BioProcessing Journal

Rapid Manufacture and Release of a GMP Batch of Zaire Ebolavirus Glycoprotein Vaccine Made Using Recombinant Baculovirus-Sf9 Insect Cell Culture Technology

For the ongoing 2014 Ebola virus outbreak, all viable options and technologies need to be evaluated as potential countermeasures to address this emerging biological threat. Novavax, Inc. has a rapid, practical vaccine development and manufacturing platform with the capability to deliver clinical trial material and, ultimately, commercial doses in response to novel infectious disease agents. This report describes the application of our platform technology for the successful generation, manufacture, and release of a clinical batch of Zaire ebolavirus glycoprotein nanoparticle vaccine three months from project initiation…

Baculovirus Expression Technology Biologics Biologics Production Cell Lines Manufacturing Quality Risk Management (QRM) Regulatory Vaccines

ebolavirus vaccine glycoprotein glycoprotein vaccine gp2 micelle nanoparticle nanoparticle vaccine sf9 baculovirus Spodoptera frugiperda Zaire ebolavirus

Using Product Lifecycle, Process Validation, and Quality by Design (QbD) Paradigms to Efficiently Take New Biopharmaceutical Products from Pre-IND to Commercial Manufacturing

This paper describes how a biopharmaceutical product development effort can be structured to identify, understand, and plan activities and goals required to efficiently and rapidly deliver new products and therapies to patients. Although the paper focuses on manufacturing, the approach can be used for all aspects of pharmaceutical product development from establishing an intellectual property position, developing a comprehensive manufacturing plan, to creating a marketing program…

Biologics Biologics Production Manufacturing Quality Risk Management (QRM) Regulatory

development pipeline ichq8 product lifecycle qbd quality by design

Continued Process Verification: Monitoring and Maintaining a State of Control

To ensure that a commercial biomanufacturing process is in a state of control, life science companies must create and successfully execute initiatives to meet continued process verification (CPV) and other monitoring guidelines. Management at pharmaceutical, biotech, and medical device companies commonly receive directives associated with data monitoring. Various challenges arise in the development and maintenance of a successful global monitoring program. Because of this, many companies develop data monitoring programs that are not scalable and sustainable. Company leaders struggle with how best to adopt, deploy, and scale monitoring systems to achieve defined quality monitoring goals. The purpose of this article is to display a maturity model to help companies navigate the major steps of implementing a global monitoring plan for continued process verification…

Biologics Biologics Production Mammalian Cell Culture Manufacturing Process Automation

cmo continued process verification contract manufacturing organization cpv data monitoring FDA fda guidelines maturity model meta-monitoring

Successful High Density Escherichia coli Fermentation Using the Eppendorf BioFlo® 320 Advanced Bioprocess Control System

The gram-negative bacterium, Escherichia coli, has a long history in the world of laboratory and industrial processes due to its ease of manipulation and well-understood genome. It is widely cultured under aerobic conditions. High cell density cultivation of E. coli is a powerful technique for the production of recombinant proteins. Indeed, 30% of the FDA-approved biopharmaceuticals on the market are produced in E. coli. An Escherichia coli fermentation run conducted using the Eppendorf BioFlo® 320 bioprocess control station achieved high cell density at 12 hours, as determined by a maximum optical density (OD600) measurement of 215.2. The weights of dry and wet cells were also measured…

Biologics Manufacturing Pre-Clinical Development

bacterial fermentation bioflo bioprocess control e coli escherichia coli fermentation high density fermentation

Virotherapy Process Optimization

An emerging application of viruses involves engineering them to treat diseases using a number of approaches. Broadly defined under the “virotherapy” umbrella, these include viral vectors used for gene therapy, oncolytic viruses, and viral immunotherapy. Although a majority of these products are in various stages of clinical development, the diversity of the therapeutic targets and wealth of future opportunities is encouraging. A significant challenge, as it is for any virus-based technology, is gaining a clear picture of the quality of a sample at any given point—from early research and development through manufacturing and product release. Of prime concern is the quantification of viruses, which in the past, has relied on slow, labor-intensive, subjective methods such as plaque titer assays and electron microscopic imaging. However, the diversity of new viral technologies now being used as the basis for innovative drugs and vaccines requires advanced, sophisticated analytical systems. In this white paper, we discuss how the real-time enumeration of viruses made possible by the ViroCyt® Virus Counter® 3100 can significantly enhance the pace of virotherapy product development…

