The pharmaceutical industry is engaged in a multitude of global health initiatives, which include partnerships with governments, intergovernmental organizations, nongovernmental organizations (NGOs), private-sector companies, and universities.  To help evaluate these partnerships, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) recently partnered with BSR, a global business network consultancy focused on sustainability. To carry out the review, BSR developed an evaluation framework to help IFPMA, its stakeholders, and companies better understand how individual partnerships are contributing to improving global health 

Last month, IFPMA published the 2012 update to its Developing World Health Partnerships Directory. The directory outlines 220 partnerships between the research-based pharmaceutical industry and its partners, including governments, intergovernmental organizations, NGOS, private-sector companies, and universities that serve people in 160 countries. The launch of the directory coincided with the release of an independent review by BSR of the contributions these health partnerships make to the health of people in low- and middle-income countries. 

“Global health issues are complex, and solutions often require a range of organizations working together,” said Eduardo Pisani, IFPMA Director General, in a Sept. 11, 2012, IFPMA release. “Understanding the value of partnerships, our industry and partners have increased these programs dramatically in recent years as highlighted in our directory. This year, we are pleased that BSR analyzed these programs and made suggestions for increasing the benefit people in developing countries.” 

 The industry-led health partnerships catalogued in the IFPMA’s 

Developing World Health Partnerships Directory 

 focus on a wide range of activities: developing new treatments, improving the availability of new and existing drugs, strengthening health systems, raising awareness, prevention, and training. They also cover various types of diseases, such as HIV/AIDS, neglected tropical diseases, malaria, noncommunicable diseases, and other multifaceted health challenges, such as improving women’s and children’s health. 

 Of the 220 global health partnerships reviewed by BSR, 20% were focused on HIV/AIDS, 16% on neglected tropical diseases, 16% on women’s and children’s health, 14% on malaria, and 14% on noncommunicable diseases.  On a program basis, 50% of the partnerships strengthen health-system infrastructure, and 79% focus on training. Thirty-six percent focus on improving availability of treatments, including donation programs. Fifty-nine percent of the partnerships are R&D-based collaborations focused on the development of new treatments, and 38% focus on awareness raising, prevention, and outreach. The majority of partnerships (62%) involve NGOs, and also include partners from government and academia, and 15% of the partnerships involve multiple research-based pharmaceutical companies. 

According to BSR’s review, 90% of companies surveyed expect to increase partnership commitments toward noncommunicable diseases while maintaining commitments across other therapeutic areas. While 65% of the industry-led health partnerships currently operate in Sub-Saharan Africa, expansion is planned in South Asia, East Asia, and Latin America. Forty percent of companies interviewed expect to increase investments in partnerships. 

 The BSR review also examined the critical success factors for increasing the impact of the health partnerships, including the adoption of a health needs-based approach, engaging in broad-based and multi-company partnerships, and aligning existing and future partnerships to maximize shared resources and expertise. Using existing country systems and local ownership  also is important as is providing comprehensive outcome tracking and impact measures, according to the BSR review. 

Articles

CSR and Sustainability Forum

A recent review evaluates the nature of global health partnerships and critical factors for their success.

Pharmaceutical Companies Partner in Global Health

The global economy and financial system is not in great shape. The European debt crisis rolls on and on, driving European economies into recession. China's growth has slowed to "only" 7%, but that slowdown is enough to reduce growth prospects of countries that export to China. India's economy is feeling the effects of institutional problems, such as corruption and poor infrastructure. The US economy is growing, but at a rate too slow to bring down unemployment.  

The apparent incompetence of political leaders has not improved the mood. The inability of the US Congress to address the nation's debt and economic issues and the uncertainty surrounding the upcoming national elections have created great uncertainty and caused business executives to scale back investment and employment plans. The failure of European political leaders to resolve their problems has undermined investor confidence and created volatility in financial markets. Even in China, where the Communist party maintains a strong grip, the impending change in leadership has added an element of uncertainty. 

In the not-so-distant past, such macroeconomic developments would have had little impact on the bio/pharmaceutical industry. Global bio/pharmaceutical  companies were generating large profits from patented blockbuster medications and pouring them back into expansive R&D programs and investments in new laboratory and manufacturing facilities.  People had to take their medicine and the effectiveness of drugs, such as Lipitor and Plavix, ensured that governments and private insurers would continue to pay for them regardless of price. Attracted by the returns on successful new pipeline candidates and flush with cash, investors poured record amounts of capital into early- and mid-stage companies. 

