 (Abbott Park, IL) received the annual Illinois Continuous Improvement Award for environmental excellence. The award is part of the Illinois Governor's Sustainability Awards program, which recognize businesses and organizations in Illinois for significant achievements in protecting the environment through sustainable business practices. The award is administered by the Illinois Sustainable Technology Center, a division of the Institute of Natural Resource Sustainability at the University of Illinois. Abbott was recognized for six projects aimed at implementing green processes and reducing carbon dioxide emissions at its manufacturing and research and development facilities in Lake County, Illinois. 

 is providing $180,000 in support to help address the recent cholera outbreak in central Haiti. This donation includes a $25,000 grant from the Abbott Fund to 

, and $155,000 in donated Abbott rehydration solutions and antibiotics. Donated products are being distributed through 

 (Baton Rouge, LA), a fine-chemicals company, reported that the Albemarle Foundation, the company’s philanthropic arm, contributed $250,000 to the Greater Baton Rouge Food Bank’s “From Hunger to Hope” campaign. The Greater Baton Rouge Food Bank distributed more than 10.8 million pounds of food in 2009. The “From Hunger to Hope” campaign is funding the acquisition and renovation of a larger warehouse facility to allow the food bank to accept, process, and distribute more food on an annual basis. 

 (Heerlen, The Netherlands) CEO Feike Sijbesma received the 2010 Humanitarian of the Year Award from the United Nations Association of New York for his commitment to corporate social responsibility and in particular for DSM’s partnership with the United Nations World Food Program (WFP). DSM has a strategic partnership with WFP to address the problem of malnutrition in the developing world. The program, “Improving Nutrition, Improving Lives,” has helped more than 2 million people in Nepal, Kenya, Bangladesh, Afghanistan, and other countries. Part of its work involves the development of a nutritional blend that can be sprinkled over food. 

 (Indianapolis, IN) and six partner companies participated in “A Greener Welcome” in early October as part of the 2010 Lilly Global Day of Service in partnership with Keep Indianapolis Beautiful and the Indiana Department of Transportation. The volunteers landscaped five interchanges along the industrial corridor of Interstate 70 in Indiana. Specially commissioned sculptures will be installed at three interchanges later in the fall.

 (GSK, London), Fondazione Telethon, and Fondazione San Raffaele formed a strategic alliance to research and develop treatments to address rare genetic disorders by using gene therapy carried out on stem cells taken from the patient’s bone marrow (

). The alliance capitalizes on research performed at the San Raffaele Telethon Institute for Gene Therapy (HSR-TIGET), a joint venture between Fondazione Telethon and Fondazione San Raffaele. GSK will gain an exclusive license to develop and commercialize an investigational gene therapy for ADA Severe Combined Immune Deficiency (ADA-SCID),  a rare and life-threatening immune deficiency, which affects approximately 350 children worldwide. In addition, GSK will codevelop with Fondazione Telethon and Fondazione San Raffaele, six further applications of 

 stem-cell therapy, using a new gene-transfer technology developed by HSR-TIGET scientists that has the potential to treat a range of rare disorders.

 is installing solar-energy panels at its Northeast Regional Distribution Center in York, Pennsylvania. Nearly 11,000 solar panels will cover an area on the roof to generate enough electricity to meet the annual energy needs of the building. 

 (Basel, Switzerland) signed a memorandum of understanding (MoU) with the World Health Organization to continue their collaboration in eliminating leprosy. Under the terms of the MoU, Novartis will continue to provide free multidrug therapy (MDT) medicines to all countries worldwide. The donation to the WHO, valued at about $26 million, will treat an estimated 1.1 million leprosy patients over the next five years, through 2015. In addition, Novartis will provide up to $2.5 million during the same period to cover costs incurred by the WHO for handling the donation and logistics. Since 2000, Novartis has donated more than 45 million MDT blister packs, the treatment recommended by the WHO, to treat approximately 5 million leprosy patients worldwide. 

