In the last few decades, laboratory and therapeutic applications of cell culture-derived biologicals have expanded from their use in diagnostic and research fields to the prevention and treatment of infectious diseases, certain forms of cancer, immunological and congenital conditions, and cell and gene therapy. While significant therapeutic benefits obtained from the use of cell culture-derived biologics (e.g., recombinant proteins, monoclonal antibodies [mAb], and vaccines) are unequivocal, the complexities associated with the manufacture of such products is acknowledged. Primary and continuous cell lines used in the manufacture can be associated with risk of contamination with endogenous retroviruses, latent viruses, or new and emerging agents. Some cell lines, such as Chinese hamster ovary (CHO) cells, have an excellent safety record with no documented safety risks…
Tag: <span>mab</span>
Immunoaffinity chromatography is an indispensable purification tool. However, its use has been limited by cost, purification cycle numbers, and storage requirements. Therefore, authors speculated that a possible solution to these problems could be CB.Hep-1 monoclonal antibody (mAb)-immunosorbent lyophilization. This study sought to assess the impact of the CB.Hep-1 mAb quantification by enzyme-linked immunoadsorbent assay and the CB.Hep-1 mAb-immunosorbent lyophilization process for its impact on hepatitis B virus surface antigen purification for pharmaceutical use. Study results found that CB.Hep-1 mAb lyophilization did not affect mAb purity and antigen recognition capacity. CB.Hep-1 mAb-immunosorbent lyophilization did not modify volume-weight factor, infrared spectrum, particle-size distribution, particle density and viscosity, antigen adsorption capacity, antigen elution capacity, antigen recovery, antigen purity, gamma immunoglobulin (IgG) leakage, and purification cycle number. Therefore, the lyophilized CB.Hep-1 mAb and CB.Hep-1 mAb-immunosorbents can be successfully used for hepatitis B vaccine production…
The price per patient for protein-based and monoclonal antibody (mAb) therapies runs into thousands of dollars per patient each year. These therapies cost considerably more to manufacture than small molecules. Hence, if mammalian or insect cell lines expressing high protein titres can be selected and optimized for protein expression using microscale bioreactor models early in development, then manufacturing costs can be reduced significantly…
Cation exchange chromatography is typically utilized in bind-and-elute mode for monoclonal antibody purification. However, during purification process development for a novel monoclonal antibody (MAb) intended for clinical use, it was determined that bind-and-elute conditions were not sufficient for removing significant levels of antibody aggregate. Based on preliminary purification data, an alternative purification method, operation of the cation exchange process in flow-through mode, was investigated.
Rocker bag bioreactors have been used successfully in cultivating cells because they provide good nutrient distribution and cell suspension while eliminating the need to validate cleaning and sterilization. Therefore, this study examined the long-term performance of a 50 L single-use bag bioreactor on a rocking platform in CB.Hep-1 monoclonal antibody (mAb) production. For such a purpose, the bioreactor was operated in a continuous mode with a mixture of serum-free media (SFM) for 62 days, and with protein-free medium (PFM) for another 62 days…
Antibody-dependent cellular phagocytosis (ADCP), which relies on macrophages to attack and devour tumor cells following antibody binding, is a potentially useful mechanism of action (MOA) for antibody drug developers and vaccine makers to consider in determining product efficacy. Unfortunately, it is often ignored in favor of more accessible MOAs driving biological function such as antibody-dependent cellular cytotoxicity (ADCC) because the assays are tedious to prepare, perform, and reproduce.