Outsourcing

A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity-characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.

The Chinese vaccine market competition is now transferring from the former price-competition model to a technology- competition model.

This 1,230-page tome is a must-have encyclopedia for any person or organization planning to interact with the biopharmaceutical market in China. It contains 23 well-written chapters and five appendices written by individuals who are experts in the areas they address. Some of these experts are not well known in the US; thus the book also provides an excellent introduction to people whose knowledge and opinions are important when considering biopharmaceuticals in China. Many chapters were translated from Chinese and this is the first time that their information has been provided to the West.

All contributors to the process should have a clear understanding of their capacity and see their work activities as a priority, regardless of where they fall on the critical path.

The three largest players have accumulated, or are in the process of accumulating, nearly a million liters of capacity between them.

The Chinese government's investments in the biopharmaceutical sector may help it become one of the leading industries in China by 2020.

NIH makes available a full range of licenses for commercial evaluation and for the sale of commercial products and services.

The changes in biologics manufacturing regulations contained in the 1997 FDA Modernization Act significantly bolstered the growth of CMOs.

China today represents a $15-billion market for pharmaceutical products. China's pharmaceutical industry has been expanding at about 20% over the past five years. It has been predicted that China will become the world's fifth largest single pharmaceutical market by 2010. With such a fast-growing market segment and a huge population, simply getting pharmaceuticals to the patients and healthcare providers is becoming a daunting task. Biopharmaceuticals distributers face the same challenge, with the added complications associated with cold-chain management, shelf-life, and product stability.

China is home to more than 400 biogeneric manufacturers, which develop generic biopharmaceuticals for the domestic population.

The number of projects in Lonza's internal biomanufacturing pipeline grew by 40% to over 75 projects.

The supply chain can be used as a tool for managing not only product supply risks, but overall business risks as well.

Offshoring to China has captured the imagination of Western managers seeking to reduce operating costs. What is the best approach?

In the rush to save money, the consequences of potential problems often are ignored.

We often assume we know what success looks like for our partner, but we never ask them, or take the time to write it down.

A major shift is occurring in the way the biopharmaceutical industry sources goods and services. Price pressures at the retail end of the value chain and a difficult fundraising environment are forcing biopharmaceutical companies to take greater control of their costs. Purchased goods and services, including contract research and manufacturing services as well as raw materials and laboratory supplies, are a major expense in most companies, so control of those purchasing decisions is coming in for special scrutiny.

Better supplier management can begin in parallel to production-related improvements.

China is becoming a much more sophisticated economy, with a large and well-educated workforce.

Nothing beats a good dictionary. It can clarify doubts, settle an argument, or prompt exploration into new areas of learning.

Many CMO relationships are established while a product is early in clinical or preclinical development.

Disposables require less space than conventional equipment, and they can be assembled offsite into complete process trains.

The lack of biomanufacturer acquisitions seems surprising.

The top 10 Chinese companies in the biopharm sector account for only 20% of the market... leaving plenty of room for growth for Western companies.

The foundation of a sound supply chain planning infrastructure requires implementing a strong, systematic forecasting process.

Interestingly, it is companies that already have the most capacity available to them that are building even more.

Moving aggressively to implement its Vision 2010 strategy, which debuted in October 2005, DSM N.V. (Heerlen, Netherlands) announced in December 2005 that it would shut down its Montreal biomanufacturing facility in early 2006. The move doesn't signal an exit from manufacturing, however, but a change in focus; DSM will simultaneously expand its expression-technology relationship with Crucell (Leiden, the Netherlands). Both moves reflect changing circumstances in the biomanufacturing sector.

Before designing cleaning procedures, it's vital to know all physical and chemical characteristics of the product ingredients.

These latest pressures on technology relate not only to the need for improved manufacturing productivity and shorter development times, but also to the need to create smarter manufacturing operations

Achieving approval of a new pharmacologic agent or device on a worldwide basis is a significant challenge. The guidelines and requirements that steer our efforts at enhancing and extending life around the world are tedious and, fortunately, comprehensive. In spite of relatively few setbacks, perhaps in no other category than pharmaceutical development are the advantages of these guidelines more evident.

Simple practices can increase profit margins and ensure gas supply.