 (North Wales, PA), in collaboration with the Philadelphia Eagles, awarded four grants totaling $125,000 to Philabundance ( a hunger-relief organization serving the Delware Valley in Pennsylvania), Students Run Philly Style (a program for improving the health of students through running), the Twilight Wish Foundation (a group helping senior citizens), and the Miracle League of Northampton Township (a baseball and softball league for children with physical and mental disabilities). 

Working to Overcome the Global Impact of Neglected Tropical Diseases

 in October 2010, the first time that WHO has issued a report specifically addressing neglected tropical diseases (NTDs). WHO’s Strategic Technical and Advisory Group for NTDs met in June 2010 in Geneva to review the report. The report recommends five public-health strategies for the prevention and control of NTDs: preventive chemotherapy; intensified case management; vector control; the provision of safe water, sanitation, and hygiene; and veterinary public health. The report also recommends a research strategy for developing new medicines, particularly for leishmaniasis and trypanosomiasis, new methods for vector control, vaccines for dengue fever, and new diagnostics. 

Articles

CSR and Sustainability Forum

A roundup of developments in corporate social responsibility and sustainability from the bio/pharmaceutical industry, its suppliers, and other public and private organizations.

As expected, last year's wave of megamergers among global pharmaceutical  companies has unleashed a follow-on wave of impending facility closings. Pfizer (New York) announced its intention to shut manufacturing operations at eight sites and close six research and development (R&D) facilities following its merger with Wyeth (Madison, NJ). Merck & Co. (Whitehouse, NJ) plans to close eight manufacturing sites and eight R&D sites in the wake of its acquisition of Schering-Plough (Kenilworth, NJ). Roche (Basel, Switzerland), which acquired full ownership of Genentech (South San Francisco, CA) in 2009, recently announced a strategic review of its operations that is likely to lead to closures. 

Past waves of pharmaceutical plant consolidation helped spawn the birth of the contract research and manufacturing (CRO and CMO) industry. For instance, most of Patheon's (Research Triangle Park, NC) current manufacturing network was assembled from divested facilities, and major European CMOs such as Famar (Athens, Greece), Recipharm (Jordbro, Sweden), and Fareva (Paris) are made up mostly of facilities once owned by global bio/pharmaceutical companies.  

CMOs often have been able to acquire these facilities for only a token investment and have received contracts to manufacture legacy products that have guaranteed them an initial revenue stream. However, it has been the sellers that have been the big beneficiaries of the sales to CMOs. The sellers have saved millions of dollars/euros in severance payments, taxes, and environmental remediation costs that they would have faced if they had closed the facilities and terminated the employees. 

Facility sales are now going to be more difficult. The contract development and manufacturing market is improving, but the new product pipeline is not as robust as it was in the middle of the last decade and competition among CMOs for the available opportunities is intense. Established CMOs don't need or want additional capacity for the most part. New market entrants that lack name recognition and a track record will have an especially difficult time gaining significant new business.  

Also, financing for deals to acquire legacy manufacturing facilities is difficult to obtain because banks in North America and Europe have tightened lending standards, and private equity investors have become more selective. In the best of circumstances, it can take five or more years for a new CMO to build a decent portfolio of contracts from nonlegacy clients, and there are few investors willing to take the chance that the effort will be successful. 

The difficulties facing CMOs trying to make a success of a manufacturing site once owned by a global bio/pharmaceutical company were highlighted recently when it was announced that Merck is buying back its active pharmaceutical ingredient (API) manufacturing site in Riverside, Pennsylvania, from Cherokee Pharmaceuticals (Riverside, PA). Cherokee, a subsidiary of the outsourcing-services provider PRWT (Philadelphia), acquired the facility from Merck at the end of 2007. 

PRWT acquired the Cherokee operation for total consideration of $22.2 million, most of which was in the form of a promissory note to Merck. In addition to the assets on the site, PRWT received a five-year supply agreement from Merck, which it claimed would generate $100–200 million in annual revenues annually from producing antibiotics and chemical APIs and intermediates. 

