This will be the second expansion at the 33,500 square foot facility in the two years since the firm bought the Business from SynPro Corp in 2006 and entered this area of manufacturing services.

Currently the firm provides therapeutic nucleic acid development and manufacturing services for the biopharma industry, including the production of DNA, RNA, phosphorothioates, mixed PO/PSs, aptamers, conjugated aptamers, siRNA and various modified RNAs.

The contract manufacturer also offers services, including development of analytical methods and processes, stability studies, quality control, and regulatory support.

As part of the planned facility enlargement, Agilent's Nucleic Acids Solutions Division is creating new large-scale nucleic acid synthesis, purification and drying capacity, that should be up and running by the end of the year. Specifically, Agilent said that it will be installing a 200-1,000 mmoL synthesizer capable of producing kilo quantities of API per synthesis batch.

Additional downstream processing capability will also be added with a 30 liter per minute chromatography system and two multi-kilo lyophilisation units.

Moreover, related infrastructure and reaction vessels will be added for custom conjugation chemistries and duplex annealing of siRNAs, "addressing the fastest growth segment of the oligonucleotide market," the firm said.

To help facilitate the project, Agilent has recently purchased all of the assets of Dowpharma's Nucleic Acid Medicines Business, for an undisclosed sum.

In response to the planned growth Agilent will also hire 20 new employees at the site over the next 12 months along with an additional 10 staff members on a contract basis, in positions spanning manufacturing and quality control and assurance.

Pharmaceutics International (PII) has New Partnership with a UK Firm that Will Bring New Preclinical and Clinical Services to the North American Market

The US firm has solidified an alliance with Bio-Images Research, which was founded in 2000 as a spin out from the Universities of Strathclyde and Glasgow.

The company specializes in gamma scintigraphy imaging services for preclinical and early-phase clinical trials and currently serves the European market, assisting firms in accelerating their formulation development programs.

PII specializes in contract formulation development, and the manufacturing of clinical trial materials of both solid and semi-solid dosage forms and company senior vice president Steve King said that the collaboration with Bio-Images "will enable PII to provide more extensive service for our customer base".

In addition, the firm said that its customers in North America will also now benefit from access to Bio-Images' university links and connections with expert consultants; a hospital base, allowing access to defined patient groups and specialist medical support; as well as its experience in "innovative labeling techniques".

Professor Howard Stevens, chairman of Bio-Images, added that through the new alliance, his company will in particular be helping PII with many of the new technologies it is now offering its customers in the area of drug delivery.

In March the contract manufacturer opened a new 30,000 sq ft development, aseptic filling, and GMP production plant near Baltimore, Maryland in the US.

Initially the aseptic filling line will fill containment and high potency small molecules for clinical trials and the commercial supply of niche products. The firm also has a lyophilized product manufacturing capability on site.

Moreover, PII gained a new UK site through an acquisition made in January of preformulation and formulation development services firm Pharmaterials for an undisclosed amount. The purchase was made to extend the development capabilities and service offerings of Pharmaceutics International's business, adding prefomulation, polymorphism, salt screening and co-crystal services to the company's repertoire.

Oso Biopharmaceuticals Manufacturing, LLC

has purchased the Albuquerque, NM-based sterile injectables manufacturing business of Catalent Pharma Solutions. Terms of the transaction were not disclosed.

The unit provides cGMP glass vial filling and lyophilization services for injectable drugs and biologics for both commercial and clinical projects. Oso Biopharmaceuticals will retain all employees associated with the business and continue to serve existing customers in North America and Europe.

Dr. Stuart Rose, chief executive officer and president of Oso Biopharmaceuticals, said, “We are delighted to have been successful in acquiring Catalent's sterile injectables business based in Albuquerque. It fits exceedingly well with our strategy to build a world class, high quality contract manufacturing company. We will work tirelessly with the talent pool in Albuquerque to meet the highest demands and expectations of our global customer base.”

Biotechnologie and Boehringer Ingelheim Will Jointly Offer a Streamlined Biopharmaceutical Production Option

Germany's Rentschler Biotechnologie and Boehringer Ingelheim have inked a preferred partnership agreement to jointly offer customers a more streamlined biopharmaceutical production option.

Under the deal, Boehringer Ingelheims clients will be entitled to use Rentschler's facilities. The contract manufacturer is focused on process development and small to medium-scale clinical supply production of mammalian cell-derived drugs, and currently operates eight independent GMP lines with fermenter volumes of up to 500 L, with a 2,500 L fermenter also due to start operations.

In return for access to these facilities, Rentschler's clients will gain access to Boehringer Ingelheim's large-scale mammalian biopharmaceutical production facilities in Biberach, Germany.

The company's services division, runs one of the world's largest biotech facilities and offers similar services to Rentschler, but with technologies optimized for large scale industrial production with fermenter volumes of up to 15,000 L.

According to the two companies, the advantages for its biopharma customers are that the combined development and manufacturing know-how and facilities will lead to "increased flexibility and ultimately more customized services".

The companies' sites are located in close vicinity to one another and they share compatible bioprocessing methods, which "guarantee a seamless project transfer," the firms pointed out.

"The cooperation with Boehringer Ingelheim will increase the value of our services, as both companies will benefit from the combined expertise and the easy transfer from small/medium to large scale production," said Dr Wieland Wolf, vice chairman of the Rentschler Group.

Europe is expected by BioPlan Associates to witness the most significant worldwide gains in biopharmaceutical manufacturing production capacity in the next five years - 66 per cent compared with only 36 per cent in the US - due to demand.

With these considerations in mind, companies in the business need to become more innovative and efficient in the way they operate, and the Rentschler Biotechnologie and Boehringer Ingelheim partnership is one example of this.

Medimetriks Pharmaceuticals, Inc.

recently announced that it has commenced operations. The newly-formed Company, led by the founder and the key Senior Management Team of the former Bradley Pharmaceuticals, will develop, license and commercialize innovative prescription products for the dermatology and podiatry marketplaces. The company is aggressively pursuing licensing opportunities, company and product acquisitions and initiating the development of a series of brands that will fill unmet needs in the marketplace. Medimetriks' objective is to build a robust product portfolio and become a leading dermatology and podiatry specialty company.

Bradley Pharmaceuticals was acquired earlier this year by Nycomed for approximately $350MM. Bradley's Doak Dermatologics Division, which represented approximately 80% of Bradley's revenue, was a leading dermatology company and the largest independent pharmaceutical marketer to the podiatry specialty. Bradley Glassman, the former Senior Vice President of Sales and Marketing for Bradley, will serve as President and CEO of Medimetriks Pharmaceuticals, Brent Lenczycki as Chief Financial Officer and Alan Goldstein as Executive Vice President, Business Development. Daniel Glassman, the former President and CEO of Bradley, will serve as Medimetriks' Chairman of the Board.

Cambridge Major Laboratories (CML) Will Begin Construction of New $30 Million (€19.2m) High Tech API Production Facility

The firm, which announced plans to invest in the new 120,000 square foot plant in February this year, said that the facility will include numerous dedicated Good Manufacturing Practice (GMP) production suites capable of making "multi-ton" quantities of several active pharmaceutical ingredients (API) at the same time.

The facility, which will be located next to CML's headquarters in Germantown, Wisconsin, is expected to create between 50 and 75 additional jobs, primarily in manufacturing and production roles.

CML explained that its current Germantown API facility, which was opened in 2004, is approaching its maximum operating capacity. The firm added that it needs the new plant to allow for the production of increased quantities of both developmental and commercial APIs.

Initially, the new Germantown site will comprise six separate manufacturing units, each with a 2,000 gallon reactor and associated isolation and containment facilities. The plant will also contain several hydrogenation and cryogenic reaction vessels, which CML said would provide considerable flexibility and allow the company to feed in work from its other API factories should the need arise.

CML also said that the facility had been designed to allow for the installation of additional 4,000 gallon API manufacturing suites when the initial phase of construction is completed in August next year.

With its November 2007 acquisition of Dutch API supplier ChemShop, subsequently renamed Cambridge Major Laboratories Europe, CML expanded its workforce to 140 employees at 3 sites in the US and Europe. Through that deal CML acquired ChemShop's 12,500 meter square API facility in Weert which features an R&D lab, several GMP kilo suites and a pilot plant production line, firmly establishing it as a major player the sector.

Both the ChemShop purchase and the new Germantown production plant are part of CML's ambitious expansion program that seeks, through acquisitions and internal investment, to maintain the 30 per cent annual growth rate that the firm has enjoyed since it was founded in 1999.

The Indian Government is Close to Rubber-Stamping an $80 Billion Industrial Hub Near Vishakhapatnam (Vizag)

which is expected to attract pharmaceutical companies to the region.

A consortium of Mittal Energy Investments, Total SA and Petroleum Corp will be the anchor tenant at the mega oil, chemical and petrochemical hub following its $7.5bn investment.

Surrounding this will be numerous pharmaceutical and chemical manufacturing facilities, spread over the 603 sq km site. The sheer scale of the site and the investment should ensure that it becomes a focal point for pharmaceutical activity within India. At this time it is unclear which pharmaceutical companies will be setting up in the region.

The operating in India the hub at Vizag should prove alluring to pharmaceutical companies owing to its scale plus the surrounding geography, culture and infrastructure.

Companies operating in the hub will be looking to utilize the large number of highly educated, English speaking graduates from the region's educational establishments.

