scale academic facilities are an excellent source of materials for early-stage clinical trials this capacity will soon be filled as the pipeline of cell therapies matures.”

The project is still at the planning stage. The location for the centre has not been selected and the precise manufacturing capabilities and capacity it will offer – other than that it will produce “tens of thousands of doses per year” - have not been decided.

But what is clear is that - like the national biomanufacturing hub being built in Darlington - the plan is to establish a facility that is flexible enough to accommodate a wide range of customers from across the cell therapy sector.

Palmer Foster said that: “Considerable flexibility will be required as each organization using the facility will have different requirements.

She added that: “As a commercially-led centre of excellence for cell therapy, the Cell Therapy Catapult is focused on innovative solutions and it's a key part of our role to keep up to date with technology, scientific, clinical and regulatory developments.”

Elsewhere in his Budget of “hard truths” Osborne set out a program of spending cuts – public sector pay limits will remain and National Health Service (NHS) and school budgets will be frozen – as part of an ongoing austerity program.

However, while cell therapy developers are trying to develop products for profit, the sector does deserve Government support according to Cell Therapy Catapult’s Palmer Foster who cited the complexity of making such treatments and the potential knock-on benefits for the UK as justification.

“The Government is supporting the cell therapy industry as a consequence of two factors - the fantastic cell therapy expertise in the UK around early-stage research, and the market failure that has previously made it hard for the industry to develop here.

“This market failure is the lack of expertise in the translational phase of research - the 'valley of death' - through which early-stage research progresses to become a less risky more investible proposition. In the UK, there are translational hurdles in the business, clinical and manufacturing parts of the development chain.”

“Growth of the cell therapy industry in the UK should lead to longer healthier lives as a result of the treatments produced, domestic and inward investment as well as skills creation and job development.”

BioIndustry Association CEO Steve Bates agreed, adding that: “Commercial manufacturers have been reluctant to commit to establishing new facilities without projects for the facilities.

“The Cell Therapy Manufacturing Centre will provide the UK with the manufacturing facilities recommended in the House of Lords report, and will help retain cell therapy manufacturing expertise and jobs in the UK.”

Kyowa Hakko Kirin Completes Plant

Kyowa Hakko Kirin has completed construction of a ¥6bn ($60m) biomanufacturing plant in Japan boasting a 12,000L stainless steel mammalian bioreactor.

The new ‘HA4 Plant’, located at the company's Takasaki site, about 100km from Tokyo, was completed, with operations set to commence in the first half of 2016.

The facility complies with GMP in Japan, the US, and the EU, and amongst the plant’s capabilities it has installed a 12,000L bioreactor for recombinant animal cells, which Kyowa Hakko Kirin spokesman Kazuaki Inoue said would be – along with all the biomanufacturing equipment on site – stainless steel.

The size of the bioreactor will allow the firm to realize a larger scale and stable manufacture of biopharmaceuticals, though when asked Inoue said it fell short of Japan’s largest bioreactor for mammalian cells with that title going to Chugai Pharmaceutical, a division of Roche.

The four-storied, 4,000m² (43,056 sq. ft) Kyowa Hakko Kirin facility also has capabilities for downstream processing with a new compatible large column purification plant attached.

Inoue was unable to disclose which biopharmaceutical APIs the new plant would manufacture but Kyowa Hakko Kirin currently makes and markets several products for the Japanese and Asian markets. These include ESPO (filgrastim) used to stimulate the proliferation and differentiation of granulocytes, and the enzyme drug Leunase (asparaginase) used for acute lymphoblastic leukemia and made with a modified strain of E. coli HAP.

Furthermore the firm has a pipeline with a number of monoclonal antibody drugs developed using its BioWa Unit’s Potelligent cell line technology which, according to the firm, uses antibodies with low fructose content which are better able to interact with immune cells and are thus more potent than antibodies that contain high amounts of sugar.

Poteligeo (mogamulizumab) has been filed in Japan for peripheral T/NK-cell lymphoma whilst Benralizumab, of which Kyowa Hakko Kirin has the marketing rights in Japan and Asia, also uses the Potelligent technology and is being developed by AstraZeneca’s biologics wing, MedImmune.

Bosch Opens New Premises in Musashi, Japan

Bosch Packaging Technology, a German provider of complete solutions for process and packaging technology, has moved into new premises in Musashi, Japan.

The company has invested €1.6m in the 3,240m² (34,875 sq. ft.) plant, which is located around 70km north of Tokyo. More than 100 people have been developing and manufacturing inspection technology for the pharmaceuticals industry there since March.

The company has relocated from its previous Honjo plant into the much larger premises and says the investment in the new site underscores its commitment to Japan as a major market for pharmaceuticals inspection technology.

Bosch Packaging Technology established its Inspection Technology unit in 2012 following the acquisition of Japanese company Eisai Machinery. It offers manual, semi-automated, and fully automated inspection machines to identify particles in pharmaceutical products. It also includes the cosmetic inspection of containers or tablets to detect defects such as scratches or discoloration.

Musashi is one of four Bosch Packaging Technology sites in Japan. Processing and packaging machines and robotics for the food and pharmaceuticals industries are developed and assembled at the Funabashi site, east of Tokyo, while the company also has sales offices in Tokyo and Osaka.

McIlvaine Company

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