Based on a regulatory filing made by PRWT in 2008, Cherokee generated revenues of $84 million in its first year, of which almost 90% came from Merck. However, overall facility utilization was low: less than 25% for the two pharmaceutical API synthesis plants on the site and almost zero for the fermentation facility. A third plant manufacturing a crop-protection ingredient had high utilization, however. 

Aside from the Merck legacy business, the only other contract announced by Cherokee over the three years in which it owned the facility was with DuPont (Wilmington, DE) for a crop-protection product. The company tried to make fuller use of its assets by entering the chemical distribution business and announced a contract with Sigma Aldrich (St. Louis) to distribute specialty chemical products. It's not clear whether this arrangement ever got off the ground. 

The Riverside buyback highlights another problem for bio/pharmaceutical companies trying to sell or divest redundant facilities: namely, that large legacy pharmaceutical manufacturing sites may not be financially viable for a CMO to operate, especially in today's business environment. Large sites such as Riverside have a lot of fixed assets that must be maintained and operated whether or not they are being utilized. Cherokee had to maintain a 340-acre site that includes three commercial-scale synthesis plants, two good-manufacturing-practice kilo laboratories, a fermentation facility with 43 fermentors, 10 warehouses, and laboratory space; little of that capacity was utilized. At almost $100 million in revenues, Cherokee would have been considered a substantially sized API manufacturer, but the cost of maintaining all of these facilities probably overwhelmed the revenue generated by the legacy Merck contracts. 

Cherokee is certainly not the first pharma-to-CMO deal not to work out well. Keata Pharma, a Canadian dose CMO, filed for bankruptcy within a year of buying its facility in Arnprior, Ontario, from Pfizer. Inyx, a UK-based CMO, went into receivership soon after buying a facility in Puerto Rico from sanofi-aventis (Paris); sanofi-aventis had to retake the facility much like Merck has. Elaiapharm (Nice, France) went through receivership and is now owned by the Danish pharmaceutical company Lundbeck. 

This is not to say that there will be no pharma-to-CMO/CRO deals in the near future. There are often good strategic reasons to complete these transactions, including filling a hole in a company's service offerings or extending a strategic relationship with a key client. In fact, in several recent deals, companies were able to achieve both of these objectives simultaneously. When Covance (Princeton, NJ) acquired Eli Lilly's (Indianapolis, IN) site in Greenfield, Indiana, it gained a 10-year services contract and some critical discovery-related technologies. Similarly, in its recent acquisition of the R&D site in Verona, Italy, from GlaxoSmithKline (London), Aptuit (Greenwich) gained discovery capabilities while enhancing a key client relationship. 

These deals show that a bargain price is no longer an adequate incentive for acquiring a redundant facility from a major bio/pharmaceutical company. There must be a strong strategic rationale and an adequate revenue stream for the facility to achieve standalone viability. Executives we spoke with say they have walked away from many offered facilities because the economics and strategic rationale were missing. The global bio/pharmaceutical companies may get offers from small and mid-sized bio/pharmaceutical companies for their redundant facilities, but CMOs and CROs are not lining up to buy them. 

 is president of PharmSource Information Services, Inc., and publisher of 

Outsourcing

Global pharmaceutical companies could have a problem getting rid of redundant facilities.

Buyers in Short Supply

The Global Reporting Initiative (GRI) is opening a new office in the United States to assist US companies in corporate sustainability reporting. The new “Focal Point USA” was launched in New York on Oct. 13, 2010, to increase the number of US companies that produce sustainability reports. GRI provides a framework for producing sustainability reports, also known as Environmental, Social and Governance (ESG) reports. The framework enables large and small companies, nonprofit organizations, and government bodies to assess their sustainability and disclose the results in a way similar to financial reporting. GRI’s new ‘Focal Point USA’ aims to increase the number of US companies reporting on sustainability in a consistent manner, to improve the quality of those reports, and to increase US organizations’ input into developing new guidelines for sustainability reporting. 

