Commonwealth Biotechnologies (CBI) has planted its first roots in Japan; as the world's number two pharmaceutical market continues to attract foreign firms.

The U.S.-based contract research organization (CRO) has expanded into Japan via one of its business units, Venturepharm Asia, a contract research business in Beijing, China, specializing in process scale-up, formulation development, manufacturing and clinical trial management.

The new office in Tokyo will focus on supplying business development and local services to the Japanese pharmaceutical and biotechnology industry, including compound screening, medicinal, computational and synthetic chemistry.

According to business intelligence firm Research and Markets, outsourcing spending by biopharma firms across all phases of pharmaceutical development is projected to increase in Asia in the next one to two years, with the quantum of increase for phase II, phase III, and phase IV trial budgets likely to be higher than preclinical and phase I budgets.

Australia, Taiwan, Hong Kong, South Korea and Japan are among the other countries in the Asia Pacific tipped by the firm to experience an increase in the number of CRO-conducted clinical research.

With regard to Japan, South Korea, and Australia, diseases affecting the CNS are likely to be among the most outsourced research areas, with Japan also likely to attract studies in the additional therapeutic areas of allergy/respiratory, pain management and dermatology.

As such, international services companies have been setting up new business operations in the country to tap in to this growth opportunity in the market.

Meanwhile, Japan is not the only region the company is eyeing for new business. In April CBI announced a new partnership with New Zealand Pharmaceuticals (NZP), under which the two firms will jointly provide their drug development services, in order to reach a wider market.

Via an exclusive referral and co-marketing arrangement, the two firms will provide drug discovery companies with a range of small molecule chemistry products and services, focused on glycotherapeutic products, for use throughout the drug development spectrum, from research, to process scale-up and commercialization.

Under the alliance, CBI's subsidiary, Exelgen will provide customers with research products and services, while NZP will supply clients with identified preclinical lead candidates, as well as good manufacturing practice (GMP) standard products for clinical applications and beyond

Microbix

Canada-based Microbix has pulled off a coup in sealing a deal with the Chinese government for construction of a facility that will increase the world's vaccine supply by 20 percent.

Construction of the $198m plant is to be jointly funded by Microbix and the Hunan provincial government, with the site due to become operational in 2013.

A more unusual aspect of the deal will see Microbix construct a replica of the childhood home of Dr Norman Bethune, a Canadian physician who is revered in China for his medical work assisting Chinese communists in resisting the Japanese in the late 1930s.

William Gastle, CEO of Microbix, said: "We've been working for a number of years to bring our technology to market, so today we're delighted to be partnering with the Province of Hunan in building and ultimately operating the most modern and efficient flu vaccine manufacturing facility on the planet.

For a small biotech such as Microbix to broker a deal with the Chinese government is an impressive feat, which the company put down to meeting the right people and the historic-friendship between Canada and China, symbolized by the construction of Bethune's childhood home.

The plant will primarily produce vaccines for the Chinese market but Microbix has said it may consider exporting some depending on the level of demand domestically.

China currently only has the capacity to vaccinate around 2 per cent of the target population but intends to increase this to 20 per cent, according to Chen Zhaoxiong, vice governor of Hunan.

Achieving this goal will be assisted by the new plant and the use of Microbix's propriety technology, Virusmax, if adopted by the plant. The technology increases yield by harvesting the vaccine which is normally discarded after becoming attached to debris in the allantoic fluid of the chick embryo.

Microbix claims the process is inexpensive to implement and does not create a serious regulatory barrier, owing to the non-toxic substances used in the technique.

Widespread adoption of the technique would assist in boosting global vaccine production levels, which the World Health Organisation believes to be too low to cope with a pandemic outbreak.

Merck Settles on Site in Ireland

Merck has settled on a site in south east Ireland for a new vaccines and biologics facility, investing €200m ($280m) in its third facility on the island.

Merck has splashed out €200m to get it hands on the 65-acre IDA Business and Technology Park in Carlow, on which it plans to build its new facility.

The plant itself will be Ireland's first stand-alone human vaccine project, and will involve a formulation and sterile filling facilities alongside R&D operations to support recently launched vaccines and future projects.

According to the IDA, Merck also intends to tap the academic scene in Ireland to seek out opportunities in biologics.

The plant is due to be up and running by 2011, employing 170 people across production, engineering, R&D, quality control, management and administration.

Merck settled on the location after considering a number of sites worldwide, making this the company's third plant in the region. The existing operations fall under the remit of Merck, Sharp & Dohme, with construction on a new R&D and manufacturing facility in Tipperary having commenced last month.

Merck is not alone in choosing to establish a number of sites in Ireland, with several pharma firms operating multiple sites in the region in response to considerable time and effort spent by the IDA and its counterparts to create an attractive environment for the sector.

Abbott, for example, operates seven sites in Ireland, Johnson & Johnson has six, Pfizer currently has five and Schering Plough and GlaxoSmithKline both have four.

Ireland has in fact become a real focal point for the industry, establishing itself as the most popular destination for development and manufacture outside the US, according to the IDA.

With considerable expertise, an attractive infrastructure and all-important tax breaks, the life sciences are the biggest source of foreign investment in Ireland, with the pharmaceutical and biotech industries bringing in the bulk of the €2.6bn the region saw in capital investment projects over 2006.

Sanofi-Aventis Invests in Vaccine Production

Sanofi-Aventis is to invest $6.25 Billion into vaccine production between now and 2015 as the company attempts to keep pace with rising demand.

This sizeable investment is in addition to the $940m the company has pumped into its French vaccine facilities between 2005 and 2008.

The company expects global vaccine sales to double to $34bn by 2016 and is investing heavily in construction or expansion at 15 sites to meet demand.

Construction of the 7,800 sq. m. (83,928 sq. ft.) facility began in 2006 and is due to be operational by the end of 2008. Once online the plant will be capable of filling 200m vials and syringes a year, doubling the current capacity of Sanofi's operations at Val de Reuil.

Sanofi's new facility is capable of producing vaccines effective against 20 diseases, including pandemic influenza strains. The plant has been designed with the capacity to quickly switch production once a pandemic flu strain is identified by the World Health Organization (WHO).

The rest of Sanofi's operations at Val de Reuil are also being revamped, with a $313m investment in new filling lines and a vaccine formulation building currently under construction.

These developments are the latest in the history of the site at Val de Reuil which has undergone significant improvements since first commencing operations in 1973.

In recent years rising demand from emerging markets has fueled the desire for increased capacity, as more people in China and India among others seek protection from seasonal flu.

This could push global vaccine production close to full capacity, especially with China recently stating its desire to vaccinate 20 per cent of the influenza target population, as opposed to the two per cent who are currently offered protection.