Today, having fallen over the patent cliff, the bio/pharmaceutical industry finds itself fully exposed to the vagaries of the macro-economy at a very inopportune time. Not only have companies lost the big profits from blockbuster drugs, they also face increased pressure from governments and private payers that are desperate to reduce healthcare expenditures. Drug prices are being forced down, generic substitution is accelerating, and it is increasingly difficult to get coverage for expensive new drugs.  

Smaller companies are being buffeted by the uncertainty in financial markets. Venture-capital funds have less money to invest as their traditional investors have become more risk-averse, and venture capitalists themselves have focused on less-risky investments with faster payoffs, such as social-media companies. In instances where they are still investing in bio/pharmaceutical start-ups, they are favoring companies with later-phase candidates with strong near-term prospects for out-licensing. Funding by way of initial public offerings is scarce. The number of bio/pharmaceutical initial public offerings is way down, and most have lost value since they were launched. 

These pressures could not come at a worse time for an industry desperately trying to maintain profitability in order to fund new product development. Pipelines at many bio/pharmaceutical companies are sparse, and R&D operations have been notably unproductive despite significant cost-cutting. High profile drugs continue to fail at Phase III despite the "kill-it-early" philosophy that guides decision-making at most bio/pharmaceutical companies. 

So, instead of a stable macro-environment in which to transition to the next generation of products, bio/pharmaceutical companies must fight fierce headwinds  to make progress. They have been forced to remake their business models not just to address the new scientific and clinical realities but also to reflect their closer connection to a world that cannot afford to maintain the rapid growth in healthcare expenditures.   

The business model changes thus far have been dramatic. Global bio/pharmaceutical companies now pursue growth opportunities in niche products, generic drugs, and emerging markets instead of traditional blockbusters. They are downsizing their remote R&D campuses while building their presence in urban centers of medical research where their researchers can be continuously exposed to new ideas and technologies (a model that other knowledge-based industries have long subscribed to). They are rebuilding R&D processes to more thoroughly assess new candidates before graduating them to expensive clinical development stages. They are re-engineering supply chains to reduce costs and increase security. Although still dependent on physicians to prescribe their medications, they are looking for ways to interact more directly with patients. 

If the fortunes of bio/pharmaceutical  companies are now closely tied to the macro-environment, then too are the fortunes of CROs and CMOs. CMO revenues and margins are directly impacted by the declining unit volumes and growing customer demands in that they help absorb the lower prices being paid by governments and insurers. Providers of preclinical toxicology and API process-development services have seen their revenues stagnate as more rigorous graduation criteria and decreasing venture-capital support have reduced the level of early-development activity. In these changing times, CROs and CMOs have two choices: they can continue their traditional strategies of passively bobbing up and down on the rising and ebbing tides of the industry or they can seize the opportunity to help bio/pharmaceutical companies deal with their increased exposure to the macro-environment.  

Clinical CROs have shown the way on how service providers can help bio/pharmaceutical companies adapt to their new realities. Although originally just a source of supplemental labor, they have come to set the standards for quality and innovation in the running of clinical trials. In particular, they have led the way in the use of information technology to revolutionize the way in which clinical data are collected and analyzed. CRO-driven technology innovation has enabled faster review and analysis of clinical data, flexible trials designs, and patient-reported data using mobile devices.  

Similarly, clinical packagers have been in the forefront of adopting sophisticated packaging and printing and logistics technologies and practices to reduce the costs of clinical-trial materials while ensuring supplies get to patients in a timely manner. All of this has enabled clinical research to be conducted faster and more cost-effectively. 

CMOs have lagged behind other service segments in identifying technologies and practices that can help bio/pharmaceutical companies respond to the changing macro environment. In particular, they need to find more flexible and lower cost manufacturing solutions to address a medical marketplace that is more focused than ever before on managing total expenditures. 

The ability and willingness of CROs and CMOs to contribute to the remaking of the bio/pharmaceutical business model, and especially to the ability of bio/pharmaceutical companies to respond to the macro-environment, is likely to determine their long-term success. 

