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COMPANIES such as Albany Molecular Research Inc. and Ricerca Biosciences are riding a wave that is not close to cresting: the outsourcing of drug-discovery chemistry. Although pharmaceutical companies have preferred [...]

The article focuses on the rising importance of excipients, the inactive pharmaceutical ingredients, due to their influence on drug efficacy and manufacturing economics. It mentions that drug formulation by drawing on a board palette of excipients is necessary for the viability of a drug product or its differentiation throughout the life cycle. The major pharmaceutical companies are expanding their production capacity for excipients as there is healthy global demand for health care.

Focuses on the benefits of the new Pharmaceutical Affairs Law (PAL) on pharmaceutical industries in Japan. Comment of Ralf Pfirmann, global business director of Clariant Pharmaceutical Fine Chemicals, regarding the amendment of the PAL; Impact of the new law on the globalization effort of Japanese pharmaceutical companies; Significance of the PAL for qualified overseas manufacturers of active drug ingredients.

Reports that the new technologies for improving expression are expanding effective capacity and lowering the cost of biologics produced by mammalian cell culture. Consideration of high cost as the key shortcoming of protein drugs; Investments made by all the major players in monoclonal antibodies to increase output per unit volume; Task entrusted to the Chinese hamster ovary in developing biopharmaceuticals.

Examines the risks and rewards of off-patent active pharmaceutical ingredients (API). Estimated value of the off-patent API market; Fragmentation of the supplier base; Decision of mid-sized companies to make custom manufacturing a significant contributor after establishing themselves in the generics market.

The article presents information on recent developments related to the pharmaceutical industry. Great Britain-based AstraZeneca, which cut 12,600 jobs between 2007 and 2009, said that it intended to cut another 10,400 by 2014. U.S.-based Eli Lilly & Co. announced plans to cut staff by 5,500 by the end of 2011. Rob Bryant, director of Great Britain-based fine chemical consultancy Brychem, warns against acquiring API facilities from pharmaceutical companies.

The article discusses how the faith in generic drugs market is growing among major pharmaceutical companies. Novartis AG has maintained one of the largest generics businesses in the world, Sandoz, since it was formed by the merger of Ciba-Geigy and Sandoz in 1996. In March 2009, Pfizer Inc. announced an expanded relationship with Indian firm Aurobindo. In May 2009, Pfizer announced another deal with Aurobindo, as well as a deal with Indian injectable generics specialist Claris Lifesciences.

The article comments on the European Commission's (EC) investigation into pharmaceutical sector of Europe. The article states that the pharmaceutical sector inquiry seems to be speculative. The article states that the pharmaceutical enquires not random and the restructuring of the pharmaceutical industry lies ahead.

The article profiles the increasing use of fluorine in the pharmaceutical market. The fluorine compounds increases the drug lipophilicity. Introduction of fluorine not only strengthens the drug's interaction with the target receptor, but also increases the drug's lifetime and influence the dose of the drug.

The article focuses on the success of Lonza, the largest independent contract manufacturer of peptide drugs. The company has been in the peptide business since 1997 and reaffirmed its commitment to the sector with a SF24 million investment in a mid-scale Tides facility in Visp, Switzerland. The launch of UCB-Bioproducts dramatically increases the size of Lonza's operation. Bernd Pomrehn, equity analyst at Bank Sarasin, cites the challenges being faced by Lonza.

This article reports that discovery chemists in the pharmaceutical industry use energetic chemistries such as azide, diazomethane, hydrazine and nitration every day, but process chemists who have to consider the risks of transferring them to large-scale production generally look for alternative routes that bear less resemblance to bomb-making. A division of GenCorp Inc., AFC Inc. was formed in the early 1990s to apply knowledge acquired during 50 years of defense work to the cGMP production of intermediates and active pharmaceutical ingredients. Roughly 40 percent of current projects involve a range of energetic chemistries. Originally part of Bofors Corp., Cambrex Corp. was spun off in the 1930s for the civil application of technologies developed in the manufacture of explosives, and it began producing active pharmaceutical ingredients in the 1940s.

