mab – BioProcessing Journal

From the Editor-in-Chief: A “Renaissance” of Sorts Within the Biologics Industry

We just completed our 6th ISBioTech Spring Meeting, and it was a resounding success. And while the attendee numbers were up considerably, the more important aspects for me were that we had the “right” people, plus incredibly valuable content. Then what impressed me the most was the happiness and hopefulness I saw during the meals, receptions, and the banquet. We’ve been organizing these meetings for over 20 years, and I haven’t experienced anything like this since our earliest days in Williamsburg…

Biologics Production

aav adeno-associated virus baculovirus expression technology biologics bioproduction car t-cells chimeric antigen-receptor expression systems hpv vaccine internal reference materials mab monoclonal antibodies rhabdovirus sf9 cells therapeutic cancer vaccines vaccine development vaccines

From the Editor-in-Chief: Biomedical Research and Biopharmaceutical Advances in Cuba

European organizations have been doing business with Cuba during its last 30 years of biotechnology development, and have benefited from both licensing and distribution agreements for generic pharmaceuticals, as well as vaccines and other biologicals. However, as far as direct US/Cuban interactions, we’ll probably have to go through a period of “low-level” scientific exchanges before there is much interaction. As a starting point, it has been proposed by the American Association for the Advancement of Science (AAAS) that an official scientific and technology agreement be established to form a broader framework for interactions…

Biologics Production

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Facility Design for Contract Manufacturing

The number of mammalian cell-culture based products is increasing rapidly and has the potential to out-pace the current production capacity. New facility construction for mammalian cell culture production is costly and time consuming. Planning for initial product launch and long-term commercial manufacturing can be daunting for promising products in late phase clinical trials…

Biologics Production

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Caliciviridae and Vesivirus 2117

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…

Biologics Production

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Characterization of a Lyophilized Immunoaffinity Chromatography Matrix Employed to Purify Hepatitis B Surface Antigen for Pharmaceutical Use

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…

Analytics Biologics Production

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Streamline Your Cell Line Screening: With the Automated, Microscale, Stirred Tank, Single-Use Bioreactor

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…

Analytics Biologics Biologics Production Cell Lines Manufacturing Process Automation Regulatory

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The Development of a Flow-Through Mode Cation Exchange Process for the Purification of a Monoclonal Antibody

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.

Analytics Biologics Pre-Clinical Development Research

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Long-Term CB.Hep-1 Monoclonal Antibody Production in a Single-Use Bioreactor on a Rocker Platform with Serum- and Protein-Free Media

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…

Biologics Biologics Production Bioreactor Scale-Up Research

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Antibody-Dependent Cellular Phagocytosis: The Mechanism of Action That Gets No Respect A Discussion About Improving Bioassay Reproducibility

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.

Biologics Biologics Production Regulatory

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Eco-Friendly Red Pigment Production by Sporosarcina aquimarina

Acetyl-4, 4′-diapolycopene-4, 4′-dioate, a C30 carotenoid and secondary metabolite, was produced by the Sporosarcina aquimarina bacteria using a 5.0 L fermentation vessel with a 3.0 L working volume. In the presence of tryptone, the biosynthesis of acetyl-4, 4′-diapolycopene-4, 4′-dioate production using a batch fermentation process was further improved. Production parameters like carbon source, pH, and temperature were studied, and maximum product was achieved, up to 1.2 g/L, where the secondary metabolite yield was 0.07 g/L and productivity, 0.00833 g/L/h. The organic constitution and significant red color intensity of the acetyl-4, 4′-diapolycopene-4, 4′-dioate molecule can be used in the textile industry as a dye, and a coloring additive in processed foods and pharmaceuticals.

Biologics Biologics Production Bioreactor Scale-Up Cell & Gene Therapy Cell Lines Fed-Batch Bioreactor Process HEK293 Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

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