BioProcessing Journal

Characterization and Qualification of Cell Substrates for Manufacturing Viral Vaccines in the United States

Cell substrates are used in various stages of viral vaccine manufacturing, as in the isolation, selection, and propagation of the virus seed or virus vector stock, as well as for the amplification of the virus to produce the final vaccine product. The various stages of cell substrate use, including cell banking, are shown in a generic manufacturing scheme in Figure 1. Traditionally, viral vaccines have been produced in animal tissues, primary cell cultures, and cell lines that either have a finite life span, such as normal diploid cells, or a theoretically infinite life span, as achieved with continuous or immortalized neoplastic cells. The cell substrates used in viral vaccines currently licensed in the US are listed in Table 1…

Manufacturing Viral Vectors

cell substrates characterization FDA safety testing vaccines viral vaccines

A Summary of the Manufacture, Biochemical Characterization, and Virological Safety Demonstration of the Mouse mAb CB.Hep-1 Used to Produce the Hepatitis B Vaccine

Monoclonal antibodies (mAb) are highly selective molecules, and an unlimited amount of mAbs with equal quality can be produced using mammalian cell cultures and animals. These molecules have remarkable applications in biomedicine, diagnosis and therapy due to the ability to reproduce exactly the same binding properties. The mAbs have been generated against an ostensible set of compounds such as toxins, drugs, blood proteins, cancer cells, viruses, hormones, environmental pollutants, food products, metals and plant materials. In general, mAbs can also be used for creating sensitive tests to detect small amounts of substances, and in therapies, abzymes, and for isolating specific compounds from complex mixtures by immunoaffinity chromatography (IAC)…

Manufacturing

ascites method characterization immunoaffinity chromatography monoclonal antibody vaccines viral clearance viral safety

Profiling Intracellular Monoclonal Antibody Expression for Improved Cell Culture Characterization and Process Optimization

Many laboratories have utilized cell-free systems or prokaryotic systems designed to produce biological molecules with single polypeptide chains, limited folding requirements, and without glycosylation. The yeast systems are used to generate glycoproteins; however, their glycosylation profiles are vastly different from those of mammalian cells. Without significant glycoengineering, the yeast-produced recombinant glycoproteins may be unsuitable as therapeutic molecules. As such, the use of mammalian cells is still the preferred method to produce complex biological molecules…

Biologics Production

antibody expression characterization flow cytometry mammalian cell culture process development specific productivity

Applying Modern Design of Experiments to Mass Transfer Characterization in Bioreactors

Mass transfer is one of the most crucial parameters during scale-up in cell culture, and may cause variations in specific yields. At the cellular level, all the cells require proper supplementation of essential nutrient sources: nitrogen, oxygen, and carbon. The ability of cells to grow, maintain viability, and provide high specific productivity depends on the proper distribution of these nutrients. The latter depends on proper mass transfer to supply oxygen, carbon, and nitrogen through agitation and aeration, along with other micronutrients…

Manufacturing

bioreactor design of experiment mass transfer mass transfer characterization mass transfer coefficient scale-up

Functionally-Improved Recombinant Antibodies: Moving Toward Higher Levels of Expression

Directed evolution has profoundly changed the way antibodies or antigen binding fragments (Fab) are produced today. Lead generation for product candidates is oftentimes based on complex combinatorial libraries containing a large collection of variant antibodies. The selection of candidate molecules by screening procedures like phage display is considered the gold standard. One major advantage of these methods is that initial candidate molecules can be further improved in terms of affinity, specificity, etc. by reiterative in vitro maturation processes using the very methods that have been used for lead generation…

Biologics Production

antibody expression antibody libraries directed evolution gene optimization phage display recombinant antibodies

Peptide Synthesis in Pharmaceutical Manufacturing

Amino acids are the most basic of building blocks in physiology, which is why peptides (oligomers of amino acids) are continuing to grow in prominence among pharmaceutical manufacturers. With inherent abilities to block and/or enhance signal transfers in the human body, peptides, when harnessed as active pharmaceutical ingredients, can treat a host of metabolic diseases, cardiovascular and heart conditions, and neurodegenerative disorders. Peptide-based drug targets are being identified at an increasingly rapid pace, both in terms of recently introduced therapies, and products in the development pipeline…

Manufacturing

peptide synthesis peptide-based therapy purification sequence analysis solid-phase synthesis

Optimization of Baculovirus-Mediated Gene Delivery into Vertebrate Cells

Baculoviruses are large rod-shaped DNA-viruses which specifically infect only arthropods, mostly lepidopteran species. Among the over 600 known species, Autographa californica multiple nucleopolyhedrovirus (AcMNPV) is the most characterized and widely used. The baculovirus genome is poorly transcribed and does not replicate in non-target cells. Thus, baculoviruses are harmless for vertebrates even though they can be found everywhere and we eat them daily on our vegetables. Baculoviruses have been applied in biotechnology for almost a century now, first as biopesticides (since the 1920s), then for recombinant protein production (since the early 1980s), and most recently for gene delivery into vertebrate cells (since the mid-1990s)…

Baculovirus Expression Technology

baculovirus-mediated gene expression BEVS gene delivery non-target cells

Authentication and Characterization of Animal Cell Lines: The Impact on Research

Propagation and culturing of animal cells is fundamental to biomedical research. Over the past decade, there has been an increased demand for cell lines for usage as both research tools and models by academic and industrial scientists. Cell culture is a critical tool in such areas as cell biology, gene therapy, genomics, transcriptomics and proteomics. The increased demand for cells and cell-based assays has triggered a remarkable boost in cell culture activities, which in turn has lead to a greater incidence of misidentified and contaminated cell cultures…

Research

animal cell line authentication characterization contaminant control microbial contamination morphology

Testing Strategies for Mammalian Cell Banks

Contamination by adventitious agents (bacteria, fungi, mycoplasma, and viruses) represents potential safety risks for biologics produced in mammalian cells. Bacterial and fungal contaminations are usually easy to detect in culture medium due to changes in pH and visual indicators such as color and opacity. Mycoplasma contamination has been detected in 15–35% of cell lines deposited in some cell culture collection. This is because mycoplasma contaminations often cause little changes that can be readily detected by visual inspection. However, bacterial, fungal, and mycoplasma contamination can be more effectively controlled than viral contamination by careful screening of initial parental cell banks, proper environmental monitoring, along with ongoing testing…

Cell & Tissue Banking

contaminant control mammalian cell culture raw materials qualification safety testing viral clearance viral contamination

Preparation of Haemagglutinin-lgG1 Fc Fusion Proteins in Insect Cells and Evaluation as Influenza Vaccines

ImmBio’s lead development candidate is an influenza vaccine based on the ImmunoBody® platform technology. An ImmunoBody is a fusion of a selected immuno-dominant antigen with a cell-binding domain — the Fc fragment of human IgG1. The use of recombinant Fc fusion proteins is well documented where it can help solubilize hydrophobic proteins, provide a handle for easy detection and purification, as well as improve half-life…

Baculovirus Expression Technology Biologics Production

BEVS influenza insect cell technology recombinant hemagglutinin proteins vaccines

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