vaccines – Page 4 – BioProcessing Journal

The NIAID/Vaccine Research Center Vaccine Pilot Plant: Design Approaches for Containment and Compliance in a Multi-Product Facility

The Dale and Betty Bumpers Vaccine Research Center (VRC) at the National Institutes of Health (NIH) was established to facilitate research in vaccine development. The VRC is dedicated to improving global human health through the rigorous pursuit of effective vaccines for human diseases. It was established by former president Bill Clinton as part of an initiative to help develop an AIDS vaccine and is part of the NIAID organization. Since the inception of the VRC, its mission has expanded to include the development of vaccines against bioterrorism and emerging infectious diseases…

Research

compliance containment eukaryotic cell culture facility design GMP prokaryotic fermentation quality assurance quality control vaccines

Production of a Recombinant Influenza Vaccine Using the Baculovirus Expression Vector System

Influenza is a highly contagious, acute viral respiratory disease that occurs seasonally in most parts of the world. The infection resides primarily in the respiratory tract (nose, throat and bronchi), but causes both local and systemic symptoms including fever, chills, cough, headache, myalgia, sore throat, and malaise. Influenza-related pneumonia is the main complication of infection. Annual epidemics cause significant morbidity and mortality worldwide. Each year, influenza infections result in an average of 110,000 hospitalizations, approximately 20,000 of which result in death. These deaths are heavily concentrated (>90%) among persons who are at highest risk for influenza-related complications — elderly adults (over 65), children under age five, patients with pre-existing respiratory or cardiovascular disease, and women in the third trimester of pregnancy. Thus, the prevention of influenza virus infection is a major public health priority…

Baculovirus Expression Technology Viral Vectors

BEVS influenza purification recombinant proteins transfection trivalent vaccine vaccines

Biopharmaceutical Contract Manufacturing at the Crossroads

Contract manufacturing of recombinant protein drugs and vaccines, as well as other biopharmaceuticals, has been the focus of considerable interest during the past decade. Fueled by a strong clinical development pipeline, primary manufacturing of biopharmaceuticals on a contract basis has attracted multinational industrial concerns willing to invest on the promise of potentially higher returns than are experienced in the production of traditional small molecule drugs. Biopharmaceutical contract manufacturers have made significant contributions to the development and subsequent commercialization of a few highly successful products. However, despite strong growth, consistent profitability has been elusive. The market has changed overr the past decade as customer projects progressed from process development through market launch. Now that several preeminent market players have successfully made the difficult transition from clinical to commercial supplier, what has been learned and how is the market expected to evolve over the next five years?…

Biologics Production Manufacturing

commercialization contract manufacturing GMP recombinant proteins vaccines

Viral Gene Vectors

An astonishing range of viruses has provided building blocks for gene delivery systems, from the simple adeno-associated virus with a 5 kb genome to the complex poxviruses with 300 kb. This review focuses on non-replicating viral vectors that infect host cells just once, without producing infections virus. Viral vectors are generally characterized by several criteria, including their ability to integrate into the host genome, coding capacity, titer, toxicity, immunogenicity, host range, duration of gene expression, and transient or stable production systems. These are precisely the features that need to be carefully studied in the context of the application when deciding which vector to use…

Biologics Production Cell & Gene Therapy Viral Vectors

adeno-associated viral vectors adenoviral vectors gene delivery gene therapy non-replicating viral vectors vaccines

Production Criteria in the Development of a K562-Based Vaccine Platform

The K562 cell line is a human myelogenous leukemic cell which has been used by several groups, including ours, as a vehicle for cell-based vaccines and immuno-gene therapies. The attractiveness of K562 cells is the ease with which they can be cultured, plus the fact that they express very low levels of MHC proteins. Low MHC expression facilitates the use of these cells in patients with different MHC backgrounds, and it may improve the in vivo survival of the cells by delaying immune rejection. Based largely on these properties, we have been developing the K562 cell line as a universal platform for expressing cytokines, tumor antigens, and other immuno-modulating proteins…

Biologics Production

cryopreservation ELISA immunotherapy mammalian cell culture protein expression vaccines

Animal Viral Vaccine Manufacturing

This paper reviews the manufacturing of veterinary viral vaccines and discusses the industry regulatory frameworks in both the European Union and the United States, the world’s two largest regulatory markets. We also address specific technical and regulatory issues associated with viral vaccine inactivation. Finally, we present two case histories for conventional viral vaccines: Foot and Mouth Disease Virus (FMDV) and Marek’s Disease, which are both long-established conventional vaccines, but nevertheless of great interest…

Manufacturing Regulatory

vaccines veterinary viral vaccines

Production of a p55gag Particle Vaccine Using the Baculovirus Expression Vector System Technology

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

HIV retrovirus-like particles vaccines virus-like particles

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