Author Archives: Maribel Rios

Analytics for Modern Bioprocess Development

Twelve years ago, about the same time the US Food and Drug Administration was putting the finishing touches on its quality by design (QbD) and process analytical technology (PAT) guidelines, I wrote an article about breakthrough pharmaceutical educational programs. That article included the perspectives from a few members in academia of the future essential skills for pharmaceutical students. At the time, bioinformatics and computerized industrial process modeling were relatively new disciplines, but their importance in future manufacturing was clear. Several…

A Global Joint Venture Strategy for Biosimilars Development

In April 2013, biopharmaceutical company Pfenex (San Diego, CA) announced a joint venture with biologics manufacturer Stelis Biopharma, Inc. (“Stelis”), earlier known as Agila Biotech, (a wholly owned subsidiary of Strides Arcolab Limited (Bangalore, India) for the commercial development of six biosimilars. The companies will also leverage technology and global development expertise from GE Healthcare Life Sciences (Uppsala, Sweden) and Bio-XCell Malaysia (Nusajaya, Malaysia). Such international, multicompany collaboration strategies have become a growing trend in the highly competitive biosimilars industry.…

Better Cells for Better Health

Since its inception 35 years ago, the biennial meeting of the European Society for Animal Cell Technology (ESACT) has built on a tradition of combining basic science and applications into industrial biotechnology to become the international reference event in its subject matter. Every other year, this gathering of academics and industry professionals features a famously exciting social program and an extensive vendor/supplier exhibition specific to animal cell technology. ESACT meetings are much-anticipated international venues for information exchange, inspiration, networking, and…

Advocating an Evolution

In a 2006 report, the US Department of Health and Human Services hailed regenerative medicine as “the vanguard of 21st century healthcare” and “the first truly interdisciplinary field that utilizes and brings together nearly every field in science” (1). To fuel support for regulatory, legislative, and reimbursement initiatives in this new therapeutic class, a small group of scientists, life science business executives, patient advocates, and other experts formed the Alliance for Regenerative Medicine (ARM, http://alliancerm.org). Starting with 17 charter members,…

Vendor Voices: Flexible Manufacturing

One strong take-away message from BPI’s flexible facilities supplement (December 2012) is that there is no single road to achieving a flexible manufacturing process. The ability to quickly modify a unit operation, process line, or entire facility to accommodate change certainly depends on several factors. Flexibility is no longer exclusively linked to single-use systems for one specific operation. It connects facility design, staffing models, and revamped technologies. Vendors and suppliers are hearing first-hand what the industry wants in flexible operations.…

Developing an Integrated Continuous Bioprocessing Platform

    Continuous upstream processing (perfusion) is not a new concept in the bioprocessing industry. Genzyme, Bayer, Centocor, and other companies have been implementing perfusion processes for many years. However, interest is now growing for extending this concept to downstream operations to create fully integrated continuous processing. During the past year, Genzyme has presented on and published about its advancement toward the development of an integrated continuous system (1). The company has completed proof-of-principle development at laboratory scale with different…

Enhancing Manufacturing and Development Efficiency

    Boosting manufacturing efficiency remains a key focus area as bioprocessing companies continue to leverage best-practice strategies for their operations. Multiproduct facilities especially are having to shift resources and maximize flexibility within narrow cost windows. Such flexibility may require reevaluation of facility layouts and design, implementation of new technologies including single-use systems, and renewed approaches toward technology transfer, operations schemes, and raw-material supply chain challenges.   Manufacturing Optimization   Manufacturers are increasingly seeking ways to increase process and personnel…

Cell Culture and Upstream Processing

    Cell culture processes are a vital part of manufacturing, yet the bioprocessing industry still needs optimized process development approaches. Increasing interest in chemically defined media, perfusion cell processes, and high-throughput approaches are driving the need for better understanding of cell culture characterization and process development for current and next-generation protein therapeutics.     Process Development   Optimizing the business process of cell line development involves creating competitive advantages with increased efficiency and reduced risk. “Intelligent business practices that…

Specialty Focus Sessions

    The value of a good bioprocessing industry conference would not be complete without presentations on the most up-to-date information about the current technologies and research in the fastest growing segments of the field. Thanks to their promising therapeutic outlooks in areas such as cancer, antibody–drug conjugates (ADCs) have created a growing number of novel biologics candidates in various phases of clinical trials. Issues associated with their scale-up, processing, and characterization remain, however. Meanwhile, novel analytical technologies have been…

A Decade of Microbial Fermentation

Microorganisms play a vital role in modern life — with applications ranging from wine fermentation to biofuel production to solutions for complex mathematical problems (1). During the past decade, microbial fermentation for protein production reached a higher level of sophistication and wider adoption. When BPI was first published in 2003, the physical and biological characteristics of many microbial cells and the attributes of their fermentation processes were well known. Nonetheless, the economic environment at that time created immense pressure on…