recombinant proteins – Page 4 – BioProcessing Journal

Production of a Recombinant Influenza Vaccine Using the Baculovirus Expression Vector System

Influenza is a highly contagious, acute viral respiratory disease that occurs seasonally in most parts of the world. The infection resides primarily in the respiratory tract (nose, throat and bronchi), but causes both local and systemic symptoms including fever, chills, cough, headache, myalgia, sore throat, and malaise. Influenza-related pneumonia is the main complication of infection. Annual epidemics cause significant morbidity and mortality worldwide. Each year, influenza infections result in an average of 110,000 hospitalizations, approximately 20,000 of which result in death. These deaths are heavily concentrated (>90%) among persons who are at highest risk for influenza-related complications — elderly adults (over 65), children under age five, patients with pre-existing respiratory or cardiovascular disease, and women in the third trimester of pregnancy. Thus, the prevention of influenza virus infection is a major public health priority…

Baculovirus Expression Technology Viral Vectors

BEVS influenza purification recombinant proteins transfection trivalent vaccine vaccines

Advanced Methods of Adenovirus Vector Production for Human Gene Therapy: Roller Bottles, Microcarriers, and Hollow Fibers

Various types of viral vectors are being employed extensively as gene therapeutics to treat cancer and genetic diseases. Among the viruses that have been produced for human clinical trials (i.e. retrovirus, adenovirus, poxvirus, adeno-associated virus, and herpesvirus vectors) adenoviruses exhibit the lowest pathogenicity yet still infect an extensive range of cell types with high efficiency. These key characteristics make recombinant adenoviruses efficient gene-delivery vehicles and excellent research tools. However, the time-consuming and complex processes of generation, amplification, purification, and quality testing associated with production of recombinant adenoviruses make it difficult for many researchers to utilize these vectors. This is particularly true with respect to cell culture optimization and the virus propagation protocols employed in vector production. In this regard, the development of innovative cell culture techniques has become vital for optimizing vector production for gene therapy…

Biologics Production Cell & Gene Therapy Viral Vectors

adenoviral vectors analysis cell culture enumeration propagation purification recombinant proteins

Biopharmaceutical Contract Manufacturing at the Crossroads

Contract manufacturing of recombinant protein drugs and vaccines, as well as other biopharmaceuticals, has been the focus of considerable interest during the past decade. Fueled by a strong clinical development pipeline, primary manufacturing of biopharmaceuticals on a contract basis has attracted multinational industrial concerns willing to invest on the promise of potentially higher returns than are experienced in the production of traditional small molecule drugs. Biopharmaceutical contract manufacturers have made significant contributions to the development and subsequent commercialization of a few highly successful products. However, despite strong growth, consistent profitability has been elusive. The market has changed overr the past decade as customer projects progressed from process development through market launch. Now that several preeminent market players have successfully made the difficult transition from clinical to commercial supplier, what has been learned and how is the market expected to evolve over the next five years?…

Biologics Production Manufacturing

commercialization contract manufacturing GMP recombinant proteins vaccines

Rapid Development of CHO Cell Lines for High-Level Production of Recombinant Antibodies

Organizations developing biopharmaceuticals are often faced with the challenge of developing, as rapidly as possible, a production system for a recombinant protein or antibody intended for use in clinical trials. For expression of antibodies and other proteins with complex post-translational modifications, Chinese hamster ovary (CHO) cells are often the host of choice. However, isolation of CHO cell lines producing even moderate levels of a protein of interest is usually a lengthy process due to the need for at least one and usually several gene amplification steps. Gene amplification, which is usually accomplished through the dihydrofolate reductase (dhfr)/methotrexate system, is a requirement for most CHO expression vectors because the absolute expression level from each copy of an integrated expression plasmid is generally very low…

Biologics Production

amplification cell line development expression mammalian expression vectors recombinant antibodies recombinant proteins

Advantages of Therapeutic Protein Production in the Aquatic Plant Lemna

More than 130 drug and vaccine approvals for 95 entities over the last 20 years have generated roughly $30 billion in revenue for the biotech industry. The vast majority of this revenue comes from 30 proteins that have manufacturing bottlenecks resulting from the complexities of consistent protein production. The lag times involved in constructing mammalian cell fermentation facilities keeps supply of immensely successful high-volume drugs like Enbrel, Rituxan, and Remicade well below estimated demand. In other cases, the complexities of peptide synthesis threaten the potential of soon-to-be-launched or recently approved drugs like Fuzeon. The Pharmaceutical Research and Manufacturers of America (PhRMA) has documented more than 371 new biotech drugs in development, supporting the view that demand for many biopharmaceuticals will continue to outstrip supply. That number does not include the multitude of biotech drugs still in research stages…

