GlaxoSmithKline (GSK) and the Harvard Stem Cell Institute (HSCI) are embarking on a five-year, $25 million plus stem cell science collaboration. GSK’s investment will support research at the university and in at least four Harvard-affiliated hospitals in neuroscience, heart disease, cancer, diabetes, musculoskeletal diseases, and obesity. In addition, GSK will fund an annual grant that supports early-stage research in stem cell biology as part of HSCI’s seed grant program.

The collaboration will integrate HSCI’s stem cell expertise with GSK’s pharmaceutical capabilities to drive advances in drug discovery research, according to the groups. This will include a staff exchange program. The collaboration will be overseen by a joint steering committee made up of HSCI and GSK scientists and managers.

“GSK believes stem cell science has great potential to aid the discovery of new medicines by improving screening, identification, and development of new compounds,” remarks Patrick Vallance, head of drug discovery at GSK. “We have carefully chosen the Boston biomedical community to collaborate with on this important venture. It has the highest concentration of leading stem cell scientists, and the Harvard Stem Cell Institute is the epicentre of that community.”

Global Nanotechnology Mission

A delegation of scientists from Russia visited Albany NanoTech, underscoring the high-tech facility's growing presence on the international stage.

The group included Leonid Melamed, chief executive officer of the Russian Corporation of Nanotechnologies, an organization started last year by the Russian government to develop nanotechnolgy in the country.

Nanotechnology is technology developed on the atomic and molecular level. Currently, its most profitable use is in computer-chip manufacturing, with companies like IBM Corp. and Advanced Micro Devices Inc. using it to form billions of transistors on a single processor.

The Russian scientists got an up-close look at the $4 billion Albany NanoTech facility, home to the University at Albany's College of Nanoscale Science and Engineering. The NanoCollege has created lab partnerships at the facility with companies like IBM and AMD (Advanced Micro Devices Inc.) to do cutting-edge computer-chip research that goes right into manufacturing.

UALR Scientist Named to Romanian Nano-Medicine Institute

The newly formed Romanian Nano-Medicine Institute has named Dr. Alex Biris, chief scientist at the Nanotechnology Center at UALR, as its honorary president. He also serves as a founding member of the organization.

The Romanian Nano-Medicine Institute facilitates research in the areas of nanotechnology and medicine, targeting cancer and chronic diseases. The Romanian institute will have parallel research programs with the Nanotechnology Center at UALR.

The Institute will be sending two surgeons in the fall and two more in the spring to perform joint research with us at UALR.

Outsourcing-Pharma Reviews Developments of WuXi PharmaTech, AMRI, Physiomics, Biofocus and Metabolon

Outsourcing-Pharma.com rounds up recent developments among contract research organizations, including WuXi PharmaTech, AMRI, Physiomics, Biofocus and Metabolon.

Private equity firm Warburg Pincus has taken a 5.4 per cent stake in China's WuXi PharmaTech, which recently withdrew from plans for a public offering of up to 10.1m American depositary shares.

"Warburg Pincus not only will strengthen our investor base, but more importantly we believe that it will provide strategic and business assistance to us," said WuXi's chief executive, Ge Li.

Albany Molecular Research Inc

(AMRI) says it has more than doubled the capacity of its Science Park III facility in Singapore with a 10,000 square foot laboratory expansion for its medicinal chemistry unit and the opening of an in vitro biology lab.

The in vitro biology group will test compounds synthesized by the chemistry teams and deliver potency data using cell-based or biochemical assays, allowing the firm to carry out complex drug discovery projects in a shorter time.

AMRI said it expects to hire at least 70 additional chemists and biologists to staff the Singapore facility over the next three years to meet increasing demand.

NIH Extends Agreement with BioFocus DPI

The US National Institutes of Health (NIH) have extended their agreement with Galapagos' service division BioFocus DPI for the operation of the Molecular Libraries Small Molecule Repository (MLSMR) until December 2010.

The MLSMR acquires and stores compounds under the contract with NIH and distributes these compounds for high-throughput biological screening throughout the NIH's academic network in the US.

According to the terms of this agreement, Galapagos will receive more than $9m (€5.7m) over the course of the two-year extension.

Physiomics Contracts with Eli Lilly

Systems biology specialist Physiomics has been contracted to perform two new cancer-related research projects for Eli Lilly, after a successful collaboration earlier this year in a study of cancer cellular processes for drugs targeting the cell cycle.

UK-based Physiomics will perform two new projects for in silico simulations in the field of oncology for Lilly. The first has the aim of finding a way to identify patients who are likely to respond to an unnamed Lilly drug, while the second will investigate the mechanistic link between various biomarkers and certain other Lilly compounds.

Metabolon Expands Agreement with Mitsibishi Tanaba Pharma

Metabolon has expanded its multi-study agreement with Mitsubishi Tanabe Pharma, giving the latter 'preferred' access to its biochemical profiling services, and forged new collaborations with Pfizer and the University of Texas. Metabolon's platform technology is used to analyse biological samples for the discovery of markers and pathways associated with drug action and disease.

Mitsubishi Tanabe has committed several upcoming research studies to Metabolon, and the two companies say they are in the process of publishing joint study results in peer-reviewed publications. Meanwhile, Pfizer is tapping the company's metabolomics platform for its bioprocess division, and will use it to try to optimise bioprocesses and reduce manufacturing costs. The agreement with the University of Texas will focus on finding new biomarkers relating to diabetes.

CeeTox Awarded $150,000 State Funding

CeeTox, a CRO based at Michigan University's Business Technology and Research Park, has been awarded state-funding of $150,000 in order to hire Pfizer staff that lost their jobs when the multinational shut down some of its R&D functions in Kalamazoo, Michigan, last year. Ceetox, which tests the toxicity of potential new drugs, has agreed to hire three former Pfizer scientists. Two other companies in the area have agreed to similar deals.

Synomics Clears Inspection by FDA

Synomics Pharmaceutical Services, a US CRO which provides bioanalytical, stability and analytical testing services for the pharmaceutical industry, has cleared an inspection of its facilities and operations in Wareham, Massachusetts, by the Food and Drug Administration (FDA).

CMC ICOS Refits Biotech Plant

A biotechnology plant once operated by ICOS has been remodelled by its new Danish owners CMC ICOS Biologics who say they also plan to expand the staff.

The 15,000-square-foot facility has been refurbished and given a new infrastructure that will accommodate the commercial manufacture of drugs for the biotech field under the practices required by government agencies, according to company president Gustavo Mahler.

The multimillion-dollar expansion adds space for another 35 workers. This is the first manufacturing facility for CMC, which also has offices in Seattle and New England. The plan is to develop the Bothell, WA facility into one of the largest contract manufacturers on the West Coast.

PharmEng Unit will make Natural Health Products

PharmEng International says that its subsidiary Keata Pharma has received a site license issued by the Canadian Ministry of Health under the authority of the Natural Health Products Regulations for manufacturing, packaging and labeling of natural health products at its facility located in Sydney, Nova Scotia.

The 46,400 sq.ft. Sydney facility includes pilot laboratories for formulation development, rooms with various capabilities such as high shear mixing, container blending and equipment for modified release technology. The facility provides formulation development and testing services to manufacture and package products in solid and liquid dosage forms.

The plant is also expected to receive its Precursor License under the Controlled Drugs and Substances Act which will allow the site to broaden the portfolio of controlled substances that it currently produces.

HollisterStier Gets UK GMP Accreditation

HollisterStier Contract Manufacturing has received a certificate of good manufacturing compliance (GMP) from the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

The certification was issued following an inspection of the HollisterStier facilities' quality systems and processes enables the manufacture of Investigational Medicinal Products for clinical trials, as well as the manufacture of a terminally sterilized diluent on the plant's new Small Volume Parenterals Line (SVP II).

The SVP II unit is a new addition to the firm's state-of-the-art production facility. The line is available to aseptically fill liquid and lyophilized pharmaceutical products in vials ranging from 2mL through 200 mL in batch sizes from 20 to 3,000 litres.

RxElite to Supply API Product to Hi-Tech

RxElite has agreed a 10-year development, supply and marketing deal with Hi-Tech Pharmacal, a manufacturer and marketer of liquid generic products.

Under the terms of the agreement, RxElite will supply active pharmaceutical ingredients (APIs) to be used in the manufacture of the generic ophthalmic product. The APIs will be manufactured by RxElite's wholly owned subsidiary, FineTech Pharmaceuticals, at its production facility in Nesher, Israel.

Hi-Tech Pharmacal will develop the finished dose formulation, and will take responsibility for all regulatory filings, and manufacture and marketing of the finished product. Upon commercialisation, the parties will share net proceeds from the sale of the product.

