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…
2013
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.…
Moving Forward with a Gene Therapy for Damaged Hearts
A cocktail of three specific genes can reprogram cells in the scars caused by heart attacks into functioning muscle cells. Adding a gene that stimulates the growth of blood vessels enhances that effect, say researchers from Weill Cornell Medical College, Baylor College of Medicine, and Stony Brook University Medical Center in a report that appears online in the Journal of the American Heart Association (1). “The idea of reprogramming scar tissue in the heart into functioning heart muscle was exciting,”…
September 2013 Issue Author Insights
Scale-Up of Adherent Vero Cells Grown on Cytodexâ„¢ Microcarriers Using WAVE Bioreactorâ„¢ Systems
Traditionally, cell-based vaccine production is performed using stainless steel bioreactors that require extensive cleaning procedures. Because disposable bioreactor systems have no need for cleaning and validation, they can significantly reduce start-up times for good manufacturing practice (GMP) manufacturing of cell-based vaccines (1). Although they are susceptible to a broad range of viruses, Vero cells were recently successfully used for industrial-scale influenza vaccine production (2,3,4). However, these adherent cells can proliferate only when provided with a suitable surface on which to…
Presenting Sustainable Fluid Handling
Picture the scene: You head to the boardroom for a meeting with a vendor who promises to optimize your company’s fluid-handling processes. “Sustainability,” he says, enshrined in the spotlight of an overhead projector, “is at the heart of today’s agenda.” You slump into your chair. Sustainability is key to your business, yet efforts to bottle this elusive ideal have so far cost more than they’ve saved. “How can a sustainable bioprocess container solution enhance my business?” you ask. “It’s about…
The RAMbio Incubator Improves Culture Growth and Protein Expression
End oxygen limitations when growing Escherichia coli, Streptomyces, Pichia, Aspergillus, and other high-demand aerobes in shake flasks. Many bioprocesses rely on aerobic growth and protein expression, yet traditional orbital shakers do not provide adequate oxygen. Cultures become oxygen limited. The RAMbio incubator solves this problem by providing active headspace refreshment using low-frequency acoustic energy that aerates standard shake flasks. Why Use the RAMbio? The increased dissolved oxygen provided by the RAMbio may benefit aerobic microbial cultures by Increasing biomass, protein,…