Meeting Today’s Challenges and Delivering Tomorrow’s Promises
We believe biotechnology has a central role in meeting urgent global challenges. Biotechnology is all around us, and it already is a major part of our lives, providing breakthrough products and technologies to combat disease, reduce our environmental footprint, feed the hungry, and make useful products.
Biotechnology isn’t easy. The science continues to astonish and amaze. Today, there are more than 250 biotechnology health care products and vaccines available to patients, many for previously untreatable diseases. More than 13.3 million farmers around the world use agricultural biotechnology to increase yields, prevent damage from insects and pests and reduce farming’s impact on the environment.
Delivering Results for the Biopharmaceutical Industry
Many biotechnology therapies are biologics, meaning they are derived from living sources such as cells. Biologics are complex mixtures whose active ingredients, usually proteins, are hundreds of times larger than the compounds found in most pills. These products usually must be injected or infused directly into the bloodstream to be effective. It typically takes 10 to 15 years and an average of more than $800 million
(including the cost of failures) to develop a new therapy. The process is rigorous and conducted in multiple stages, beginning with lab and animal testing, followed by clinical trials in humans, regulatory review and, if a product is approved, post-marketing studies and surveillance. Since most biologics are derived from living cells, like living cells, they are susceptible to injury from extremes in temperature, shock, vibration, pressure, and humidity in the logistics environment. Since the 1980s, the global market for such products has expanded enormously due to the development of biotechnology-derived drugs and now tops $100 billion in value.
Increased Regulatory Interest in Biologics
In 2008, five of the top 10 best-selling pharmaceutical products in the world were biologics requiring refrigerated storage and handling between 2–8°C. They were Enbrel, Rituxan, Remicade, Epogen/Procrit, and Avastin. By 2014 biologic pharmaceuticals will be seven of the top 10, and sales growth of such products will average 8% per year. Protein-based drugs are playing an increasingly important role in the treatment of many conditions. Since the first recombinant human insulin product entered the market in 1982, over 100 different recombinant protein-based drugs have been approved. Another 400 biologics and protein-based drugs are in various stages of clinical development. With this demanding scale and the globalization of production, controlled-environment logistics for biologics has drawn increased regulatory interest over the past five years. Both government and industry have put forward practical guidances for qualifying cold-chain transportation processes, sensors, and packaging. Quality systems are expanding from manufacturing-centric approach into both the clinical and commercial supply chain.
Our multi-disciplinary team is ready to help you with your cold chain needs or existing program. For more information, contact us today.