San Jose Hoping to Tap into Biotech Boom with Local CMO

The city of San Jose in the US is hoping to lure a pharmaceutical contract manufacturer to its Edenvale Technology Park to help kick start the development of its fledgling biotechnology industry. San Jose's redevelopment agency is hoping to find $23m for the project with the help of state and federal funding.

The recommendation to attract the CMO came from PharmaBioSource California, a consulting firm retained by the redevelopment agency to look into the feasibility of the move. At the moment the need to source manufacturing from elsewhere in the US or overseas is holding back the development of the biotech sector in San Jose, according to the San Jose Biocenter, which has 22 biotech tenants on the Edenvale campus.

Dalton Adds New LC-MS/MS Instruments

Dalton Pharma Services of Canada has expanded its contract analytical services offering with the introduction of two validated LC-MS/MS instruments, which have been qualified for GMP testing of drug products.

The new equipment will assist in the identification, quantification of related substances, pharmaceutical degradation products and impurities to support the preparation of registration dossiers for clients' drug development programmes, said the firm.

Medical House to Supply Autoinjector to Dr Reddy's

UK-based drug delivery specialist the Medical House (TMH) has signed a non-exclusive development, licensing and supply agreement with India's Dr Reddy's Laboratories.

Under the terms of the deal, TMH will customise its proprietary, patented ASI disposable autoinjector device technologyfor use with an undisclosed Dr Reddy's drug, to create a new self-injectable product. The accord covers an initial five-year term of supply, within the US, EU and Canada, with an option for Dr Reddy's to extend it to the rest of the world.

First commercial supply of the customised ASI device is expected to be in 2009-10 and TMH will receive a technology access fee during the term of the agreement.

Abeome and Cato to Develop Cancer MAbs

Biotechnology firm Abeome has obtained an equity investment by Cato BioVentures and has established a collaboration deal with Cato Research, Cato's global contract research and development organisation.

Merck Invests in Vaccine Plants

US drug giant Merck & Co hopes that an additional $300m (€190m) investment in its vaccine manufacturing plant in Durham, North Carolina will cement its position at the forefront of the global vaccines market.

The expansion, which will create between 150 and 180 new jobs, will add bulk vaccine production capacity, cold store warehousing space and administrative offices. Merck plans to complete the work by 2010 but will begin using the facility's existing production capacity early next year.

The expansion would boost to 400 the workforce the pharma giant will base at the Durham complex, at Treyburn Corporate Park. The expansion would mark a third phase for the facility. Earlier this year the first $300 million, 235,000-square-foot phase was completed. Construction is in progress and set to be finished in 2010 on the facility’s second phase, a $100 million, 110,000-square-foot site with a sterile processing facility, quality testing labs, and a high-speed packaging line.

Merck has said it expects to start shipping vaccines by 2009 from the Durham plant, which broke ground in 2004 after the company received nearly $40 million in state economic incentives. For the second phase, Durham County awarded $1 million toward site work.

The site will manufacture Merck's measles, mumps and rubella (MMR) and chickenpox vaccines, as well as its Zostavax shingles vaccine, which was approved by the US Food and Drug Administration (FDA) in May last year.

Prior to the Durham announcement, Merck's UK subsidiary, MSD, unveiled detailed plans for its €200m vaccines plant in Carlow, Ireland. The company said that when construction is completed in 2011 the facility "will play a central role" in its global operations and will employ around 170 highly-skilled manufacturing staff.

The news will be seen as a positive move for Merck's global vaccine operations following the FDA's criticism of manufacturing operations at the firm's main production plant in West Point, Pennsylvania earlier this year.

Booming Global Vaccines Sector

In the last few months several pharmaceutical players have sought to strengthen their positions in the global vaccines market, which a recent report by BCC Research predicted would grow nearly 11 per cent a year and reach a value of $34bn by 2013.

In June for example, Sanofi-Aventis said it would invest up to $6.25bn to expand its vaccine production capacity between now and 2015, while prior to that Canada's Microbix unveiled plans to construct a $198m manufacturing plant in Hunan, China.

Although the vaccine manufacturing industry will continue to be dominated by prophylactic products, particularly those that prevent influenza infection, the emerging therapeutic vaccines sector represents a significant opportunity. This means that big pharma is likely to continue to invest in vaccine production capacity and technology for the forseeable future.

International Labs Acquired by Bilcare and MeadWestvaco

Contract packaging company International Labs has been taken over in a joint acquisition between India's Bilcare and MeadWestvaco of the US.

The deal should enhance the capabilities of Bilcare and MeadWestvaco, giving them an increased presence in the contract packaging market. Financial details of the 50-50 venture have not been disclosed.

MeadWestvaco believes that by combining the skills possessed by each company they can bypass several steps in the supply chain and make adherence packaging more widely available.

International Labs has two good manufacturing practice (cGMP) compliant facilities in St Petersburg, Florida, covering 60,000 sq. ft. with the capacity to produce products across the pharmaceutical packaging spectrum.

The two acquirers will be looking to exploit International Labs' manufacturing capacity and contracts as they seek to make best use of their respective capabilities.

Bilcare offers pharmaceutical companies assistance in finding the appropriate packaging from design to manufacture.

Prior company ties

Links between the companies were already in place prior to the acquisition, with International Labs using MeadWestvaco's Shellpak compliance packaging technology.

Shellpak is a pre-filled child resistant medication package that negates the need for pharmacists to count out pills.

This speeds up the dispensing process, negates the chance of mistakes in number or type of pills and reduces operational costs, according to MeadWestvaco. In addition the blisters are imprinted with information regarding the dosing dates and times, which should improve patient compliance.

Hillsborough Commission Approves $6M to Lure Draper Laboratories to USF

The Hillsborough County (Fla.) Commission has approved a $6 million incentive intended to help persuade Draper Laboratories, a Cambridge, Mass., weapons and biotechnology company, to open a $20 million nanotechnology and BioMEMS research lab at the University of South Florida campus in Tampa, FL.

In addition to using county money, USF would receive $10 million from the state of Florida, while the university’s research foundation would chip in another $4 million. The funds would help Draper build labs and purchase equipment — and does not include the costs USF has already paid for construction of the 20,000 square foot building Draper is considering.

In return for the county and state cash, Draper would create at least 100 jobs, with the promise of up to 271 more jobs in five years. “Our economic impact modeling projects that 111 to 171 additional or indirect jobs will be generated as a result of this project. Estimated overall cumulative economic impact ranges from $204 million to $337 million within five years of ramp up,” Gene Gray, director of Hillsborough County’s Economic Development Department, told commission members, according to a report by Tampa radio station WMNF.

Gray said Draper is also expected to generate a $150 million to $300 million dollar increase in research grants by leveraging USF’s research capacities in nanotechnology.

USF is one of two Florida sites being eyed by Draper. The company is also considering developing a $14 million electronics manufacturing facility in St. Petersburg.

Draper is the successor to the Massachusetts Institute of Technology’s old Instrumentation Laboratory of MIT. MIT divested itself of the company in 1970, bowing to Vietnam War protestors, and the company moved off campus three years later

New York ESDC Chairman Starts Work on Restructuring Economic Development Agency

The new chairman of New York state’s Empire State Development Corp. told reporters last week he has begun work on a restructuring that is intended to end more than a year of fractiousness among top officials of the state’s economic development agency.

“I’d like to get it resolved yesterday. More important than that is to get the right people in the right jobs,” said Robert Wilmers, who is also the chairman and CEO of Buffalo, NY-based M&T Bank. “We’re going to have a CEO, and we’re going to have somebody in charge of upstate, and somebody in charge of downstate. And the four of us will work very closely together.”

Wilmers said a national search firm is to be hired soon, pending word from “the state bureaucracy. That isn’t stopping us from looking.” He has ruled out taking the CEO job, and serves as chairman without pay.

The CEO would serve as the agency’s top day-to-day officer, the role now held by president and chief operating officer Avi Schick, who will leave the agency in September. The CEO is also expected to balance the upstate and downstate fiefs — and avoid the mistake made by Gov. David Paterson’s predecessor, Eliot Spitzer, when he positioned the upstate and downstate heads as co-chairmen of ESDC in 2007. That structure has been blamed for the turf battles and slower decision-making that has plagued the agency for more than a year.

Under Spitzer’s predecessor George Pataki, ESDC had a full-time chairman, Charles Gargano, the onetime US ambassador to Trinidad and Tobago under president George H.W. Bush. In June, he was named the $2,000-a-week senior vice president of governmental affairs by publicly traded PERF Go-Green Holdings of New York City, according to a company filing with the US Securities and Exchange Commission.

