vaccines – 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

biologics bioproduction cigb cuba expression systems herber biotec mab monoclonal antibodies polyclonal antibodies therapeutic cancer vaccines tropical diseases vaccine development vaccines

Adventitious Virus Contamination Testing: Massively Parallel Sequencing in a Multimodal Solution for Biopharmaceutical Safety Testing

Virus contamination of commercially valued cell cultures can be a health risk to the general population and imposes financial burdens on manufacturing and biopharmaceutical companies. We investigated the use of massively parallel sequencing/next-generation sequencing (MPS/NGS) and bioinformatics for the detection and subsequent identification of adventitious contamination. Specifically, the Illumina® HiSeq 2000 instrument, in the 2 × 100 base pair (bp) paired end (PE) run configuration, was used to determine the identity and limit of detection of a DNA virus spiked into a virus vaccine, and an RNA virus spiked into a mammalian master cell bank (MCB). This configuration provided sufficient sequence read lengths and depth of coverage to detect and identify spiked-in SV40 and measles viruses in a background of vaccine, MCB, and host nucleic acid that make up the bulk of these samples. Furthermore, the detection of 30 SV40 reads within one tested sample suggested a < 1 plaque forming unit (pfu) sensitivity in a background of 2.8 × 107 infectious adenovirus serotype 5 (Ad5) particles. Results from subsequent virus vaccine testing suggested the presence of non-viable virus DNA contamination in the sample. Therefore, we propose that a multimodal approach, in which broad-range screening for known or unknown adventitious agents by MPS/NGS is complemented by targeted virus detection assays (e.g., PCR-based and infectivity assays), should provide the most useful safety monitoring information. We suggest that MPS/NGS and the accompanying bioinformatics is a sensitive, broad-range, and long-lasting tool with the ability to improve upon existing biosafety testing within a larger testing program…

Biologics Production

bioinformatics cell culture dna contamination host cell proteins mammalian cell bank massively parallel sequencing master cell bank mcb measles virus next generation sequencing PCR plaque forming unit SV40 vaccine production vaccines viral contaminants virus contamination virus detection assays virus spikes

Protein Expression in Corynebacterium glutamicum

Since its beginnings in the 1970s, recombinant DNA technology has become integral in the production of pharmaceutically important proteins such as blood factors, hormones, growth factors, interferons, interleukins, and vaccines. Recombinant technology was developed in Escherichia coli, and because of its long history of use and ease of manipulation, the bacteria remains a common expression system. However, E. coli is limited in the types of proteins it can express, and production can be hampered by the formation of intracellular inclusion body aggregates which complicate the processes of protein recovery and purification. The non-pathogenic Corynebacterium glutamicum can accumulate amino acids extracellularly and has historically been used for the commercial production of amino acids glutamate and lysine. More recently, C. glutamicum has been developed as an expression system with the ability to secrete properly folded, functionally active proteins into the fermentation broth. Production in C. glutamicum has the same advantages of scalability and ease of culturing as in E. coli, but with more simplified recovery and purification processes…

Biologics Production

amino acids biopharmaceutical product safety corynebacterium glutamicum e. coli expression system inclusion body aggregates interferons protein purification protein recovery vaccines

Expediting Clinical Batch Production of Viral-Vectored Vaccines and Gene Therapy Products

There are approximately 400 vaccines in commercial manufacture targeted at 24 infectious diseases. Of these vaccines, about 300 are viral-based. It is estimated that 1400 vaccines are in development, half of which are viral-based (~ 640 viral vaccines, ~ 200 viral vectors, ~ 60 virus-like particles). Another 240 gene therapy products are in development that utilize the same viral-based technology. A live vector vaccine is one that uses a weakened or harmless microorganism to transport antigenic viral pieces into a cell in order to stimulate an immune response. Vectored vaccines show promise in reliably inducing potent cell-mediated immunity, which is essential for complex diseases such as AIDS, malaria, and cancer…

Biologics Production

antigenic viral pieces biologics cell-mediated immunity gene therapy products immune response live vector vaccine vaccines viral-vector vaccines

Direct, Real-Time Antibody-Based Quantification of Baculovirus

The impact of viruses—in geopolitical human health issues, in the production of vaccines and recombinant proteins, and in gene therapy and cancer treatments—highlights the need for a better understanding of the systems that are dependent upon them. A primary barrier to recognizing the full potential of these life-saving biomedical approaches is the scarcity of analytical methods capable of providing biologically relevant information without hindering the pace of development and production. ViroCyt® is a Colorado-based biotechnology company with one overriding focus: Enabling the rapid and specific quantification of viruses and virus-related particles. The ViroCyt Virus Counter® was designed to meet this objective.