Johnson Electric Opens Cleanrooms in Shajing, China

The medical products group of Johnson Electric, one of the world’s largest providers of motion actuators, announced the opening of four new cleanrooms in Shajing, China. These new facilities will increase Johnson Medtech’s medical manufacturing capacity by one million additional Class II and Class III medical devices and subassemblies per year to accommodate increasing demand

Johnson Medtech’s state-of-the-art cleanrooms encompass 14,000 square meters (150,640 sq. ft.) on three floors. The new facilities include an ISO 6 Class 1,000 cleanroom equipped with an air shower, three ISO 8 Class 100,000 cleanrooms, an engineering office, a testing lab and a document control room.

Construction will also begin in July 2008 on an additional control manufacturing area, which will provide an assembly line and plastic injection workshop. The site will offer increased medical design, engineering, prototyping, testing, manufacturing, supply chain and logistic management capabilities to help accelerate the time to market for the growing list of medical device manufacturers in Johnson Medtech’s client roster.

Miocrobix Seals Deal with China

Canada-based Microbix has pulled off a coup in sealing a deal with the Chinese government for construction of a facility that will increase the world's vaccine supply by 20 percent.

Construction of the $198m plant is to be jointly funded by Microbix and the Hunan provincial government, with the site due to become operational in 2013.

The plant will primarily produce vaccines for the Chinese market but Microbix has said it may consider exporting some depending on the level of demand domestically.

China currently only has the capacity to vaccinate around 2 per cent of the target population but intends to increase this to 20 per cent, according to Chen Zhaoxiong, vice governor of Hunan.

Microbix claims the process is inexpensive to implement and does not create a serious regulatory barrier, owing to the non-toxic substances used in the technique.
Widespread adoption of the technique would assist in boosting global vaccine production levels, which the World Health Organisation believes to be too low to cope with a pandemic outbreak

PacificGMP and pacific Biopharma Group Merg

A merger between PacificGMP and Pacific Biopharma Group is to create one of the largest single-use biomanufacturing facilities in the US or China.

A new company, China Quantitative Biomedicine, will be formed by the merger, which is to build a 61,000 sq. m. (656,360 sq. ft.) contract manufacturing facility in Taizhou, China, for the production of therapeutic proteins.

This facility will use PacificGMP's single-use technology throughout the biomanufacturing process, which the company believes significantly reduces the cost of protein production. It is anticipated that the facility will primarily manufacture proteins destined for the US and European market but it also places the company in a position to capitalize on rising demand in Asia.

The facility is due to be completed by the end of 2008 and will be the showpiece of China Medical City; a new 12 sq. km. life sciences focused Science Park, situated 2.5 hours outside of Shanghai.

Under the terms of the merger PacificGMP will receive funding to develop the Taizhou facility and ensure it is compliant with current good manufacturing practices (GMP) prior to audits by the US Food and Drug Agency (FDA) and the European Medicines Agency (EMEA). Some funding will also be made available to expand PacificGMP's operations at its San Diego facility.

PacificGMP's facilities make as much use of disposable plastic technology as possible, as opposed to the reusable, stainless steel equipment traditionally used in biomanufacturing. The company claims this enables it to manufacture products for preclinical and clinical trials in less time and at a lower cost. These benefits are in part achieved by negating the need for cleaning of the vessels, which can be a lengthy process requiring skilled personnel.

PacificGMP also claims the process offers more flexibility, enabling the manufacturer to rapidly scale up from 1 liter to 15,000 liters with ease.

Angel Biotechnology

Angel Biotechnology has inked a new deal with Novolytics, under which it will manufacture and supply materials for the latter's clinical trials. The materials will be compliant with good manufacturing practices and used by Novolytics in its bacteriophage-based MRSA prophylactic treatment, which is due to enter Phase I/II clinical trials in 2009.

Angel's facilities at Edinburgh will be used for the production, which is due to run for seven months.

PharmEng

Canadian contract manufacturer and consultancy firm PharmEng says that its wholly-owned Keata Pharma subsidiary is relocating from its current base in Perth, Ontario to a new site in Sydney, Nova Scotia.

The 46,000 square foot Good Manufacturing Practice (cGMP) facility will house PharmEng's pharmaceutical consulting division, formulation development laboratories and production rooms capable of conducting high-shear mixing and container blending. In addition, the site provides equipment for the production of drugs that have modified release technologies.

Keatat's goal in the long term is to use the site to produce drugs in a variety of dosage forms ranging from medical suppositories to topical and injectable products.

Pharmaceutical Product Development

Pharmaceutical Product Development (PPD) becomes the latest contract research organization (CRO) to venture into new territory with the opening of an office in Istanbul, Turkey.

The firm, which already has offices in Russia and the Ukraine said that the move is part of the planned growth of its Phase II-IV clinical development services in Eastern Europe - an emerging clinical trials hot spot.

Turkey in particular is one of seven emerging market countries, along with China, Brazil, Mexico, South Korea, India and Russia, that are tipped to contribute a quarter of the pharmaceutical industry's global growth within the next few years, with their market value expected to grow 12-13 per cent next year alone to be worth $85-90bn.

"With a population of 74 million people, Turkey is becoming an attractive place to conduct clinical trials," said Eshelman, CEO. From this new location the firm plans to conduct clinical monitoring services in key therapeutic areas.

Meanwhile, PRA International has announced the relocation of its existing German operations in Berlin into a facility that triples the size of its existing site.

The move was required to accommodate increased staff acquired in PRA's early phase services business following the purchase of Pharmacon late last year, in addition to the company's "increasing need for headcount" within Germany, specifically the Product Registration group.

PRA's Central and Eastern European Early Development Services business is headquartered in Berlin and from this location, PRA provides project management, clinical monitoring, biometrics, pharmacovigilance and late-phase services. This business unit also has operational sites in Poland, Hungary and the Czech and Slovak Republics.

SpineMark

Recently, spinal-focused CRO SpineMark has established an alliance with Wooridul Hospital of Korea to develop spine centers of excellence and facilitate clinical research on a more international scale.

Through the joint venture, SpineMark and Wooridul said they plan to co-establish a CRO and set up spinal research organizations (SROs) in Korea, Shanghai, Singapore, Japan, India and Abu Dhabi.

In addition, they plan to develop a medical education centre with a training facility in Singapore, similar to the Medical Conference Center that SpineMark already has in Texas, in order to train physicians on the latest clinical advancements in spine care.

Under the agreement, medical device companies will be able to contract with SpineMark and Wooridul to gain access to their network of research sites.

Pacific Biometrics

Pacific Biometrics said it has been awarded a series of contracts with a top multinational pharmaceutical company to the value of $1.3m, to provide biomarker assay-development and testing services for 21 preclinical and clinical drug development programs.

Specifically, the company will set up and validate custom assays and test clinical samples for novel biomarkers and for anti-drug antibodies. Testing has already commenced and is expected to continue into the fourth quarter of 2009.

Krka

Slovenian drug maker Krka has paid just under $1.6m (€1m) for a 7.5 percent stake in two Chinese drug and chemicals firms, namely Zhejiang Menovo Pharmaceuticals and Anhui Menovo Pharmaceuticals.

