BioProcessing Journal

Biopreservation of Cells for Use in Biotechnology and Cell Therapy

Today, technology has reached a point where organisms (bacteria, plant and animal cells) can be genetically engineered to produce specific macromolecules and perform complex chemical reactions. Hence, they are called “cellular factories.” Cellular factories have applications in: biomedicine (e.g., implanted insulin secreting cells for the management of diabetes); biotechnology (recombinant protein and enzyme production for pharmaceutical and food industries); bioremediation (toxic waste and pollutant clean-up); green chemistry (production of chemicals with minimum toxic bi-product generation); alternative energy generation (electricity and hydrogen production by bacteria); biosensors (e.g., devices housing “canary cells”, which can signal the presence of pollutants, viral agents, or toxic chemicals); bioreactive devices (that can detect low concentrations of chemicals, etc.)…

Biologics Production Cell & Gene Therapy

biopreservation cellular factories controlled rate freezing cryopreservation post-thaw assessment stability viability assay

Development and Validation of a Calcium Mobilization Assay for the Detection of Neutralizing Antibodies to Alefacept in Human Serum

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…

Biologics Production

alefacept anti-drug antibodies anti-psoriatic therapeutics calcium mobilization assay immunogenicity recombinant proteins

PCR Turns 25: Celebrating the Past and Anticipating the Future

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…

Nucleic Acids Research

amplification gene expression genetic research genotyping molecular research PCR polymerase chain reaction

Reflections On the GFP Nobel “Buzz”

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…

Research

bioluminescence capstone terminal cloning chromatofocusing green-fluorescent protein research funding technology transfer

Rapid Development of High-Performance Stable Mammalian Cell Lines for Improved Clinical Development

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…

Biologics Production

cell line selection mammalian cell line development recombinant proteins stability therapeutic proteins vector construction

Manufacture and Stability of the Recombinant Adeno-Associated Virus Serotype 2 Vector Reference Standard

Recombinant adeno-associated viral (rAAV) vectors have proven to be efficient vehicles for gene transfer in animal models. The attractive features of this vector system are long-term gene expression with little or no associated toxicities following administration to a variety of tissues. Previous and ongoing clinical trials in humans demonstrate a very good over-all safety profile. However, one of the caveats of this work that has been carried out by several laboratories is the inability to normalize vector doses administered by different investigators to animals and humans. Most of the work to date has involved AAV serotype2 vectors, but vector systems based on other AAV serotypes are being rapidly developed…

Viral Reference Materials Viral Vectors

adeno-associated viral vectors FDA helper virus-free transient transfection infectious titer purification stability testing standards

Expression Vector Engineering for Cell Line Development — New Roles for “Old” Sequences

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…

Manufacturing

cell line development expression vector engineering intervening sequences protein expression transgene expression

Optimization of Peptone Supplementation In the Development of a High-Performance CHO Growth and Production Medium

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…

Biologics Production

animal-free peptones cell culture media media supplement peptone supplementation process optimization

Membrane Chromatography: An Alternative to Polishing Column Chromatography

With the development of bacterial fermentation and mammalian cell culture as the sources for new recombinant products came a standardization of raw feed stocks. Therefore, manufacturers came to share the same types of problems. This standardization allowed a more systematic approach to process development divided into upstream (bacterial and yeast fermentation or mammalian cell culture) and downstream processing activities…

Manufacturing

antibody purification chromatography downstream processing membrane chromatography purification viral clearance

Extreme Pipetting Mission #2: Holy Geyser! Understanding How Pipetting Warm and Cold Liquids Affect Data Integrity (part 2)

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…

Research

data integrity pipetting thermal disequilibrium volume variation

BioProcessing Journal Posts

SEARCH