It is this workforce which has driven the rapid growth of Vizag from a small fishing village during colonial times to the industrial monolith it is today. This industrial expansion has been supported by improvements in the region's infrastructure.

Consequently, the hub will have excellent links by air, which has undergone rapid improvement in recent years. This has resulted in increased capacity for international airlines and permission for night flights. The city is also well connected to the rest of India by air and rail.

This should facilitate the movement of people to the hub, as well as the transport of goods to market. Vizag's natural harbor will also play a vital role in dealing with exports, which are anticipated to be $13.6bn per annum. Infrastructure at the hub itself is to be developed through significant governmental funding, with central government pumping in $1.2bn and the state, Andhra Pradesh, supplying $500m.

The sums of money involved signify the commitment of the Indian government to see the nation build on the impressive growth it has achieved in recent years.

HemCon Medical Technologies Completes Acquisition of Alltracel Pharmaceuticals Plc

HemCon Medical Technologies Inc. today announced it completed the acquisition of Dublin, Ireland-based Alltracel Pharmaceuticals Plc in a cash-for-stock deal. The purchase occurred through Castlerise Investments Limited, a newly formed wholly-owned subsidiary of HemCon Medical Technologies. Alltracel will operate as a wholly-owned subsidiary of HemCon and maintain its headquarters in Dublin. Combined projected revenues will exceed $100 million (USD).

HemCon developed the chitosan-based hemostatic HemCon® Bandages and ChitoFlex® dressings that are used by military and medical first responders as well as health care professionals around the globe. HemCon is also the manufacturer of the high-performance consumer bandage, KytoStat™, which launched in February 2008.

Alltracel currently licenses their proprietary technologies across a wide spectrum of industries in the cosmeceutical, nutraceutical and wound care markets. In addition Alltracel offers private-label oral care products licensed in Europe through the Butler and GUM brands. The acquisition expands distribution opportunities for HemCon's KytoStat Bandage and other products in Europe while also expanding Alltracel's oral care products and medical technologies in the U.S.

The acquisition provides HemCon access to Alltracel's joint venture with Elmarco and its proprietary nanotechnology manufacturing process called Nanospider®. HemCon will leverage this process to develop and aggressively grow its market share in acute wound care products.

Sanford Health Breaks Ground on Bio Facility

Sanford Health will break ground next month on a 185-acre project on Sioux Falls' south side that will transform a soybean field into a collective of biomedical research, office and light manufacturing buildings.

The development eventually could include jobs for more than 6,000 people inside 2 million square feet of building space.

The groundbreaking will be June 2, during the week of the Sanford Festival - the culmination of events announcing the disease the health system will focus on for the Sanford Project. But Sanford faces challenges in recruiting companies to the research park, particularly since South Dakota has so few biomedical research programs.

The park is one of several projects in the works. Construction of Sanford Children's Hospital, to open in spring 2009, is ahead of schedule. Plans for a new heart and vascular building on the north end of Sanford's campus have more than tripled in scope since it was announced last year.

Renderings of the park's first building show a four- or five-story "collegiate Gothic" style structure largely imagined by Sanford chief executive Kelby Krabbenhoft. Construction will begin in summer 2009 with completion in 2011.

The first building in the park will consolidate research efforts under way by Sanford Research/USD. Sanford temporarily will house researchers in the former Premier Bankcard headquarters. The health system recently bought the building south of the airport.

University of Colorado in Boulder to Update Science Buildings

The state will provide $27 million to the University of Colorado for the Boulder campus to fix up, or completely overhaul, some of its most dilapidated buildings.

The outdated Ekeley science building will receive $11.6 million. The fume hoods in those labs no longer work and force students to breathe chemical fumes that should be ventilated outside, campus officials have said.

The aged Ketchum Arts and Sciences building, which also has poor ventilation and has fallen below safety codes, will receive $8.4 million from the state for renovations. That’s $1 million shy of what the campus had originally requested.

Boulder campus architects are in the design phase of those makeovers, said Jeff Lipton, acting vice chancellor of administration. Construction could begin in a year, he said.

The campus’ top priority is a $128.3 million biotechnology building, which would provide office and lab space for 60 science and engineering faculty members, as well as 600 researchers. The building would allow for CU researchers to partner with businesses. Colorado is home to 360 biotechnology firms, 57 of which are in Boulder, according to CU officials.

The proposed site for the building is on the East Campus, near Colorado Avenue and 30th Street. Construction could begin as early as July 2009, and the building is scheduled to open by early 2011, said Paul Leef, campus architect.

Other priorities include a new aerospace and energy building; a new geosciences hub; improvements to Hellems Arts and Sciences, which was originally built in 1921; renovations to the Guggenheim geography building; and $34 million to go toward more faculty offices as professors are feeling a space crunch.

The Board of Regents, at its June 5 meeting, will vote whether to endorse the projects and budget requests that make up the Boulder campus’ five-year construction plan.

Vetter Approved for New Plant

Vetter Pharma-Fertigung GmbH & Co. KG has received a manufacturing license in accordance with German Drug Law from the Tuebingen Regional Board for its new state-of-the-art plant, Ravensburg Vetter South, for aseptic filling of liquid and lyophilized drugs. After a planning and construction period of three years and an investment of 100 million euros, one of the world’s most modern production facilities is now ready to begin work. Thanks to the highest possible level of automation and an ultra-modern restricted access barrier system, Vetter can offer products of the highest quality. In addition to dual-chamber syringes and cartridges, the new location will also fill liquid or lyophilized vials, as well as single-chamber cartridges. The new, flexible production lines make it possible to change systems and formats, including line clearance, cleaning and disinfection, much more quickly than with previous design concepts. With the new facility, Vetter is broadening its portfolio of services and expanding its capacity in aseptic manufacturing by about 30 percent.

Vetter has been active as an independent pharmaceutical service partner for biotech and pharmaceutical companies for over 50 years, and began focusing on the fill and finish of liquid and lyophilized drugs about 25 years ago. Vetter Commercial Manufacturing handles the entire process, from compounds and aseptic filling to final packaging of the product.

Hefty Funds Lay Foundations for Stem-cell Facilities

The California Institute for Regenerative Medicine (CIRM), the state's stem-cell agency, has awarded $271 million to 12 institutions to seed a building boom of research facilities across the state.

The awards were made at the CIRM's 7 May meeting. The largest, $44 million, went to Stanford University in Palo Alto; the smallest, $3 million, went to the University of California, Santa Barbara. Every University of California campus except Riverside received an award, as did the Buck Institute for Age Research in Novato; the University of Southern California in Los Angeles; and a consortium of four San Diego institutions called the San Diego Consortium for Regenerative Medicine.

California institutions hope the new facilities, scheduled to be completed in two years, will help them recruit more scientific talent. The new buildings will be a boon for scientists working on human embryonic stem cells, but will also aid those studying other aspects of regenerative medicine, such as adult stem cells and immunology.

Goodwin Biotechnology has announced that it has finally completed the construction of its expanded manufacturing facilities, which were 10 years in the planning.

Via an investment from its parent company, Wallace Pharmaceuticals, the US biopharmaceutical contract manufacturing organization (CMO) was able to afford the expansion, which will now allow it to scale up its operations to manufacture therapeutics for late-stage clinical trials.

As part of the expansion project at its Plantation, Florida facility, which started in 2006, Goodwin doubled its good manufacturing practice (GMP) production space and added a 200L and 500L stirred tank bioreactor train to its hollow fiber and perfusion capabilities.

Indeed, as the biopharmaceutical industry matures and more and more biologic drugs are moving through research and development pipelines, new opportunities are being created for contract manufacturers that engage in the highly specialized area of biopharmaceutical production, as the manufacturing of biopharmaceuticals is an expensive, complex, and highly technical process in comparison to that of small molecules and investment in manufacturing capacity for biopharmaceuticals is a risky decision for most companies as product development timelines are lengthy and have a high probability of failure.

Goodwin is not the only biopharmaceutical CMO to have the idea of increasing capacity and capabilities to capitalize on this growing industry demand.

Cobra Biomanufacturing Company

is now pushing into the new and more lucrative area of commercial manufacturing on its viral vaccine production side of the business, as well as in to Phase III and eventually commercial scale manufacturing on its protein production side of things.

Catalent Pharma Solutions

has just announced an expansion of its bioreactor capacity in order to meet an increase in mammalian cell culture demand.

The US biopharma outsourcing services company said that its expansion will also more than double its present bioreactor capacity by 2009, with the addition of a 1,000 liter bioreactor train in its Middleton, Wisconsin facility.

Pfizer's Plans for a New €190 Million Manufacturing Plant in Shanbally, Ireland

The facility will produce small quantities of candidate drugs for clinical trials, creating around 100 jobs when it becomes operational at the end of 2009. It will be built on the 28-acre vacant lot adjacent to Pfizer's existing Ringaskiddy manufacturing unit that has been the subject of much speculation since the firm applied for planning permission last summer.

The unit will "manufacture and purify a variety of mammalian cell derived proteins at pilot scale on behalf of PGR&D [Pfizer Global Research and Development]. Jacobs Engineering will manage the construction project but it is too early to discuss the specific facilities that will be available at the site.

The investment is in marked contrast with Pfizer's ongoing program of cost cutting and restructuring which, as recently as last month, saw chief financial officer Frank D'Amelio announce plans to reduce its number of production facilities to 44 by the end of 2009.