The two companies, which are based in enterprise zones in the Chinese cities of Shangju and Guangde, are involved in the manufacture of active pharmaceutical ingredients (API) and chemical intermediates. Both operate under current good manufacturing process (cGMP) accredited conditions.

Zhejiang and Anhui have been making key chemicals and drug intermediates on Krka's behalf for several years. The new investment is part of Krka's strategic effort to boost its chemical synthesis capacity over the medium to long term.

In a press statement Krka's CEO Joze Colaric commented that acquisition had guaranteed a competitively-priced supply of APIs and chemical intermediates for the firm's pharmaceutical manufacturing operations.

At present, the Ljubljana-headquartered drug maker owns and runs facilities in Slovenia, Croatia, Poland, Russia and Germany that make a wide range of branded and generic pharmaceuticals and cosmetic products.

According to official statistics from China's customs office, the country exported APIs worth around $8.9bn in 2007, up 35.7 per cent on the previous year. With demand for APIs continuing to grow, an increasing number of European and US drug makers are investing in Chinese manufacturers in order to secure future supplies.

Germany’s Schreiner MediPharm Opens First U.S. Facility in Blauvelt, NY

Schreiner MediPharm, a Germany-based global provider of specialty pharmaceutical labeling solutions for over 50 years, recently opened its first U.S. production facility, Schreiner MediPharm, L.P., 30 miles from New York City, in Blauvelt, New York.

The state-of-the-art 15,240 sq m (164,000 sq .ft.) facility will be fully validated and ISO-certified and feature a variety of advanced screen and flexo printing technologies, according to Schreiner.

Specialty peel-off labels, expanded content labels, combination hanger labels, functional syringe labels, brand protection and RFID solutions will all be produced on site.

With a multi-faceted product line that includes specialty peel-off labels, combination hanger labels, brand protection and RFID solutions, expanded content labels as well as functional syringe labels, Schreiner MediPharm is committed to patient safety and compliance and setting new standards of excellence in the pharmaceutical industry.

Based in the Munich area of Germany, Schreiner MediPharm is a global leader in the development and manufacture of innovative, specialty labels with value-added benefits that have set the standard in the healthcare and pharmaceutical industries. Schreiner MediPharm’s expertise is based on over 50 years experience. The family-owned company provides specialty labels and label printing services to the biggest names in the healthcare market in over 20 countries around the world.

Indiana University Gets Lab of the Year Award

Indiana Univ., Bloomington, is considered one of the most beautiful college campuses in the nation, with its abundance of flowering plants and trees and cool Indiana limestone buildings. A 20-acre area in the southwest corner of this campus, known as the Old Crescent, is now also home to R&D Magazine’s 2008 Laboratory of the Year High Honors winner—Simon Hall.

Simon Hall is a multidisciplinary science building, located between the existing chemistry, biology, and physics buildings, in a style that blends perfectly with the surrounding buildings and the university’s landscape environment. Nearly half of the building’s 140,000 GSF of floor space was built below grade to complement, and not overwhelm, the scale of the existing buildings and maximize space for its vibration-sensitive instrumentation. To address today’s increasing need for flexible research space, all of Simon Hall’s labs were designed to be modular and easily reconfigured. And by incorporating an open lab environment, shared technical support areas, and centralized analytical facilities, the building is also well-suited to foster collaborative research.

“The building blends in with the surroundings making it seem like a master plan had been developed that always had this facility planned there,” says Jim Contratto, Director of Business Development at McCarthy Building Companies, St. Louis, Mo., and a judge in the 2008 Lab of the Year competition. “I also like the idea of meeting and intellectual sharing spaces being outside on terraces where the outdoors draws people.”

“I’m impressed that a university that has been traditionally very conservative on its lab buildings finally ‘got it’ and built a flexible building,” says Richard Rietz, an independent laboratory design consultant and another judge in the 2008 Lab of the Year competition. “That they put Simon Hall in the correct location to foster interdisciplinary science is also remarkable given that so many like buildings have been pushed to edges of or off the basic science portion of college campuses. I also like the fact that they preserved the open space by putting the core labs underground and also avoided protruding into the nearby on-campus woods.”

Preserving and enhancing the landscape

In order to provide the amount of space required by researchers in Simon Hall and respect the tradition of the campus, several levels of the facility are located underground. An expansive green roof covers 26,000 ft2 of laboratory space, located directly beneath the grassy, park-like quadrangle. After construction, the character of the landscape was extended into the quad, contouring the land and rebuilding the hills that had been leveled off in the 1940s. A selection of flowers and plants that thrive in shallow soil dot the area, which is also equipped with special waterproofing, drainage, and irrigation systems.

To enhance the experience of the scientists and researchers who work in Simon Hall, the ground plane was manipulated to work with the architecture for maximum day lighting. This effort provides access to natural light and exterior views for virtually all offices, labs, and common areas within the building, even those located below grade.

A network of campus spaces was also created, linked by a pedestrian circulation system. New pathways to connect building entries to existing corridors were added to preserve the collegial feel of the green spaces.

Sharing an architectural design

Taking visual cues from the adjoining Myers Hall, a 1930s art modern building that was originally the medical school, Simon Hall incorporates many of that building’s features and design elements. Simon Hall echoes Myers in its isolated symmetry and works in unison to complete it. By creating tension between the buildings, the relationship between them is reinforced. Aesthetically, Simon Hall fits with the distinctive limestone buildings and collegiate gothic architecture on the Old Crescent site.

Simon Hall also was designed to achieve a high level of modern sustainability and energy efficiency which was aided by a rigorous life cycle cost analysis throughout the design and construction phases. The building features two types of heat recovery, including a high-efficiency enthalpy wheel with exhaust air streams. Simon Hall also has a chilled-water cascade system that optimizes the efficiency of the central utility plant. It also has a variable air volume air circulation system, occupancy sensors in the offices and conference rooms, and increased water conservation through high-efficiency fixtures.

Grouping of the labs

By virtue of Simon Hall’s location on the quad, it is physically central to traditional science departments on the Indiana Univ. campus. A series of tunnels connects Simon Hall to three other science buildings providing quick, easy access between them and eliminating the need for a loading dock that directly services Simon Hall.

The building provides scientists with low- and high-fume hood intensive and instrumentation lab spaces. A row of generic labs and office space for research assistants and post-docs occupies the north side of the building. In the center of the building, lab support spaces and offices occupy each side of a glass-lined corridor. The south side of the building contains more chemical intensive lab stations with correlating fume hoods. Every floor has a mixture of lab configurations, each flexible and adaptable for specific customization to accommodate a variety of uses and promote collaboration between disciplines.

“The lab layout is user friendly with lots of light and glass,” says McCarthy’s Contratto. “Simon Hall is a well-thought out design where faculty should feel very comfortable. It also reveals that not all lab designs require a Buck Rogers design. A lab can be laid out for a client that allows teaching and research in a comfortable environment.”

