Author Archives: Maribel Rios

Successful Commercialization Through Industry Collaboration

    Nearly a year ago, the International Society for Cell Therapies (ISCT) decided to integrate industry into its organization to build a stronger platform for commercializing therapies. Robert Deans, vice president of regenerative medicine at Athersys, was invited to serve as a leader of ISCT’s Industry Task Force, which aimed to identify industry roles in its organization. Within two months, the task force invited industry members and chartered a white paper (1) that described how ISCT should go forward.…

Combination Products for Biotherapeutics

    Combination products (see the “Definition” box) are experiencing steady growth in the pharmaceutical industry. According to one report, about 30% of products currently in development are combination products (1). Expanding interest in such products can be attributed to manufacturers’ need to generate new market value for current products that will soon lose patent, requirements for long-term patient care, pressure to reduce healthcare costs, and consumer interest in localized drug delivery with improved therapeutic effectiveness (2). During the 2008…

Working Toward Animal-Free Processing

    Biological therapeutics is one of the fastest growing segments of the pharmaceutical industry — so much in fact that the overall cell culture media and supplements market used in bioprocessing applications is reportedly near $800 million (1). An increasingly important trend in cell culture is risk reduction throughout the supply chain, including a stringent focus on key raw materials. Accordingly, the industry has increasingly adopted animal-component-free materials to mitigate concerns over safety, transmissible spongiform encephalopathies, and other contaminations.…

Managing Manufacturing Networks

    Smart management and maintainance of multiple production sites is essential for global manufacturers and suppliers to reach both existing and emerging markets. Optimal performance of these networks requires keen efficiency, due diligence, and cost reduction. Biomanufacturers are taking a close look at their facilities when developing strategies for reducing time to clinic and decreasing the cost of operations, including labor, energy, raw materials and supplies, and other resources. The Managing Manufacturing Networks track of the BioProcess International Conference…

Recovery and Purification

    Downstream processing can be complex, expensive, and time-consuming part of biotherapeutics production. Biomanufacturers are seeking technologies to clear bottlenecks and incorporate rapid in-or at-line analytics. Data obtained from using these methods under a well established design space can then help companies better characterize, monitor, and control their processes. The BioProcess International Conference and Exhibition features a Recovery and Purification track over three days, 22–24 September 2010, that will cover these issues and provide attendees with the information needed…

Minimizing Costs and Process Times with Local Biomanufacturing

For a growing number of biopharmaceutical companies, the world is getting smaller. They are operating in smaller, more flexible facilities; servicing potentially smaller markets; and managing local products. Local manufacturers are looking for ways of doing standard processing less expensively without making changes that carry regulatory risk. Most of these facilities are vaccine manufacturing sites. The upsurge in localized diseases and need for global pandemic preparedness (especially under uncertain capacities) have countries such as Malaysia, India, China, and Brazil pushing…

Navigating the Logistics of Local Biomanufacturing

    As much as one-third of the world’s population lacks access to essential medicines, and in the poorest regions of Africa and Asia, this figure rises to one-half (1). Along with other organizations, Medicins sans Frontieres (MSF, Doctors Without Borders) advocate for a combination of global and regional policies to lower drug prices sustainably, including local drug manufacturing. At this year’s annual meeting of the Biotechnology Industry Organization (BIO), during a session on building vaccine capacity in developing countries,…

Flexible Manufacturing

Flexibility has quickly become one of the most noticeable buzzwords of the bioprocessing industry. Understanding what constitutes a “flexible” process ranges from the simple application of one specific type of technology (e.g., single-use systems, automation, standard controls) to a somewhat extreme concept of a “throw-away” process. But whatever the definition, the factors leading to the need for more flexible approaches to biomanufacture are clear: Rapid, sometimes unexpected, changes in a company’s business situation and/or product portfolio (whether for patients or…