Additionally, the plant is a further indication that Pfizer is looking to biologics to bolster its portfolio ahead of the impending loss of patent protection for some of its highest earning products. In recent years, the firm has developed its biotechnology arm with the acquisition of a number of specialists, including ConvX and PowderMed, in 2006 and 2007.

The Irish biotechnology sector will also be reassured by Pfizer's move following the firm's sale of facilities in Little Island and Loughbeg, County Cork, in 2007.

Ireland's tax system has long been an attractive proposition for major drug and biotechnology firms. Last month for example, GlaxoSmithKline said it would invest a further €30m in its over-the-counter (OTC) facility in Dungarvan, while Genzyme said it would put another €130m into its plant in County Waterford. More recently Shire announced plans to relocate its tax residency to Ireland to help reduce costs.

Hospira Ends Manufacturing in Morgan Hill, CA

The decision to end manufacturing operations at its facility in Morgan Hill, California in the next three years may cost Hospira up to $35m (€22.7m), according to a document the firm filed with the US Securities and Exchange Commission (SEC).

Hospira said that running costs at the plant, which currently employs around 600 people, have become prohibitively expensive. The specialty pharmaceutical firm plans to transfer the majority of its Morgan Hill operations to other facilities and third party companies, but will maintain a 100-strong team at the facility.

Tareta Adams, Hospira's director of public affairs said that the company is "to move the Plum XLD infusion pump manufacturing line to existing space in another Hospira facility," but added that "the specifics regarding the subsequent phases of the transfer of manufacturing are not yet finalized."

She went on to say that "the 100 positions that will likely remain in Morgan Hill will be responsible for limited manufacturing, the repair business and key functions, such as materials logistics, engineering, on-market product support and customer service."

In recent years, Hospira has been reducing manufacturing capacity in an effort to improve efficiency. In 2005 for example, the firm shut down its facility in Donegal, Ireland, moving production operations to plants in Costa Rica and the Dominican Republic, while in 2007 it closed a production site in Ashland, Ohio.

Hospira has also sold off its manufacturing facility in Montreal, Canada and is to phase out production at its plant in North Chicago, Illinois, by 2010.

Hospira's Heparin Contamination Free

Hospira's heparinised saline product is one of several named as being free of oversulphated chondroitin sulphate (OSCS) by Australia's Therapeutic Goods Administration (TGA).

The TGA's analysis was prompted by the emerging global contamination problem that was sparked by the discovery of OSCS in heparin made by U.S. firm Baxter. The Australian agency's work did identify OSCS in a heparinised saline product made by the UK's AstraZeneca's.

Agilent Purchases Dow Pharma Unit

Agilent's purchase of DowPharma's Nucleic Acid Medicines business is the second time in recent years that the US scientific measurements specialist has ramped-up its nucleic acid manufacturing capabilities.

The deal, financial terms of which were not disclosed, will expand Agilent's existing nucleic acid active pharmaceutical ingredient (API) production facility in Boulder, Colorado. The plant was originally gained through Agilent's purchase of SynPro in 2006.

Agilent plans to introduce a 200-1,000 mmole synthesizer capable of manufacturing kilogram quantities of APIs per run. It will also install a 30 liter per minute analytical chromatography system, two multi-kilo lyophilisation units and the corresponding infrastructure and reaction vessels for custom conjugation chemistries and duplex annealing of small interfering RNAs at the 35,000 square foot facility.

The program is expected to create around 30 new jobs in manufacturing, quality assurance, and quality control roles in the next 12 months.

Chesapeake Closes Brussels Facility

Another difficult quarter for US-based packaging company Chesapeake has seen it make plans to close its factory in Brussels, Belgium. The Brussels pharmaceutical carton factory and its 42 employees are the first to face the axe.

The closure will take place over the coming months, with Chesapeake hoping the move will improve the efficiency of its Belgium operations. Some of the products made at the Brussels plant being transferred to the company's carton manufacturing facility in Gent.

A rosier picture of the coming year was painted by Chesapeake, with an increase in the volume of pharmaceutical packaging sales predicted during the coming months.

The company also claimed that the key UK and Ireland markets were starting to show signs of improving. This was in response to changes Chesapeake had already implemented in its attempts to improve service levels.

ORF Genetics Opens in Iceland

The opening of ORF Genetics' $1m production site for recombinant proteins in Grindavik, Iceland, is yet another groundbreaking move by this year's winner of the Icelandic Centre for Research's innovation award.

The new greenhouse facility, which is built near one of the country's major lava fields, uses renewable geothermal energy to power the indoor cultivation of barley that has been modified using the firm's Orfeus bioproduction platform.

The Orfeus system uses barley's endosperm storage cell, characterized by its bio-chemically inert environment and lack of endotoxins, as the production host. Other advantages of this system include low protease activity and secondary metabolite content and simple protein content all of which aid in downstream processing. In addition, barley has received the US Food and Drug Administration's generally recognized as safe designation (GRAS).

ORF's co-founder and chief financial officer, Dr Júlíus Kristinsson, said that the firm had been working towards the launch since 2000. He explained that "Iceland's position on the border of two tectonic plates means that it has vast geothermal reserves," and added that "around half of the buildings in the country are heating using geothermal energy."

Kristinsson went on to say that Iceland's geographic location also provides an optimum greenhouse environment, helping to reduce the risk of overheating and thereby reducing costs associated with cooling at the site. He added that the facility uses geothermal energy to power its lighting, which is vital to maintaining the quality of the crop produced.

The 22,000 square foot site employs a soil-less hydroponic system of conveyor belts that is capable of producing up to 90 different proteins at the same time. It will initially be used for the production of the company's biorisk-free ISOkine range of recombinant proteins of animal origin for clients in the medical research, drug discovery and cosmetics sectors.

Kristinsson said that the firm expects to cultivate four crops a year and will achieve yields of 1kg/m2 per harvest.

Kristinsson added that because it is located near to one of the country's largest geothermal power stations, there is scope for considerable expansion of production at the facility, in terms of both space and energy supply.

He also said that, while the majority of ORF's customers are involved in laboratory research, the company plans to begin expanding its client base to include pharmaceutical firms in the next few years.

LyondellBasell Completes HACCP Certification

Dutch polymer, petrochemicals and fuel specialist LyondellBasell Industries has completed hazard analysis and critical control points (HACCP) certification of management systems at its monopropyleneglycol (MPG) USP/EP manufacturing facilities in Fos-sur-Mer, France and Botlek, the Netherlands.

HACCP is primarily focused on preventing pharmaceutical and food safety hazards. The system covers the entire production process from raw material procurement, manufacturing, storage, handling and distribution to eventual use of the finished product.

Qarles added that, while LyondellBasell's MPG USP/EP product already complies with current good manufacturing practice (cGMP) standards, completion of the HACCP assessment allows the firm to "go one step farther and stand behind our management systems by committing to certify them. As a member of the European Chemical Industry Council (CEFIC), we are committed to … safety and the principles of responsible care."

Bushu Pharma Grows in Japan

Bushu Pharmaceuticals, Japan's largest dedicated contract manufacturer, has been going from strength to strength as Japan's pharma outsourcing industry awakens.

As the outsourcing trend has taken off in the country since 2005 when a law change made it easier for companies to outsource drug manufacturing, Bushu has seen its sales nearly double, from 4.1bn Yen a year in 2003 to 7.8bn Yen in 2006. Similarly, its customer base has followed the same trajectory, rising from 27 to 46.

At the moment revenue is almost evenly split between Japanese and international clients, but Bushu is making a concerted effort to attract more business from around the globe.

The company specializes in the manufacturing of solid dosage forms, as well as reformulation and packaging especially for the Japanese market.

Most of the solid dose work comes from within Japan. The clinical trials manufacturing component of this is steadily growing, as more trials are being conducted in the country by foreign firms, although still a very small proportion compared to domestic commercial.

Most of the company's international work is in relation to contract packaging, as it is extremely difficult for foreign manufacturers to package products appropriately for the Japanese market.

In terms of drug dosage forms, Japan's market requirements are different form many other countries. Granules are a preferred dosage form, with around 10 per cent of all drugs on the Japanese market being sold in this form. Large sized tablets are also a no no, as are colored tablets. White and perhaps yellow are the colors that are acceptable to consumers, said Bushu president Takayuki Kasai. Because of these requirements Bushu undertakes a lot of work with pharma firms from around the world who wish to successfully sell their product on the Japanese market but first of all need to reformulate them into an acceptable dosage form.

Meanwhile, the firm also carries out high potency production and primary packaging in a dedicated facility built for a client, as well as 2-8 degree cold chain storage and packaging of biologics, a growing area in Japan, along with the rest of the world.

The warehouse has high speed shutters to keep insects and other particles out, coupled with an air shower to blow particles out as the door opens. Wood palettes have been phased out as they have been in the US and only plastic and aluminum palettes are now used.

Everything that enters the warehouse is either individually wiped down or vacuum cleaned to remove any particles. Insects that are caught in insect exterminating machines are regularly counted and classified as to their species so as to keep an eye on any trends of note.

Each manufacturing building is separate and has its own air handling facilities so there is no mixing of air in different rooms. The workers of each separate segment are also required to wear different color coded uniforms so as to eliminate possible contamination this way.

A unique feature of pharmaceuticals manufactured in Japan is that wherever possible, 100 per cent of the raw material ingredients undergo a sieving process to remove any foreign material that should not be there. Bushu uses two types of sieve, depending on the type of material, an oscillating sieve, or a brush-type sieve. Prior to sieving, all the bulk material delivered is subject to an acceptance test and any material found to be "substandard" according to Japan's stringent expectations, is returned to the supplier.