“I like the core laboratories that can be reconfigured to different core labs in the future,” says Rietz. “The wood furniture that comes apart piecemeal to allow different lab configurations is clever. Truly reconfigurable university labs are an idea that has been long in the evolving stage. Finally, we’re seeing some owners step up to the plate and actually build these buildings. This lab breaks with tradition in several significant ways: It’s not a departmental building; it can be reconfigured for different kinds of investigators; and it’s placed where it needs to be for science, not where the growth is occurring on the other side of the campus.”

Lab design with flair

On the lower level of Simon Hall, the inclusion of a clean room for nanofabrication, a cryo-electron microscope, and state-of-the-art equipment for looking at protein structures will allow scientists on the Indiana Univ. campus to undertake groundbreaking research.

Transparency is also important in Simon Hall’s lab design. In today’s research environment, the multidisciplinary research teams require open and highly visible environments to achieve high rates of return. Open stairways in Simon Hall enhance the visibility and connectivity within the multistory building, while views into daily research activities stimulate impromptu conversations. Transparency within Simon Hall is achieved through extensive use of interior glass walls that also helps to showcase the science in the building and provide an avenue of outreach to industry.

The overall lab design was made with several concepts in mind, including:

Interactivity—Each large laboratory block within Simon Hall consists of three to six modules and is connected by an open ghost corridor to an adjacent lab block and faculty office. Offices are arranged in clusters of three to five faculty and an administrator. The office suites are located on each floor and have direct access to the corridor and labs, providing connections between faculty and research assistants.

Modularity—To maximize flexibility, labs and lab support areas were designed at a consistent size with a consistent layout. This modularity allows space to be reassigned easily and quickly.

Modular utilities—The same utilities are available at standardized lab locations, including reverse osmosis water, lab hot and cold water, natural gas, compressed air, cylinder gas, vacuum, and domestic water. As a result, to maximize cost and efficiency of building systems, generic labs with higher- or lower-hood intensities were designed. These labs are supported by the central system’s diversity to be converted at a later date.

Adaptability—Uniform support zones were created within each lab. These are adaptable for a variety of uses, including chemical/media prep, tissue culture, dark rooms, equipment rooms, constant temperature rooms, or cold rooms. These zones are planned to be directly adjacent to the lab and accessible to neighboring researchers to promote shared use and collaboration.

Flexibility – Instrumentation labs were developed around a ‘dance floor’ concept, allowing them to be quickly renovated. The fixed casework, hoods, and sinks are located around the perimeter of the lab, with utilities provided via overhead service carriers. The peninsulas use mobile instrumentation carts, mobile tables, or equipment carts. Where provided, fixed casework is free of utility services, simplifying quick reconfigurations that are necessitated by changes in equipment and/or research objectives.

Special areas

In addition to the flexible lab spaces, Simon Hall also provides for specialized core facilities. By housing these instruments and centers within one central multidisciplinary hub, the university has maximized its investment, allowing multiple researchers access to state-of-the-art technologies. These include:

A high-field NMR facility containing 800- and 600-MHz NMRs supported by cryo-probes.
Biosafety level 3 facility
An ISO 6 (formerly Class 1,000) clean room
A high resolution cryo-transmission electron microscope
An x-ray crystallography suite

Each of these platforms comes with its own unique demands for supporting building systems.

Lab safety features are organized in a clear and uniform method within Simon Hall. This provides an environment of good laboratory practices for investigators. At each lab entrance, there are built-in standardized safety stations including first aid kits, fire extinguishers, shower and eye-wash stations, fire blankets, contact lists, and phones. Glazing around the perimeter of the labs and entries provides an increased ability to monitor the research activities from research assistant offices and public spaces.

Bayer Uses Tobacco at Halle Facility for Protein Manufacturing

Germany's Bayer hopes that its pilot-scale production facility in Halle, Saxony-Anhalt will help establish its tobacco plant-based expression system as leader of the lucrative protein manufacturing sector.

While protein synthesis using transgenic plants like maize, tobacco, oilseed grape and soya is at an advanced stage of development, conventional methods require the creation and maintenance of crop strains that contain genetic material that encodes the desired protein.

Bayer's process, which was developed Icon Genetics prior to its acquisition by Bayer in December 2005, utilizes a virus-based mechanism to transfer the desired DNA sequences to the tobacco plants in order to expedite the protein production process, and remove the need to develop transgenic plant strains.

Virus-based DNA Transfer

Bayer's technique uses high-yield tobacco plants produced in a rich growth media containing a modified version of the bacteria Agrobacterium tumefaciens that has been implanted with a tobacco mosaic virus (TMV) containing DNA encoding the desired protein.

The virus infects the tobacco plants, injecting its genetic material into the nucleus of the plant's cells where it is expressed when they are subsequently retuned to the Halle facility's greenhouses.

The advantage of Bayer's technique is that because the DNA sequences can be rapidly transferred to wild-type tobacco plants, no potentially time consuming crop development steps are necessary. While the tobacco plants eventually lose the recombinant DNA as the TMV infection runs its course, a batch production process can be implemented to ensure that there are always plants available.

In addition, because genetic manipulation of TMV is a relatively straightforward and established technique, Bayer's approach could be readily adapted to produce a wide range of proteins in a relatively short period of time.

PharmaForm Expands with New Contract

PharmaForm, a subsidiary of US-based Akela Pharma, has been awarded a contract for the development and manufacture of a generic version of a commercial product.

The production is being undertaken on behalf of an unnamed pharmaceutical company at PharmaForm's facility in Austin, USA.

It is anticipated that the contract will generate revenues of $1.5m to $2m over the next 12 to 18 months. Included in the contract is the transfer of technical support for GMP manufacturing, process validation, quality release testing and stability characterization.

PharmForm is expecting to sign additional contracts with the client, to assist with the manufacturing of clinical supplies and commercial products.

Acceleron Pharma Expands Facility

Acceleron Pharma has commenced plans to increase its headcount by 40 per cent and double the size of its administrative, laboratory and manufacturing facilities in Cambridge, USA.

It is thought the expansion will create a second manufacturing facility for growth and differentiation factors-related proteins, with the company expecting to begin Phase II studies with ACE-011 later this year.

Malaysia YSP to Build in Viet Nam

Malaysia-based YSP Southeast Asia Holdings has allocated $12m to build a manufacturing facility in Vietnam producing its pharmaceutical products.

The site is due to be brought online before the end of next year and YSP expect it to generate 10 per cent of its total revenue by 2010.

India’s Dishman Pharmaceuticals to Build in Shanghai, China

India-based Dishman Pharmaceuticals and Chemicals is planning to build a facility in Shanghai, China, in what will be the company's first oversees greenfield plant.

The active pharmaceutical ingredient (API) manufacturer is investing $10m in the site, which it believes will produce 3000 metric tones (mt) of quaternary salts and 500mt of medicine intermediates.