The Big Four accounting and professional-services firms in the United States (Deloitte, Ernst & Young, KPMG, and PriceWaterhouseCoopers) agreed to provide donations to sponsor GRI’s new Focal Point USA for the first two years. Additionally, The Conference Board, a business and research assocation, agreed to host the GRI Focal Point USA on a 

 basis during that same period of time. The Conference Board has a Center for Corporate Citizenship & Sustainability and sees its relationship with GRI as a way the center can help make sustainability integral to core business strategies. 

In general, sustainability reports provide stakeholders with insight into key performance indicators for energy and water use, greenhouse-gas emissions and waste, and for social-performance indicators related to human-rights issues. This information helps investors, customers, employees, nongovernmental organizations, and other stakeholders understand a company’s ability to manage sustainability risk and related competition issues. 

According to data cited by GRI, approximately 80% of the global 

250 companies and the 100 largest firms in the US produced ESG reports in 2008–2009. However, the prevalence of reporting among the 

 Global 2000, or the top 2000 companies on a worldwide revenue basis, is much lower, at just over 30%. 

GRI aims to help organizations and companies learn about reporting on their sustainability performance and to make ESG reporting a mainstream practice by 2015, according to a Oct. 15, 2010 GRI press release. This goal is supported by several policies and policy documents worldwide. For example, a guidance issued by the Securities and Exchange Commission (SEC) in February of 2010 clarifies existing regulations stating that US companies should disclose certain specific climate-related impacts. The guidance also cites GRI Guidelines as a framework for ESG reports (1). GRI is emphasizing disclosure of information relating to the “triple bottom line” of people, planet, and profit, a commonly cited sustainability concept. In 2009, there was a 25% increase in the number of organizations worldwide using the GRI Guidelines for their ESG reporting, according to GRI. 

During the past 12 months, GRI has been engaging more closely with US companies, financial institutions, business associations, investors, and government agencies to examine ways to better integrate ESG data into financial reporting. Over the next 10 years, GRI will work with other organizations to develop a framework for integrated reporting to better unify financial and ESG reporting. 

In May 2010, GRI and the members of the United Nations Global Compact, a corporate social-responsibility initiative launched by the UN in 2000, agreed to align their work in advancing corporate responsibility and transparency. The UN Global Compact is a leadership platform endorsed by chief executive officers as a strategic platform for advancing sustainability and corporate citizenship. The compact has more than 7700 corporate participants in more than 130 countries and is structured as a joint public and private initiative. It serves as a policy framework for the development, implementation, and disclosure of sustainability principles and practices by offering participants specialized work streams, management tools, resources, and topical programs and projects to help advance sustainable business models and markets as part of a broader goal to build a more sustainable and inclusive global economy, according to the UN. The UN Global Compact has two objectives: to mainstream 10 UN principles involving human rights, labor, the environment, and anticorruption in business activities around the world and catalyze actions in support of broader UN goals, including the Millennium Development Goals, which are eight major objectives for poverty alleviation and related healthcare goals for the developing world. 

Under the terms of the agreement, GRI will develop a guidance regarding the UN Global Compact’s 10 principles and issue areas to integrate centrally in a next iteration of its Sustainability Reporting Guidelines, a comprehensive framework developed to facilitate transparency and accountability for businesses and other organizations seeking to disclose their environmental and social performance. At the same time, the UN Global Compact will adopt the GRI Guidelines as the recommended reporting framework for businesses that have joined the compact.

Commission Guidance Regarding Disclosure Related to Climate Change

The Global Reporting Initiative begins an effort to increase the level and strength of sustainability reporting among US-based corporations.

GRI Targets US Corporate Sustainability Reporting

An increasingly important focus in global-health initiatives is on noncommunicable diseases. Global and national health efforts in the developing world generally focus more on communicable diseases such as malaria, tuberculosis, and HIV/AIDS, but noncommunicable diseases such as diabetes, heart disease, and cancer are also important concerns for these nations. 