As a rule of thumb, the particle classification in Japan is class 100,000 (meaning 100,000 particles per cubic feet) for solid dosage form manufacturing areas as opposed to class 1,000,000 class in other countries. Air is filtered substantially more in the manufacturing areas in Japan producing a much cleaner environment.

Another difference of note that is unique to Japan is that for storage purposes, the ambient temperature is considered as between 1 and 30 degrees Celsius, where as in Europe and the US ambient temperature is classed as 15-25 degrees Celsius.

According to Japanese law, product can be stored between 1-30 degrees Celsius if stability data has been taken at 25 degrees Celsius with a relative humidity of 60 per cent. EU and US companies perform stability testing at the same conditions but their laws stipulate that product can then only be stored at 15-25 degrees with some exceptions.

Canada-based Biovail Revealed Plans to Close Two Puerto Rican Manufacturing Plants

Operations will be closed down within 18 to 24 months, with some of the manufacturing processes being transferred to the company's facility in Steinbach, Canada.

The restructuring plan was launched following a fall in first quarter profits of 40 per cent and will cost Biovail $80m to $100m. However the company is expecting to make savings of $30m to $40m a year upon completion of the closures, enabling further investments.

Biovail CEO Bill Wells said: "We intend to invest over $600m in research-and-development through 2012, exploring niche in-licensed and acquired late-stage new chemical entities, new indications and in-house reformulation opportunities."

This positive outlook is despite disappointing first quarter results which have further added to Biovail's woes, following a difficult period for the company fraught with internal tensions.

However, the challenges facing Biovail seem relatively minor when compared to Puerto Rico's beleaguered pharmaceutical sector which has seen a flood of companies cut back operations on the island in recent years. This has resulted in the loss of over 3,000 jobs and although there is a movement to attract biotech companies the number setting up operations is not yet compensating for the pharmaceutical exodus.

UK Architects RMJM to Design $90 Million Biotech Facility in Beijing

UK architecture firm RMJM has been appointed design architect for a state-of-the-art $US90 million biotechnology research and development centre in Beijing , it was announced today.

The new facility is for Genzyme Corp, one of the world’s leading biotechnology companies.

The facility is to be built at Zhongguancun (ZGC) Life Science Park which is dedicated to academic and government research centers as well as pharmaceutical and biotechnology companies. It will be used for research and development activities for orthopedics, transplant and immune disease, oncology, endocrinology and cardiovascular disease.

The new commission further consolidates RMJM’s standing in designing high-tech biomedical science facilities.

The UK-based international firm also designed the National University of Singapore Graduate Medical School (GMS) and The Centre for Translational Medicine at Yong Loo Lin School of Medicine (YLL). Both of these projects in Singapore are under construction.

Innovative green features will create a healthy and comfortable workplace for employees, and reduce its environmental impact. They include: a narrow foot print and 4-story atrium to maximize natural ventilation; living roof to reduce pollution caused by storm water runoff; a solar thermal system that will provide a significant portion of the building's hot water and reduce its energy consumption; low-flow fixtures to limit water usage; a high-performance exterior glass system that will provide employees with significant natural light, contributing to a pleasant working environment, and reducing the facility's dependence on electricity; and a censored motorized blind system to control light and heat gain.

The facility is expected to be completed by 2010.

RMJM designed the Beijing Olympics Media Centre for the 2008 Olympic Games.

Genzyme is one of the world’s leading biotechnology companies. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2007 revenues of $3.8 billion. In 2007, Genzyme received the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation

MPI Expands in Michigan

US preclinical services firm MPI Research has revealed its intentions to undertake a $330m that will result in the creation of 3,300 new jobs.

The contract research organization (CRO) will establish new facilities in Michigan, close to where the company is already headquartered in Mattawan, in a project that is expected to take five to seven years to complete.

The firm will fit out two former Pfizer laboratories that the drug giant donated to the state, which in turn is leasing them to MPI. Around 400 new employees will work out of these two facilities, which are located in Kalamazoo.

Another expansion will take place at MPI's nearby site in Mattawan, where the remaining 2,900 new staff members will eventually be based.

The company currently has 1,000 clients and 1,600 employees. In addition to its headquarters, the firm also has operations in Pennsylvania, US and China, after it formed a joint venture with China's Shanghai Medicilon in January to provide preclinical services in the country.

MPI chose Michigan as the location of its expansion after being lured by an incentives package offered by the state, which includes tax credits to the value of $86m over 15 years, in exchange for the creation of 3,300 jobs.

The preclinical drug testing industry is currently valued at $17.5bn, of which 23 per cent ($4.1bn worth) is outsourced by life sciences and biopharma firms to services providers such as MPI, with the remainder being done in-house. However, as drug discovery continues to become prohibitively expensive and pharma firms struggle to keep costs at a minimum, preclinical work is now being outsourced at double the rate that it was ten years ago and the $4.1bn preclinical services market is growing at an annual rate of 15 per cent.

MPI currently sits in the number three position in terms of preclinical CROs, behind the industry giants Covance and Charles River Laboratories, who together employ over 16,000 staff and generate $2.8bn in annual revenue. MPI is a long way off this status, but via the capacity expansion, the firm has decided to seize what it sees as a huge opportunity and attempt to capture more market share than many of its more conservative competitors by trumping them in size.

SUNY Upstate Medical University Grows

SUNY Upstate Medical University has a plan for regional growth through research, clinical care, and education. It also has $320 million in state funding to help make it happen.

SUNY Upstate says the 2008-09 state budget has money earmarked for six projects that will help to address key issues across the region, such as the shortage of physicians and other health professionals and access to services, while creating new job growth through research.

David R. Smith, M.D., president of SUNY Upstate, says the help his school received from state, county, and city lawmakers creates the foundation for regional growth.

SUNY Upstate is among the stakeholders working with Empire State Development Corporation (ESD) on a $40 million redevelopment plan for the Kennedy Square apartment complex at 950 E. Water St. in Syracuse that will include the New York State Biotechnology Research Center, along with medical research, office, and classroom space for SUNY Upstate.

The school has partnered with the city of Syracuse, Onondaga County, the SUNY College of Environmental Science and Forestry, and the Metropolitan Development Association of Syracuse and Central New York on the project.

The research center will cover four of the property’s 14 acres, and Smith says SUNY Upstate will seek proposals from private developers so the remaining 9 or 10 acres can be used for retail and residential space.

State lawmakers have also approved the $72 million expansion of the university’s Institute for Human Performance (IHP). Smith says the building is at capacity, as is the university’s other key research facility, Weiskotten Hall.

The expansion will add 85,000 square feet to the facility at 505 Irving Ave. and there will be parking underneath the structure. The design development for the expansion should take about 15 months and then construction would take an additional two years.

“It’s a very technical building with a lot of exhaust structures, a lot of EPA compliance, so that would give us about a three year timeframe on the nearside, probably a little more for completion,” says Smith.

In addition, SUNY Upstate has been awarded $36 million for a new academic building. Smith says the design work for the structure will be about six months behind the work for the IHP, and he adds the university is looking at a couple different sites for the facility.

He also contends that the new academic building is “vital” to the university’s vision of growth. The $36 million will pay for a facility with more office space and larger auditoria, saying the school’s current space allows for 160 to 180 students, but it needs capacity for well over 300 students so faculty can do the kind of testing and teaching that needs to be done. The university will also receive $10 million for a cord blood center. SUNY Upstate says the school would be a key player, along with the state health department and other organizations, in leading work on a research center investigating the potential for life-saving treatments through umbilical cord blood.

Smith would like to see the cord blood center built near the biotech research center and says both projects are on a three-year timeframe.

The state funding for SUNY Upstate also includes $150 million in bonding authorization to help modernize patient rooms at University Hospital, as well as to build a $50 million cancer center and a $15 million heart center.

Smith says the university will conduct a fund-raising campaign around construction of the cancer center. The cancer center will be constructed near the Regional Oncology Center and it is expected design development will begin this summer. The remaining portion of the $150 million in bonding will pay for modernizing existing hospital rooms, outside the ones included in the vertical expansion of the hospital’s East Tower.

In the Southern Tier, SUNY Upstate will use $12 million for phase one of renovation work on an historic building called Binghamton Castle, which will be the future home of the university’s Binghamton campus.

The facility will be used to train 80 third and fourth-year medical students on an annual basis. Binghamton Castle will also be the site of the university’s forthcoming physician-assistant degree program, which will begin accepting students in 2009.

With $320 million in new investment for SUNY Upstate, Smith says it’ll mean more cranes in the air, and more people on the payroll. He believes the new construction and expansion will lead to anywhere between 800 and 1,000 new jobs for SUNY Upstate in the next decade.

“We believe we’re going to bring in close to 120 to 150 additional faculty. Those are all largely close to six-figure jobs, when you add benefits. They need with them administrative assistants often, certainly laboratory technicians, usually a multiplier of two to three on top of that, so quickly you’re up to around 450 to 500 jobs, just with the drive on the faculty side,” says Smith.

But his concern is SUNY took a 3 percent cut on the operating side in the current state budget (as did all state agencies) and the funding of faculty members remains a concern. Smith also says SUNY has one of the lower faculty-to-student ratios in the country.

The New York State Commission on Higher Education recommended in December 2007 that SUNY hire an additional 2,000 faculty members over the next five years. Smith believes the state is too far behind and the legislature will have to find a way to invest in new faculty.