This article reports that once an ideal, optical purity is becoming a necessity, driven in part by the availability of the tools that make it possible, including asymmetric chemocatalysis. Today, several companies specialize in the development and application of the technology and both fine chemical and pharmaceutical companies increasingly consider it an essential component of their toolboxes. The chiral opportunity is expanding quickly. Revenues from chiral manufacturing, including both synthesis and separations, totaled over $1 billion in 2003, and they are projected to grow to over $1.6 billion in 2008.

This article reports that pharmaceutical and fine chemical companies are looking closely at microreactors. Most of the top ten global pharmaceutical and one chemical companies have already acquired the Cytos Lab System, a microreactor product developed by Cellular Process Chemistry Systems GmbH (CPC). CPC customers Sigma Aldrich and Clariant are even using microreactors in production. Last week, pharmaceutical company Bayer Technology Services GmbH, an affiliate of Bayer AG, announced that it had acquired the microreactor company Ehrfeld Mikrotechnik AG, based in Wedelsheim, Germany.

Reports on the emergence of China as an important source of low-cost active pharmaceutical ingredients. Number of Chinese active pharmaceutical ingredients manufacturing companies; Production of 1,350 different active pharmaceutical ingredients; Major players in the Chinese fine chemicals industry including North China Pharmaceutical, Lukang Pharmaceutical; Xinhua Pharmaceutical and Shijiazhuang Pharmaceutical.

Reports on the investment of the pharmaceutical industry into ionic liquids development. Allocation of budget for research consortia; Flexibility of the ionic liquids; Assessment of the melting point and viscosity.

Reports on the plants constructed by pharmaceutical companies to increase its capacity worldwide. Mergers of pharmaceutical companies; Production and research units built by Schering-Plough in Singapore; Project of Wyeth-Ayerst in Ireland.

Focuses on the impact of advances in genomics and drug discovery technologies on contract biopharmaceutical manufacturing. Application of microbial fermentation in biopharmaceuticals manufacture; Advantages of microbial fermentation over mammalian cell culture; Cost of fermentation and purification facilities; Pharmaceutical companies involved in biopharmaceutical development.

Provides information on the success of foreign pharmaceutical investments in Ireland as of October 25, 1999. Expansion of the Ballydine facility of Merck; Acquisition of Cambrex by Irotec Laboratories; Acquisition of the Arklow facility by AlliedSignal.

The article presents information on Rx-360, a pharmaceutical supply chain risk consortium, and comments of Guy Villax, chief executive officer (CEO) of Portugal's Hovione, on it. Villax says generic drug firms have the most to gain from membership in Rx-360, but few recognize it. According to him, mostly wrongly assume that they will not be welcomed by the large innovator firms behind the initiative.

The article focuses on a growth in the active pharmaceutical ingredients (APIs) manufacturing business in Italy. The Italian API manufacturing continues to grow despite some challenges arising from the changes in the patent law. According to the study report "The World API Market" by the Chemical Pharmaceutical Generic Association (CPA), the country remains the leading producer of APIs in Europe, holding 10.4% of the 2008 global merchant market for innovative and generic products.

The article offers information on two new initiatives that help drug companies reduce supply chain risk by enhancing the effectiveness of on-site audits, while reducing cost. One of these schemes is Rx-360, a non-profit consortium of pharmaceutical companies and their suppliers. One Rx-360 member, U.S.-based fine chemicals firm SAFC, has an alternative approach to audit sharing as part of its new Vendor Audit Services (VAS), launched in March 2009.

The article presents information related to the pharmaceutical industry. Big pharmaceutical firms are trying to generate orally disintegrating tablet (ODT) as discovery programs are not providing new products as quickly as older products are losing patent protection. Schering Plough's Chiritin (loratadine) Reditabs, made in 1996, were the first approved ODT by the U.S. Food & Drug Administration.

The article explores the economic condition of fine chemical companies capable of making active pharmaceutical ingredients (APIs) in South Korea in 2009. Results of an economic analysis conducted show a growing demand for drugs in the nation but chemical companies making APIs are relatively small. The government hopes that the growing demand of drugs will encourage companies to invest in the pharmaceutical industry because it may offer them the chance to survive in the struggling economy.

The article reports on Pfizer Inc.'s green chemistry initiative (GCI). It started in 2001, encouraged by improvements made in the manufacture of sertraline (Zoloft) and sildenafil (Viagra). The original process for manufacturing these drugs involved titanium tetrachloride, a hazardous material that reacts violently with water. Pfizer chemists developed a more efficient method in the late 1990s. For its achievement, Pfizer was awarded the Green Synthetic Pathways Award. INSETS: THE 12 PRINCIPLES OF GREEN CHEMISTRY;THE GREENEXCHANGE.