By 2011 the company is expecting the 40,000 sq m (430,400 sq. ft.) facility to bring in revenues of $20-25m. Shanghai was chosen as a location due to its proximity to Dishman's raw material suppliers.

Clean Modules

Clean Modules has launched its next generation of modular cleanrooms, which it claims are bigger, stronger and more stable than before.

The use of hot rolled steel frames instead of timber is said to make the modular building feel more like a traditionally constructed structure. This use of steel also enables the creation of wider and longer cleanrooms, capable of housing larger rooms.

Modules are constructed off-site, with "plug and play" electrics and air systems reducing the installation time. In addition the next-generation models offer superior insulation and fire ratings.

Clean Modules markets the structures as a fast and convenient method of adding additional cleanroom space to a facility.

Patheon Moves into New Headquarters in Research Triangle Park

Patheon, fresh from announcing a new corporate brand and logo, has continued its makeover by moving its corporate headquarters from Toronto in Canada to Research Triangle Park in North Carolina, and will also build a new laboratory in the US state.

The contract development and manufacturing company said that the move would bring it into close proximity with many of its major clients and future prospects. A location for the new lab site in Research Triangle Park has already been chosen, it said, and should be ready for operation in the next three months. The headquarters should be up and running at the end of the year.

Research Triangle Park is claimed to be the largest research park in the US and is home to 136 research-based companies, including top pharma and biopharma firms such as GlaxoSmithKline, Biogen Idec and Eisai. Meanwhile, North Carolina as a whole has more than 330 biotechnology companies, said Patheon.

Patheon was quick to point out that there will be "no impact to Patheon's significant regional presence in Ontario, Canada, where it operates four facilities with over 1,500 employees."

The analytical development facility will be built at Durham and will support Patheon's US-based pharmaceutical development operations in Cincinnati, said the firm. It will initially offer stability studies, validation testing and analytical chemistry services.

In total around 100 new employees will be hired - split between the headquarters and laboratory sites - with a few senior executives making the move from Ontario.

The company has sold off some plants and businesses, refocused and downsized others, all of which helped it slash its losses in the second quarter compared to the same period in 2007.

It has also just opened a new subsidiary in Japan, once again in order to be geographically closer to its customers in the Pacific Rim.

Celltrion Teams with SAFC Biosciences in Manufacturing

South Korean biopharmaceutical firm Celltrion is teaming up with SAFC Biosciences to improve its manufacture of biologically-active pharmaceutical ingredients (API).

The new collaboration, financial terms of which are not being disclosed, will use custom growth media developed by SAFC to increase clone productivity (the amount of API produced by each organism) in Celltrion's manufacturing processes. The overall aim is to make the South Korean firm's offering more economical and attractive to industrial clients.

The global market for contract biomanufacturing, which was worth $2.5bn in 2006, will grow at about 5 per cent a year through to 2011. It predicted that optimization of growth media and expanding production capacity will be crucial to the success of companies operating in the sector.

A study also suggested that the success of the 350 or so biologic drugs that have been approved so far will see manufacturers increasingly turn to CMOs to provide additional production capacity, driving further expansion.

Celltrion is a contract manufacturing organization (CMO) that was founded in February 2002 by US firm VaxGen and a group of Korean partners. The organization’s primary focus is the provision of scalable production capacity to the emerging biomanufacturing market, although it has recently begun expanding its in-house R&D operations.

Celltrion's flagship facility is in the southern city of Incheon which, at around 215,000 square feet, and is the largest in the region. The site is capable of production runs in the 50,000 to 150,000 liter range under good manufacturing practice (GMP) accredited conditions.

Previously, SAFC worked with Celltrion to provide media development support through its immediate advantage program, which supplies industrial clients with made to order culture media allowing them to bypass often expensive and time consuming development steps.

The new project will use SAFC's Cell Xpress clone selection technology and LEAP (laser-enabled analysis and processing) technology to analyze and select clones based on specific parameters, including protein secretion, thereby improving manufacturing yields.

SAFC and Celltrion envisage that, if successful, the new partnership will lead to the establishment of a long-term supply agreement.

Eli and Rexam Expanding Insulin Manufacturing Facilities

Eli Lilly and Rexam are both investing in their French manufacturing facilities in preparation for the production of an insulin pen they are developing.

Rexam is due to commence with a 3,800 sq. m. (40,888 sq. ft.) expansion of its facility in La Verpillière, with Lilly's Fegersheim site undergoing a €35m overhaul to update its production equipment.

This work is being done to obtain the production capacity needed to satisfy the global insulin pen market, which is due to reach $22bn by 2012 according to The Global Diabetes Market.

Rexam's expansion will be solely used for the manufacture of the insulin pen components that the company is responsible for. To achieve this the facility will be equipped with injection presses, marking machines, an assembly line with ultrasound welding, sticking and packaging technology.
To monitor this process a camera viewing system is also being installed, which will enable each phase of production to be controlled. Fifty jobs will be created by the expansion, which is due to be completed in 2009.

Lilly's Fegersheim plant is to have 600 sq m (6,456 sq. ft.) revamped with new production methods to meet global demands. This is a further improvement to Lilly's biggest production site, which received investments of €640m from 1992 to 2009. Through these investments the work force on site tripled between 1993 and 2004.

Fegersheim has grown to specialize in the injectables market, with production capacity for insulin, parathyroid hormone and growth hormones.

The insulin pen itself will be constructed at the Fegersheim site. The pen is composed of over a dozen plastic parts and a spring, which are all manufactured at Rexam's facility. These parts can be divided down into two sub-sets, those responsible for dosage selection and another which forms the protective cap.

All these plastic parts are constructed around the glass insulin containing cartridge, which is produced at Lilly's Fegersheim site.

Modular Cleanroom Construction Makes the Difference at St. George Hospital

The completion of a 408m2 (4,390 sq. ft.) major new aseptic pharmacy unit for the St Georges Hospital NHS Trust, London, UK is a significant example of the benefits of using modern modular construction techniques compared to a traditional cleanroom build. The project was completed on time with minimal disturbance and the final cost was within budget with a projected saving of 5% compared to other methods.

Site Selection & Preparation Most Estates Departments recognize the problem of locating a new unit within a limited site, and in close proximity to existing resources and this was no exception. A suitable location was identified above an existing lightwell, however the existing structure was not designed to support a new building on this scale.

In addition, access to the site was severely restricted because it was almost completely surrounded by buildings up to six stories high, housing many of the main hospital functions. Disruption to these services would have had a dramatic impact on the operational capability of this major teaching hospital.

Choice of Modular Cleanroom SolutionFaced with the many restrictions to the site, the Trust and Clean Modules quickly realized traditional cleanroom building methods would be impractical. Consequently a solution constructed from fourteen steel modules set on a critical load bearing steel frame was developed, which had a number of advantages. The modular construction provided a lightweight but rigid structure which could be prefabricated off-site and moved into position with the minimal amount of disruption to patients, staff, emergency services and public transport.

