with Dr. Laura Juckem High-efficiency transient transfections of suspension- adapted Chinese hamster ovary (CHO) cells enable researchers to bridge upstream and downstream processes. This helps to provide confidence that a recombinant protein will have the same properties throughout its development as a biologic. As drug targets become increasingly complex, proper protein folding and posttranslational modifications become more relevant. Early upstream work with the same cell type — e.g., CHO instead of HEK 293 cells — ensures similar product quality from…
2014
Parallel Cultivation of Microorganisms – Using Rigid-Wall Single-Use Bioreactors
with Dr. Sebastian Kleebank In recent years, single-use bioreactor solutions have been successfully established for animal and human cell culture processes. Such technology is under investigation for microbial applications. Sebastian Kleebank is development and application laboratory manager for the Eppendorf line of bioprocess products. His cell culture and microbial laboratory performs parallel cultivations for prototype testing, user training, and software development. Kleebank’s Presentation “The BioBLU 1f bioreactor has a gas-inlet filter for sterile gas supply. It has a fully featured…
December 2014 Issue Author Insights
December 2014 Spotlight
Editorial Advisor Retires BioProcess International — and the overall industry — will miss retiring editorial advisor Laurie Donahue-Hjelle, formerly associate vice president at Life Technologies, Inc., in Rockville, MD. She earned her BA in biochemistry at the University of CA–Berkeley and a PhD in molecular, cellular, and developmental biology at the University of CO–Boulder. For most of the 1990s, Laurie served on the faculty of Texas Tech University’s Health Sciences Center (department of cell biology and biochemistry), where her laboratory…
Modern Laboratory Design: Creating a Space for Effective Collaboration
When asked to envision a modern biotechnology laboratory, lay persons might describe what they’ve seen on an episode of CSI: Miami. Gleaming glass and striking colored lights might look good on television, but they are not what biological researchers need to do their work most effectively. Most of the real biological laboratories I’ve visited, in fact, have been stark, white, fluorescent-lit environments that more resemble something out of 2001: A Space Odyssey. But those are becoming passé. The newest concepts…
Accelerated Product Development: Leveraging Industry and Regulator Knowledge to Bring Products to Patients Quickly
A Chemistry, Manufacturing and Controls (CMC) Strategy Forum titled “Accelerated Product Development: Leveraging Combined Industry and Regulator Knowledge to Bring Products to Patients More Quickly†was held in Washington, DC, on 27 January 2014. Biological therapeutics in development are demonstrating remarkable results in the clinic for many indications. So companies are seeking ways to accelerate the approval of these therapies and rapidly bring them to market. Many such products take the form of well-characterized proteins (e.g., IgG1 or IgG2 monoclonal…
Revenue per FTE and Cost per FTE: Metrics of Operational Efficiency and Performance
www.graphicstock.com Revenue from operations (herein referred to as revenue) and operating cost (herein referred to as cost) are two independent sentinels of a corporation’s performance and return on investment (ROI), which is defined as the ratio of revenue to cost (revenue/cost). Although a company can actively manage cost by controlling its number of full-time employees (FTEs) and the number or type of activities, it cannot directly manage revenue. Revenue is entirely driven by market forces. So if a company experiences…
Exploring Options for Dual Sourcing of Single-Use Components
As the bioprocess industry progressively adopts single-use technologies for large-scale manufacturing (1, 2), biomanufacturers’ increased reliance on integrators for critical production equipment continues to raise concerns about supply chain security. The need to mitigate risks associated with the supply of single-use components (e.g., bioreactors, aseptic connectors, tubing, filters) has led to growing interest in the dual sourcing of those materials. To that end, integrators and end users alike are exploring the definition of functionally equivalent products, how functional equivalency can…
The US Biosimilars Future Is Hard to Predict: Global Health Policy, Innovation, Prices, and Profits Are All at Stake
Enthusiasm in the United States over opportunities for biosimilars has waned since such products were first launched in Europe. The hesitation stems from confusion and uncertainty surrounding regulations. Manufacturers and suppliers are looking for guidance from the US Food and Drug Administration (FDA), which has promised guidelines that are still in process after five years. Even naming protocols for biosimilars are clogging the works. And in the absence of coherent FDA guidelines, many US states are haphazardly implementing laws concerning…
The 2014 BPI Awards: Recognizing Excellence in Bioprocessing
The mission of the BioProcess International publication has always been to deliver valuable industry information to the biotechnology community to continue on the path of scientific advancements, revolutionary technological applications, and strategic partnerships and collaborations. We are honored to cover this market and work with the many talented people sharing their expertise and projects. Now is the time for us to recognize and honor the outstanding people, organizations, and technologies that have significantly influenced and advanced the efficiency of biotherapeutic…