Outsourcing

The inaugural West Coast meeting for the Clinical Supplies Support Group (CSSG, www.jeiven.com/clinical_supplies_support_group.htm) was held in San Diego on June 8, 2007.

Intas Biopharmaceuticals Limited (IBPL, Gujarat, India, www.intasbiopharma.co.in) has become India's first dedicated biopharmaceutical company to receive certification from the European Agency for the Evaluation of Medicinal Products (EMEA, London, UK, www.emea.europa.eu) or an EU-GMP certification for its manufacturing facility at Ahmedabad, Gujarat.

Biologics manufacturing is a technologically complex, highly regulated process. In comparison to small-molecule manufacturing, biologics manufacturing requires far more planning, investment, and skilled personnel and, therefore, can be much riskier. For biotech companies requiring such manufacturing capabilities and experience, partnering with a biologics-focused contract manufacturing organization (CMO) can be a good solution.

Outsourcing has been a cornerstone of our industry for decades.

In China, the presence of a substantial biogenerics industry reflects a growing need to provide healthcare to domestic populations, at a reasonable cost.

Eden Biodesign (Liverpool, UK, www.edenbiodesign.com), SAFC (St. Louis, MO, www.sigmaaldrich.com/SAFC/Pharma), Midatech Group (Oxfordshire, OX, www.midatechgroup.com), Cellexus Systems (Cambridgeshire, UK, www.cellexusbiosystems.com), and BioConvergence LLC (Bloomington, IN, www.bioc.us) are sprucing up their product development and services with the construction of new manufacturing facilities.

Venture capital insiders say that the flow of funds into biopharma shouldcontinue, driven by the large amount of money available for investment.

China's central government is aware of the need to improve intellectual property protection and enforcement.

By outsourcing high-end processes that demand advanced analytical and technical skills, biopharm companies are reaping substantial savings.

Are the deadlines for your outsourced projects often not met? Are you unsure of the status of your project at any given time? Is the original budget of your study typically exceeded?

Partnering with a surging number of CROs, CMOs, CSOs, and other niche providers, biopharm companies in 2007 will have an estimated spend of more than $7 billion on international clinical trial outsourcing alone.

Consider the number of patients, the dose each will receive (and how this dose is calculated), the number of doses per patient, and what overage is needed to allow for vial breakage.

The greatest benefits of outsourcing are realized when a company takes a strategic approach rather than a tactical approach.

The contract manufacturer must have sufficient capacity so it can absorb possible surge in demand, and back-up capability in case of a power failure or other event.

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.