Wilmers said the agency’s biggest challenges are those of the state: “If the economy continues to not do well, it’s going to hurt the ESDC just like it will hurt every aspect of the state’s operation. That, I think, is the [agency’s] greatest challenge. My greatest challenge is to put a team together.”

Answering a BioRegion News question, Wilmers said ESDC would not await the outcome of the reorganization to act on economic development policy issues and projects.

“There are a lot of very talented people who have been working at the Empire State Development Corp. for a long time. And just because I showed up as chairman, we can’t put everything on hold,” Wilmers said. “The organization has had a life before I showed up, and it will have a life after I go away. Hopefully, I can help improve the process.”

Wilmers addressed reporters during his fourth day on the job, minutes after ESDC’s board “adopted” the general project plan for Columbia University’s planned $6.3 billion mixed-use project for Manhattan’s West Harlem. The project is set to include nearly 2.6 million square feet of new research lab space [See report, this issue].

Fishers Plan $12 Million Biotech Incubator in Indiana

The Fishers (Ind.) Economic and Community Development Commission has joined with Mark Long of Long Performance Advisors to establish the Fishers Research and Technology Campus, a cluster of tech facilities to start with a $12 million building set to open within the next 18 months.

The building will be between 40,000 and 50,000 square feet, and be designed for startup biotechnology companies from Indiana universities and research institutes. According to the commission, the building will offer wet laboratories, flexible tenant spaces suitable for research and development, and production facilities.

In addition, the facility will provide shared conference space and a network of professional consultants, such as attorneys and accountants, who can mentor early-stage entrepreneurs.

The commission has hired Long, who served as president of Indiana University’s Research & Technology Corp. from 2002 until early this year, to head development of the Research and Technology Campus. Long — who also built the IU Emerging Technologies Center, the university’s flagship business incubator — will continue to teach entrepreneurship and life sciences courses at IU’s Kelley School of Business.

The commission is a partnership between the town of Fishers and the Fishers Chamber of Commerce.

ICON Approved for Second Half of 2005 Incentive Toward Consolidation

New York state’s economic development agency, the Empire State Development Corp., has approved $112,500 for ICON Central Laboratories, a provider of clinical research and development services to the pharmaceutical and biotechnology industries.

The award was the second half of a $225,000 Economic Development Fund grant approved in 2005. The grant is intended to help the company consolidate its Farmingdale, NY, operations from three leased facilities into a nearby refurbished facility, as well as acquire new machinery and equipment.

ICON has promised to retain 225 full-time jobs in New York State through this year.

New Jersey Assemblyman Introduces $500 Million, Five-Year Stem Cell Venture Capital Bill

New Jersey Assemblyman Neil Cohen (D-Union) has introduced a bill that would allow investors to contribute up to $500 million over five years to fund stem cell research efforts in New Jersey. The proposed New Jersey Stem Cell Research Assistance Program is intended to stimulate the state’s stem cell research effort by encouraging venture capitalists to invest in research funding.

The bill (A-3131) has been referred to the Assembly Financial Institutions and Insurance Committee for consideration. The measure would direct the New Jersey Economic Development Authority to establish the program through a specially created venture capital fund. Investors could deposit up to $500 million into the fund, in five annual $100 million installments.

EDA would review individual research grant applications, in conjunction with the New Jersey Commission on Science and Technology, and distribute money from the fund case-by-case.

The fund would be capped at $100 million in research loans annually, part of which would be required to fund non-profit and academic research projects. Individual research loans would be capped at $50 million per project, per year. Any unused loan revenue from year to year would be able to be rolled over into the next year.

To encourage participation by venture capitalists, the measure also would grant investors tax credits equal to their contribution in the fund. These credits — which could not exceed $100 million per year — would only be issued if a funded research project failed to repay the loan or otherwise collapsed. Tax credits would be non-transferable, and would not be able to be exercised for five years after the initial investment of venture capital.

“Investing in stem cell research is one of the single most important activities New Jersey can be engaged in,” Cohen said in a press release. “It offers the chance to generate life-changing treatments and cures for those suffering from incurable or untreatable diseases. And it lays the groundwork for billions of dollars in economic investment in the state at a time when the national economy is in a recession.”

Cohen said in the release he first formulated the idea to use venture capital as a means of stem cell research funding after reading about investment firms funding economic development in other states. Cohen says he plans to meet with Wall Street investment banks to discuss his legislation in the coming weeks.

At least one investment firm has publicly endorsed Cohen’s bill — NW Financial Group, which has offices in Jersey City and Trenton, as well as New York City.

Kansas Bioscience Authority Awards Nearly $4.9 Million to Four Life Sciences Companies

The Kansas Bioscience Authority last week approved a total $4.85 million in investments to four early-stage life sciences companies:

Ventria Bioscience of Junction City has received a $3.75 million convertible note as part of a $7.5 million financing plan to expand operations in Kansas, including adding jobs and production capacity. The financing is intended to help the company prepare for the commercial launch of its pediatric health product designed to shorten the duration of acute childhood diarrhea — an application of Ventria’s ExpressTec proprietary protein/peptide production system.

MGP Ingredients, Atchison, Kan., will receive $500,000 to develop and further commercialize biobased, biodegradable resins to economically replace plastic. The biobased resin can be used for products such as disposable cutlery, DVD cases, and bottle caps — and is biodegradable. The project is expected to create 54 jobs, with $9.9 million in capital investment to build production capacity in Onaga, Kan.

KC BioMediX of Shawnee will receive an equity investment of $400,000 to commercialize technologies developed at the University of Kansas for the care of infants born prematurely. The company’s FDA-approved device, the NTrainer System, treats preemies who have difficulty feeding orally so they can quickly gain strength and grow. This award follows a $150,000 KBA investment last fall and is part of a $4 million round of company financing.

VasoGenix Pharmaceuticals of Lenexa will receive $200,000 for the development of its patented controlled release drug treatment for heart failure. The company is completing pre-clinical studies of its treatment that uses a molecule with a history of safe use in humans and which aims to improve human health while reducing re-hospitalization costs by $6 billion per year. The company has promised to match KBA funding with private investment.

University Projects Job, Research Funding Gains from Minnesota Biomedical Research Program

The Minnesota Biomedical Research Program will create work space for more than 100 primary researchers and 500 support staffers in four new or expanded buildings within the University of Minnesota, Frank Cerra, senior vice president of health sciences, told the university’s Board of Regents.

The $300 million research program — which includes $220 million approved by the state legislature this year — is also projected to draw more than $100 million in new research funding annually.

To tap into the research program’s funds, however, U of M must come up with 25 percent of the funding for the buildings, as well as finance the recruitment and salaries of faculty members and researchers employed there. The university took a step in that direction when it recently received its largest-ever gift — $65 million toward cancer research — from the Masons fraternal order.

U of M will use its funding to expand the Center for Magnetic Resonance Research, by creating buildings focusing on cancer, cardiovascular health and infectious diseases. When completed in 2013, the four buildings will feature 400,000 square feet for research.

The $65 million that the university recently received from the Masons for cancer research is the first of several philanthropic gifts in the works. In addition, Cerra said, money from the partnership between the university's hospital and Fairview Hospitals will be used. Other sources will include partnerships with industry, the re-allocation of funds within the Academic Health Center, and additional state support.

NY’s ESDC Awards Pall $500,000 toward Renovation of New Global HQ

Pall Corporation, which specializes in fluid filtration, separation and purification technologies, has received $500,000 from New York’s economic development agency, the Empire State Development Corp., toward renovations to a Port Washington, NY, site that will become the company’s new global headquarters.

Pall has been headquartered on Long Island since it was founded in 1946.

The company’s new 238,000-square-foot headquarters will consist of 24,000 square feet of new space added to an existing building. Inside, the new HQ will feature expanded R&D and technical capacity, new offices, conference, and training areas.

Charleston City Council OKs $5 Million Incubator Plan for Vacant Building

The Charleston, SC, City Council last week approved a $5 million plan to lease a vacant former mattress factory building at 645 Meeting St. to a state agency that would transform the building into an incubator for startup biotechnology and medical equipment businesses.

The South Carolina Research Authority would renovate the city-owned 36,000-square-foot building for use by Medical University of South Carolina researchers seeking to nurture their own startup businesses using technologies developed at the school.

Officials hope to open the incubator in the fall of 2009.

The city of Charleston would lease the building at $1 a year for up to 50 years.

The city would continue to own the former Weil’s Mattress Co. building, which officials said had been inhabited during the past decade only by squatters.

