The recombinant protein alefacept (Amevive®) is an immunomodulator approved for the treatment of moderate to severe chronic plaque psoriasis. In phase 3 clinical studies, treatment of psoriatic patients with alefacept at a safe and well-tolerated dose caused meaningful reductions in psoriasis area and severity index and in physician global assessment scores as well…
BioProcessing Journal Posts
Beginning with the production of the very first recombinant deoxyribonucleic acid (DNA) molecule in 1972 and continuing through the following decade, DNA-focused molecular biology researchers firmly positioned themselves on the cutting edge of scientific inquiry. With each passing day, month and year, these researchers made significant leaps forward in understanding, modifying and manipulating the key roles that DNA plays in all living organisms. Some of the key milestones…
In October 8, 2008, the Nobel Prize for Chemistry was awarded to Osamu Shimomura, Martin Chalfie, and Roger Tsien ostensibly for the discovery, cloning, and applications of green-fluorescent protein (GFP). This protein is associated with bioluminescence in coelenterates, including jellyfish and sea pansies. This award is as much a celebration of basic research as it is an acknowledgement of the achievements of three accomplished researchers…
Since the first approval for human use of a recombinant protein therapeutic, this sector of the pharmaceutical market has grown rapidly. The first approved protein therapeutics were small, non-glycosylated proteins such as insulin and human growth hormone; they were produced in bacterial systems. With the advent of mammalian cell-based production systems, it became possible to produce more complex, glycosylated proteins for use as recombinant therapeutics…
Expression vector and cell line engineering is the basis for expression and industrial production of biopharmaceuticals. The ultimate goal is to obtain clonal cell lines that secrete the protein of interest with high cell-specific productivity, and at consistently high levels over an extended number of cell generations, allowing for scale-up and cost-efficient large-scale manufacturing. Productivity and stability of expression are thus the prerequisites for developing commercially viable processes…
Optimization of the key factors in a biopharmaceutical process is necessary to meet the continuous rise in the production demands. One of the key factors in the process addresses the diverse nutritional and growth requirements of the cell culture—peptone supplementation. Peptones are low molecular weight protein digests, which provide nutrients such as amino acids, peptides, vitamins, and minerals to the culture medium. They are widely accepted as the supplements that enhance the performance of a chemically-defined cell culture medium, and have successfully been used for over thirty years…
After braving the home of the world’s worst weather to study the affect of barometric pressure on pipette volumes, the ARTEL Extreme Pipetting Expedition team embarked on its next mission to explore the impact of another environmental condition on laboratory data. The destination: Yellowstone National Park, boasting the world’s largest active geyser field, and more than 10,000 geysers, steam vents and mud pots. The ARTEL team landed in the 2.2 million acre park and realized they were certainly not in Mount Washington, New Hampshire anymore (the venue for Mission #1). As hot springs bubbled and a geyser spewed steam up to 135 feet in the air just a short distance from Expedition members, the thermal variation at Yellowstone National Park was evident…
A basic engineering study has been performed to evaluate three different strategies for the production of monoclonal antibodies (MAbs) from Chinese hamster ovary (CHO) cells. Cells are expanded in suspension culture and are then inoculated into either fed batch or perfusion culture for MAb production. The first strategy, which is also the current industry standard, uses fed batch culture with the cells in suspension in a stirred tank fermenter. The second strategy uses perfusion culture with the cells immobilized on Cytopore™ microcarriers in a stirred tank fermenter. The third and final strategy is perfusion culture with Cytoline™ microcarriers in a fluidized bed fermenter. Perfusion cultures, while leading to a somewhat lower product titer, were characterized by a much smaller equipment footprint. This in turn led to a >30% reduction in investment costs and a 12% reduction in MAb production costs calculated over five years of depreciation and ten years of production time…