Baculovirus Expression Technology Biologics Production Process Automation Research

antibody labeling bacmam baculovirus gene transfer mammalian cells nucleic acids quantification of baculovirus vaccines virocyt

Fetal Bovine Serum: Risk Management

Safety is typically viewed, perhaps unconsciously, as the result of a collection of factors, conditions, or behaviors. For example, consider “safety” in the context of personal, financial, or travel. With each, safety is defined as a set of component risks that have been managed to satisfactory levels for a particular situation. The same is true for product safety and risk, whether it be for raw materials or finished goods. The “safe” use of fetal bovine serum (FBS) is achieved by the management of controllable risks to a level that is acceptable for each particular application. For example, risk reduction requirements for research applications are not as stringent as for diagnostic, therapeutic, or manufacturing applications. Each end-user must decide on the level of risk reduction that is appropriate for their application…

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

animal sera animal-derived materials biologics raw materials biotherapeutics cell culture cgmp fbs fetal bovine serum gamma irradiation geographical origins isia safe use serum serum traceability vaccines

Serum: What, When, and Where?

For over 80 years, fetal bovine serum (FBS) and other animal-derived materials have been widely used in the production of vaccines, and more recently, biotherapeutics, for both human and animal applications. Ever since FBS was initially developed as a cell culture reagent, there have been efforts made to avoid the use of this critical commodity. The International Serum Industry Association (ISIA) recognizes the requirement for robust risk assessment and management, and has several ongoing programs designed to help mitigate the risk of using animal-derived materials. This article will provide an outline of the state of the industry and of these programs…

animal sera animal-derived materials biologics raw materials biotherapeutics cell culture fbs fetal bovine serum isia serum traceability vaccines

Improving Process Economics When Developing a Vaccine Portfolio

Over the last few years, the challenges of vaccine development have created perhaps an unprecedented level of scrutiny, not just within the biotech industry, but also in the consciousness of the general public. This was certainly the case during the recent H1N1 influenza outbreak. The demand to know when a vaccine would be available, and if producers could meet the global demands consistently made front page news. The challenge of rapid and scalable manufacture is of course nothing new in biopharmaceutical development and in many respects, monoclonal antibodies are leading the way as the industry moves towards the required level of industrialization.

antibody production cho cells clinical development cmo complex biologicals contract manufacturing FDA influenza novel vaccines phase 1 phase ii process economics regulatory guidelines risk-based-approach scalable manufacturing vaccine portfolio vaccines

Demonstrating “Abdala” Subunit Vaccine Thermostability Study

From a regulatory standpoint, vaccine stability must be demonstrated, along with the prediction of stability during temperature excursions, before a vaccine can be approved for use in humans.

In this work, Abdala subunit vaccine thermostability was studied under thermal stress conditions (2–8°C [control], 25°C, 37°C, 45°C, and 60°C) for 15 days. Molecular integrity of the vaccine active pharmaceutical ingredient was monitored by SDS-PAGE, immunoblotting, RP-HPLC, mass spectrometry, and circular dichroism spectroscopy analysis. While functionality was monitored by immunogenicity assay, inhibition of binding between receptor-binding domain (RBD) and receptor, angiotensin converting enzyme 2 (ACE2), and RBD/ACE2 binding assay.

Results showed that no degradation, loss of disulfide bridges, nor modifications of secondary structure of the RBD molecule were detected at 25°C and 37°C. Moreover, high titers (1:48,853-1:427,849) of anti-RBD-specific mouse antibodies were detected with the ability to inhibit, to different degrees, the binding between RBD/ACE2.

In conclusion, the Abdala subunit vaccine is stable under thermal stress and storage conditions, which has an advantage over non-subunit vaccines previously approved or currently in development against COVID-19. The demonstrated high stability of this vaccine is a key factor in ensuring vaccine effectiveness, extending immunization coverage with fewer production runs, simplifying immunization logistics, and reducing cold chain-associated costs.

Biologics Production Regulatory

cold chain storage subunit vaccine thermal stress thermostability vaccines

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