John Gregg, SCRA executive vice president of property and asset management, told the Post and Courier his agency would lease space to up to 20 startups at below-market rates, with the authority breaking even or faring slightly better on its investment.

Under the state’s Innovation Centers Act of 2005, SCRA must develop three research centers — one each with MUSC, Clemson University, and the University of South Carolina.

The authority broke ground on a research center with Clemson earlier this year in Anderson, SC, while SCRA is working with USC to find space in Columbia.

Medicago Launches Feasibility Study on Developing Pandemic Vaccine Production Plant in France’s Genopole D’Evry

Medicago, a Quebec City, Quebec-based vaccine developer, said it had obtained a grant of an undisclosed sum from the Quebec Ministry of Economic Development, Innovation and Export Trade to conduct a feasibility study, in collaboration with France’s Genopole biopark, for the establishment of a vaccine production facility in France.

The ministry would finance 40 percent of the study, which would be conducted by SNC Lavalin with help from Medicago and the Genopole d'Evry, located near Paris in Evry, France.

Medicago is developing VLP vaccines against H5N1 pandemic influenza, capable of being produced in large quantities one month after the identification of pandemic strains.

"The objective is to establish a facility that offers surge capacity to produce pandemic vaccine doses and eventually other biodefense related products, as well as offering bioproduction services to local companies," Andy Seldon, Medicago’s president and CEO, said in a written statement.

Medicago expects to complete its study by the end of 2008.

Chinese Medical Device Maker Wins Tax Credit toward Beachwood, Ohio, HQ

The Ohio Tax Credit Authority has approved a six-year, 35 percent job creation tax credit valued at $189,838 for Chinese-owned GammaStar Medical Systems, which plans to create a new $4.1 million North American headquarters in the Cleveland suburb of Beachwood, Ohio. In return for the tax credit, the company has promised to create 35 full-time jobs over three years.

GammaStar’s new HQ would initially be within the Beachwood Development Center business incubator, near Chagrin Boulevard and Green Road, with a permanent site to be determined later. Beachwood officials have promised the company $145,000 in subsidies, while GammaStar is pursuing an additional $225,000 through Ohio’s Third Frontier high-tech economic development program, which assists medical device makers.

GammaStar is owned by GammaStar Medical Group of Shanghai, developer of the Gyro Knife, a precision device used to destroy cancerous tumors with radiation while limiting damage to healthy tissue. The device has been approved for use in Europe, and GammaStar has asked the US Food and Drug Administration for similar approval by August.

Clarion University Expands Science and Technology Center

Construction on Clarion University's new science and technology center is being described as steady this season with completion on track for next May, an official said.

Officials say the facility is a commitment to strengthening the knowledge base of students entering the science technology workforce and providing a hands-on lab experience for non-science majors.

There is state budget funding of $31 million to construct the facility with Clarion University required to raise $2.7 million in matching funds.

The center, which will replace Peirce Science Center, is expected to be one of the few LEED-certified science buildings in the country and possibly the first certified public university building in Pennsylvania.

Leadership in Energy and Environmental Design requires meeting national standards and reflects facilities that best meet sustainable environmental energy concerns.

The new 98,000-square-foot building will feature 40 laboratories, seven classrooms and two seminar rooms. Some classes will also be taught in the laboratories. There will be 55 offices, and smart classrooms will be available throughout the building with wireless Internet inside and outside.

The current planetarium and auditorium will be renovated and add another 8,000 square feet to the complex.

S&T Bank has provided a $100,000 contribution toward the project.

Bafna Facility Gains MHRA Approval

India-based Bafna Pharmaceuticals' facility has received approval from the Medicines and Health Care Products Regulatory Agency (MHRA) to export products to the UK and European Union.

In gaining approval Bafna becomes the 36th company in the Indian pharmaceuticals industry (IPI) to receive accreditation from the MHRA. The company is now seeking to expand its reach into the EU and to other regulated markets.

Excela PharmSci's New North Carolina Facility

Virginia-based Excela PharmSci is to build a new manufacturing facility in Lenoir, North Carolina, having considered sites as far away as India.

The company is to receive a $250,000 grant from the One North Carolina Fund to help fund the site, which is due to hire 55 workers over the next three years.

in-PharmaTechnologist.com

round-up of developments in the pharmaceutical manufacturing space features news of Interlink's new Irish lab, Rentschler's biotechnology investment and GSK's plan to wind up operations at its Crawley Plant.

Rentschler Sells Drug Division and Invests in Biotech

Contract development and manufacturing specialist Rentschler has set its sights firmly on the biotechnology market with the announcement of a €14m ($22m) investment in its production facility in the southern German city of Laupheim.

The move, which comes only months after the completion of €50m worth of development work at the site, coincides with the sale of Rentschler's pharmaceutical division to fellow German company Riemser Arzneimittel.

While financial details have not been disclosed, the divestiture coupled with the increased biotechnology investment is clearly an indication of Rentschler's belief in Europe's developing biotechnology contract research and manufacturing services (CRAMS) sector.

The firm has nine stand-alone GMP suites with volumes of 30, 250, 500 and 2,500 litres, allowing the production of material for clinical trials and for market supply. The range of services also comprises the sterile filling of pre-filled syringes and injection vials.

GSK to Shut Crawley Plant

GlaxoSmithKline (GSK) plans to close its plant in Crawley, UK by the end of 2011. At present, the facility manufactures both the Parkinson's disease drug Requip (ropinirole HCl) and the beta blocker Coreg CR (carvedilol phosphate), as well as various treatments for HIV/AIDS, skin infection, depression and hypertension.

Intertek BioClin Open New Irish Analytical Lab

Intertek BioClin says that the additional laboratory capacity provided by its new laboratory in Athlone, Ireland, will allow it to offer a broader range of contract research, bio-analysis and research services to clients in the pharmaceutical industry.

The 882.5 square metre (9,495.7 sq. ft.) facility, which replaces Intertek's existing laboratory space, was gained through the acquisition of Irish contract research organisation (CRO) BioClin in February. The site houses bioanalytical and pharmaceutical product analysis capabilities as well as a stability-storage unit and secure document archive.

United Drug Signs Deal to Acquire Sharp Corp.

United Drug of Ireland has signed a deal to acquire Sharp Corp, a contract pharmaceutical packager based in the U.S., for $99 million.

The transaction is expected to close within 30 days and represents a major push into the US contract packaging market for United Drug, which is already a major player in this sector in Ireland and the UK and, to lesser extent, continental Europe.

The deal will be settled in cash on completion, funded by internal resources and debt, according to United Drug, which said it expects it to close within 30 days, depending on the usual regulatory and antitrust approvals.

The Irish company, which combines pharmaceutical wholesaling and supply chain activities with contract services in packaging, sales and marketing and other commercial areas, has been pursuing scale of late with a series of small-scale acquisitions.

In April 2007 it expanded its presence in the contract packaging sector in continental Europe via the purchase of the healthcare packaging division of Belgian firm Budelpack, adding to existing facilities in the UK and the Netherlands.

Sharp is one of the largest independent pharmaceutical contract packaging companies in the US, with a staff of about 600 people. The company provides packaging services to large pharmaceutical, generic, biotechnology and consumer healthcare companies.

Sharp employs about 600 people in Upper Macungie and a packaging facility in Conshohocken. Sharp's management, led by chief executive George Burke, will remain with the business along with all other employees.

The latest deal brings contract packaging back to the fore at United Drug after a long spell in which it has been boosting its commercial services offering.

Vitro Diagnostics Opens New Facility

Vitro Diagnostics, Inc., dba Vitro Biopharma, has announced the opening of a new corporate facility in the Coors Technology Center located in Golden Colorado. The new facility will be used for manufacturing, research & development and administrative functions. It is especially suited to support FDA-compliant manufacturing of the company's human stem cell products for various commercial applications in medical research, pharmaceutical manufacturing, drug discovery and cell therapy of diabetes and other diseases. The company is leasing the facility from a third party at a rate comparable to its prior facility leases.

Keata Plant Gains GMP Certification

PharmEng's wholly owned subsidiary, Keata Pharma, has received a drug establishment license for its manufacturing facility in Sydney, Nova Scotia.

The license was granted following a good manufacturing practices (GMP) inspection and grants Keata permission for the manufacturing, testing and packaging of capsules, powders, solutions and tablets.

The state-of-the-art facility has now begun commercial production with shipping of product commencing immediately.

Plethico Cuts Back on CRAMS but Expands in Dubai

Plethico Pharmaceuticals has signaled its intent to cut back on its Contract Research and Manufacturing Services (CRAMS) business as higher inflation and rising crude oil prices put the squeeze on profit margins.