The open modules also provided a versatile space into which the state-of-the art new cleanrooms could be created without the usual size limitations imposed by portable buildings. This framework had another advantage in that existing air handling units could be re-located easily and additional units accommodated efficiently.

Precision timing and minimal disruption restricted loads in London and no blocking of hospital routes, especially Accident & Emergency, meant the delivery of the prefabricated components, manufactured at a remote location, was only possible over two weekends, set six weeks apart. Each lift on to site involved a massive three-part crane with 60m extension, which could only operate in calm weather and took several hours to assemble before it was operational. Achievement of this feat required military-like project planning to get the fleet of thirty two articulated lorries into position on time and in the correct order with no waiting allowed at the hospital itself. During the lifts, there was a strong coordinated effort between the 10-strong Clean Modules installation team and Trust.

Safety was paramount, and the planning phase demanded a detailed Health & Safety risk assessment, particularly during the two lifts. As a result a strict lift route was developed with areas underneath, including wards and a canteen, closed during the transfer. This was carefully marshaled to prevent any personnel movement whilst materials were overhead. Outside, the Metropolitan Police and London Transport were involved with temporary diversion of bus routes and traffic as first the crane arrived, followed by the precisely timed arrival of the lorry fleet.

The cleanroom design itself had to accommodate up to fifty staff and the range of different workflows and quality constraints needed in aseptic pharmaceutical preparation. Again the modular framework enabled the internal space to be utilized to the maximum even with a limited single access point to the facility.

A good example of the flexible space benefits of using the modular construction is seen in the main Command and Preparation Room and GMP Grade D Aseptic Unit, which are 12.2m x 6.5m and 10.5m x 6.5m respectively. The rooms’ widths are nearly double what could have been achieved with a straightforward mobile building solution. This gave the Pharmacy Department the space to install the latest Grade A isolator technology in the form of nine Amercare and La Calhene isolator cabinets with Clarus hydrogen peroxide generators and rapid gassing ports. The open layout of the Aseptic Unit and the carefully planned layout of the Command Centre and interconnecting hatches between the two means the facility will be able to cope with the expected growth in demand over the next decade. In addition to the main unit, the facility also features a complete Grade D Cytotoxic Cleanroom Suite, which contains three isolators for the preparation of cancer drugs specific to each patient. In support of these main production areas, change areas, storage, preparation, checking and cleaning have all been taken into account with dedicated locations created for each.

The external appearance of the new facility is clean and modern, making use of a 0.5m2 silver grey Trespa cladding integrated perfectly with the window layout to create smooth lines minimize the impact on the surrounding structures.

Inside, the Aseptic Unit benefits from one of the first rapid gassing hydrogen peroxide sterilization units installed in an NHS hospital. This enables the latest efficient production methods to be deployed, raising standards and the capacity to meet growing demands. The new unit also uses an advanced facility management system that is capable of continuous monitoring of temperature, humidity, room pressures, and particles as well as other equipment and storage fridges, with a remote alarm links. This system is fully validated to the FDA CFR 21 Part 11 and GAMP 4 standards required for all pharmaceutical systems. The FMS is linked to the hospital management system and provides local and remote alarms and logging. Overall control of the air system is provided by the Hospital Trend controls. Commenting on the new facility, Phillip Gent, QA Manager said: “Without Clean Modules, we would have struggled to build the facility, which we desperately needed to expand our services to the hospital. Their modular solution really made the difference and we are delighted with the results. John Robinson, MD of Clean Modules remarked: “St Georges represented many of the challenges we face when planning every cleanroom build, but the scale of difficulty was exceptional. For us, this unit provides a fantastic example of where modular construction wins over traditional construction. We are proud to have achieved this result quickly, without disrupting the hospital, and within budget.” Clean Modules specialize in the design, construction and project management of Clean Room installations, controlled environments, clean-air and conditioning systems. In addition to specialist container cleanrooms, the company has considerable expertise in pharmaceutical, medical, hospital, and biotechnology applications.

The University of Chicago Medical Center Plans $700 Million Expansion

The University of Chicago Medical Center, preparing to embark on a $700 million expansion, has settled on a final design for a new hospital pavilion that will use a modular design executives say allows for flexibility should future renovations be needed.

The 10-story, 1.2 million-square-foot hospital pavilion will span a two-block area on East 57th Street, just north of the Comer Children's Hospital and the Duchossois Center for Advanced Medicine in the Hyde Park neighborhood on the city's South Side.

The final design and construction plan received final approval last week from the University of Chicago board of trustees. It will be officially unveiled Monday, and construction will begin next year.

Hospital executives say the design is flexible because it uses modular cubes that are each 31.5 feet across and 18 feet high. The more than 100 "repeating modules" on each floor can be reconfigured for a wide range of uses, allowing the facility to adapt to new technology and the ever-changing delivery of medical care.

The medical center's bed count will not change significantly. Once the new pavilion opens in 2012, the main adult hospital building, known as Bernard Mitchell, will convert to all private rooms.

Included in the new pavilion's features are 80 private patient rooms as well as 24 intensive care beds on each of the top three floors. The sixth floor will house 24 operating rooms.

St. Mary’s Hospital Pharmacy Opens Cleanroom

St. Mary's Hospital Pharmacy has created a certified "797 Clean Room" to improve patient and employee safety. This special room is dedicated to the preparation of intravenous medications, including chemotherapy drugs, and meets the stringent requirements of U.S. Pharmacopoeia regulation USP 797.

USP 797 is designed to cut down on infections transmitted to patients through IV medicines and to better protect pharmacy staff from potentially hazardous exposure to drugs.

The Joint Commission on the Accreditation of Healthcare Organizations is mandating that hospital pharmacies create clean rooms.

St. Mary's began the process in summer 2007 and selected Orlando-based Pharmaconomics to assist in designing the clean room to ensure that it meets all USP 797 standards.

The room was built under the guidance of administrative coordinator Sylvia Barrett with the assistance of St. Mary's engineering staff. It was completed in February and dedicated in May.

German Town Innovation Center Hopes to Become Bio Incubator

Montgomery County, Maryland, economic development officials planned to start marketing the proposed Germantown Innovation Center incubator among other programs at BIO 2008, an annual international biotechnology conference in San Diego hosted by the trade group Biotechnology Industry Organization of Washington, D.C

The idea is to lease as much space as possible prior to the incubator’s opening, which is scheduled for September, said John Korpela, the county’s business incubator development manager.

The Germantown center is slated to be the county’s fifth incubator, helping fledgling companies grow by providing space, conference rooms, receptionists, consulting, seminars and other assistance, usually at lower costs than business owners could find on their own.

The new 32,000-square-foot incubator will be on the Germantown campus of Montgomery College, on the second floor of the 67,000-square-foot Goldenrod office building. Workers had hoped to start renovating the building last fall, but the project’s start was delayed until the spring.

The first floor will be used for classrooms and office space for college officials.