At a United Nations press conference held in February 2010, the issue of noncommunicable disease was addressed by representatives of the Caribbean Community (CARICOM) Initiative on Non-Communicable Diseases. CARICOM is an organization of 15 Caribbean countries and dependencies that work on economic integration and development. “Noncommunicable diseases are a development issue as much as a health issue,” said Donatus St. Aimee, permanent representative of Saint Lucia, following a briefing to member states on the CARICOM Initiative on Non-Communicable Diseases coorganized by the World Health Organization (WHO). CARICOM and other groups have raised the issue that, unlike communicable diseases such as HIV/AIDS and malaria, the prevention and control of noncommunicable chronic diseases have not formally been integrated into the world development agenda, including the UN Millennium Development Goals, a set of poverty alleviation and healthcare goals for developing nations.

In February 2010, WHO’s Director-General Margaret Chan addressed more than 100 stakeholders at the first Global Forum of the Non-communicable Disease Network (NCDnet) in Geneva, pointing to the problem of noncommunicable diseases in developing countries. “Diseases once associated with abundance are now heavily concentrated in poor and disadvantaged groups. Developing countries have the greatest vulnerability and the least resilience,” she said. 

NCDnet, a voluntary network of UN member states, donors, philanthropic foundations, UN agencies, nongovernmental organizations (NGOs), and the private sector, focuses on the prevention and control of noncommunicable diseases in low- and middle-income countries by augmenting collective advocacy, increasing resources, and promoting effective global and regional action to strengthen national capacity. It evolved from the May 2008 meeting of the 61st World Health Assembly, at which health ministers endorsed the Action Plan for the Global Strategy for the Prevention and Control of Noncommunicable Diseases (NCD Action Plan). The NCD Action Plan defined six objectives for implementation during a six-year period from 2008 to 2013. Under each objective, specific sets of action for UN member states, the secretariat, international groups, and other partners are detailed. Objective 5 of the 

 specifically calls upon member states, WHO, international partners, and other stakeholders to promote partnerships for the prevention and control of noncommunicable diseases. The creation of NCDnet is in direct support of this objective.

Noncommunicable diseases currently account for 35 million deaths annually worldwide, the majority of which happen in low and middle-income countries (28.1 million), according to an April 13, 2010 UN press release. In developing countries alone, an estimated 8 million such deaths per year are premature (i.e., people aged below 60 years of age) and could potentially be prevented. WHO forecasts that globally, deaths from noncommunicable diseases are likely to increase by 17% over the next 10 years, with the greatest increase projected in Africa (27%), followed by the Eastern Mediterranean region (25%). 

“It’s not like we have to wait for these countries to develop their economy, then start to suffer from noncommunicable diseases,” said UN WHO Coordinator of Health Promotion Gauden Galea in the Apr. 13, 2010 UN release. Galea noted that four chronic diseases(i.e., cardiovascular disease, diabetes, cancer, and chronic respiratory illness) are responsible for 60% of the world’s deaths, and 80% of these deaths are happening in the poorest populations of the world.

To address that problem, in May 2010, the UN General Assembly adopted a resolution calling for the curbing of premature deaths from noncommunicable diseases. “There is a sense of urgency,” said the UN Assistant Director-General Ala Alwan, in a May 14, 2010 UN  press release. “Tackling these diseases constitutes one of the major challenges for sustainable development in the 21st century.”

Many of the deaths caused by noncommunicable diseases in developing countries could be prevented by reducing exposure to tobacco use, unhealthy diets, physical inactivity, harmful use of alcohol, and by improving early detection of breast and cervical cancers, diabetes, and high blood pressure, according to WHO. In spite of signs that death rates from noncommunicable diseases have stabilized or even declined in many high-income countries in recent decades, research points to deaths from these diseases increasing in all regions of the world. Continuing on the current trajectory, more than 40 million people will die from them annually by 2015, according to WHO. 