Sanjay Pai, Plethico's chief financial officer, said: "We will trim our CRAMS business because the margins are getting squeezed out. Many of our CRAMS deals are coming up for renegotiation and if we don't get what we want, we have to trim that vertical."

Plethico claims its CRAMS business generates revenues of more than $23m per annum, with the majority of its clients being Indian pharmaceutical companies.

Despite the planed cut backs the Company is investing $23m setting up a fully automated plant in Dubai for the manufacture of medicated lozenges at an investment of Rs100 crore. This facility will be used to supply the Gulf region, U.S. and UK.

Florida Biologix Wins Manufacturing Contract

Florida Biologix has been awarded a manufacturing contract from the National Taiwan University Hospital, which will involve the production of a Phase I clinical batch of a novel therapy for a rare genetic disease - aromatic amino acid decarboxylase (AADC) deficiency.

Deficiency of AADC disrupts the formation of the neurotransmitters dopamine and serotonin is impaired and the passage and signalling within the brain is disrupted, causing problems with movement, mood and sleep patterns.

The award is a boost to Florida Biologix, which is only in its second year of operations. The US firm specialises in the manufacture, testing and filling of biopharmaceuticals

Patheon Extends Relationship with SK Life Science

Patheon has been selected by SK Life Science as the development services partner for two of the Korean company's central nervous system drug candidates. This extends an existing business relationship between the two companies.

Patheon recently completed Phase I development and clinical materials manufacturing for SK Life Science's pain drug candidate. Patheon will provide formulation and analytical development services as well as clinical supplies for one of the CNS candidates in multiple dosage forms, as well as development and clinical materials manufacturing services for another CNS candidate in Phase I clinical trials.

The global CNS market is expected to grow to $63.9bn by 2010.

Vitro Diagnostics Opens New Facility

Vitro Diagnostics has opened a new facility for the development and manufacture of stem cell products for commercial application in the pharmaceutical industry.

The plant, which is located in the Coors Technology Center in Golden Colorado, is fully compliant with US Food and Drug Administration (FDA) regulations covering the manufacture of human stem cell products. It will be used for the production of stem-cells for use in medical research, drug production and discovery, including cell therapy for diabetes.

Vitro is leasing the unit from a third party at a rate comparable to its prior leases. Further details of the agreement were not disclosed.

Dr. Jim Musick, Vitro's President and CEO, commented that the new facility puts in place: "the appropriate infrastructure to provide stem cell products that are manufactured to stringent specifications when combined with new manufacturing equipment that the Company has recently acquired."

According to data released at last year's Stem Cell Summit, the global stem cell market has grown from zero to $87m in under three years and is predicted to reach a value of $8.5bn over the next decade.

While embryonic stem cells are capable of differentiating into all of the various cells of the body, adult stem cells are more limited in differentiation capacity and can generally only form cell types that make up their tissue of origin. Adult stem cells are currently used for transplantation therapy of blood disorders, including leukaemia.

AAIPharma Receives GMP Status

AAIPharma's contract manufacturing facility in Wilmington, NC has received European Medicines Agency (EMEA) good manufacturing practice (GMP) status.

The award, which follows an inspection of the facility by Sweden's Medical Products Agency (SMPA), is covered by the European Union's Mutual Recognition Procedure (MRP).

The accreditation allows AAIPharma to manufacture drug tablets, capsule products and solid dose formulations for pharmaceutical clients wishing to operate in the lucrative European market.

The GMP status also entitles AAIPharma to offer testing and analytical services for industrial clients wishing to supply pharmaceutical products and drug intermediates to the region.

AAIPharma believes that the accreditation, coupled with the Food and Drug Administration (FDA) GMP status already held by its US production facilities, cements its position as a major player amongst contract manufacturing organisations (CMO) worldwide.

Earlier this year, following a $1.5m (€954,732) renovation, AAIPharma's sterile manufacturing plant in South Carolina, received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to produce aseptic and lyophilised pharmaceutical products.
AAIPharma said that the award, which followed similar approval from the FDA, had positioned the plant to deliver aseptic contract manufacturing services to pharmaceutical clients wishing to supply both commercial and clinical sterile drug products throughout the US and Europe.

Global CMO Sector

Over the last few years the development of the CMO sector has been nothing short of dramatic. As global economic factors and competition have forced big pharma companies to increasingly seek outsourcing solutions for manufacturing operations, the CMO industry has blossomed into a thriving and dynamic global market.

As a result, compliance with regulatory bodies around the world is vital to the ongoing success and development of firms like AAIPharma as it enables them to attract the widest range of possible industrial clients.

Paradise Valley Community college Expands Life Science Building

Construction crews have begun grading an expanse of dirt at the southwestern corner of Paradise Valley Community College.

It is only a hint of what is to come: a two-story life sciences building.

The complex, which is slated to open by fall 2009, will house a variety of biology programs, providing students and faculty an expanded platform for study and lab work.

Pfizer Facility in Germany Recieves Awards for Facility of the Year

When the Pfizer team in Illertissen, Germany conceptualized their NEW CONtainment (NEWCON) facility in April 2004, the main, practical purpose was to create a manufacturing plant for oral solid dosage forms including high potent compounds with a high degree of integrated automation to produce the smoking cessation drug varenicline (Chantix^®, Champix^®).

Compelling Features Lead To Recognition

Upon completion, however, the US $48.8 million (US $59 million with soft costs), single floor, single containment module facility boasted such a compelling array of ground breaking features that it went on to capture the 2008 Process Innovation category in the annual Facility of the Year Awards (FOYA) competition, sponsored by the International Society for Pharmaceutical Engineering (ISPE), INTERPHEX, and Pharmaceutical Processing magazine.

Located in Germany's Bavarian region, the Illertissen facility has a total production floor area of 7,800 m2 that consists of 3,000 m2 of production space, including the currently idle areas for potential expansion. Construction ended in September 2007 and production began in October 2007, when the German inspection license (PIC) was granted to the facility. The plant currently uses a production area of 1,600 m2 and has a production capacity of 1 billion tablets per year.

Groundbreaking PAT Implementation

Holger Weyhers, Head of Production, points out that all unit operations at the Illertissen facility are within a single containment module, supported by automated systems without any manual handling. "What we have accomplished in terms of automation, process integration and process analytical technology (PAT) is groundbreaking - these are the features that really stand out," he says. The facility includes an automation layer for process sequencing, automated transport systems and a manufacturing execution system (MES) layer for electronic batch records (EBR) and data archiving.

Zeroing in on the accomplishments of the Illertissen team, Weyhers says, "This facility is unprecedented in the entire pharmaceutical industry. We have nothing like this in the Pfizer network, and I strongly believe at this stage that there is nothing comparable in the entire pharmaceutical industry when it comes to the manufacture of solid dosage forms and the containment philosophy."?"The PAT applications are front running and innovative," says George Bernhard, Director of Right First Time at Pfizer. Right First Time, which was launched in 2003, uses Six Sigma tools and includes PAT, which is included in the FDA framework for quality assurance (QA) in the pharmaceutical industry

Bernhard explains that operationally, the instruments in the facility, which are quite sensitive, have already attained 95% robustness. "Our goal, however, is to get to 100% robustness, which will allow us to have full process control," he says. This is a part of the integrated process control strategy in which the process will be fully automated from beginning to end. "The vision is that you push a button and get tablets out at the end that won't need to be tested," he says.

"This is the first facility with such a high degree of integration with IT automation. You will not find another facility in the world with a similar technical approach," says Ernst Sander, Managing Director, PhC Pharma Consult, a Heidelberg-based engineering firm that provided design and engineering services at the facility, and which has a long-standing relationship with Pfizer, Illertissen.

Containment Issues Shape Facility Design

Weyhers holds responsibility for production at the facility and sets and manages output targets as well as ensures that all GMP requirements are satisfied. He says that the new plant is directly associated with the smoking cessation product varenicline (Chantix^®, Champix^®), which was launched in 2006.

"The issue with this product is that it falls into Pfizer's occupational exposure band (OEB) 4. This means that from an operator safety perspective, this product cannot be handled in a conventional, open manner. We were required to design and build a containment facility for this purpose," he says.

Weyhers explains that Pfizer Illertissen used its pilot facility, which has the capability to handle high potency drugs, to support the initial launch phase of Chantix in 2006. "But based on the demand forecast for Chantix, it became quite obvious that the capacity of the pilot facility would not be sufficient to support the demand. This, in essence, is the background for the design phase, the planning and the building of NEWCON.