The second-floor renovations for the incubator cost about $6.9 million, according to a report by the Maryland Economic Development Corp. That private entity, which was formed by the state of Maryland to issue bonds to finance such projects, is assisting in the construction and project management phase of the incubator. The county plans to sublease the second floor from the college.

The incubator should have space, including wet labs, for 20 to 30 businesses that focus on biotechnology and information technology. The campus also plans to house a 40-acre business park with more than 500,000 square feet of space and a 127,000-square-foot bioscience education center.

The latest Montgomery incubator to open — the 23,000-square-foot Rockville Innovation Center, which opened about a year ago in the city’s downtown square — is currently full with a small waiting list, Korpela said.

Patheon Announces Expansion of Manati, Puerto Rico Facility for High Potency Manufacturing

Patheon Inc. (TSX: PTI) a global provider of drug development and manufacturing services to the international pharmaceutical industry, announced it will expand the Manati, Puerto Rico facility to add a dedicated high potency and controlled substance manufacturing area. Patheon will invest a total of $2.8 million in this new 3,386 sq. ft. area that will include three manufacturing suites, air lock containment areas, and humidity controlled air systems.

The three manufacturing suites will enable Patheon to combine in one manufacturing area technology transfer, bulk production, bulk packaging, and storage. The production area will have capacity for high potency (containment down to 1 (micro)g/m(3) OEL) and humidity controlled solid dosage form products. The construction project is currently in a fast track mode with completion expected, based on current activity, by the end of September 2008.

Patheon has been contracted by one customer to utilize the suites and the expansion will also provide substantial capacity to serve additional high-potency projects.

Ipsen Expands with Acquisition

Ipsen plans to spend about $421 million in the near term on acquisitions that will intensify its presence in North America. The firm will take over Tercica, gaining drug candidates in the endocrinology field, Vernalis’ U.S. operations for products against neuromuscular disorders, and certain hematology assets of Octagen.

The U.S. subsidiary purchase gives Ipsen a neurology-focused commercial team, which already markets Apokyn in the U.S. to neurology specialty physicians. The company believes this will aid in the launch of Dysport for cervical dystonia, which has been accepted for filing by the FDA.

Finally, Ipsen will initially pay Octagen $10.5 million for all OBI-1 related assets. OBI-1 is a biopharmaceutical being developed to treat hemophilia. Ipsen already has worldwide, exclusive rights to this product, but today’s transaction will give it full control of development and commercialization.

Kendle to Purchase Contract Research Organization (CRO) in Canada

The acquisition of the business, called DecisionLine Clinical Research Corporation, will see Kendle join the ranks of the growing number of CROs bolstering their early phase capabilities.

The firm said that the purchase of DecisionLine gives it new scientific expertise with psychopharmacology high-end exploratory/translational medicine capabilities, from first-in-human to proof-of-concept trial conduct, as well as additional drug development consulting, medical writing, data management, biostatistics and other support service offerings.

In particular, DecisionLine specializes in the conduct of Phase I studies involving the measurement of pharmacodynamic effects of central nervous system (CNS) drugs - one of the key disease areas tipped for growth in drug development in the coming years.
It is also "recognized worldwide as a leader" in the conduct of human abuse liability studies and the assessment of abuse potential and risk mitigation, said Kendle.

The newly-acquired business also has an 82-bed, 36,000-square foot medical facility staffed by 110 full-time and 130 part-time scientists, including clinical pharmacologists and neuropsychologists, physicians, research nurses and pharmacists.

Kendle's existing early phase capabilities include a 48-bed Clinical Pharmacology Unit in Utrecht, The Netherlands, with on-site project management, recruitment and screening, sample handling, pharmacy, quality control, clinical data management, biostatistics, medical writing, a Phase IIA team and independent Clinical Quality Assurance. It also has a 118-bed Bioequivalence Unit in West Virginia.

Kendle said that the acquired business will be absorbed into its Early Phase unit, under the authority of Philip Davies, vice president of the division.

Under the deal, DecisionLine´s founders Dr Edward Sellers and Dr Myroslava Romach will join Kendle's Early Phase organization, with Dr Sellers serving as general manager, Early Phase, Toronto and senior scientist, Kendle International and Dr Romach assuming the roles of head of Clinical Operations and Medical Affairs, Early Phase, Toronto and senior scientist, Kendle International.

Singapore Expanding Biotechnology Sector

In Singapore, several new biologics facilities are under construction on behalf of multinational pharma companies. Biologics contract manufacturer Lonza entered Singapore to set up an 80,000L capacity mammalian facility for commercial scale manufacturing. Biotech giant Genentech snapped up all the capacity at Lonza's facility and now Lonza is building a new plant of the same capacity to fill further demand. At the same time Genentech is also building its own microbial plant.

In addition, last October Novartis announced plans for a $700m biotechnology facility, to be built alongside the company's new solid-dose manufacturing plant on the island. The project, which is expected to be completed by 2012, represents Singapore's largest ever vertically integrated investment and the most Novartis has ever spent on a single manufacturing facility.

Meanwhile, GSK Biologicals is in the midst of building a new S$300m vaccines facility and when it becomes fully operational in 2009, it will be the first large scale bulk biologics manufacturing plant in Singapore.

In March the company also opened a new medicinal chemistry lab in one of the region's biomedical hubs, Biopolis, having invested S$20m in the new operations.

In terms of Biopolis, which is a centre dedicated to biomedical R&D activities, Yeoh said that the original site is now full, with all the space being occupied by 25 domestic and international companies, including GSK who is focusing on neuroscience, Novartis who is researching tropical diseases, and Eli Lilly who is investigating metabolic diseases and cancer.

The idea behind Biopolis is that the on-site facilities are shared by around 2,000 scientists across all the businesses operating there.

Due to the popularity of the centre, 400,000 sq.ft of new laboratory space is being created and will be ready to be occupied some time next year.

Also, Eisai opened a Regional Clinical Research Centre in the country so that they can oversee their Asia-Pacific run trials from this location - becoming the first Japanese pharmaceutical company to do so. This year it has been relocating its UK-based clinical trials to this new location.

Affymetrix has set up its first GeneChip Probe Array manufacturing facility outside US. Over the past year the operation has been ramped up to over 110 employees.

Moreover, Schering-Plough has recently invested in a trigeneration unit for its plant, following in the footsteps of Pfizer.

The S$18 million unit will help the company reduce its energy consumption at the Singapore plant substantially from 12.5 MW currently to 9.3 MW annually, and reduce its annual carbon oxide emission by 24 per cent. It does so by generating electricity, steam and chilled water from a singe fuel (natural gas). This unit is due for completion this month.

Meanwhile, earlier this year a large undisclosed pharmaceutical company has just initiated an expansion of its Phase I activities in Singapore, although Yeoh said that the firm was "not comfortable with disseminating any information regarding this to the international media".

