BioProcessing Journal Posts

Serine-threonine kinases of the Mitogen Activated Protein Kinase (MAPK) pathway represent potential drug targets for a wide range of diseases. As part of an effort to understand the biology of the pathways, several human serine-threonine MAPKs were produced. Optimization and modification of current methodologies used in the baculovirus expression system resulted in the generation of large amounts of active MAPKs. Compounds found to inhibit the MAPKs in vitro, subsequently showed activity in cell-based assays and animal models. The processes to be discussed were developed to yield large quantities of three active human serine-threonine MAPKs by the baculovirus expression system…

Baculovirus Expression Technology Biologics Production

The baculovirus expression system promises to revolutionize the production of recombinant proteins for use as clinical products. The technology is robust, efficient, and low-cost when compared to other cell based systems. The technique may also present an advantage in producing safer products versus the equivalent materials made with mammalian cells. Proteins can be produced in insect cells without animal supplements such as fetal calf serum. In the current climate of concerns over Bovine Spongiform Encephalopathies, and bovine viral risks, this method offers a significant safety, as well as cost advantage, over other production methods…

Baculovirus Expression Technology Regulatory

Globally, an estimated 36 million people are living with HIV, and some 20 million people have already died of AIDS. Today, there is still no HIV vaccine available. HIV virus-like particles are an attractive vaccine candidate due to their ability to induce both antibody and cytotoxic T-lymphocyte responses. In this article, we describe the development of a production process for an HIV particle vaccine, HIV-1 p55 (gag). The gag precursor protein (p55) is sufficient for assembly and cellular release of retrovirus-like particles. We expressed the p55 gag protein using the BEVS technology in Spodoptera frugiperda expresSF+ cells…

Baculovirus Expression Technology Biologics Production

Apoptosis is an essential biological process that has been conserved among eukaryotic organisms throughout evolution. Apoptosis, or programmed cell death, is necessary for embryological development, tissue homeostasis, immune system maintenance and development, and as a defense mechanism against the progression of cancer and viral infection. With the advent of biotechnology and the development of associated molecular biology techniques such as recombinant DNA technology and mammalian cell culture, tissues can be extracted from organisms and have their cells cultured as single cell suspensions or adherent monolayers. Therefore, these cultures can function as living production facilities for antibodies, recombinant glycoproteins, vaccines, hormones, growth factors, and more. However, the cell’s ability to control its own death is not lost upon its manipulation from the organism to culture. Consequently, apoptosis, which is so fundamentally important in-vivo, becomes a detriment to biochemical manufacturers in-vitro…

Uncategorized

Protein-based therapeutics have led to the emergence of the biotechnology industry and should drive rapid growth in the industry over the next decade. In 2001 alone, six major biologics were approved by the FDA. According to our analysis, there are 39 biologic products (antibodies and non-antibody recombinant proteins) that are currently in Phase III clinical testing and about 60 in Phase II testing, which we estimate could lead to 34 new products on the market in the next four to six years. By our estimates, such a new product outpouring would lead to more than a doubling of the number of profitable biopharmaceutical product companies (currently 15) by mid-decade. The focus of this report is to evaluate the manufacturing aspects of biotechnology models and analyze the current and future capacity needs of the industry…

Biologics Production Manufacturing

Baculovirus expression technology, or BEVS, gained its first broad industry exposure in the early 1980s, primarily through the many papers published by students and post-doctoral fellows in Dr. Max Summers’ laboratory at Texas A&M University (College Station, Texas). This technology fostered popular appeal because of its simplicity and high protein expression capabilities. As more work was done, it became even more evident that this was a very rapid, and relatively inexpensive method for producing proteins. It was also postulated that BEVS would offer a valuable means of producing recombinant proteins for use in human therapy, especially since baculovirus was considered non-infectious to human cells. It was thought that any problems with post-translational modifications of the manufactured proteins could be worked out, and fully functional glycoproteins could be manufactured…

Baculovirus Expression Technology

The development of reference testing reagents has been used successfully in the past to standardize measurements among laboratories, particularly for biological products such as recombinant cytokines. This approach was recommended by many parties with a stake in adenovirus vector delivery in order to address the fact that particle units and infectious units are not standardized in the field. This has made interpretation of preclinical and clinical data, as it relates to the amount of adenovirus vector administered, difficult to compare across the field. An Adenovirus Reference Material is being developed to define the particle unit and infectious unit for adenovirus gene vectors, and create a commonality for comparisons, especially for data related to vector safety…

Viral Reference Materials Viral Vectors

We have developed a procedure for large-scale enrichment, growth and harvesting of T cells suitable for adoptive immunotherapy. In two recently completed clinical trials, we investigated the feasibility of immune reconstitution in patients with HIV infection, or with relapsed/refractory Non-Hodgkin’s Lymphoma (NHL) following infusions of autologous activated CD4+ T cells or CD4+/CD8+ T cells. Autologous T cells were activated via CD3/CD28 stimulation, ex vivo, and were then reinfused…

Cell & Gene Therapy

Introgen Therapeutics has been producing clinical-grade adenoviral vectors in scaled-up processes, in cGMP facilities, for over five years. Semi-automated hand filling, using a Watson-Marlow 505Di/L pump, has been used over this period to fill batch sizes of up to 2 liters of adenovirus. While this procedure has been robust and demonstrated a high level of sterility assurance through regularly scheduled media fill studies and product testing, the firm needed to move to the next level of fill sizes. Anticipating up to 10,000 fills in 3 mL vials, Introgen has worked in collaboration with M&O Perry Corp. to develop an automated fill capability that utilizes the same base procedure but in an automated fashion…

Biologics Production Viral Vectors

A formulation for purified adenoviral vectors was developed that provides stability through freeze-thaw stress and long-term storage at non-frozen temperatures. To evaluate the various test conditions, a panel of stability indicating methods was assembled, which included laser light scattering, HPLC, and transgene expression assays. Preformulation studies were conducted, and the effects of buffer species, pH, cryoprotectants, and salts upon adenoviral vector stability were determined…

Viral Vectors