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

, tel. 703.383.4903, Twitter@JimPharmSource, 

Outsourcing

The weak global economy adds to the challenges of bio/pharma companies and their suppliers.

The Macro View

Pharmaceutical companies are increasing their investment in Russia as that country’s pharmaceutical industry, like other emerging markets, are expected to see strong growth. Encouraged by a state plan to increase domestic production and R&D in Russia, pharmaceutical companies are making greenfield investments as well as partnering with local companies as a means to access Russia’s pharmaceutical market. 

Russia’s role in pharmaceutical industry growth 

Russia’s pharmaceutical industry growth is part of shifting industry growth from developed markets to emerging markets. Annual global spending on medicines will reach nearly $1.2 trillion by 2016, according to the IMS Institute of Healthcare Informatics. In the developed markets, including the United States, Europe and Japan, spending will decline to 57% of the global total due to expiring patents for a number of significant brand-name drugs, slower increases in spending on branded products, and increased cost containment measures by payers. Alternatively, so-called “pharmerging” markets will reach 30% of global spending by 2016, as population and economic growth contribute to dramatically higher use of medicines in these markets. The pharmerging countries, which include the major emerging markets of the BRIC (Brazil, Russia, India, and China) countries and second- and third tier emerging markets, are expected to nearly double their pharmaceutical spending by adding $150 billion and $165 billion in growth by 2016, according to the IMS Institute of Healthcare Informatics. Among the BRIC countries, China’s pharmaceutical market is expected to be the largest and reach $161 billion by 2016, followed by Brazil at $47 billion, India at $29 billion, and Russia at $27 billion, according to IMS. Russia’s pharmaceutical market was ranked eleventh in 2011 and is expected to move to the ninth position by 2016, surpassing established markets of Canada and the United Kingdom, according to the IMS Institute for Healthcare Informatics. Russia’s pharmaceutical market is expected to reach $27 billion by 2016, increasing by $10.7 billion between 2011 and 2016. 

Unlike other BRIC countries, such as India and China, which have a domestic manufacturing base, Russia is largely dependent on pharmaceutical imports. Its domestic biomedical industry accounts for only 0.2% of the global market, but the country is committed to change that through an ambitious program, Pharma 2020. Pharma 2020, a state-initiated plan, seeks to boost output of local medicines from 25% of gross sales in 2010 to 50% by 2020, upgrade domestic pharmaceutical manufacturing operations to GMP standards, and increase the level of innovator pharmaceuticals in the Russian market (1). Several pharmaceutical majors are increasing their presence in Russia with manufacturing and R&D investment.

 Pharmaceutical companies position in Russia 

In September 2012, Takeda Pharmaceutical completed construction at its pharmaceutical manufacturing facility in Yaroslavl, Russia. The company has invested approximately EUR 75 million ($97 million) in the 24,000-m

production plant, which is expected to be fully operational by 2014. The plant, which is approximately 280 kilometers from Moscow, is one of the first by a major multinational company in Yaroslavl’s pharmaceutical cluster. 

 The Yaroslavl facility will enable Takeda to meet demand in Russia initially for several products: Cardiomagnyl (acetylsalicylic acid and magnesium hydroxide), Actovegin (derived from calf blood), and calcium tablets. The plant will have the initial capacity to manufacture 90 million sterile ampuls and more than two billion tablets per year. Liquid-sterile production includes solution preparation, washing of ampuls, sterilization, filling, inspection, and packaging.  Solid production will encompass all stages, from weighing, mixing, and granulation through compression, coating, and packaging. The company expects to create 200 managerial and technical jobs during the next three years with the new plant. 

Takeda estimates that it is the seventh largest pharmaceutical company in Russia and expects company annual growth rate of 15% in Russia between 2012 and 2016. “The completion of this ambitious project further demonstrates Takeda’s transition into a truly global business, and strategic investment into key emerging markets, such as Russia, is a major part of this strategy,” said Yasuchika Hasegawa, president and CEO of Takeda Pharmaceutical, in a Sept. 11, 2012, company press release. “Russia is our largest emerging market in terms of revenues and is expected to contribute significantly to our growth over the next few years.” 

