Hosted by the Biotechnology Industry Organization (BIO), this year’s global event for biotechnology — the BIO International Convention — will take place 22–25 April 2013 at the McCormick Place in Chicago, IL. The 2013 BIO International Convention is where the global biotech community meets, showcasing and connecting the people, companies, and innovations that help fulfill the promise of biotechnology through healing, fueling, and feeding the world. The convention is expected to draw more than 16,500 industry leaders from 48 states…
2013
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.…
Risk Assessment and Business Impact Analysis of the Supply Chain
In the United States, up to 40% of businesses affected by a natural or human-caused disaster never reopen (1). The biopharmaceutical industry is not immune from disasters of a dizzying variety. But biotechnology companies often put all their supply needs in one proverbial basket. Companies need to understand fully the ramifications of contingency planning for single product lines. Imagine having to set up distribution and shipping plans for multiple products with different environmental needs, for shipping to different markets, and…
Sponsors Look to Asia for Potential Contract Partners
As the biopharmaceutical market continues its global expansion, biomanufacturers are becoming increasingly comfortable with the idea of outsourcing activities to international destinations. This year, China expanded its lead as the primary potential destination. This measure of interest shows how the country’s international outsourcing potential and global perception have changed over the past five years. It also suggests a greater international awareness of opportunities opening up in China for local production. Figure 1: () More than a quarter (26.2%) of the…
Biophysical Analysis of Living Cells
Adecades-old technology is finally emerging from clinical laboratories and demonstrating its utility in drug discovery and development. Cell therapy researchers bring their laboratory experiences with them as their science is commercialized. And as biopharmaceutical production engineers incorporate quality by design (QbD) and process analytical technology (PAT) into their work, they find that a method for monitoring the state and distribution of living cells can help build valuable upstream process knowledge. In flow cytometry, cells are suspended in fluid to flow…
A High-Yielding, CHO-K1–Based Transient Transfection System
Biotherapeutics have emerged as effective treatments for many diseases. It’s estimated that every year hundreds of new biotherapeutic candidates enter development (1). Stable transfection of host cells to establish high-producing cell lines is the approved method for generating clinical-grade recombinant biologics. However, biotechnology companies needing to speed up their developmental timelines are increasingly relying on material generated using transient transfection (1, 2). Unlike stable gene expression (SGE) that requires several months of laboratory and process work, transient gene expression (TGE)…
Analysis of Bacterial Biomass Growth and Metabolite Accumulation
Mathematical modeling has been widely used in microbiology and biotechnology for several decades. The main objective of modeling is to find optimal conditions for microbial growth and biosynthesis of useful metabolites. We modified the well-known equation of Perth–Marr (1) — proposed to calculate the energy consumption of a substrate— to analyze the energy consumption by cells for growth and viability maintenance. Our study includes that theory along with our own development. Our initial modeling work was carried out with Yersinia,…
Screening Yeastolate Raw Material Used in Insect Cell Culture Media
Insect cell culture is widely used as an industrial platform in recombinant protein production for research and diagnostics (1, 3,4,5). Many commercial yeastolate products are intended as nutritional supplements for not only insect cell culture, but also for mammalian cell culture and bacterial fermentation applications (6,7,8,9,10,11,12,13,14,15). Yeastolate plays an important role in modern biological production because it can be very effective in promoting insect cell growth and enhancing production of recombinant proteins. The product is known to contain amino acids,…
Process Optimization of Biosimilars Production Using NMR Profiling
With a compound annual growth rate potential of ∼52% during 2010–2015 (1), the global biosimilars market represents a significant driver in biologics development and manufacture. Increased competition, quality-by-design (QbD) directives, and rising costs are compelling biosimilars manufacturers to search for advanced technologies they can use in optimizing production processes to remain competitive and maximize new opportunities. Here, we discuss biomanufacturers’ needs for robust, standardized cell-culturing procedures that comply with QbD directives. We also describe an effective new NMR-based bioanalysis technology.…
IBC Life Sciences Presents The 2013 Biopharmaceutical Production Conference Series
IBC’s Biopharmaceutical Production Conference Series has offered high-quality programs covering topics from upstream to downstream for over 25 years. This series provides market-driven information, networking, and business development opportunities by covering a wide spectrum of topics with emphasis on current industry challenges. Biopharmaceutical Development and Production Week 25 February – 1 March 2013 in Huntington Beach, CA: IBC’s Biopharmaceutical Development and Production Week provides updates on current and emerging methods to improve your bioproduction capabilities. This event delivers strategies to…