SUNY Upstate is the Syracuse area’s largest employer, and Smith almost seems apologetic over the distinction, saying he’d like to see a broader economy for the Central New York region.

Fort Valley University Gets New Biotech Center

Fort Valley State University, GA, will soon be buzzing with the sounds of construction equipment. Within the next few months, projects totaling nearly $54 million are expected to begin springing up all over Fort Valley State's campus.

At the end of this month, a groundbreaking ceremony is scheduled for a $3.1 million biotechnology center. Construction will begin in July on the 8,000-square-foot structure, which will connect to the Stallworth Agricultural Research Station.

The building, funded by the U.S. Department of Agriculture, will house four laboratories and a lecture hall with a capacity for 100 people. The center is expected to be completed by June 2009.

The anticipated influx of new students will mean a need for more classroom space. A 59,000-square-foot science center is on the university's construction schedule. The $20 million facility will feature state-of-the art technology and additional classroom and laboratory space. Like the dorm expansion, the science center is slated to be completed in fall 2009.

TitleEisai Builds New Pharma Manufacturing Center

Eisai has begun building a £100m (€147m) European headquarters in the UK which will include a new pharmaceutical manufacturing facility - its first production plant in Europe.

The Japanese juggernaut wants to increase sales of its drugs in the European market and will use its new UK manufacturing base to improve the supply chain to this region.

The new plant forms part of Eisai's new European Knowledge Centre

(EKC) in Hatfield, north of London, where the firm has already begun relocating most of its UK-based research and development, production, and marketing operations as part of a consolidation effort.

The manufacturing facility will undertake formulation, finished dosage, packaging, warehousing and distribution of most of Eisai's drugs on the European market, although some drugs, such as injectables will not be suitable and will continue to be made in Japan, as will all bulk ingredients, company spokesperson Andrew Day told In-PharmaTechnologist.com.

It is hoped construction will be completed by early 2009, with the creation of over 250 new jobs - doubling the current workforce at the site.

Qisda and AUO Expands LCD Facility in Europe

Qisda has said it will team up with AU Optronics (AUO) to expand its LCD module (LCM) facilities in Europe in anticipation of the EU imposing tariffs on LCMs next year.

Qisda, looking to increase its LCM capacity, already set up an LCM plant in Guangzhou, China in the fourth quarter of 2007, according to the company. The monthly capacity of the Guangzhou plant will be 700,000 units, chiefly for monitors in the second half of 2008, it said.

The company said it will also increase the LCM capacity at its Suzhou, China plant, where monthly capacity for the segment has already reached 700,000 units. The Suzhou will mainly cater to the monitor segment, but it will also produce applications for TVs, it said.

Qisda reported that April consolidated sales totaled NT$11 billion, up 11% sequentially and 26% on year. It attributed the revenue growth to increases in LCD monitor shipments.

Shire Opens Site and Brings 680 Jobs

Governor Deval L. Patrick joined executives and employees from Shire Human Genetic Therapies (HGT), a business unit of global specialty biopharmaceutical Shire plc, to break ground on the new Lexington, MA campus that will serve as the global center for Shire HGT's research, development, manufacturing, and US commercial activities. The company will invest $394 million to remain in Massachusetts and expand the company's Lexington campus, resulting in the creation of 680 additional jobs.

An important factor in the company's decision to stay in the Commonwealth was the commitment of $40.5 million in tax and non-tax incentives to include grants for public infrastructure, in addition to the approval by the town of Lexington and the Commonwealth of a Tax Increment Financing (TIF) agreement.

Shire HGT is currently headquartered in Cambridge, but has transferred some operations to Lexington Technology Park. With the decision to stay in Massachusetts, and the construction of a new manufacturing plant, most aspects of the organization will be located on a central campus dedicated to Shire. This location offers many advantages to the company, including the opportunity to develop a larger research and development facility; the ability to expand to fit Shire HGT's growth plans; proximity to the Cambridge area life science cluster; and the presence of an exceptional talent pool and highly skilled workforce.

StemCyte Locates in New Jersey

StemCyte Inc. has located its East Coast operations in Ewing, N.J. The move, supported by a Business Employment Incentive Program (BEIP) grant through the New Jersey Economic Development Authority, puts StemCyte's executives in close proximity to one of the company's collaborators: world-renowned spinal cord injury researcher Wise Young, MD, PhD, at Rutgers University.

In addition to the New Jersey location, StemCyte has operations in California and Taiwan. The company is also developing StemCyte India Therapeutics in collaboration with Apollo Hospitals and Cadila Pharmaceuticals.

StemCyte, Inc., an international leader in cord blood banking, is fully accredited by the American Society for Histocompatibility and Immunogenetics (ASHI) for both low-resolution and high-resolution HLA tissue typing.

The HLA Laboratory facility in Arcadia, CA offers HLA typing and Chimerism Analysis services for transplant centers, international stem cell registries, other medical laboratories, and even individual family typing throughout the world.

Montgomery College Expands in Maryland

Hopes for a new up county economic boom in the life sciences are rising with the quickening pace of construction and fundraising for two new building projects on Montgomery College’s Germantown campus.

Crews are renovating a former office building on Goldenrod Drive that will serve as the home of the Germantown Innovation Center, a facility that will become the fifth business incubator managed by the county’s Department of Economic Development. The renovation had been scheduled to begin last fall but several complications delayed work until the arrival of spring. Construction is scheduled for completion by mid-September, and county officials hope to have 40 percent to 60 percent of the space leased by then, said John Korpela, manager of the county’s business incubator development.

The second planned building, the 127,000-square foot Bioscience Education Center, located off of Observation Drive, is in the design and engineering phase. It missed on a bid to receive $2.9 million in the recent state legislative session, but won $1.7 million from Congress in the current congressional session. College officials first conceived the center in 2000, and unveiled it as part of a 10-year building expansion plan in 2004.

Hercules Pinkney, vice president and provost of the Germantown campus, said he expects the projects, along with a 40-acre science and technology park, will be part of a ‘‘three-legged stool” promoting education, research and business development.

The business incubator is intended to be a place where new companies can situate themselves until they are strong enough to stand up on their own, Pinkney said.

The incubator will occupy the top floor of the 67,000 square-foot building and host 20 to 30 businesses specializing in life sciences and other forms of advanced technology. The facilities will include wet laboratories, two modular cleanrooms and 45 offices, according to college and county economic development officials.

The first floor of the building will be used by the college for classroom space.

The Bioscience Education Center will offer several major benefits to students and businesses, Pinkney said.

First, it will allow Montgomery College to form a partnership with the University of Maryland at College Park that will offer a baccalaureate degree in biotechnology, he said.

Second, it will open up a partnership between Montgomery College and Montgomery County Public Schools that promises educational opportunities that include teacher education, summer camps and high school academies.

The goal is to promote contacts between students, educators and businesses that will train students for jobs in biotechnology and provide businesses with a workforce, Pinkney said.

The center will generate 4,000 new jobs and almost $2 million per year in state and county tax revenue after completion, according to a funding request for fiscal 2009 submitted to Congress by college officials.

No date has been set for the beginning of construction, but Pinkney is confident of the project’s future after Congress approved $1.7 million in the current congressional session. The money, obtained by U.S. Rep. Christopher Van Hollen Jr. (D-District 8) of Kensington, will be used for parks, roads, waterlines and other infrastructure in the 40-acre parcel adjacent to the center. The county and college have lined up $2.7 million of the estimated $3.5 million to $4 million needed to complete the infrastructure, Pinkney said.

Pradeep Ganguly, the county’s director of economic development, said he has found strong interest in the Germantown projects as prospective locations among companies in India interested in establishing a presence in the United States. Ganguly said county officials and representatives from 19 local businesses who visited India in November found several companies interested in locating close to Montgomery College’s Germantown campus as a result of the plans for the new buildings.

State Sen. Robert J. Garagiola (D-Dist. 15) of Germantown, who sponsored two unsuccessful efforts to obtain up to $2.9 million for the Bioscience Education Center in the recent legislative session, said he is confident the project will be ‘‘at the top of the list” of projects to be funded in the next session. He estimated groundbreaking will begin in two or three years.

Peptisyntha Expands cGMP Manufacturing

Peptisyntha Inc. has started the next expansion of its cGMP-compliant manufacturing facilities in Torrance, California. The first phase of this expansion program will be completed by the end of 2008. This new expansion at Peptisyntha Inc. reflects the need for additional lab and office space based on the double-digit growth enjoyed by the company since its inception, with the production of peptides in solid phase for clinical or commercial use.

This expansion of the cGMP production capacity in Torrance, California, complements ongoing investments in the production operations of the liquid phase peptide synthesis capacity at Peptisyntha SA in Brussels, Belgium.

The peptide business makes a significant contribution to the overall platform of technologies of Solvay Organics, a business unit focused on high added value organic chemical specialties serving a wide array of market segments with innovative molecules, materials and solutions for novel applications.

Peptisyntha SA and Peptisyntha Inc. are fully owned subsidiaries of the Solvay Group.

Syngenta to Build New Biotech Center in Beijing

Syngenta will build a new biotech research & technology center in Beijing, China. Its focus will be on early-stage evaluation of GM and native traits for key crops such as corn and soy, in the areas of yield improvement, drought resistance, disease control and biomass conversion for biofuels. The new facility will have a global scope and will complement Syngenta’s biotech research activities in the US. The investment will be approximately $65 million in the first five years.