"It is also the reason we moved the project forward by six months. Initially the plan was to have the facility fully commissioned and available for production during 2008, but we managed to have the plant ready by November 2007," says Weyhers.

A Company with a Long History of Success

Based in New York City, Pfizer has been in continuous operation since its inception in 1849. The global drug giant has annual revenues estimated at some US $47.79 billion and an enterprise value as of May 2008 at some US $124.22 billion. It discovers, develops, manufactures, and markets a broad range of human and veterinary drugs throughout the world.

In 2007 Pfizer's Chantix® received the prestigious "Prix Galien USA Award" for Best Pharmaceutical Agent in 2007 based on its efficacy. Chantix represented one of the fastest product launches in the pharmaceutical industry in Europe - with launches in 16 European countries within a period of five months, according to a benchmark from IMS Health, which provides market intelligence to the pharmaceutical and healthcare industries.

In addition to Chantix, Pfizer's pharmaceutical product offerings include Lipitor, a blockbuster drug that helps to lower blood cholesterol, Norvasc for the management of high blood pressure, Caduet for cardiovascular issues, Lyrica for neuropathic pain, Aricept for Alzheimer's disease, Zoloft for the treatment of depression and anxiety, Celebrex for arthritis pain, inflammation and acute pain, Zyvox for bacterial infections, Selzentry/Celsentri for some forms of HIV, Viagra for erectile dysfunction, and Zyrtec for allergies and hives, among others.

Global Support Leads To Local Excellence

The Illertissen facility drew from both Pfizer's world class pharmaceutical and engineering capabilities and German industrial capabilities, which boasts some 75 years of experience in pharmaceutical manufacturing. "We had the support of Pfizer Global Engineering, which was kept in the loop and appraised of all progress. They did not come up with solutions for us - these were essentially formulated on site, and we managed to come up with our own solutions throughout the project," says Weyhers.

Tracing the early development of the project, Sander says, "Pfizer Illertissen has a very strong internal team, which has considerable knowledge of process technologies. The internal team was involved in the selection of engineering and design companies, and they picked PhC Pharma Consult, which has a strong relationship with Pfizer in Illertissen."?"We were involved in the pilot project plant before NEWCON. We worked on an integrated design, which integrated process, equipment specification, building services, architecture and automation of the facility as part of our general contract for engineering and design with Pfizer."

Weyhers noted that the Pfizer team, the PhC Pharma Consult team and all the suppliers and subcontractors worked very successfully together during the entire project - driven by a solid team spirit and a success oriented philosophy.

Sander explains, "This was one of the strongest teams we have ever put together. The team members were working closely together with a strong focus on being successful. The leaders of Pfizer Illertissen placed a great deal of trust in us, which allowed for the building of a team on a very friendly basis, and where everybody supported each other."

Current Site a Manufacturing Powerhouse

Today, the Illertissen site sits on 510,000 square meters (867,000 sq. ft.) of land, and the production and testing facilities occupy some 23,450 square meters (252,322 sq. ft.). The site has a total of 598 employees and currently produces approximately 80 MM packs per year. The Illertissen plant supplies 82 countries worldwide, including the United States.

Illertissen has also served as a launch site for new products. In the last 10 years, 5 products with 13 strengths and 323 stock keeping units (SKUs) have been successfully launched without missing any launch date. Its track record of successful innovations include the ultrasonic fill weight control for bead filled capsules in 2003, capacity fill weight control for powder filled capsules (MG2 G100 worldwide first prototype) in 2005, wallet packaging line in 2006, PAT applications for blend and tablets from 2003 and ongoing, NIR for raw material testing in 2006 and first regulatory filed NIR water content determination of film coated tablets in 2007, as a replacement for Karl Fischer.

The NEWCON facility is a single floor, single containment module ("cell concept layout"), which can house up to 3 productions trains. Currently, only 1 train is being used for the production of the high potent drug product Chantix^®, according to Weyhers.

"The equipment train, however, could be used to accommodate various other products so that we could operate under a multipurpose mode if needed. We also have the flexibility and the space already available to expand the operation and add other unit operations if needed," says Weyhers. At the moment, PhC Pharma Consult is engaged in ongoing work in capacity enhancement at the facility, he adds? Weyhers believes that the automation and process integration aspects may have been decisive factors that swayed the FOYA judges. He explains that the degree of automation in the facility is completely novel. The MES layer system triggers all process sequences from dispensing to coating, in the automation layer. Transporting of goods and materials is carried out automatically by automated laser-guided vehicles without any operator control. Processing is executed at the equipment level. The batch data are collected automatically into the MES and raw data are archived.

"This means that the automation layer takes care of the entire process flow, performs plausibility checks, and uses the results of the checks as a trigger for the initiation of the next unit operation. This degree of automation and process integration is unique and absolutely impressive," he says.

The Pfizer Illertissen teams points out that the facility incorporates all the elements of modern manufacturing. PAT applications are installed across the manufacturing process to support the vision of continuous quality verification. With respect to safety, no operator attendance is required, which substantially enhances workers' health and safety.

"Apart from the automation levels, we minimized the changeover times by using washing in place systems and cleaning in place systems, all of which helped to minimize the changeover times from one step to another. It is also integrated in the process and in the automation layer," says Sander.

Incorporated among the hazard control features at the facility are state-of-the-art containment techniques. HEPA filters were installed to protect the outside air. Production facilities were fully automated, and operators are able to work without personnel protective equipment (PPE).

Environmental Issues Given Priority

Cognizant of the need to observe green principles, the facility sought to minimize its environmental impact by using natural gas to produce steam, optimize waste separation and operate coolers with ground water in a separate loop - and assessing the impact of production waste water on water dwelling organisms.

With the need for the efficient use of energy, the project team implemented innovative technologies and concepts for saving energy. The heating, ventilation and air conditioning (HVAC) system use well water instead of conventional coolers. It also makes use of a heat recovery system for exchanges between supply air and exhaust air. The facility was outfitted with a central building control system for the regulation and optimization of HVAC energy consumption - complete with assessments to reduce air exchange rates in compliance with GMP and EHS requirements. The equipment in the facility were fitted with frequency controlled pumps and motors. The building was insulated to minimize heat loss, and energy fluxes are monitored.

Award Recognizes Innovative Thinking

Turning to the question of what the award means for his organization, Weyhers says, "It is a big honor to be the Facility of the Year category winner in Process Innovation. This is the first time that Pfizer has received an award for process innovation - and this is the result of our hard work and innovative thinking."

"From the PhC Pharma Consult perspective, this is great honor for us because this is the first time that one of our client's projects has received this award. I think that the biggest benefit for us is the knowledge and the know-how we have gained together with the Pfizer team for the next steps.

"We now have a high degree of knowledge in the world of OEB 4 and 5 products and we know how to design and build production facilities to handle them with the highest degree of automation," says Sander.

Bristol-Myers Squibb will carry out $3.7 Million Upgrade

Bristol-Myers Squibb (BMS) has agreed to carry out a $3.7m upgrade of production facilities that are in breach of US Clean Air legislation (CAL), according to an Environmental Protection Agency (EPA) statement.

BMS identified and reported several CAL violations during a voluntary audit of 25 manufacturing facilities, following an initial EPA request for compliance data for the firm's plant in Evansville, Indiana.

Under the terms of the new settlement, BMS will "retire" or refurbish 17 of its hydrochlorofluorocarbon (HCFC) refrigeration units at manufacturing facilities in Mt Vernon, Indiana and Hopewell in New Jersey. The firm has also agreed to take similar action at two of its plants in Puerto Rico.

In addition, the drugmaker has been ordered to pay approximately $127,000 in civil penalties for the reported violations and to take steps to bring a further 13 of its production plants up to code.

Additionally under the terms of the settlement, BMS will replace two comfort cooling stations at its plant in New Brunswick, New Jersey with a new air conditioning system linked to a centralised refrigeration unit.

When all of the measures are completed in July next year, the New Jersey-headquartered firm will have removed approximately 2,880 kilograms of HCFCs from its manufacturing operations.

Pfizer Must Clean Up Its ACT

Last month, Pfizer agreed to pay $975,000 to resolve alleged violations of US PharmaMACT regulations, in the first settlement of its type in a federal court.

The breaches occurred between October 2002 and December 2005 at a manufacturing plant in Groton, Connecticut, that has since been divested as part of Pfizer's ongoing restructuring plan.

The PharmaMACT legislation was introduced in an attempt to control emissions of hazardous air pollutants used during pharmaceutical manufacturing operations.