 In April 2012, Novo Nordisk broke ground today on a new $100 million plant in Russia that will formulate and fill insulin into Novo Nordisk’s Penfill cartridges and pack the FlexPen prefilled insulin delivery device for the Russian market.Located in Grabtsevo Technopark in the Kaluga region, the plant is expected to start manufacturing in 2014. The company's intention to establish insulin production in Russia was first announced in April 2010 during the visit to Denmark by Dmitry Medvedev, President of Russia. At that time, an agreement of cooperation between the Government of the Kaluga Region and Novo Nordisk was signed.  Sanofi also recently increased insulin capacity at its facility in Orel, Russia. Sanofi obtained the facility following its acquisition of a controlling stake in the pharmaceutical company Bioton Vostok in 2010. 

Novartis is proceeding with a new $140-million manufacturing plant for pharmaceuticals and generic drugs in St. Petersburg, Russia. The plant is expected to produce approximately 1.5 billion units per year (oral solid dosage forms). The new greenfield facility is in the Novoorlovskaya Special Economic Zone located to the north of the St. Petersburg city center. Novartis began construction of the facility in 2011. The facility is expected to be completed and approved for commercial production in 2014. 

 The facility is part of a $500 million five-year investment into Russian healthcare infrastructure announced by Novartis in December 2010. This plan addresses three core areas: local manufacturing, R&D collaborations, and public health development in Russia. These activities include collaborations with both universities and academia, but also with emerging Russian private business in different areas of medical science. The scope of these collaborations may include such efforts as out-licensing of Novartis compounds to Russian companies with proven scientific capabilities, in-licensing and scouting for promising drug candidates from Russian scientists and universities, and modeling and simulation activities for clinical trials. Novartis is actively working in all of these areas, identifying high potential projects to be jointly developed. Additionally, Novartis also has made a commitment to double its investments in drug development in clinical trials in Russia and expects to enroll approximately 4000 individuals by the year 2013, said the company in announcing its plans in December 2010. 

 In 2011, AstraZeneca announced  plans to establish a Predictive Science Center in St. Petersburg, the company’s first such center in Russia. The center will focus on developing bioinformatices, data-analysis methods, software, and systems to evaluate safety and efficacy of new drugs. Approximately 30 people will be employed at the center through local collaborations and organizations. Also in 2011, AstraZeneca began construction of a new $150-million manufacturing facility in the Kaluga region in Russia to supply locally produced medicines. The company also has partnerships with several R&D institutes in Russia, including the the Skolkovo Innovation Center and Russia Venture Company, for research and clinical trials. 

 Abbott Laboratories signed an agreement in July 2012 for several R&D projects in Russia with the country's ChemDiv Research Institute (CDRI).  The first collaboration between CDRI, the research entity of ChemRar Hi-Tech Center, and Abbott will focus on creating an advanced new formulations of existing Abbott's pharmaceutical products. CDRI and Abbott are also discussing regarding several programs for joint small molecule medicine's development and enhancement. ChemRar's R&D company, Intellectual Dialog, also launched a research project with Abbott aimed at prevention and treatment of selected viral diseases impacting children and the elderly. Intellectual Dialog will conduct discovery research in collaboration with Abbott. 

 In July 2012, Pfizer granted exclusive development and marketing rights to Russian firm SatRx for its dipeptidyl peptidase-4 (DPP-4) inhibitor PF-00734200 for Type 2 diabetes.SatRx, which is part of the ChemRar Hi-Tech Center, received worldwide rights (excluding China) to the drug as monotherapy or in combination with other diabetes drugs. Pfizer will receive royalties and milestone payments based on commercialization activities. The agreement was developed as partial fulfillment of a memorandum of understanding reached in March 2011, under which Pfizer and ChemRar agreed to explore collaborations focused on research, development and commercialization of innovative compounds and vaccines to treat cardiometabolic, infectious and oncologic diseases in Russia and other countries.In 2010, GlaxoSmithKline formed an alliance with JSC Binnopharm for the local secondary manufacture of several GSK vaccines. Under this alliance, which was announced in November 2010, GSK will supply bulk vaccine and provide technology and expertise to enable Binnopharm to undertake the secondary manufacture, including filling and packaging of GSK vaccines. Binnopharm will be responsible for gaining approval of their facilities to allow supply of GSK cervical cancer, rotavirus, and pneumococcal vaccines under Binnopharm's trademark for the Russian public market. 

