2013

Inactivated Poliovirus Vaccine Made in Modular Facilities with Single-Use Technology

If current efforts to eradicate polioviruses worldwide are successful, then the oral poliovirus vaccine (OPV) currently used for routine immunization in low- and middle-income countries (LMICs) will be replaced by inactivated poliovirus vaccine (IPV). IPV will become the only option for such countries if they want to continue to vaccinate against polio (1). Because IPV is currently considered to be too expensive for use in LMICs, strategies are being undertaken to make IPV more affordable (2). Some experts estimate that…

New Paradigms for Process Validation

    Both the United States and the European Union have recently evolved guidance on how to execute process validation (1, 2) with the prospect of a more appropriate life-cycle approach. It goes beyond the traditional three to five lots run at the center point of proposed ranges for operating parameters. New approaches leverage product design and process development information. They facilitate adapting the quality by design (QbD) paradigm to allow for a science- and risk-based selection of critical process…

Manufacturing

We editors think of the “manufacturing” theme as a sort of catch-all category for technical issues that aren’t specifically protein-production or separation/purification related. For us, that has always included assay development and other analytical topics that are more product- than process-focused. For the purposes of this conference-guide supplement, however, we have developed a separate article for analytical matters. So what falls under manufacturing? In past BPI Conferences, tracks such as “Production and Economics” and “Scaling Up from Bench to Clinic”…

NIR Spectroscopy for Process Monitoring and Control in Mammalian Cell Cultivation

The quality by design (QbD) and process analytical technology (PAT) approaches have shown significant benefit in the classical pharmaceutical industry and are now strongly influencing bioprocessing. Monitoring critical process parameters (CPPs) during biotechnological cell cultivations is essential to maintaining high efficiencies and quality. Commercial sensor systems for real-time inline monitoring are available for some parameters, such as pH or the concentration of dissolved oxygen (DO). For others such as glucose concentration, total cell count (TCC), and viability no robust online…

Analytics and Quality

Since the concept of “well-characterized biologics” entered the biopharmaceutical industry’s vernacular late in the 20th century, increasing emphasis has been placed upon product and process characterization. Analytical laboratories have always been vital to bioprocessing, whether they were performing in-house quality assessments, preformulation and other types of product characterization, and process scale-up and optimization support, or outsourced viral safety and product testing. Recent advances in analytical technologies such as high-performance liquid chromatography (HPLC) and mass spectrometry (MS), as well as other…

Enhanced 2-D Electrophoresis and Western Blotting Workflow for Reliable Evaluations of Anti-HCP Antibodies

Biologic drugs are subject to unique regulatory and technical requirements because of their origin and expression in genetically engineered host cells, as well as their underlying physicochemical properties and elaborate purification processes. One such requirement is the accurate monitoring and effective removal of process-derived impurities such as host-cell proteins (HCPs) and DNA/RNA, viruses, cell culture media, chromatographic leachates, and so on (1). Of those impurities, HCPs are perhaps the most challenging to accurately monitor. Each expression system’s proteome consists of…

Poster Presentations

Cell Culture and Upstream Processing Gary Boch (Cevec Pharmaceuticals) Custom Chemically Defined Media for CAP-T Cells Maurizio Cattaneo (BioVolutions) DoE for Continuous BioProcessing of Therapeutic Monoclonal Antibodies Stephanie Dubois (ATMI LifeSciences) Linear Scalability of Virus Production in Integrity®iCELLis®Single-Use, Fixed-Bed Bioreactors from Bench Scale to Industrial Scale Thomas Falkman (GE Healthcare) Assessment of Process Performance and Product Quality in High-Performing Fed-Batch Cultures Kathleen Harrison (Frieslandcampina Domo) Influence of Soy Protein Hydrolysates on Robustness of Cell Culture Experiments Clint Pepper (Bend Research)…

Upstream Chemistry Analysis in Cell-Based Process Development

Cell line selection is important to any pharmaceutical company’s development pathway for biological compounds (1). In cell-line selection laboratories, many different, slightly variable cell lines are tested in parallel for desired characteristics. Candidate cell lines are chosen for further development on the basis of their performance in basic tests of critical quality attributes (CQAs). Historically, such cell lines were selected in large-volume containers because it was necessary to have sufficient volume in culture to allow repeated sampling without damaging the…

Automation of Microbioreactors

Current methodologies in genetics and microbiology enable researchers to influence metabolic pathways of microbial cells in many directions. Beside the academic interest in investigating fundamental functions in metabolic pathways, commercial production of valuable compounds by microbial hosts is state of the art. For example, such products include enzymes (lipases, proteases, phytases), therapeutic agents (insulin, antibodies), bulk chemicals (lysine, glutamate, citric acid), or the microbial cells themselves (used in brewing or milk processing), with therapeutic agents probably the fastest growing market.…