The new center, Syngenta Biotechnology (China) Co Ltd, will be built at Zhongguancun Life Science Park in Beijing. Until the new facilities are completed in 2010, adjacent temporary facilities will enable operations to commence from summer 2008. The biotech center will initially employ some 100 researchers and staff, increasing to around 200 after the new building is opened in 2010.

China is both an important producing and consuming agricultural region. Syngenta is expanding its partnerships to contribute to further growth in Chinese agriculture with seeds and crop protection technology. Earlier this month, Syngenta completed the share transaction with leading Chinese corn seeds company Sanbei Seed Co Ltd in Hebei province, in which it has taken a 49% stake. Last year, Syngenta entered into a five-year research collaboration with the Institute of Genetics and Developmental Biology (IGDB) in Beijing on the development of novel agronomic traits for key crops such as corn, soybean, wheat, sugar beet and sugar cane.

EMD Serono Expands Research in Billerica

EMD Serono Inc., a biotech company based in Rockland, said it plans to invest $50 million to expand its facilities in Billerica for drug research, where it is also expected to add more than 100 workers.

Fereydoun Firouz, president and CEO of EMD Serono, told Mass High Tech in August 2007 that the firm planned to expand in Massachusetts. The biotech firm is a U.S. unit of Swiss drug firm Merck Serono, which is owned by German pharmaceutical giant Merck KGaA.

EMD Serono said it plans to begin construction of the 125,000-square-foot expansion in Billerica in early 2009 and complete the project in 2010. The company now operates a protein production facility in Billerica, and the facilities are expected to total 210,000 square feet of lab and manufacturing space once the addition is complete.

The life sciences company employs about 650 workers in Billerica and Rockland, as well as 200 more employees around the United States, according to company officials.

Biotechnology firm EMD Serono has opted to set its sights on its Billerica plant for its expansion project, and not its headquarters in Rockland.

The U.S. biotech arm of German drug maker Merck KGaA plans to invest $50 million into a massive expansion at its Billerica campus and move about 90 research employees from Rockland to Billerica in 2010.

EMD Serono officials said, however, the company plans to eventually see a net growth in jobs at both locations. Estimates provided by the company show that the combined work force at both Massachusetts sites would grow by about 40 percent from about 600 people right now to nearly 850 people by the end of 2012.

The plans call for a 125,000-square-foot expansion to the campus on a 47-acre property that the company owns in Billerica. The company already has a 57,000-square-foot lab building there and a 24,000-square-foot manufacturing plant.

The researchers at the Billerica site would focus on developing cancer treatments. Serono had started researching oncology drugs before it was acquired by Merck last year. Merck already had a more established cancer research force that included scientists at the Billerica plant, which was folded into the EMD Serono operations. The company does business as EMD Serono in the United States to avoid confusion with Merck & Co., a separate drug company based in New Jersey.

Elmar Schnee, president of Merck’s biotech division, said Merck will now have three major research centers. Besides the Billerica campus, the other centers he named are in Serono’s hometown of Geneva and Merck’s headquarters city of Darmstadt, Germany.

Schnee said the strong academic and hospital support for life sciences research and a state government that views the industry as a priority were among the factors behind Merck’s decision to invest in an expansion in the Boston area.

An EMD Serono spokeswoman said about 100 employees currently work in Billerica and 500 work in Rockland. The company plans to expand its Billerica work force with the 90 members of the Rockland research team and at least 100 new jobs, bringing the total number of jobs in Billerica to nearly 300 by 2012.

By that date, the company also expects to add about 160 corporate and clinical support jobs at the 200,000-square-foot headquarters building it leases in Rockland, the spokeswoman said. That would bring the employee count in Rockland to about 550 over the next four years.

Chesapeake’s Manufacturing Facility First to Receive Certification

U.S.-based Chesapeake's Manufacturing Facility in Kunshan, China the First Pharmaceutical Packaging Plant in the Nation to Receive the PS9000:2001 Certification.

US-based Chesapeake's manufacturing facility in Kunshan, China has become the first pharmaceutical packaging plant in the nation to receive the PS9000:2001 certification.

The certification signifies the plant has met the requirements laid down by the Pharmaceutical Quality Group of the Institute of Quality Assurance for producing printed pharmaceutical packaging.

Chesapeake's facility opened in late 2007 and the company has worked quickly to get the plant up to an internationally recognized standard.

The recognition of Chesapeake's facility in one of the world's fastest-growing pharmaceutical markets is good news for a company which - by its own admission - is facing a 'challenging' time. Its pharma division in particular is facing an increasing competitive environment.

This rapid proliferation of skills and knowledge has allowed Chesapeake to quickly gain the certification which applies ISO 9001: 2000 and ISO 9004:2000 to pharmaceutical printed and contact packaging materials.

The 36,000 sq ft Kunshan facility was set up by Chesapeake to house machinery for digital plate making, digital label printing, high-gloss varnishing, foil stamping and laminating.

Chesapeake chose to site the plant in Kunshan as it already has a pharmaceutical plastic bottle manufacturing plant in the city. The creation of this Chinese hub gives Chesapeake a base from which to establish itself in the nation's market.

Products from the two plants are sold within China and to multinationals. Demand within China for packaging that adheres to international standards is growing as the government tries to improve the nation's reputation with regards to quality.

This focus by the government is expected to translate into impressive growth of the Chinese pharmaceutical packaging industry. A report by The Freedonia Group predicted China's pharmaceutical packaging would grow by 12.5 per cent a year between 2006 and 2009.

In particular the market for anti-counterfeit packaging for products looks certain to rise, with those originating in China under scrutiny in light of the level of counterfeiting in the nation.

Consequently, Chesapeake's position as an internationally certified manufacturer providing a complete packaging service within China could potentially reap dividends.

Iowa Central Community College Broke Ground on the New Bio-Science Health Science Center on the Fort Dodge Campus

Work will begin immediately on the new 34,600-square foot building, geo-thermal pond which will be used for heating and cooling of the building, four new parking lots and newly designed pedestrian plaza. The new facility is scheduled to be opened on July 1, 2009. It is part of the first phase of the new campus master plan put in motion in June of last year with passage of an $18 million bond referendum.

Kolacia Construction of Fort Dodge was awarded the general building contract with a low bid of $9,070,000 which covers all aspects of the project.

When completed the Bio-science Health Science Center will be a LEED certified state-of-the-art facility, addressing two of the region's most critical workplace need areas with biotechnology and health care training. The Bio-science portion of the building will house the bio-diesel quality testing lab, biotechnology lab, organic and general chemistry classrooms, and microbiology classrooms.

Health Science programs in the new building will include Medical Assistant, Radiography and the new Ultrasound program.

The new building will also include a 250-seat auditorium and lecture hall, and student lounge and study area. Visitors will be able to view displays explaining the many Green Building features of the new structure.

Building Designer Randy Cram talked about the building's LEED certification. ``We are going for a Gold Certification which is very hard to get. There are only a few buildings in the state like that,' he said. ``It was very important to Iowa Central that this building be as environmentally friendly as possible and we are excited to be involved in a project like this.' Cram noted the involvement of Brian Clark and Associates, contracted to implement the new campus master plan and KWJJ, the electrical contractor. McClure Engineering of Fort Dodge was also represented.

The new building isn't the only campus project made possible by the passage of the bond issue in 2007 to quickly take shape. Work will soon begin on the new campus road and entry way from U.S. Highway 169. Allied Construction of Charles City submitted the low bid for that project. When completed, the road will connect with the circle drive around central campus. Target completion date for the new road project is Aug. 1.

M+W Zander Gets Contract from Wyeth for Singapore Projects

PM Group and partner M+W Zander, have won two prestigious nutritional projects for Wyeth Nutritionals in China and Singapore totaling US$400m.

PM Group, the Irish-headquartered project delivery specialist provides services in project and construction management, architectural and engineering design and a range of technical and consulting services to the biopharma, food, healthcare, infrastructure and advanced technology sectors. PM group recently announced the acquisition of Devereux, an award winning architectural practice based in the UK. With 1,700 people employed worldwide, the acquisition will support PM Group's expansion into the healthcare and education sectors where Devereux has specialist expertise.

Wyeth has appointed the partnership to provide full design, project and construction management services for the development of a new world-scale greenfield infant nutritional facility in Suzhou, a major city north of Shanghai, China. With an anticipated handover date in late 2010, this would be Wyeth's largest greenfield undertaking to date in Asia with a gross floor area approximating 50,000m2. The Singapore project is a 12,000m2 expansion of an existing facility, which will be completed by late 2009.

The new US$280m facility in Suzhou, China will primarily produce infant formula milk powder and other nutritional products and will become part of Wyeth's global nutritional manufacturing and supply network. At full operation, the plant is expected to employ about 500 employees. Products made at this facility will primarily supply the local market.

The PM and MWZ alliance was formed in early 2007 to deliver a full range of project management, architectural and engineering services in the biopharmaceutical & nutritional industry sectors across Asia.

PM Group has a long-standing relationship with Wyeth that started with a major expansion of their Askeaton nutritional facility back in the early 90's. More recently they have been entrusted with the delivery of significant projects on their Grangecastle site in Dublin, the largest biotech site of its type in the world.

In Ireland, PM Group is currently working on a number of prestigious projects including the €redevelopment of Lansdowne Road stadium, biomedical facilities for Wyeth in Dublin and Centocor in Cork as well as the Pier D Development and Extension at Dublin Airport.