1. 1. G. Peach, “Russia Pledges $4 billion for Pharma-2020 Plan,” 

Global Feature

Several Big Pharma companies strengthen their manufacturing presence in Russia.

Pharma Majors Build Manufacturing Capacity in Russia

reports that it was included on both the Dow Jones Sustainability World Index  (DJSI) and North America Index for the eighth consecutive year. As a member of the Dow Jones Sustainability World Index, Abbott ranks among the top 300 of the 2500 largest companies worldwide in corporate sustainability. The DJSI recognize leading companies in each industry sector for responsible economic, environmental and social performance. Abbott was named the industry sector leader in several categories, including environmental reporting and climate strategy. Abbott also led the industry in innovative philanthropy, stakeholder engagement, and risk and crisis management. Abbott also was named one of the top three "Best in Class" companies in its industry sector for financial, environmental and social performance by Storebrand Investments and has been included on the Ethibel Excellence Investment Register since 2005 in recognition of the company's economic, social and environmental performance.

is making available approximately EUR 200,000 ($258,331) for 49 students of the natural sciences, engineering, and medicine as well those training to become science teachers or young people from skilled non-academic professions. The scholarships are targeted at students and vocational trainees in natural science and medical disciplines who would like to realize a particular foreign study project and require financial support for this. In addition to German-based applicants who would like to study abroad, the foundation supports scholarship recipients from outside of Germany who wish to realize a comparable project in Germany.  Academic disciplines receiving support this year include biology, biotechnology, chemistry, molecular biology, and human and veterinary medicine. Seven Kurt Hansen scholarship recipients are also receiving assistance for teacher training in biology and chemistry. 

reports that applications for the 2013–2014 school year are available for the 15th Annual Lilly Reintegration Scholarship. The program provides funding for tuition, books, and laboratory fees to people living with bipolar disorder, schizophrenia, and related schizophrenia-spectrum disorders, so they may pursue and achieve their educational and vocational goals. 

) presented several environmental and sustainability programs at sessions at the CleanMed Europe conference, held Sept. 26¬28, in Malmo, Sweden. CleanMed is a conference focused on sustainable healthcare and addresses the environmental impact of the healthcare sector at the local, regional, and global levels. The presentations complement a recently released Johnson & Johnson report, 

The Growing Importance of Sustainable Products in the Global Health Care

, which examines the growing demand for sustainability in global healthcare. Janssen’s environmental sustainability programs include the Earthwards process for greener products and the use of on-site renewable energy sources.

. has issued its 2011 global corporate responsibility report. The report reviews performance and activities within the four key corporate responsibility areas that the company has identified as mission critical: access to health, environmental sustainability, employees and ethics, and transparency. The company estimates it global corporate giving at $1.3 billion and reaching 273 million people through its major responsibility programs and partnerships. Its contributions include $34.7 million for partnerships to address barriers to health. Its employees have volunteered 210,500 hours, and the company has reduced its global water use by 1 billion gallons. 

,  have jointly launched a new, free-of-charge, online pharmaceutical disposal guide for healthcare providers and facilities called the “Pfizer Responsible Disposal Advisor.” Pfizer says it is the first pharmaceutical company to make this resource available to healthcare professionals to help guide them through complex waste disposal requirements. Pfizer is using WM’s PharmE Waste Wizard, an online search engine that provides waste categorization and disposal information for healthcare facilities, including physician practices, clinics, ambulatory surgery centers, and walk-in clinics. The information provided in the Pfizer Responsible Disposal Advisor does not apply to medicines discarded by consumers. 

 has been recognized by the Carbon Disclosure Project (CDP) for actions to reduce emissions and mitigate the risks of climate change. For the first time, CDP named Pfizer to its Carbon Performance Leadership Index (CPLI), which highlights those companies within the FTSE Global Equity Index Series (Global 500) and the Standard & Poor’s (S&P) 500 Index that have demonstrated a strong approach to climate strategy and emissions reduction in their CDP responses.This year, Pfizer is ranked number two in the healthcare sector by the CDP for its carbon performance in the united in the S&P 500, and number three in the healthcare sector in the Global 500. Pfizer met its first greenhouse-gas reduction goal in 2007 and is in the process of designing its third public goal.

