Author Archives: Maribel Rios

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 Bioreactor and Upstream Technologies

A high-quality product begins with efficient upstream process equipment. Ten years ago, manufacturers were still warming up to single-use bioreactors, which were mainly rocking-bag–based solutions. The benefits relating to cleaning and validation were clear, but their use as bioreactor vessels was still new, and stainless steel systems up to 20,000 L in scale were still needed. Today’s facilities are a hybrid of sophisticated single-use components and stainless steel equipment, the mechanisms of both having undergone improvement during the past decade.…

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…

A Decade of Harvesting Methods

    The preliminary separation of a protein of interest from a reactor “soup” of process impurities (e.g., cell debris, colloids, lipids) is the first step in a downstream process. It is also a primary step that introduces a significant risk of product degradation, bioburden concerns, or process errors, especially if a harvest method is not a good “fit” with a newly designed bioreactor (e.g., single-use) or fermentation vessel. In 2003, BPI’s first year, industry concerns revolved around potential capacity…

A Decade of Fill–Finish and Packaging Solutions

    In 2003, BPI’s first year of publication, the Food and Drug Administration released a draft of its updated guidelines on aseptic processing. In it, the agency included the statement, “A well-designed positive pressure isolator, supported by adequate procedures for its maintenance, monitoring, and control offers tangible advantages over classical aseptic processing, including fewer opportunities for microbial contamination during processing” (1).That kind of statement, seemingly approving one technology over another, was unprecedented in an FDA guidance and perhaps an…

Outlooks on Standardization

    The Friday workshop of the 2011 BPI Conference in November may have been titled “Industrialization of Single-Use Manufacturing Technologies,” but in the discussion afterward, the mainly end-user audience zeroed in on an on-going debate in single-use implementation: standardization. Comments and questions echoed the current opinions, most of which were well known to the all-supplier panel and others present. To follow up on this discussion, I spoke with members of that panel because — as one expert put it…

Ten Years 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…

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).…