Outsourcing

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.

Catalysts are important tools in the synthesis of active pharmaceutical ingredients. Recovery of precious-metal catalysts from a pharmaceutical manufacturing process is a factor in cost control and environmental compliance.

The financial performance of the pharmaceutical majors was generally favorable through the first half of 2007, with most companies reporting moderate to double-digit growth. Industry leader Pfizer, however, reported a sales decline for the second quarter and flat revenues through the first half of 2007. Pfizer Chairman and CEO Jeffrey Kindler says the company remains committed to its plans for cost-cutting, more outsourcing, and increasing its position in biologics.

The company begins production at a new $100-million manufacturing facility for prefilled injection systems, plans further investment in packaging facilities, and targets both early-phase development and commercial manufacture.

An industry survey finds that pharma's outsourcing practices keep the industry from reaping the full benefits of outsourcing.

Although North America accounts for the largest share of the pharmaceutical market, Brazil, China, India, Indonesia, Mexico, Russia, and Turkey are projected to account for almost one-fifth of the global market by 2020. The rising participation in select countries' drug-development activities is evident by recent investment and outsourcing by the pharmaceutical majors.

An industry survey finds that pharma's outsourcing practices keep the industry from reaping the full benefits of outsourcing.

Driven by a rapidly ageing population and a known high consumption of pharmaceuticals, the French pharmaceutical market has always appeared buoyant.

While some companies float with the tide, others grab market share while business is good.

Pharma companies and CMOs build positions in mAbs.

While some companies float with the tide, others grab market share while business is good.

Preferred models for clinical and nonclinical services move in opposite directions.

Preferred models for clinical and nonclinical services move in opposite directions.

The more experienced contract manufacturers go far beyond superficial process improvements, drawing on their own expertise and resources to improve the service, value and flexibility they offer their clients.

Key to the success of outsourcing stability studies is the relationship/partnership between the client and CRO. It involves a high degree of trust and mutual support

...Scotland has a favourable regulatory environment, funding support from its government and some of the most advanced research facilities in the world.