The NCD Alliance, which consists of the International Diabetes Federation, the World Heart Federation, the Union for International Cancer Control, and the International Union Against Tuberculosis and Lung Disease, has been a strong advocate to raise the awareness of the need to include  noncommunicable diseases in global-health efforts. The group supports a forthcoming meeting, the UN High Level Summit on Non-Communicable Diseases, which is scheduled for September 2011. The UN announced the summit in May 2010. 

NCD has articulated the following five major objectives as part of  its 

 • Leading a civil-society movement for noncommunicable diseases 
 • Producing evidence based arguments to support the cause of  noncommunicable diseases
 • Acting as the global voice for its members and people with noncommunicable diseases 
 • Creating a global plan for NCDs and sharing innovative solutions and best practices on noncommunicable diseases 
 • Working with likeminded NGOs, governments, and businesses to take forward NCD Alliance key concerns to and from the summit 

As global efforts focus on noncommunicable diseases, companies, and countries are also focusing on the issue. For example, in late October 2010, the pharmaceutical company 

 (Bagsvaerd, Denmark) launched a training manual specific to the diagnosis and treatment of diabetes care for children in developing countries in cooperation with the 

International Society for Pediatric and Adolescent Diabetes

 (ISPAD). ISPAD is a professional organization that aims to promote clinical and basic science, research, education, and advocacy in childhood and adolescent diabetes. According to an Oct. 27, 2010 Novo Nordisk press release, childhood diabetes has a high mortality rate in developing countries, where life expectancy for a child with newly diagnosed Type 1 diabetes is typically less than one year. Novo Nordisk initiated the Changing Diabetes in Children program in 2006 to improve the conditions for children with diabetes in the developing world, where access to insulin, monitoring tools, and healthcare professionals knowledgeable about the disease is limited. 

In August 2010, Kenya launched a comprehensive national diabetes strategy, the first such effort by the country and by a country in Africa, according to the 

 (WDF), an organization focused on preventing and treating diabetes in the developing world. There are an estimated 1.6 million people living with diabetes in Kenya. The overall goal of the National Diabetes Strategy is to prevent or delay the development of diabetes in the Kenyan population and to improve the quality of life and reduce complications and premature mortality in people with diabetes, which involves national, regional, and district efforts, including the training of healthcare workers. 

Under the national program, nine diabetes clinics have been established in provincial hospitals in all Kenyan provinces, and screening and awareness camps have been conducted. Besides the recently launched National Strategy, manuals and guidelines for comprehensive diabetes care have been developed. In addition to providing support to Kenya, WDF has granted support to national programs in two other African countries, Uganda and Ghana.

The prevention and treatment of noncommunicable diseases is becoming an increasingly important consideration in global health initiatives.

Targeting Noncommunicable Diseases in Global Health

CPhI Worldwide, the large exhibition of contract manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical intermediates, and fine chemicals, was held in Paris in early October, and many companies took the opportunity to announce investments in augmenting their services, products, and capabilities. Below is a roundup of developments from exhibitors at CPhI and the International Contract Services Expo (ICSE), an exhibition that is colocated with CPhI that also features contract manufacturers of finished drug-product manufacturing and formulation-development services. 

 (Newcastle, UK) is investing in a new high-containment facility in Queenborough, United Kingdom. The facility is scheduled to be completed in May 2011. 

 (Craigavon, UK) is expanding its biocatalysis business with a $4-million investment for discovering new biocatalytic platforms and for other research areas. These areas include hyperactivation of biocatalysts to reduce enzyme loadings, drivers for cofactor recycles, and resolving problems with equilibriums. 

 (Riverview, MI) is investing to expand its Riverview, Michigan, facilities. The expansion is part of an ongoing five-year, $20-million investment program. The company announced the latest expansion in July 2010, which involves the construction of a storage and  materials-handling facility as well as the addition of reactor capacity. 