 has been recognized as the most sustainable healthcare company globally in the Dow Jones Sustainability Index (DJSI), for the fourth year in a row. The DJSI World and DJSI Europe Indexes track the performance of the leading sustainability companies based on best-in-class approach in environmental, social, and economic performance. This year’s DJSI assessment emphasized a number of Roche’s efforts as a sustainable company. They include Roche’s strategy thath focuses on medical innovation and its personalized healthcare approach, which addresses healthcare efficiency and improves health outcomes. Roche’s program on developing future leaders and respecting human rights were also recognized, together with the company’s pilot program for differential pricing in developing countries that aim to expand the number of people able to access Roche medicines. In 2009 Roche defined a number of five-year corporate goals, including a diversity objective to increase the percentage of women in key positions by at least 50%, an energy efficiency goal of a 10% reduction in energy consumption, and an increase in energy efficiency by end of 2014.

) have formed a new research collaboration agreement to accelerate the discovery and development of novelcompounds against tuberculosis (TB). Under the agreement, Sanofi and TB Alliance will collaborate to further optimize and develop several novel compounds in Sanofi’s library that have demonstrated activity against Mycobacterium tuberculosis, the bacterium that causes TB. This includes in-depth research of lead compounds based upon identified chemical derivatives of natural products, which have promising potential to treat all forms of TB, and the chemical optimization of other series of compounds that have been identified as hits through high-throughput screening.

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

CSR and Sustainability in the News

As contract manufacturers and fine-chemical producers assemble for CPhI Worldwide, in Madrid, Oct. 9–13, companies are proceeding with expansion of manufacturing capacity, services, and forming new partnerships. Some highlights from 2012 thus far are outlined below. 

has announced a partnership with the Center for Pharmaceutical Engineering Science at the University of Bradford in the United Kingdom. The agreement will enable Bradford scientists to use the GMP capabilities and assets held at Aesica while Aesica will have access to the center’s research facilities. 

 is expanding its UK commercial packaging facility with the acquisition of a Noack N 623 blister packaging line from Romaco. The acquisition comes in response to growing client demand for enhanced flexibility related to larger blister sizes and innovative multi-unit blister formats, coupled to a requirement for nonpermeability and enhanced environmental protection, particularly product humidity control. Earlier this year, Almac increased blister capacity at its US commercial packaging facility in Audubon, Pennsylvania. 

In other news, Almac has launched a new reagent offering based on the provision of homogeneous full-length histones with defined patterns of modification. The histone reagents provide a tool for researchers for drug targets in the field of epigenetics. Almac also expanded its refrigerated storage and labeling facilities at its UK site. 

 entered into an agreement with Knopp Biosciences to provide various discovery-related services that include medicinal chemistry, drug metabolism and pharmacokinetics, and computer-aided drug discovery, as part of AMRI’s Smartsourcing platform. 

 United Drug, a provider of healthcare services, acquired the clinical-services company 

 from Bilcare Limited for a total consideration of $61 million. Bilcare Limited is retaining its clinical supplies business in Asia. 

 is planning an expansion of its large-scale API manufacturing facility in Germantown, Wisconsin. The expansion comes three years after commissioning the new site. The expansion will include additional reactor capacity as well as isolation equipment. Alongside capacity additions, CML has made additional investments in engineering controls to ensure the sustainability of the business. 

 and ADC Biotechnology have agreed to provide customers with development and manufacturing services for antibody drug conjugates. ADC is developing a “lock and release” solid-phase immobilization technology for production of ADCs. The alliance will offer services for the development, scale-up, manufacturing, and formulation of protein-based drug conjugates. ADC Bio will provide access to proprietary solid-phase immobilization technologies for conjugation and long-term storage of ADCs, and Carbogen Amcis will focus on focus on small- to large-scale GMP supply and on the formulation of ADCs. 

 has agreed to supply an API for a customer’s Phase III program. The agreement is expected to contribute more than $20 million in revenues to Cambrex, which will expand its large-scale multipurpose cGMP assets in 2012 and 2013. 

