Incomes currently generated by the global cell therapy market are estimated to be ~US$400 million. That value represents 10 main products, some of which have been on the market since the late 1990s (e.g., Dermagraft and Apligraf, with >$100 million yearly revenues each). Cell therapy product revenues are low compared with those of the biopharmaceutical market (~$100 billion). But the market’s growth potential and clinical pipeline are leading to higher expectations. The sector’s compound annual growth rate (CAGR),…
Search Results for: regenerative medicine
Streamlining Cell Therapy Manufacture
The cell therapy industry (CTI) is no longer a cottage industry; it is a distinct and sustainable component of the global healthcare sector (1). Today, CTI prospects are strong, with annual revenues exceeding US$1 billion/year, supported by improving investor sentiment and public support (1,–3). The next phase of CTI growth — toward a multibillion-dollar global industry — will depend on the biomanufacturing community innovating to meet growing market demands and providing products at affordable costs to healthcare payers.…
Small–Batch-Size Production
After coexisting as close cousins in the world of life sciences, the bioprocessing and cell therapy industries now find themselves as possible allies in the pursuit of solutions to small–batch-size production technology. As cell culture titers continue to increase and biotherapies become more “personalized,†pressure is increasing on the bioprocessing industry to find more cost-effective and flexible technologies for producing smaller batch sizes than before. At the same time, the cell therapy industry (renowned for its small–batch-size production)…
Quality Control During Manufacture of a Stem Cell Therapeutic
Development and manufacturing of a therapeutic stem cell product requires extensive quality control (QC) to ensure the identity, quality, and safety of the cells. Here, we describe our QC pipeline to optimize the manufacturing of our MultiStem adherent stem cell product, which is in clinical trial testing for stroke, acute myocardial infarction, inflammatory bowel disease, graft versus host disease, and solid organ transplantation. Screening for growth, marker expression, immunosuppression, and multipotent differentiation — in combination with “-omics†screening for gene…
From The Editor
One disadvantage of having covered this industry for so long is that we can get too used to terminology that is no longer quite adequate. This emerged in discussions with our advisors and readers throughout the creation of our anniversary awards program. For want of other available terms, BPI has (from the start) rotated issue themes of upstream, downstream, and “manufacturing” — that third category or “pillar” that encompasses filling and finishing and activities that occur throughout process and product…
Success Stories from the Asia–Pacific
The Asia–Pacific region is a vast geographic area with a loose definition — covering East Asia, Southeast Asia, and Oceania. It includes a variety of cultures and races and is home to both developed and developing countries. Depending on the definitions of the region, the gross domestic product (GDP) varies from $500 per capita in East Timor to $41,500 in Australia, and the populations climb from a mere 55,500 in Australian Samoa to a vast 1.3 billion in China (1).…
From the Editor
Conference themes and approaches can be looked at as sort of a crazy quilt representing the state of the industry: with pieces of all different shapes and colors that come together to form a cohesive whole. They fit together in many ways, depending on the organizers (quilters?); many pieces are omitted and saved for the next quilt. But how to find the most successful combinations requires technique as well as imagination. Here are some topics I’ve been…
Australia
Australia is the only Asia–Pacific country that’s home to one of the world’s top-10 biotechnology companies (in revenue): CSL Limited, a maker of drugs, vaccines, antivenoms, blood products, and diagnostics. Many companies in the West consider this country a “gateway†to the Asia–Pacific region because of its relatively familiar culture, language, laws, and infrastructure. Indeed, Australia’s proximity to Singapore, Indonesia, Malaysia, and the rest of Asia compares favorably to the rest of the English-speaking world. For cell therapies…
China’s New Five-Year Plan
In October 2010, the Communist Party of China’s Central Committee approved its 12th Five-Year Plan for National Economic and Social Development (FYP) (2011–2015), which it ratified on 14 March 2011. During those five years, China will continue to focus on government-guided economic development, industry, and technology. The FYP outlines the government’s commitment toward reforming its economy and increasing its domestic consumption to decrease its dependence on exports for future growth of its gross domestic product (GDP). Other initiatives…
India
India is well known as a key destination for bioprocess outsourcing and a major supplier of active pharmaceutical ingredients and raw materials. The global pharmaceuticals manufacturing outsourcing industry is expected to reach US$100 billion by 2015 (1). India has the potential to capture 8–10% of this industry by 2015 and become one of the top 10 global markets by value (2). By comparison, India’s biotechnology industry (consisting of biopharmaceuticals as well as other sectors) has gained global attention…