Outsourcing

Change is inevitable, as is contract manufacturing. But which companies will survive the drifts?

Could sloppy due diligence practices hurt CMOs and their clients?

In 2007, the global pharmaceutical market is expected to grow moderately while biologics, generic drugs, and specialty-initiated drugs are projected to increase at double-digit rates. These trends for finished pharmaceuticals are reflected in the global market for APIs, where the merchant generic API market is expected to see strong demand. On a production basis, India and China are forecast to raise their shares of the global generic API market against industry strongholds Italy and Spain. Meanwhile, the US is expected to hold its its position as the leading producer of biotechnology-based APIs in an area traditionally dominated by captive production. And biogenerics or biosimilars gradually reshape the market.

Company and People Notes: Evotec and Renovis enter agreement, Amgen to lay off 675 workers, more.

Company and People Notes: Catalent expands Bolton, UK, warehouse; Biotica appoints Edward E. Hodgkin as CEO and director; more.

Sartorius has officially started up operations at its new plant in Beijing. By building the new facility, the company has now doubled its production capacity in China from approximately 4000 m2 to more than 8000 m2; an additional building phase makes it possible to even quadruple the floor space in the future. The investment volume for the new plant site is about ?10 million.

Company and People Notes: Baxter and Halozyme Expand Relationship, Crucell Names COO, More.

Purchase-order contracting is a commonly used approach to conducting commercial transactions, but it is a risky proposition when applied to pharmaceutical transactions, including the buying and selling of contract services and pharmaceutical ingredients. The authors examine the contract provisions covered in a commercial-supply agreement that are likely to be omitted under purchase-order contracting and the risk-reduction benefits that a commercial-supply agreement can offer in pharmaceutical procurement transactions.

Aptuit expands its drug-development capabilities with the formation of Aptuit Laurus to take advantage of the growing pharmaceutical outsourcing market in India.

Contract manufacturers slim down to improve profitability.

How the Indian pharmaceutical sector is reinventing itself

In a nation of more than 1 billion people, the importance of vaccines goes beyond healthcare-it is a matter of national security. Armed with this belief and a philanthropic vision that most Indians could be protected against hepatitis, DT–Polio, and other afflictions, Dr. Varaprasad Reddy entered the nascent Indian biotechnology sector in 1992 and has since managed to threaten the monopoly of large laboratories. That year, the Hepatitis B vaccine cost $33 per shot, and yet some families were subsisting on less than $1 a day. Meanwhile, India was importing only 180,000 doses per year.

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The authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.

Contract manufacturers and pharmaceutical ingredient suppliers proceed with select investments in biologics manufacturing, small-molecule synthesis, and formulation as the industry prepares for CPhI Worldwide in Milan.

FDA approvals renew the threat of competition from India and China.

A spate of drugs are scheduled to come off patent, offering vast potential and competition.

Industry and regulatory experts provide advice on inspection preparation and best practices.

The tightening of intellectual property rights in India under GATT/TRIPS was a crucial inflection point for pharmaceutical outsourcing in India.

Risk management is essential in any successful outsourcing partnership. The author outlines the steps toward identifying, understanding, and controlling risk in key manufacturing areas.

The authors analyze the supply–demand trends for contract biologics manufacturing and the strategies of pharmaceutical and biotechnology companies and their suppliers in the value chain.

A booming market may be stressing the service-delivery system.

This article is written to assist clinical manufacturing representatives at pharmaceutical companies who are faced for the first time with outsourcing the manufacture of clinical supplies. The author describes the identification, writing, and execution of documents required to support the contract manufacture of products for clinical studies.

Using basic project management tools and ideas in the transfer process saves time and money and ensures high success rates.