Pharmaniaga Pursues Indonesian Plan

Malaysian generics manufacturer Pharmaniaga has earmarked around $93m for the purchase of a manufacturing plant in Indonesia as it looks to expand its operations this year.

Indonesia is the company's second largest market after Malaysia and Pharmaniaga has now signaled its intent to further establish its manufacturing presence in the nation.

This move is not to increase market share in Indonesia but is part of the company's plan to expand exports which was discussed at the annual general meeting.

The company has now hired a firm to help it find a plant capable of producing $25m to $31m worth of products a year. This would be a significant addition to the $62m worth of products currently manufactured at Pharmaniaga's three Indonesian plants.

Corden PharmaChem Temporary Lay-offs

Corden PharmaChem has temporarily laid-off 61 of its 105 employees at its manufacturing facility in Cork, Ireland following an explosion last month.

One worker was killed in the explosion at the site which produces active pharmaceutical ingredients and also offers contract manufacturing services.
An internal investigation into the explosion is underway, with Corden expecting the site to be operational again in July.

Nisvizh Expands Packaging Capacity

Nisvizh Pharmaceutical Plant, a government-backed pharmaceutical firm in Belarus, is in the process of installing its second 'Bottlepack' plastic blow-fill-seal line.

This will increase the factories capacity to 10m bottles, in 250ml and 500ml sizes. Coupled to the increase in capacity is a desire to export its plastic packaged pharma products to new markets. The firm already sells products in Russia, Moldova, Kazakhstan, Uzbekistan and Tajikistan.

CCM Pharmaceutical Expansion

The Chemical Company of Malaysia is pumping $41.9m into expanding its pharmaceutical division.

Of this $15.5m has been allocated to expanding the pharmaceutical manufacturing capacity at the company's Bangi facility, with a further $23m being used to improve its manufacturing and warehousing facilities in Klang.

Helix Medical Expands Thermoplastic Manufacturing for the Medical Industry

Contract manufacturing group Helix Medical hopes that expansion of its global production capacity will help it corner the pharmaceutical industry's injection molding thermoplastics market.

Helix' new capacity includes two thermoplastics injection molding presses that are capable of applying between 28 and 300 tons of pressure during manufacturing operations.

The firm has also installed advanced silicone injection molding technologies with 7 silicone cells, meaning that it is able to manufacture both thermoplastic and silicone-based product in the same Class 100,000 cleanroom.

Thermoplastics and silicones have a wide range of applications in the pharmaceutical sector, ranging from the medical devices and drug delivery market to the packaging and manufacturing sectors.

Increasingly, pharmaceutical firms are outsourcing certain aspects of manufacturing operations in order to keep pace with the growing global drug market, which is expected to grow by between 3 and 6 per cent this year. This is particularly true if, as is the case with thermoplastics molding, if the discipline is outside the core focus of the pharmaceutical sector.

Furthermore a new report predicts that the US pharmaceutical packaging market will be worth $16bn (€10.3bn) by 2012, providing an additional market for manufacturers offering thermoplastics manufacturing solutions.

Sites in the U.S. and China

The Helix facilities in question are the 72,000 square foot plant in Baldwin Park, California and the 35,000 square foot medical component site in Shenzhen, China. The plants were formerly owned by US Thermoplastics specialist APEC, which Helix acquired earlier this year. Helix' other production operation, which is in Gloucester, Massachusetts, was gained through the acquisition of Jenline Industries in 2004. The site is currently used for the manufacture of silicon-based products for the healthcare, biopharmaceutical and pharmaceutical industries.

Neuland Labs Expanding Services with Joint Venture

India's Neuland Laboratories is expanding its service offering with a shift into contract research and clinical testing via a joint venture with Cato Research of the U.S.

Neuland is best known as a manufacturer of bulk active pharmaceutical ingredients, currently manufacturing around 1000 tons of API a year mainly for customers in the generics industry, as well as medicinal chemistry services, process development, analytical research and scale-up activities.

The deal with Cato is a pivotal part of that strategy and involves setting up a contract research organization (CRO) based in Hyderabad - Cato Research Neuland India - that will provide clinical trial services, data management, statistical analyses and regulatory expertise. It will focus initially on Phase II and III testing, with the ultimate aim to provide a full suite of services from Phase I to IV.

The company has already announced plans to double its manufacturing capacity with the construction of another manufacturing facility, having opened a new R&D facility in 2007. It has another R&D facility due to open within the next year.

Swedish Orthopedic Institute Opens in Seattle

The 372,000-square-foot Swedish Orthopedic Institute (SOI) has 11 stories -- with five floors devoted to patient care, two for medical offices, and four of underground parking. Key elements include:

84 new inpatient beds (28 on each of three floors)
10 dedicated orthopedic operating rooms
15 pre-operating/stage-2 recovery beds
13 post-anesthesia care unit (PACU) beds
Outpatient pharmacy
Pre-admission areas, conference rooms and a café.

While demand for orthopedic and spine services at Swedish has exploded in recent years, the medical center has not had dedicated orthopedic diagnostic and treatment space since its inception in 1910. Swedish has 54 active orthopedic surgeons on staff, many of which were heavily involved in the vision for and design of the new facility. Surgeons who practice in the new facility will provide the full spectrum of orthopedic care from joint and spine surgery to surgeries on hands, feet, shoulders, elbows and the many other bones in the body. The Institute even has affiliated surgeons who specialize in the removal of tumors of the bone.

SOI is unlike a traditional hospital setting in many ways. It is closer to the birthing suite model, where families can be with the patient in a natural environment. Patients will have access to extensive clinical education and rooms that feature wireless Internet access, DVD players, flat-screen televisions, and room service-style food service. The unique environment will also allow patients to get up, move around, exercise and socialize with others during recovery, not stay isolated in their rooms.

Swedish calls its treatment process for joint-replacement patients the 'Joint Journey,' which is a comprehensive educational program to guide patients through each step of the joint-replacement process. It is designed to create a stress-free experience for people having a hip, knee or other joint replaced, leading to the smoothest possible transition from hospital to home and full recovery.

SOI clinicians will also be able to work more extensively on outcomes-based research. Because orthopedic patients will not be co-mingled with other diagnoses, there will be greater opportunity to do integrated, specialized research.

CB Richard Ellis represented Swedish as the project manager of the Orthopedic Institute and led the team, which included leading architectural firm, NBBJ, who designed the new building and the general contractor, Sellen Construction.

Swedish is the largest, most comprehensive nonprofit health provider in the Greater Seattle area. It is comprised of three hospital campuses — First Hill, Cherry Hill and Ballard — a freestanding emergency department and specialty center in Issaquah, Home Care Services, and the Swedish Physician Division - a network of about 40 primary-care and specialty clinics. In addition to general medical and surgical care, Swedish is known as a regional referral center, providing specialized treatment in areas such as cardiovascular care, cancer care, neuroscience, orthopedics, high-risk obstetrics, pediatrics, organ transplantation and clinical research.

McIlvaine Company,

Northfield, IL 60093-2743

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