Bristol-Myer Squibb Pharmaceutical Research Facility Certified Green by GBI

Bristol-Myers Squibb Company's Wallingford, Conn., research facility was recently recognized by the Green Building Initiative (GBI) for assessing the energy-efficient and high-performance sustainability practices at the facility using a new module of the Green Globes rating system—Green Globes for Continual Improvement of Existing Buildings (Green Globes-CIEB).

Lifebridge Neuroscience Center Opens at Baltimore Hospital

LifeBridge Health Brain & Spine Institute recently opened at Sinai Hospital in Baltimore. The $5.4 million, 26,700 sq.ft. neuroscience inpatient facility offers a full range of services for brain, spine, and peripheral nervous system diseases using sophisticated diagnostic techniques and state-of-the-art surgical modalities.

Sinclair Pharmaceuticals Enters Agreement with Wockhardt

UK-based Sinclair Pharmaceuticals has entered into a manufacturing and distribution agreement with Wockhardt, an Indian pharmaceutical and biotech company.

Under the terms of the 10 year agreement Wockhardt will distribute four of Sinclair's products in India.

At a later date the manufacture of products destined for the Indian market will also shift to Wockhardt's facilities, with the possibility of other products being added to the agreement.

Dr Michael Flynn, CEO of Sinclair Pharmaceuticals, noted: "We are very pleased to appoint Wockhardt as our distributor for these products in India. Wockhardt is a dynamic and rapidly growing company and we hope this is the first step towards forging a long-term and mutually rewarding relationship.

"We have a very active programme pursuing opportunities in the BRIC (Brazil, Russia, India and China) countries and the Middle East which we believe offer substantial growth opportunities for the sales of our products in the coming years."

The agreement grants Sinclair's Atopiclair, Aloclair, Papulex and Decapinol access to the Indian pharmaceutical market, which the company believes is worth $7 billon and is growing at a rate of 17 per cent.

By transferring the manufacture of its products to India Sinclair is set to increase its margins. At present Sinclair produces the medicines from facilities near Paris but the manufacture of those destined for the Indian market will moved as soon as Wockhardt's facilities are ready.

The deal gives Sinclair access to the potentially massive Indian market and is part of a concerted effort by the company to extend its reach into emerging markets.

Wockhardt has also adopted an expansionist attitude in recent years, moving into international markets through acquisitions such as Pinewood and Morton Grove. These acquisitions were intended to strengthen the company's hand in the US and Europe, respectively.

This policy of inorganic growth has seen the number of employees at the company rise to 7,500 people, with $670m in sales generated last year. Operating profit in 2007 was up 50 per cent on the previous year as the company's acquisitions pay dividends.

The European market accounts for the bulk of sales but the agreement with Sinclair signals Wockhardt's intent to continue strengthening in India.

Tower Investments Plans to Build in New BioBusiness Park in Minnesota

Tower Investments has announced plans for a 40,000-square-foot research, development and manufacturing facility in Pine Island, Minn., that would be the first building to be constructed as part of the 200-acre BioBusiness Park at Elk Run.

The building would house the Biotechnology Center at Elk Run, a nonprofit organization committed to the development of biotechnology firms, their technologies and research institutions. Slated to break ground in the fourth quarter of 2008, the facility will be built-to-suit for institutions and start-up firms. Amenities will include an executive suite concept for development, quality and regulatory services; 20 ISO class production clean rooms; and support for cell/protein/tissue therapeutic platforms.

“Our vision for BCER is to complement public and private efforts to increase biotech industry in the region,” said Marks, “and to establish a full-service facility where the best in the field can usher products from pre-clinical safety studies through to commercialization,” Alex Marks, senior vice president of Tower Investments, said in a statement. “We expect to have 40 total operational staff with technical, scientific, and engineering experience.”

BCER will be located just off Highway 52, a 15-minute drive from Rochester, Minn., home of the Mayo Clinic and the University of Minnesota. The Minnesota Department of Transportation has designed a new highway interchange at Elk Run, intended to link Pine Island and the immediate area.

The design and construction team includes architects Perkins + Will, and general contractor PCL Construction Services, both based in Minneapolis; and land planner DTJ Design of Boulder, Colo.

Tower announced plans for BioBusiness Park at Elk Run at the Biotechnology International Organization’s 2008 International Convention. BioBusiness Park at Elk Run would be part of Elk Run, a 2,325-acre, master-planned mixed-use community.

Formed in 1989, Tower Investments is a private, family-owned real estate investment and development company with more than 100 real estate projects in 17 states.

Syngenta Expands at RTP

Swiss-owned agribusiness Syngenta will grow at North Carolina’s Research Triangle Park, after inking a lease for 19,776 square feet at One Park Drive, the 78,000-square-foot office building within Park Center. The firm will relocate 80 administrative employees now based at the company’s roughly 300-person global biotech and biofuels R&D headquarters within RTP, at 3054 Cornwallis Road, freeing space at the lab building.

Syngenta specializes in developing insecticides for crop protection as well as plants capable of tolerating drought. The company generated about $9.2 billion in sales last year, and employs more than 21,000 people in more than 90 countries. That workforce includes more than 60 people the company added at RTP last year.

Syngenta’s Crop Protection unit has its North American headquarters west of RTP in Greensboro, NC.

Jade Pharmaceutical Will Acquire Sichuan ZhiTong Pharmaceutical

Jade Pharmaceutical, a subsidiary of Californian drug firm AMDL, is to acquire privately-held China-based distribution specialist Sichuan ZhiTong Pharmaceutical (SZP)

SZP, which sells traditional Chinese medicines, health foods, medical equipment and generic drugs, has been distributing AMDL's domperidone anti-emetic product since the fourth quarter last year, generating revenue of approximately $100,000 (€63,000) a month.

Prior to the announcement, AMDL terminated a previously announced letter of intent (LOI) to acquire Guangzhou-headquartered distributor Guangzhou Lazon Pharmacy Co. The firm said that the decision was "based on material uncovered through the due diligence process."

The new LOI that AMDL, Jade and SZP signed stipulates that an independent Chinese business valuation specialist will determine a fair value for SZP, providing a starting point for subsequent discussions.

The agreement also requires that Jade and SZP form a consolidated sales force to distribute numerous AMDL products locally, include the anti-aging skin treatment GoodNak, the antibiotic Levofloxacin and the anti-emetic Ondansetron.

A recent report by Pacific Bridge Medical revealed that the Chinese drug sector grew 20 per cent in 2007, and predicted that it will join the top ten largest pharmaceutical markets in the next few years. The increasing use of western medical treatments in China makes the country an attractive target for drugmakers around the world.

As a result, an increasing number of drugmakers are forging distribution agreements with local Chinese distributors in an attempt to secure a strong presence in the region and leverage local market knowledge.

International Growth Plan to drive Second Quarter Profit

In June, AMDL hired consulting firm Strategic Growth International (SGI) to help it identify and establish additional investment opportunities both at home and abroad.

Commenting at the time company CEO Gary Dreher, said that: "SGI has a strong reputation with an exceptional team and we're excited to have them as a partner to communicate our corporate story [and] the great progress we're making with new products and technologies in the US, China and other global markets."

AMDL also forecast a positive set of second quarter results last month. The firm expects its net income after taxes for the period to be $1.1 million, on revenues of $6.3 million. For the similar period of the previous year, the company reported a loss of $1.9 million on revenues of $2.4 million.

The Tustin, California-headquartered company also predicted that its income in the third and fourth quarters will reach $4.9 million and $6.7 million, respectively.

For the full year, AMDL expects its earnings to be in the $9.5m to $12.2m range. The company reported a net loss of $1.26m in 2007. It also said that it hopes to achieve a 100 percent increase in full year 2008 sales. Gross margins are expected to range between 48 percent and 52 percent.

Moll Continues Significant Facility Investments

Moll Industries, Inc., which recently announced construction of a 100K Clean Room operation in its Empalme, MX, facility, has announced expansion of its Seagrove, NC, facility. The expansion is expected to be completed in late July.

Juan Resendez, COO, said this is a planned expansion within one of the 3 buildings in the Moll-Seagrove complex. Resendez went on to say, "This represents capital investment exceeding $2,000,000 and is a solid indicator of how serious we are about growing this segment of our business. The Seagrove Operation has a solid operations team which delivers consistent quality on-time. We are confident this investment will make this operation even more attractive to our current and future customers. As a corporation we feel having medical molding capability in three countries -- United States, Mexico and Ireland -- will allow us to meet global demand for this ever growing market segment."