Catalent Pharma Solutions Announced Expansion of Bioreactor Capacity

The U.S. biopharma, an outsourcing services company, said the expansion will more than double its present bioreactor capacity by 2009, with the addition of a 1,000 liter bioreactor train in its Middleton, Wisconsin facility.

The firm indicated that the capacity expansion is in response to "increased client demand for production to support clinical trials across Asia, Australia, Europe and now the United States".

As the biopharmaceutical industry matures and more and more biologic drugs are moving through research and development pipelines, new opportunities are being created for contract manufacturers that engage in biopharmaceutical production, such as Catalent.

The manufacturing of biopharmaceuticals is an expensive, complex, and highly technical process in comparison to that of small molecules and investment in manufacturing capacity for biopharmaceuticals is a risky decision for most companies as product development timelines are lengthy and have a high probability of failure.

Catalent uses its proprietary GPEx technology to assist companies in the development of new biopharmaceuticals.

The company has so far generated over 150 cell lines for production of recombinant proteins and antibodies, one of which is now being used to manufacture a biosimilar product, and others which have been used in clinical trials on three continents.

Moreover, Catalent said it has also now supplied two biotech companies with GPEx-produced proteins that are currently being used in the US in clinical trials for the purpose of filing a investigational new drug (IND) application with the Food and Drug Administration (FDA).

Novavax Opens Vaccine Facility in Maryland

Novavax has opened a vaccine production facility at its headquarters in Rockville, MD. The 5,000 sq. ft., $5 million pilot- and commercial-scale manufacturing plant will be dedicated to infectious disease vaccines. The site will initially supply an influenza vaccine for ongoing clinical programs with planned annual capacity of 10 million doses.

Unlike traditional egg-based vaccine production, Novavax reports that its facility employs cell-based technology and disposable manufacturing systems. The company expects that its manufacturing techniques will produce vaccines within 12 weeks of flu-strain identification. This is less than half the time required by current manufacturers of approved vaccines, according to Novavax.

Novavax says that it has four vaccines in development addressing pandemic influenza, seasonal flu, varicella zoster, and an undisclosed infectious disease target. The pandemic flu candidate is in Phase II testing.

Prolient Updates Facility

US-based Prolient has improved its "closed loop" bovine serum albumin (BSA) manufacturing process, in what it describes as a "major step forward".

A new facility housing the technology has been opened, which contains many process innovations and includes one of the largest and most efficient biological lyophilizers (freeze-driers) in the world. This gives Prolient control over the drying and packaging phase of the BSA production process, allowing it to do everything in-house. BSA plays a vital role in medical diagnostic assays, life science research reagents, microbiological media and pharmaceutical and veterinary culture media.

Prolient believes that the advances it has made in BSA manufacturing enable to it to produce a consistently higher quality product. This level of control over the whole supply chain should prove reassuring to users of BSA given current concerns over contamination at different stages of product production.

Prolient has also been pioneering in its use of technology, with this latest facility utilizing a sterile bag-in-tray system and fully dedicated stainless steel chamber. Through this system the company believes that a contaminant-free product can be produced at the end of the drying cycle. This product is then sifted and packaged in a HEPA-filtered and monitored dry cleanroom to ensure that no contamination occurs at this final stage of the process.

Prolient claims its BSA is low in endotoxin's, bioburden and virtually protease and IgG-free. In addition it has the lowest levels of fatty-acids in the industry, according to the company. By using BSA that is virtually contaminant free the chances of background interference when performing assays is reduced.

Cobra Biomanufacturing Expanding

Cobra Biomanufacturing is now pushing into the new and more lucrative area of commercial manufacturing on both sides of its business - viral vaccine and protein production - as well as pushing its presence in France.

Currently the firm only conducts contract work up to Phase III in its viral vaccine business, however, at the beginning of the year the UK firm entered into a manufacturing development agreement with GenVec, involving its lead product candidate TNFerade, that could lead the firm beyond this for the first time.

At its facility in Oxford, UK, Cobra is undertaking the scale-up and validation of the manufacturing process for the biologic compound, which is being developed as a potential treatment for pancreatic cancer.

The current agreement is to take the product as far as Phase III however, Simon Saxby, the new chief operating officer (COO) of Cobra told Outsourcing-Pharma.com in a recent interview that it is hoped that a commercial manufacturing agreement will follow from this within the next two years.

Moreover, because viral products are so potent, the company already has the scale required to make commercial quantities.

Currently the firm only conducts contract work for proteins from the preclinical stage up to Phase II but there are plans in place to grow this to Phase III and eventually commercial scale also. It is "yet to be determined" as to how Cobra will achieve this, although Saxby said that the firm is exploring its options - to either build, acquire or partner - to gain the new capacity, and the intended timeframe to achieve this is over the next 12 to 18 months.

Meanwhile, Cobra recently received recognition from the French Ministry for Higher Education and Research as an approved research and development service provider.

This allows French companies, which outsource research and development work to Cobra, to be able to benefit from the research and development tax credit (Le Crédit d'Impôt Recherche (CIR).

The approval was granted for 2007-2009 and is capped at €16 million per company per year.

Dr. Reddy’s Laboratories Signs Agreement to Buy Manufacturing Business of BASF

India's Dr Reddy's Laboratories has announced the signing of a definitive agreement to buy the U.S. pharmaceutical contract manufacturing business of chemicals giant BASF.

The acquired business is involved in the production of generic prescription and over-the-counter products for both branded and generic companies in the US, with a turnover of $43m last year.

Along with the deal comes BASF's manufacturing facility in Shreveport, Louisiana, as well as customer contracts - including a tolling and supply agreement - in addition to related abbreviated new drug applications (ANDAs), NDAs and trademarks. The acquired facility employs 150 people and manufactures solid, semi-solid and liquid dosage forms.

No financial terms of the transaction were revealed, although Dr Reddy's did say that it would be funding the acquisition using "internal cash reserves or other committed credit facilities".

Only last month the company revealed it is boosting its contract manufacturing business with the purchase of US firm Dow Chemical's small molecules business.

The acquired unit operates out of Dowpharma's UK sites at Mirfield and Cambridge. Together they employ 80 staff and are said to be worth $25m. No financial terms of the deal were disclosed.

In addition to gaining the sites along with their customer contracts, products, process technologies, intellectual property and trademarks, Dr Reddy's also obtained a non-exclusive license to Dow's Pfenex Expression Technology for biocatalysis development.

BioDuro and NCSED Receive Accreditation from AAALAC

U.S.-based BioDuro and The National Center for Safety Evaluation of Drugs (NCSED) in Beijing have received full accreditation from the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC).

BioDuro is a life science outsourcing company which has been collaborating with the NCSED to provide preclinical toxicology, drug metabolism and pharmacokinetics for clients around the world.

Over 750 organizations in 29 countries have received AAALAC accreditation but as of August 2007 only seven toxicology laboratories in China had been certified.

The situation in China's outsourcing competitors is not any better, with only one organization in India having gained accreditation.

This dearth of accredited facilities puts BioDuro and the NCSED in a position of strength, with the combination of low costs and high standards proving attractive to pharmaceutical companies.

AAALAC accreditation should guarantee high standards, accountability and a commitment to animal welfare. It is recognized in 30 countries as a benchmark for responsible, ethical laboratory animal care. To maintain accredited status the institution must be re-evaluated every three years.

Further confirmation of high standards at BioDuro's facilities may help swell the companies' client list, which it claims includes nine of the top 12 global pharmaceutical companies. In total BioDuro lists 40 pharmaceutical and biotech companies as clients.

Business at BioDuro currently appears to be going well with another AAALAC application filed for its rodent vivarium in the Zhong Guan Cun Life Sciences Park. In addition expansion commenced on 13 March at another section of this facility, which will house the growing chemistry and bioanalytical services teams.

MPI Research Expands in Michigan

U.S. preclinical services firm MPI Research has revealed its intentions to undertake a $330m expansion that will result in the creation of 3,300 new jobs.

Another expansion will take place at MPI's nearby site in Mattawan, where the remaining 2,900 new staff members will eventually be based.

However, as drug discovery continues to become prohibitively expensive and pharma firms struggle to keep costs at a minimum, preclinical work is now being outsourced at double the rate that it was ten years ago and the $4.1bn preclinical services market is growing at an annual rate of 15 per cent.

Eurofins Medinet Established New Dedicated Central Laboratory in Suzhou, China

Eurofins Medinet has established a new dedicated Central Laboratory in Suzhou, China, after it had started successfully its operations of another Central Laboratory in Singapore in early 2007. Located near the Yangtze River, Suzhou is home to many high-tech and pharmaceutical enterprises. The facility's proximity to the Shanghai Hongqiao domestic airport ensures a close management of transportation and maintenance of specimen integrity. The newly built facility is accommodating the growth of clinical trials being conducted in China, thereby meeting the special (regulatory) requirements the industry is facing.

SGS Life Science Services Opened Three New Offices in Poland

SGS Life Science Services has opened three new offices in Poland, Czech Republic and Romania as part of an initiative to expand its Global Clinical Development (GCD) services. The offices located in Prague, Warsaw, and Bucharest, respectively, will provide clinical trial monitoring services, study feasibility, and site selection, as well as support the regulatory aspects in these countries. The offices are staffed with teams experienced in conducting clinical trials in the pharmaceutical and CRO industry as well as in academia. The teams cover a wide range of therapeutic areas with special emphasis in CNS, infectious disease and cardiovascular disease. Also, SGS’ main office for GCD in Belgium will provide complementary services including project management, data management and statistics, regulatory affairs, and medical affairs.