has established a global alliance with Parexel International to help streamline the clinical-trial supply process. The alliance will provide a fully integrated service offering aimed at ensuring the timely and efficient delivery of clinical-trial materials. In other news, Catalent Pharma Solutions and CTC Bio have agreed to provide services to South Korean pharmaceutical companies seeking to commercialize solid oral-dose and controlled-release products in the US and Europe. 

 has expanded the capacity of its Wisconsin-based API manufacturing plant as a result of an increased demand for contract manufacturing of commercial APIs as well as additional upgrades for improving safety and GMP systems. 

has signed a biologics contract manufacturing agreement with Recepta Biopharma, based in Brazil. The contract covers the process development and cGMP manufacture by DSM of one of Recepta’s lead antibodies at DSM’s facilities in Groningen, the Netherlands.

 has invested $2 million to expand its facilities for equipment for product mixing and capsule-filling. Delivery of the new equipment started in August and will be completed by February 2013. 

Haupt Pharma successfully passed inspections by FDA at four sites in Germany during the first half of 2012. 

 agreed to acquire an API manufacturing facility and an associated R&D facility from Orchid Chemicals & Pharmaceuticals, an Indian pharmaceuticals company, for approximately $200 million. The proposed acquisition follows Hospira’s 2010 purchase of Orchid’s generic injectable business and permits Hospira to be vertically integrated into certain beta-lactam antibiotic APIs. 

 has expanded its solutions to solve issues of poor bioavailability, patient acceptability, and delivery for non-oral routes of administration. Hovione’s toolkit of solutions includes crystal design, particle-size reduction to the micro or nano-scale, and amorphous solid dispersions. These services are offered from bench to commercial scale and are complemented with formulation development and clinical manufacture to Phase II. 

 contract manufacturing and services division has launched an analytical services unit that will provide laboratory method development and related analytical testing as part of its integrated service offerings. 

has announced a EUR 3-million ($3.69 million) investment to expand its highly potent API manufacturing capabilities at its Le Mans, France, facility. The expansion is expected to be fully operational by the beginning of 2013.

 and Molecular Profiles have formed an agreement to deliver end-to-end services from initial drug discovery to early- and late-phase manufacturing. 

 sold its global secondary clinical packaging and clinical distribution services business to Bellwyck Packaging Solutions, a provider of clinical-trial and contract services for secondary packaging. 

has received regulatory approval from French health authorities to fill biotechnology products at its site in Monts, France. The Monts site, which employs 200 personnel, comprises three filling lines. Two large capacity lines are used for glass vials for injection and a third one is an aseptic line that fills cartridges. 

, part of Sigma-Aldrich, plans to expand its operations in Scotland by investing in the development of a new powder-manufacturing facility on its Irvine site. SAFC’s new facility in Irvine is its second powder manufacturing facility, which will support SAFC’s risk-management program, providing an internal back-up supplier for its customers. The new facility will be used to service customers across Europe and will create 24 new jobs. The project is being supported by a £1.5-million ($2.42 million) Regional Selective Assistance grant from Scottish Enterprise. 

 has announced that its Tainan, Taiwan, facility will provide commercial manufacturing of topiramate, the API for Vivus’s Qsymia, a new drug for treating obesity that was approved by FDA on July 17, 2012. 

 completed an expansion of its Fairfield, New Jersey, facility on Sept. 20, 2012. The expansion enlarges the size of the facility from 15,000 to 30,000 ft

 by adding modernized and new GMP/GLP-compliant laboratories, and increases ICH Zone 1–4 storage capacities. 

has begun construction of its new compression molding facility in Sri City, India. The plant will become part of West’s global supply chain for its pharmaceutical packaging operations. 

 facility in Tampa, Florida, on Sept. 14, 2012. The building will be used for primary and secondary packaging, labeling, distribution, and warehouse services. This is the company’s second facility in the Tampa Bay area, and the company says it will be audited and approved for domestic as well as European clinical trials. 

Contract Manufacturing

Fine-chemical manufacturers producers and contract manufacturers roll out manufacturing and service expansions at CPhI in Madrid.

PTSM: Pharmaceutical Technology Sourcing and Management-10-03-2012

Pharmaceutical Companies Partner in Global Health

The Macro View

Pharma Majors Build Manufacturing Capacity in Russia

CSR and Sustainability in the News

Fine-Chemical Producers and Contract Manufacturers Assemble at CPhI