Over the past 24 months, the leadership of the Bio-Process Systems Alliance (BPSA) has initiated a pilot program to demonstrate the joint feasibility of collecting and sharing pertinent industry business data. We began with “quality-complaint data” centered on the premise that product complaints are tightly associated with product-quality defects in single-use systems (SUSs). This approach can be viewed as “risk assessment 101.” BPSA’s Representation of the Single-Use Industry BPSA is an industry organization primarily comprising drug manufacturers, single-use system suppliers,…
Manufacturing
Adenovirus Downstream Process Intensification: Implementation of a Membrane Adsorber
Historically, companies developing vaccines have used attenuated pathogens, inactivated infectious agents, or antigenic constituents purified from pathogenic sources. In the past 20 years, technological advances such as recombination and viral vectors, have enabled development of vaccines against diseases with previously no available treatments (1). Viral vectors have become one of the most rapidly evolving and promising fields in vaccinology and regenerative medicine. In addition to preventing infectious disease, they have a broad range of potential applications, including treatment of hereditary…
The Critical Role of Media in Intensified Upstream Processes
As the need for novel therapeutics increases, so does pressure on the biopharmaceutical industry to improve productivity, accelerate development, increase, and reduce costs — all while ensuring drug product quality. Upstream intensification strategies such as perfusion culture can address those challenges and achieve higher protein titers that can translate into higher throughput, improved flexibility, and compressed timelines. Successful implementation of perfusion culture or the transition to perfusion from fed-batch culture requires a different and strategic approach to media selection, not…
Forward Thinking — Evolving the Cell and Gene Therapy Industry: Modern CAR T-Cell Process Addresses Future Demand
It is an exciting time to be involved in the cell and gene therapy industry. We have come to a tipping point where we have shown that the science works. Now we need to industrialize and standardize it, so we can get these life-saving therapies to more patients. As an industry, we can learn from all the experience in the biologics space. With monoclonal antibodies (MAbs), we have transitioned from a manual process to a more standardized and automated set-up.…
Production of Transient Lentiviral Vectors in HEK 293T Cells: Cultivation on Fibra-Cel Disks in a Single-Use, Packed-Bed, Stirred-Tank Bioreactor
Although demand for lentiviral vectors (LVs) for cell and gene therapy is increasing, the standard two-dimensional culture systems used to produce LVs present significant disadvantages. Current bottlenecks in LV production are caused mainly by such disadvantages. Switching to use of bioreactors can eliminate those problems because bioreactors offer the benefits of process automation, tight regulation of production conditions, and reduced labor input. The study reported herein was carried out by the group of David Parsons at the University of Adelaide.…
Single-Use Tubing Systems: Confidence Through Validation
Single-use systems (SUSs) are becoming increasingly common in bioprocessing operations because of their low capital requirements and validation costs. As this trend continues to develop, pharmaceutical manufacturers are asking SUS manufacturers to provide assurance that their products comply with current good manufacturing practices (CGMPs) and do not alter drug products by exceeding established operating ranges. Certification of product cleanliness has become common for manufacturers of final packaging components such as vials and stoppers, but rarely are tubing products certified to…
Flow Monitoring in Continuous Processing and Single-Use Systems
Flow sensors placed at critical points in both upstream and downstream processes fulfill the regulatory goals of the process analytical technology (PAT) framework. PAT has been defined as a mechanism for design, analysis, and control of biotechnical and pharmaceutical manufacturing processes through measurement of critical process parameters (CPP). Constant flow monitoring can support its overall targets fundamentally to reduce production cycling time prevent rejection of batches enable real-time release increase automation and control improve energy and material use facilitate continuous…
Streamlining the Path to Clinical Manufacturing
Careful consideration of lot size is crucial for multiyear success of a cell therapy business. RoosterBio’s product design and acceleration business works with the company’s customers to help make plans that are appropriate for their stages of product and clinical development. We use the following major considerations in creating a sound multiyear strategy with intermediate milestones: Understand what the future looks like and work backward Use reasonable to conservative assumptions to estimate a range of needs Invest in the right…
Rapid Mammalian Cell Harvest Without Centrifugation for Antibody Purification: Using a Novel System for Cell Culture Media Clarification
Monoclonal antibody (MAb) expression systems typically use signal peptides to ensure secretion of antibodies into cell culture media. Although that reduces the complexity of purification and prevents the need for cell disruption, it does require using expensive and time-consuming techniques to separate cells from antibody-containing cell culture fluids. In this study, we describe our tests of the novel Sartoclear Dynamics Lab V system (Sartorius S Lab Instruments GmbH and Co. KG) for rapid clarification of cell culture media without requiring…
Smart Sensors and Data Management Solutions for Modern Facilities
Bioprocess manufacturers continue to seek technologies for increasing productivity and shortening timelines from discovery to commercialization. Innovations such as high-throughput systems, automated platforms, and the latest clarification systems all have made processes efficient and robust. And with the increasing adoption of quality by design (QbD) principles, including the use of process analytical technologies (PAT), biomanufacturers are mitigating the risks of errors in their operations better than ever before. A critical part of mitigating risk is gathering meaningful process data and…