Analytics Biologics Cell & Gene Therapy Pre-Clinical Development Process Automation Viral Vectors

gene therapy oncolytic applications virocyt virotherapy virus counter

Two-Step Purification of Antibody from Tobacco Plants for Vaccine Manufacturing: Aqueous Two-Phase Extraction and Affinity Chromatography

The purification of PHB-01 plantibody derived from tobacco leaves imposed difficulties when the plantibody solid-liquid extraction design was performed. Thus, our study focused on assessing a combination of an aqueous two-phase extraction (ATPE) procedure and affinity chromatography for solving some of the issues in plantibody purification. This was done using a complete factorial redesign, different polyethylene glycol (PEG)/K2PO4 proportions, and pH values in each partitioning variant.

Biologics Biologics Production Chromatography Downstream purification Vaccines

affinity chromatography antibody purification ascites atpe cb.hep-1 monoclonal antibody non-transgenic tobacco plantibody protein quantification tobacco plants vaccine manufacturing

Design and Optimization of a Purification Process for MY32/Ls Protein Solubilizing Inclusion Bodies for a New Vaccine Against Sea Lice

Sea lice are the most problematic marine pathogens the salmon industry has to deal with, significantly affecting Europe and America. The worst offenders are genera: Pseudocaligus, Caligus, and Lepeophtheirus. Over €305 million in losses are estimated. Recent results have suggested that subolesin/akirin/myosin32 are good candidate antigens for the control of arthropod infestations such as sea lice. The aim of this study was to design and optimize the purification step of MY32/Ls protein to obtain the active pharmaceutical ingredient against sea lice. Non-chromatographic purification strategies were employed, based on published works, to establish rupture, washing, solubilization, and refolding conditions…

Biologics Biologics Production Downstream purification

inclusion bodies MY32/Ls protein protein folding protein purification sea lice vaccine

Billion-Cell Hypoxic Expansion of Human Mesenchymal Stem Cells in BioBLU® 5c Single-Use Vessels

Stem cell-based regenerative medicine has great potential to advance the therapeutic treatment of human diseases. Among the various stem cell platforms, mesenchymal stem cells (MSCs) represent one of the most promising options. Currently, there are over 500 clinical trials based on MSCs registered at the NIH’s ClinicalTrials.gov website. Although successful expansion of MSCs in vitro has been well-established, higher-yield, billion-cell expansion of MSCs remains a bottleneck. In this study, we successfully demonstrated large-scale culture of human adipose-derived mesenchymal stem cells (AdMSCs) in an industrial, single-use vessel at 3.75 L scale.

Biologics Biologics Production Bioreactor Scale-Up Cell Lines Regulatory Research

bioblue cell differentiation celligen blu bioreactor hmsc hypoxic expansion mesenchymal stem cells msc single-use vessels stem cell culture stem cells undifferentiated cells

Preparing Biotherapeutic Extracellular Vesicles: Ultrafilters, Mesenchymal Stem Cells, and the Regulatory Horizon

Extracellular vesicles (EVs) are particles of varying size, structure, and composition, which are secreted from cells and frequently mediate intercellular communication. Because they have been shown to travel through the circulatory system and also through biological barriers to deliver their molecular contents to distant target cells, there has been growing interest in using EVs, such as exosomes, as drug delivery vehicles. In the past ten years, the number of published articles linking EVs to drug delivery has increased 20-fold. EVs are being engineered to deliver protein, RNA, and small molecule cargo to target cells, tissues, and entire systems. Also, EVs derived from certain cells show inherent, therapeutically beneficial activity.

Analytics Biologics Biologics Production Downstream production Regulatory

antigen-presenting cells cell therapies evs exosomes extracellular vesicles liposomes mammalian cells T-cell therapy therapeutic evs ultracentrifugation

Achieving MAb Binding Greater Than 120 mg/mL With Novel, High-Flow Agarose Ion Exchange Resins

Agarose-based chromatography beads were first introduced by Stellan Hjertén in 1962. Fifty years later, beaded agarose has become the dominant resin for protein purification and is extensively used, ranging from research-scale in sub mL volumes to full-scale manufacturing in > 500 L chromatography columns. Recent resin development work has focused on increasing capacity and selectivity through different grafting technologies and ligand developments.

Analytics Biologics Biologics Production Chromatography Downstream production Regulatory

agarose iex atps chromatography chromatography resins downstream processing dynamic binding mab binding monoclonal antibodies therapeutic proteins

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