The article offers information on Cedarburg Pharmaceuticals that focused on process development and contract manufacturing. Cedarburg has expanded its activities to include the manufacture of niche generics when the outsourcing market fall in 2003. Cedarburg's products include fentanyl base and fentanyl citrate, exemestane, remifentanyl and delta-9 tetrahydrocannabinol (THC). INSET: SPREADING THE WEALTH.

The article discusses the formulation of solid state drugs by pharmaceutical companies to ensure better benefits for the patients taking these drugs. Among the pharmaceutical companies that made solid-state chemistry acquisitions are SAFC and Aptuit. SAFC acquired Pharmorphix while Aptuit purchased SSCI. SAFC chief scientific officer Chris Frampton states that they will recommend which solid form customers should take for their drug substance. INSET: BREATHING EASY.

This article discusses why fine chemical manufacturers see continuous flow reactors as a competitive advantage in the manufacture of pharmaceuticals. Ian Grundy, vice president of NPIL(i), said as flow processing allows for telescoping of stages, companies can reduce lead times, working capital and fixed capital. Aslam Malik, president of Informex USA, said continuous flow reactors offer higher-quality product and greater safety.

The article focuses on the use of risk management in outsourcing of development and manufacturing in the pharmaceutical industry. Outsourcing may be used to avert risks by reducing financial exposure, cutting time to market and several other factors. However, it also increases the risk through the reduction of flexibility and variability of contractor quality.

The article presents information on the Pharmaceutical Manufacturing Research Program (PMRP). Details of the first and second phase of the PMRP are provided. It cites the manufacturing performance data provided by active pharmaceutical ingredients manufacturing facilities. It discusses the influence of the use of information technology. INSET: THE FDA STUDY.

The article features the Greenwich, Connecticut-based company Aptuit and cites its plans to become a complete drug-production services organization. Aptuit has entered the active pharmaceutical ingredient manufacturing when it acquired the Eagle Picher Pharmaceutical Services company in September 2006. Aptuit boasts that they lead in the pharmaceutical development industry with having to offer the most types of services.

The article focusses on the pharmaceutical trade between Western companies and China. It reports that inspite of the threat of piracy in China, the companies increasingly regard it as a viable location for cost-effective drug-discovery chemistry. The article discusses the role of Sundia's US-trained management team of China, whose members have 10 to 15 years of US experience, in developing the pharma trade. The article covers the comments of the experts expressing their views on the venture.

The article reports on the booming generic drugs industry. A number of factors attribute to the growth in the generic drugs which include the expiration of major drugs expected over the period of 2006-2012. The $65bn generics global market account for nearly 12% of the total pharmaceuticals market. However, taking competition into consideration, there lies a big challenge ahead for the generic players to maintain the returns of the low prices.

The article highlights Solvay's plans of venturing into Cosmetics, electronics, energy conservation and renewable resources other than pharmaceuticals, that will need the development of substantial intellectual property. Solvay's Peptisyntha is ruling the market in the cGMP manufacture of peptides. Girindus manufactures oligonucleotides by both solid and liquid-phase synthesis.

The article focuses on BudgetFTE, a business unit established by Cambridge Major. Michael Major, president and CEO of Cambridge Major, believes that the business which is founded on a completely new business model can lower costs of services of full-time equivalents in the U.S. BudgetFTE provides chemistry services to the pharmaceutical and biotechnological industries.

The article reports on the emerging drug discovery contract research and services business in India. Young pharmaceutical companies in India are taking advantage of low costs, deep talent and new guarantees of intellectual property protection to pursue medicinal chemistry contracts that were once the province of Western companies. India's pharmaceutical industry used to focus on copying existing drugs. Its foremost skills were reverse engineering and process development rather than medicinal chemistry and the other activities associated with drug discovery.

Reports on the adoption of the chemical industry to Dowpharma's Asymmetric Hydroformylation of olefins. Demonstration of the potential of the technology to reduce the cost of goods as a result; Development and commercialization of the technology; Applications of Asymmetric Hydroformylation of olefins in the pharmaceutical industry.