BASF to Sell Shreveport Facility

BASF has signed a definitive agreement to sell its manufacturing facility in Shreveport, LA and the related contract manufacturing business for finished pharmaceuticals to Dr. Reddy's Laboratories, headquartered in Hyderabad, India. Financial details were not disclosed.

As part of the agreement, BASF's 150 employees will transfer to Dr. Reddy's. The 42-acre Shreveport facility currently manufactures and packages prescription and OTC pharmaceutical products, liquids, tablets and creams for the North American market. BASF is divesting the site and related business in order to concentrate on core businesses in its Care Chemicals division, which include custom synthesis services, excipients and active ingredients for the pharmaceuticals industry.

University of Michigan Renovates Science Facilities

A $36-million renovation project at UM-Dearborn and a $15-million project at HFCC took a major step forward last Wednesday when the Michigan House of Representatives approved a number of capital outlay projects at Michigan's public universities and community colleges.

At UM-Dearborn, the fund would help the school renovate science laboratories and computer facilities in the campus's Science Building and the Computer and Information Science Building. Those buildings were built for the campus's opening in 1959 and were last renovated in 1985.

Henry Ford Community College to Renovate Science Building

The legislation approved by the House also includes a $15 million project at Henry Ford Community College.

HFCC's project is to renovate its Science Building to expand career training opportunities in life sciences, biotechnology and healthcare.

The HFCC Science Building Project will create a science facility for the 21st century that will address critical components of the state's new economic focus on life sciences and biotechnology. The capital outlay funds will allow HFCC to renovate and expand classrooms and laboratories in its Science Building to meet the increasing demands from students for science and related courses.

HFCC also has plans for new programs in biotechnology and life sciences, as well as expanded health career programs. Currently, HFCC graduates more registered nurses than any other college or university in the state, about 340 annually. However, the regional need for nurses is still unmet.

HFCC's new associate degree Biotechnology Technician Training Program, set to begin in January, will prepare HFCC students for work in the biotechnology industry. The program is being developed with the help of local biotechnology companies. The learning centerpiece of the program will be a state-of-the-art automated DNA sequencer which will be used to teach students how to determine DNA bases from various organisms and study genes.

HFCC also is expanding its Energy Technology Program with a curriculum focused on the science of renewable energy. HFCC offers five courses on renewable energy sources: Introduction to Energy, Geothermal Systems, Wind Source and Fuel Technology, Smart Home Control Technology and Co-generation and Power Backup Systems.

Pfizer to Close Terre Haute Facility

Pfizer is planning to close its Terre Haute, Indiana manufacturing facility which had received $300 million of investment to prepare it for Exubera production.

The money has been ploughed in since 1999 but Pfizer pulled the plug on Exubera last October after the drug once touted as a potential blockbuster suffered a series of setbacks.

Pfizer is maintaining that the plant's closure is unrelated to Exubera's failure or the effectiveness of the site and is instead citing falling demand for the antibiotics produced at the facility.

The future of the plant has seemed bleak since Pfizer slashed the workforce by 660 in January this year and warned the remaining staff that the facility may close in the future.

Production of antibiotics will continue at the plant until the middle of next year when the remaining 140 employees will leave the facility for the last time.

Over this time a stockpile of Unasyn (ampicillin/sulbactam) and Pfizerpen (penicillin G potassium) antibiotics is to be built up buying Pfizer the time to consider whether to continue production elsewhere.

There are a decreasing number of options for alternative sites of production as Pfizer continues its plan to close at least 22 sites over a two year period, which will result in savings of $2bn.

Pfizer expects to have shed 10,000 employees by the time it has reduced the number of production sites to 44.

Although there have been undoubted casualties from Pfizer's cost cutting regime opportunities abound for astute businesses.

Numerous manufacturing plants have come onto the market, being picked up by companies including Actavis and Keata Pharma.

Marchesini's Integra Opens New Packaging Line

Italy's Marchesini presented its new fully-integrated robotic blister production line, Integra. The system, which is designed to combine carton thermoforming and packaging in a single good manufacturing practice (GMP) approved production block, is capable of handling 300 blister packs or 150 cartons per minute.

Integra consists of a fully enclosed feed unit that can be removed and replaced with a second sealed unit during cleaning operations, thereby allowing production to continue. The system also incorporates the Robocombi connection unit, which is designed to pick up individual blisters and place them directly in the cartoner buckets without any intermediate processing.

Marchesini Group spokeswoman Manuela Goldoni told in-PharmaTechnologist.com that Integra's "compact nature, the ability to install it in two different rooms even if it is a single block and the robotized connection [the Robocombi] which guarantees blister pickup and placement directly in to the conveyor buckets," are just some of the advantages the system has over competitor products.

Marchesini also demonstrated its MB460 robotized thermoformer and MA305 continuous-motion cartoner.units. The MB460 uses a series of vertical plates that descend when production runs are halted, helping to prevent overheating. The MA305 is built with a balcony structure that allows full visibility and inspection, which allows for the easy identification and residue at the end of a batch.

From here product is moved to the FA04 balcony-structure bundler stretchbander, the final stage of Marchesini's system, which is capable of producing up to 50 bundles of sealed product per minute.

Romaco's P91 S and VF-18 Offers New Packaging

During its presentation, Italian packaging equipment specialist Romaco launched the P91 S intermittent motion cartoner. The system is capable of packaging 140 cartons per minute, equivalent to the rate achieved by machines that operate continuously.

The cartoner replaces the chain and cog mechanisms, common to older systems, with a sophisticated timing belt. Romaco explained that this approach minimizes the level of mechanical wear and tear, thereby helping to lower maintenance costs.

To date, four manufacturing firms have ordered the P91 S system, with Italian drug maker Farmigea scheduled to be the first to receive it. Marco Benvenuti, manager of Farmigea's plant in Pisa, said that "we have high hopes of extremely flexible control of production, as well as savings in costs and time."

Romaco also demonstrated its VF-18 aseptic liquid filling technology. The platform has the capacity to fill 18,000 vials an hour in accordance with the strictly aseptic needs of the pharmaceutical industry. The system is designed to allow through-wall installation, minimizing the required clear room space.

Sepha's PackScan Seeks to Follow in BlisterScan's Foot Steps

Northern Ireland-based industrial packaging specialist Sepha launched its PackScan testing technology, which provides manufacturers with a novel means of assessing the integrity of product sachets.

Several years ago, Sepha's pioneering BlisterScan testing system enabled drug manufacturers to conduct a non destructive assessment of blister packs, replacing the destructive methylene blue dye (MDT) test, sparking a minor revolution in the industry. The firm is hoping that its new technology will have a similar impact among pharmaceutical sachet manufacturers.

PackScan is designed to test the integrity of up to four product sachets at the same time and is capable of detecting leaks as small as 10 microns in diameter. The system can be "changed over" to a new product line in around half an hour and is controlled via a touch screen display that is compliant with CFR 21 Part 11 data storage standards.

In addition, because the assessment is non-destructive, those non-porous sachets that pass can be returned to the manufacturing line, helping to provide cost savings and reduce the level of wastage.

MEDICAL DEVICES

Moll Adds 2,500 sq. ft. Class 100,000 Cleanroom in Sonora Mexico

Moll Industries, Inc. announced that, as part of their continued commitment to support their existing and growing customer base, construction has begun on a new 2500 Sq Ft., Class 100,000 Cleanroom in their Empalme, Sonora, Mexico facility.

Keith Dunlap, VP of Sales and Marketing for Moll, said, "An existing customer opportunity emerged that has driven us to invest in one of our strongest and most operationally excellent plants. The room will also service the growing US, Mexican and South American NAFTA opportunities which our newly expanded sales team is bringing to the business." While declining to name the customer, Dunlap indicated it is a world leader in medical components and Moll wants to be positioned to grow with their needs, as well as position the company to attract new business. Dunlap went on to say, "With our known quality, overall operational excellence and the investments we are making to support medical molding in North America, Europe and Mexico, Moll is well positioned to take on new growth in this important market."

Juan Resendez, COO of Moll, said that this cleanroom build effort was spearheaded by the plant staff in Empalme. He also indicated that this is a graphic example of challenging Moll engineering and demonstrating their flexibility as a solid supplier to the market place. He went on to say, "We have strived to put the right people in place as a foundation for our company's growth and it is gratifying to see them step up to the challenge."

Conan Miller, Corporate Director of Asset Management for Moll, indicated that the Empalme cleanroom will be built within the existing facility and will be a fully functional operation complete with separate material handling, crane capacity and required HVAC. The completed clean room should be ready by the end of June with three machines moved in initially. Miller went on to say, "This expansion now gives Moll medical molding capability in three of our five plants." Moll currently has clean rooms and controlled environment rooms in Seagrove, NC and Donegal, Ireland.

Moll Industries, Inc. is owned by Highland Capital Management of Dallas, TX and maintains operations in Seagrove and Lexington, NC; Ramos Arizpe, Coahuila; Empalme, Sonora; and Donegal, Ireland. Moll has full FDA Compliance, TS and ISO Certification. With injection molding machines ranging from 25 to 1500 tons, Moll supplies molded and assembled components to the medical, appliance, industrial, and automotive markets.

McIlvaine Company,

Northfield, IL 60093-2743

Tel: 847-784-0012; Fax: 847-784-0061;

E-mail: editor@mcilvainecompany.com;

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