(Phillipsburg, NJ), formerly Mallinckrodt Baker, debuted its new name and identity following the recent acquisition of Avantor by an affiliate of New Mountain Capital (New York), a private-equity investment firm, from 

 (Dublin, Ireland). Covidien is retaining the Mallinckrodt name. Raj Gupta, formerly chairman and CEO of the specialty-chemical company Rohm and Haas (Philadelphia) was named executive chairman of Avantor Performance Materials. 

(Charlottetown, Prince Edward Island, Canada) is expanding its current good manufacturing practice (CGMP) microbial contract fermentation services at its facility in Charlottetown, Prince Edward Island, Canada. The expansion doubles the company’s capacity to handle clinical-stage projects and is expected to be completed in the fourth quarter of 2010. 

(Bubendorf, Switzerland), part of Dishman Pharmaceuticals and Chemicals (Ahmedabad, Gujarat, India), reported on its new high-potency manufacturing facility in India, which opened in January 2010. 

 (Somerset, NJ) reported on its Optiform compound-optimization platform, a solid-state and automated analysis platform for salt, crystal-form, and cocrystal screening. The platform was developed and refined during the past 10 years by 

 (GSK, London) and has been applied to more than 500 compounds. GSK entered into an agreement with Catalent to use the Optiform platform to support its internal screening activities. The deal between Catalent and GSK was brokered by SR One, GSK’s corporate venture fund. The Optiform compound-optimization platform and team is part of Catalent’s Development and Clinical Services team of 300 based in Research Triangle Park, North Carolina.

 (Muttenz, Switzerland) launched two replacement solvents, Highsol P99 and Highsolv E99, for use in organic synthesis. The solvents are designed as replacements for tetrahydrofuran, dichloromethane, toluene, and 

-methyl-2-pyrrolidone. Clariant also launched Mevopur, a line of color and performance masterbatches and compounds for pharmaceutical packaging and medical devices. 

 (Redwood City, CA), a biocatalysis company, expanded its line of Codex panels with the introduction of Codex screening kits. The screening kits consists of 24 enzymes, which represent two commonly used enzyme classes: ketoreductases and transaminases. 

, which recognize developments in improving pharmaceutical manufacturing and products, were awarded to three companies at CPhI in Paris. Thermo Fisher Scientific (Waltham, MA) received the Gold Innovation Award for TruScan, a hand-held spectrometer used for raw-material and finished drug-product identification. BASF (Ludwigshafen, Germany) won the Silver Innovation Award for its Soluplus excipient, a solublizer that is used in hot-melt extrusion applications. Zeon (Tokyo) won the Bronze Innovation Award for process innovation and green chemistry, for its solvent, cyclopentyl methyl ether.


 (Horgen, Switzerland) launched “FYI: Formulation Yields Innovation,” a new program that highlights the importance of the design and formulation of pharmaceutical excipients in driving innovation. The program centers on three main areas: value creation and cost containment, drug safety and efficacy, and product life-cycle management. 

 (Livingston, UK), reported on receiving US and European patents for its DuoCap capsule-delivery system. The DuoCap system is a single oral dosage unit that consists of a capsule in-a capsule. The inner and outer capsules may contain the same API with  multiple release profiles such as an immediate-release formulation from the outer capsule and a controlled-release formulation from the inner capsule. The system also is used to target different areas of the gastrointestinal tract respectively in the inner and outer capsules. It also can be used as a way of delivering combination drugs in which the APIs may be incompatible in a single capsule. 

, which were organized by Via Media UK in conjunction with Via Connect, were announced during the week at CPhI Worldwide in Paris in early October.

 (Parsippany, NJ) was recognized for the most improved process by developing a biocatalytic route for a pharmaceutical intermediate. 

 (Somerset, NJ) was recognized for the best contract-manufacturing project. The project used the company’s expertise in softgel technology, overencapsulation, and packaging for launching Duodart, a fixed-dose combination therapy. 

(Geneva) was awarded the best contract analytical project, which involved its new service for industrial gas analysis in pharmaceutical manufacturing. SGS worked with a large pharmaceutical company to develop the new service and deliver qualified and validated methods within six months. 