This article reports that companies such as Albany Molecular Research Inc. and Ricerca Biosciences LLC are riding a wave that is not close to cresting, the outsourcing of drug-discovery chemistry. Although pharmaceutical companies have preferred to keep the earliest portions of their pipeline in house, the pursuit of efficiency at all levels has made it impossible to hew to tradition, and they increasingly entrust their earliest and most sensitive chemistry to others. For any company considering the outsourcing of services, one of the most important questions to be answered is the fate of the intellectual property generated by the relationship.

This article reports that Ian Shott, the former chief operating officer of Chirex, has been building a new services business targeting the life sciences sector. Named Excelsyn, the Great Britain-based organization currently includes a management consulting business, an engineering technology firm and a molecular development facility offering services and technologies ranging from R&D to small-scale manufacture of pharmaceutical and specialty intermediates and ingredients. A veteran of the chemical industry with notable stints at ICI, Zeneca, Lonza and Rhodia Chirex, Shott, now chairman of Excelsyn, is going to focus tightly on the supply chain of established and emerging pharmaceutical companies.

Discusses the preparations being made by pharmaceutical companies in India to satisfy the Agreement on Trade-Related Aspects of Intellectual Property. Changes in the patent laws of the country; Criteria for issuing exclusive marketing rights; Devotion of considerable resources in upgrading the country's patent infrastructure.

Deals with the decision of the pharmaceutical industry to focus on biologics, high potency and developmental scale projects. Capital expenditures of the industry; Allocation of the industry's capital expenditures.

Examines the factors which contributed to the increase in the revenues posted by Albany Molecular Research Inc. for the fist quarter of 2001. Recruitment of employees and scientists; Research and development projects on the structural modification of active compound on several drugs; Research and technology licensing agreements with other pharmaceutical firms.

Focuses on the pharmaceutical outsourcing strategic plans of NextPharma Technologies SA. Background on the company; Acquisition of Pharbil Pharma GmbH; NextPharma's purchase of equity interests in Aerojet Fine Chemicals LLC.

Details the plan of Great Lakes Chemical Corp. to become a major force in the market for pharmaceutical intermediates and bulk actives. Major steps taken by the company; Information on the NSC Technologies acquired by Great Lakes; Benefits of Great Lakes on the acquisition; Information on the strategic agreement signed by Great Lakes with Monsanto.

Discusses the outsourcing process development strategy of pharmaceutical companies. Factors influencing the increasing number of chemical entities entering and adopting the strategy; Benefits of outsourcing contracts; Contractual agreements for the outsourcing of process development work.

Focuses on the contenders in the drug pipeline and some of their successful products in the market. Correlation of research and development (R&D) to pipeline potential in the pharmaceutical industry; Amount spent by Pfizer in R&D; Details on drugs making a hit in the market.

Focuses on the consolidation of pharmaceutical and fine chemicals companies in India and China. Factors contributing to increased consolidation; Competition in the market; Effects of globalization in both countries; Challenges facing companies entering the international market.

The article presents the author's views on the prospects of company that supplies the pharmaceutical industry. The author states that these are difficult times for any company that supplies the pharmaceutical industry. According to the author, in the longer term, companies that can most readily change position to meet the needs of their customers are most likely to succeed.

The article introduces the current issue of the journal including an article on the pharmaceutical industry in India and China, an article on meagre product pipelines of pharmaceutical companies, and an article on innovative efforts to reduce risk in the supply chain through information sharing.

The article focuses on the methodical approach taken by Hovione SA, a company making active pharmaceutical ingredients (APIs), to sourcing and manufacturing of products in view of changes in the pharmaceutical markets of nations such as China, India and Brazil. According to Luis Gomes, vice president of generics at Hovione, the emerging markets have created new opportunities for such companies. It states that in March 2008, the company acquired a manufacturing facility near Shanghai, China.

The article focuses on the importance of maintaining the regularity in the supply of inactive ingredient in drugs, with specific reference to the ExcipientFest Americas 2008 to be held on April 16-17 in San Juan, Puerto Rico. It is stated that ensuring the safety and reliability of supply is more challenging than ever these days. Chris Moreton of FinnBrit Consulting says that excipients are not held in the regard they should be, but without excipients, most drugs are not convenient.