Conan Miller, Corporate Director of Asset Management, said the 1000 sq. ft. expansion of an existing clean room was required to handle new medical component work which demanded larger electric molding machines than are currently available in Seagrove. Miller went on to say, "In addition to increasing the size of a Class 100K clean room, there are upgrades to the facility's HVAC, additional through-wall conveyors to reduce movement within the clean room, upgrading a gowning room for a separate controlled environment assembly room, and increasing the size of a break room."

Miller indicated Moll is purchasing 3 new Toshiba 390 ton electric machines, and the automation, auxiliary and machines combine to an average of approximately $440,000 per work cell. Moll-Seagrove currently operates 40 injection molding machines ranging 33 to 500 ton, with four 100K Clean Rooms, one 10K Clean Room and two controlled environment rooms within the multi-building complex. Moll-Seagrove currently employees 142 and will add an additional 12 people as the new work comes on-line. Consumer and food industry parts round out the facility's largely medical molding offerings.

With operations in Empalme & Ramos, MX; Seagrove & Lexington, NC; and Donegal, Ireland, Moll maintains 142 machines from 22 to 1450 tons. Moll primarily services the medical, appliance, industrial and automotive markets and employs approximately 560 people worldwide. Moll Industries is owned by Highland Capital Management of Dallas, TX.

Lonza Acquires Contract from Osiris Therapeutics

Lonza has scored a contract manufacturing agreement from Osiris Therapeutics for its investigational adult stem cell therapy is building a new facility to support future business activities in this area.

The Swiss manufacturer will be responsible for the clinical and commercial supply of Osiris' lead candidate Prochymal, which is being evaluated in Phase III clinical trials for three indications - acute and steroid refractory graft versus host disease (GvHD) as well as Crohn's disease.

The drug is also being developed for the repair of heart tissue following a heart attack; the protection of pancreatic islet cells in patients with Type I diabetes; and the repair of lung tissue in patients with chronic obstructive pulmonary disease (COPD).

No specific terms of the agreement between the pair were disclosed, although Lonza did reveal that in preparation for the commercialisation of the drug it is constructing new production facilities.

This includes the establishment of the first commercial-scale allogeneic good manufacturing practice (GMP) manufacturing facility, along with the creation of additional capacity to manufacture GMP grade cell culture media for therapeutic applications.

The site will also be used by the firm to generate new business in commercial-scale adult cellular therapeutics manufacturing in the future - an emerging production area.

Russian and Pakistani CRO have New Alliance

Russian and a Pakistani contract research organization (CRO) have formed a new alliance as the global clinical spread continues in this industry.
Russia's Synergy Research Group has established an international partnership with Metrics Research, as part of its plans to form a worldwide CRO network that is capable of competing with global CROs on bids for large international multicentre clinical trials.

Synergy's alliance network already includes CROs from the US, Europe, India and the Ukraine and Pakistan was chosen as the company's next target because the country is "one of the world's emerging clinical trials market today".

Metrics' CEO, Khurram Zaki Khan, added that Pakistan is already "on the radar screen of multinational pharma companies and CROs", with several Phase II and III US Food and Drug Administration (FDA) registration studies currently ongoing.

"The Central and South Asian nexus is pivotal in providing clinical research services to the growing, evolving and competitive R&D industry of the world," said Khan.

[This alliance] will "reap the benefits of this untapped market - especially at a time when the government of Pakistan and relevant ministries are promoting clinical research activities in Pakistan", he said.

Sandwiched between the region's two major emerging pharma locations - India and China - Pakistan is now looking for its small share of the action.

For the last ten years the country has been building up its capabilities in the pharma industry, including the establishment of drug manufacturing facilities, infrastructure and export capabilities. Since 2000 Pakistan has been in compliance with the TRIPPS agreement and has put in place intellectual property legislation and its pharma industry is now on the launching pad waiting to take off.

In terms of its attractiveness as a place of clinical research, Pakistan has a population of 173m, and a vast number of treatment-naïve patients.

Commenting on the alliance, Elena Zhuk, general director and CEO at Synergy, said: "Together we are able to offer our sponsors access to more than 300 million patients."

Igor Stefanov, Synergy's director for business development added that now the company is able to conduct trials in Pakistan through its new partner, it is "planning some joint marketing and business development tasks, by preparing and sending proposals, and conduct presentations to the existing clients and prospects, and assisting each other with related language and cultural translation issues."

Metrics is the first registered CRO in Pakistan and provides services that include project management, clinical operations and monitoring, data management, biostatistics, medical report writing, regulatory affairs and quality assurance.

Chapel Hill Gets EPA Support for Toxicology Center

The University of North Carolina at Chapel Hill will use $3.4 million from the US Environmental Protection Agency over four years to establish the Carolina Center for Computational Toxicology, where researchers will develop computational toxicology and bioinformatics tools and will conduct interdisciplinary studies with environmental and health science researchers.

The new center “will strengthen our capacity for understanding and predicting the inter-individual differences in risk from environmental exposures,” said UNC School of Public Health Professor Ivan Rusyn in a statement last week.

The center will develop and publish informatics models and tools and will pay “special attention” to the usefulness of the tools to the risk-assessment community and investigative toxicologists.

The center will study protein-protein and protein-chemical interactions in nuclear receptor networks, chemical-perturbed networks, and compounds for predicting pathobiological responses. The researchers also will develop toxicological tools for studying the role of genetic diversity involved in responses to toxicants, as well as predicting outcomes based on genetics using statistical modeling and high-throughput screening.

Millipore Will spend $3.4 Million to Expand Drug Discovery Unit’s in St. Charles, MO

The Billerica, Mass.-based firm also said that it plans to hire an additional 60 employees at the St. Charles site. Millipore gained the site through its $1.4 billion acquisition of Serologicals in 2006.

The firm said that it is seeking LEED certification of the expanded and renovated 17,000-square-foot space. Millipore noted that the expanded facility is one of three buildings on the firm’s 43-acre Missouri Research Park campus.

WuXi PharmaTech and Covance form JV

WuXi PharmaTech and Covance have entered into a Memorandum of Understanding to create a 50/50 joint venture to provide preclinical contract research services in China. Operations of the proposed joint venture will be located in a 323,450-sq.-ft., purpose-built facility in Suzhou, China, which is currently being built by WuXi. This facility, expected to be completed in 2009 and designed to meet the FDA and worldwide regulatory standards, will provide GLP toxicology, drug metabolism and bioanalytical chemistry services. In addition to the facility, which will be provided by WuXi, Covance plans to make an initial investment of approximately $30 million. Financial and structural details of the joint venture are expected to be disclosed once definitive terms are agreed and the entity is officially formed later this year.

Cleanroom Boom for GW, Tessy, Nypro, Hi-Tech, and Integrity

Cleanrooms are the currency of the realm in medical molding, and many molders that currently sell into, or would like to serve the medical market, are adding or expanding such operations in their plants. At the recently completed Medical Design & Manufacturing East event in June in NYC, GW Plastics (Bethel, VT) said that it is currently building a new Class 8 (Class 100,000) cleanroom at its facility in Tucson, AZ, with the room to hold 10-12 presses. Medical has grown from about 50 percent of sales five years ago to about 66% of GW’s sales of almost $100 million/yr.

Also, like GW, moving more work from automotive to medical is custom molder Tessy Plastics (Elbridge, NY), which is doubling the size of its two cleanrooms and purchased 10 injection molding machines, with 10 more likely to be added by the end of this year. Roland Beck, Tessy president, said that the company will expand its cleanrooms, from 10,000 to 20,000 sq.ft. and 5000 to 10,000 sq.ft, with ten new machines, Sumitomo’s and Niigata’s, already in place. The company has lowered its exposure to the automotive market from 30% of sales to 1%, with medical now constituting 50% of its business.

Contract manufacturer Nypro (Clinton, MA), which runs more than 1400 molding machines in 17 countries, is also tasking more and more of those presses with molding work within cleanrooms. At the same event, Al Cotton, Nypro’s director of corporate communications, said the company is adding new cleanrooms at plants in Tijuana and Massachusetts, with those cleanrooms built to Class 8 standards and housing new machines and robots, with production dedicated to medical.

Hi-Tech Tool and Mold’s (Pittsfield, MA) Ann Fyfe said the company is planning to expand its Class 100,000 (ISO Class 8) cleanroom from 4500 to 7500 ft2. Last year, the company announced a 20,000 sq.ft. addition to its operation, including the cleanroom and an expansion of secondary operations. Custom molder Integrity Plastics (Denver, PA) announced that it had just certified its cleanroom, which was added in 2006. The company, which has 36 molding machines, runs four Engel’s (two 60- and two 150-tons) in the newly designated Class 100,000 (ISO Class 8) cleanroom, according to Chuck Schneider, in charge of new business development.

McIlvaine Company,

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