Author Archives: Maribel Rios

Clinical Development of Biosimilars

    Biosimilars require comparative studies that are different from the typical placebo-control clinical trials for first-generation proteins. A typical clinical trial programs must show equivalence of a biosimilar to the originator protein. Hans-Peter Guler, senior vice president of clinical development at INC Research, recently discussed with me the primary objectives and approaches to conducting an equivalence design.   By contrast with trials for originator proteins, equivalence trials require a different statistical approach. The biosimilars company needs agreement from the…

Recovery and Purification

    A downstream process that leverages the advantages of innovative technologies such as disposables, in-line monitoring, and high-throughput systems as well as the robust methods for its harvest and purification steps can significantly improve in a company’s time (and cost) to clinic or commercialization. The 2011 BioProcess International Conference and Exhibition provides forward-thinking presentations that can help you define, characterize, and simplify your downstream design space.   Process Development   Many biomanufacturers have already experienced the advantages of high-throughput…

Biosimilars in Development

    The 2009 Biologics Price Competition and Innovation Act (BPCIA) provided the bioprocessing industry with the legislative pathway toward approval of biosimilars. US Food and Drug Administration information regarding how it will translate that legislation, however, had been limited until an August 2011 article finally provided some insight on how those guidances might actually play out (1). As expected, the agency appears to be implementing a science-driven approach, with sponsor companies needing to apply complementary orthogonal analytical methods to…

Manufacturing Management and Analytical Strategies

    The need to streamline costs, shorten development timelines, and stretch valuable resources is driving biomanufacturers to seek innovative ways of enhancing manufacturing efficiency. Analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility. Effective management of a good manufacturing practice (GMP) facility requires a keen eye on all those factors. The Enhancing Manufacturing and Development Efficiency track of the 2011 BioProcess…

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…

Singapore

Begin a discussion about Singapore, and most likely the word hub enters the conversation. This small country is giving a full-force effort into earning a reputation for being the technical, financial services, and industrial center of the Asia–Pacific region. Its gross domestic product (GDP) per capita (~$57,200 in 2010) is comparable with most Western developed countries. Like South Korea, India, and China, Singapore aims to grow its market share in the biosimilars sector. The difference, however, says Pete Gagnon (CSO…

Optimizing Cryopreservation for Therapeutic Cells

    Biopreservation suppresses degradation and enables postpreservation recovery of structure, viability, and function. Although there are several biopreservation techniques (indicated in “Biopreservation Methods” box), most laboratories use either standard cryopreservation protocols (the far majority) or vitrification (much more limited in broad systems application) when freezing cells for research and clinical applications. Isopropanol freezing containers such as the Mr. Frosty device from Nalgene Labware have made cryopreservation easier in many applications, and controlled-rate freezers allow users to program and manipulate…

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.…

Technologies on the Cutting Edge

    On the brink of bringing exciting new therapies to commercialization, cell therapy developers are taking notice of how other companies are addressing processing and technical challenges. Here, leaders from Dendreon, Advanced BioHealing, and Pluristem describe their current cell therapy programs. And two organizations —the Alliance for Regenerative Medicine (ARM) and McLaughlin–Rotman Center for Global Health —provide details on the promises of regenerative medicine.   Cellular Immunotherapy   Dendreon’s Provenge (sipuleucel-T) cell therapy induces an immune response to aid…