Biologics Production

peptide synthesis plant-based protein production protein expression recombinant proteins therapeutic proteins

Transfected Cell Line Enrichment Using the Gel Microdrop (GMD) Secretion Assay

The Gel Microdrop (GMD) Secretion Assay involves encapsulating cells within a biotinylated agarose matrix, followed by capture and detection of cell-secreted molecules with fluorescent markers. This technology differs from other encapsulation methods in that the small size of the microdrop (<50 ?m diameter) creates a defined microenvironment around the cell without impeding the fusion of nutrients, antibodies, or nucleic acid probes into the GMDs, or the diffusion of secreted products out of the GMDs. Large numbers of GMDs can be readily analyzed using flow cytometry, and sub-populations of rare or high-secreting cells, as small as 0.1%, can be detected and recovered in one day. This assay format is a rapid alternative to limited dilution cloning (LDC)...

Biologics Production

characterization encapsulation recombinant proteins therapeutic proteins transfection

Development of Novel Transgenic Insect Cell Lines that Support Humanized Glycoprotein Production by Baculovirus Expression Vectors

The baculovirus-insect cell system consists of a recombinant baculovirus vector and its host, which may be a lepidopteran insect larvae or an established lepidopteran insect cell line. Hundreds of different recombinant proteins have been produced using the baculovirus-insect cell system, facilitating biomedical research on protein structure, function, and the roles of various proteins in disease. In addition, many biotechnology companies are using this system to produce recombinant proteins for potential clinical use as vaccines, therapeutics, or diagnostic reagents…

Baculovirus Expression Technology

glycoprotein glycosylation insect cell line N-glycosylation recombinant proteins

Growth Characteristics and Expression of Recombinant Proteins by New Cell Clones Derived from Trichoplusia ni (BTI Tn5B1-4) High Five™ Cells

It is well known that the characteristics of a cultured cell line do not always remain stable and may change upon continuous passage. Most continuous cell lines, even after cloning, possess several genotypes that are constantly changing. There are numerous selective and adaptive culture processes, in addition to genetic instability, that may promote phenotypic changes in cell growth, virus susceptibility, gene expression, et cetera. Similar detrimental effects of long term passaging of insect cells have also been reported for continuous cell lines. In this paper, we describe the isolation of cell clones from low passage BTI Tn5B1-4 cells (High FiveTM Cells), and report their growth characteristics and high level of recombinant protein production…

Biologics Production

cell culture cloning protein expression recombinant proteins

Complex N-glycosylation of Recombinant Proteins by Insect Cells

The insect cell/baculovirus expression system typically results in more rapid expression and higher concentrations of recombinant proteins than what can be achieved with other animal cell culture systems. The lack of complex glycosylation in the proteins produced by this system, however, limits its use in the commercial-scale production of therapeutics. Complex glycosylation is required in many cases for adequate protein activity and pharmokinetic characteristics. In contrast to the protein’s primary structure, which is encoded by the genetic material and is constant regardless of the host utilized, the extent of glycosylation is determined by the host, and by the protein itself. Even cells from different tissues of the same organism provide different glycosylation profiles. In addition, culture conditions and the cellular metabolic state can also influence protein glycosylation…

Baculovirus Expression Technology Biologics Production

glycosylation N-glycosylation pharmokinetics recombinant proteins

Utility of a Recombinant Adeno-Associated Viral Vector Reference Standard

Recombinant adeno-associated viral (rAAV) vectors are known to be efficient vehicles for gene transfer in animal models. The attractive feature of this vector system consists primarily of 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 overall safety profile, but problems persist due to the lack of any systematic method for normalizing doses administered to animals and humans. To date, most of the work involves AAV serotype 2 vectors, but vector systems based on other AAV serotypes continue to develop rapidly. Administered doses are usually based on titer, but the defective nature of AAV makes determining vector infectious units difficult. Titering methods based on vector genomes (using hybridization, real-time PCR, or spectrophotometry) are more reliable, but give no information as to the infectivity of the vector. Determining infectious titer is critical, as the ratio of infectious virions to vector genome-containing virions helps to determine the dose, potency, and strength of the vector preparation…

Viral Reference Materials Viral Vectors

adeno-associated viral vectors infectious titer recombinant proteins safety standards

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