 (London) were recognized for the most effective scale-up and technology transfer project. 

 (Milan), a producer phytochemicals,  was awarded best new product for Meriva, a proprietary complex of curcumin. 

(Basel, Switzerland), a global logistics provider, was recognized as a supply-chain management category winner. 

 the contract-manufacturing arm of the pharmaceutical company 

 (Espoo, Finland), is investing EUR 5 million ($7 million) in its plant in Oulu, Finland, to expand its capabilities in high-potency manufacturing. The company conducted a SafeBridge precertification inspection in the third quarter of 2010. The expansion is expected to be operational in early 2012.

 (Dessau-Rosslau, Germany) is expanding its viral-vaccine production capacity with the addition of a new high-speed filling line and additional lyophilization capacity. The expansion is scheduled to be completed by mid-2013. 

 (ISP, Wayne, NJ) is launching a high-purity crospovidone (Polyplasdone Ultra and Polyplasdone Ultra-10) in November 2010 as part of its toolkit for increasing the bioavailability of poorly water-soluble drugs. The product will be manufactured at its facility in Texas City, Texas. ISP recently published results of a study demonstrating the solubilization benefits of Polyplasdone crospovidione in formulations of poorly water-soluble drugs. 

 (Bagsvaerd, Denmark), developed and launched a recombinant source of sodium hyaluronate, which is not derived from animal-based raw materials. Sodium hyaluronate is traditionally derived from rooster combs or from strains of 

 bacteria, which may potentially result in safety risks from animal proteins, viruses, or endotoxins, according to the company. Novozymes uses fermentation for producing 

 sodium hyaluronate. The product is used in drug formulations and may be used in drug-delivery systems, including nanocarriers, micelles, cross-linked hyaluronic acid molecules, hydrogels, powders, minipellets, implants, sponges, films, and conjugates. Novozymes is constructing a new CGMP facility for its 

-based hyaluronic acid in Tianjin, China. The facility will make pharmaceutical-grade products. Large-scale GMP production is planned for the first quarter of 2011. 

In other news, Novozymes reported that the US Food and Drug Administration has accepted a Type IV Master File for its recombinant albumin product, Albucult. The product is derived from the company’s proprietary yeast-expression technology.

 (Mumbai), completed the latest phase of its investment program to increase production capacity for antibody drug conjugates at its facility in Grangemouth, Scotland. The expansion will support the GMP production for the planned launch of new cancer treatment by an undisclosed US-based biotechnology company in 2011. 

 (Gorinchem, The Netherlands) is investing EUR 15 million ($21 million) in a new manufacturing facility in the United States for its biomedical polymers. The company’s biopolymers business includes lactide-based polymers such as polylactic acid and lactide/glycolide copolymers. The company currently manufactures biopolymers at its facility in The Netherlands. Construction of the US-based facility will begin in 2011 and is expected to be completed by the end of 2011. 

 (St. Louis, MO) completed its expansion of its high-potency fermentation capabilities at its facility in Jerusalem. Production was scheduled to begin in October 2010. 

 (Leverkusen, Germany) is considering setting up capacities for manufacturing highly potent APIs at its facilities in Leverkusen, Germany, and Redmond, Washington. The company reported on the news in an Aug. 24, 2010, press release, in announcing its activities at CPhI. In early October 2010, Saltigo also reported that it will jointly develop processes for the synthesis of APIs and intermediates with Reuter Chemische Apparatebau (RCA, Freiburg, Germany). RCA produces chiral substances.

Contract Manufacturing

Contract manufacturing organizations and fine-chemical suppliers unveiled capacity, product, and service expansions at CPhI Worldwide in Paris last month.

PTSM: Pharmaceutical Technology Sourcing and Management-11-05-2010

CSR and Sustainability Forum

Buyers in Short Supply

GRI Targets US Corporate Sustainability Reporting

Targeting Noncommunicable Diseases in Global Health

Contract-Service Providers Announce Expansions at CPhI Worldwide