Upstream

Flexibility in Next-Generation Facilities Through Rocking Motion Bioreactors

The biopharma industry continues to face increased demands for more efficient production processes and flexible solutions. Increasing efficiency in upstream bioprocesses leads to improvements in yield, speed, and cost-effectiveness. However, an often-overlooked feature of intensifying production processes is how they contribute to a more flexible and streamlined process, essential to meet the demands of this dynamic industry. What you will learn: Understand the issues creating operational challenges for the biopharma industry. Explore how an intensified seed train can increase upstream…

Fine-tuning Transient Transfection Conditions is a Prerequisite for Optimal Upstream AAV Manufacturing

Setting up robust and reproducible bioprocesses is a top priority for all biotechnology companies focused on developing life changing AAV-based gene therapies. To do so, innovators crave for breakthrough technologies to maximize productivity while controlling the cost of goods (CoGs) of their AAV vector manufacturing workflow, key to accelerate the speed to commercialization of their clinical programs pipeline. Helper-free triple plasmid transfection of HEK293 cells – adherent or suspension – is the most used upstream method for AAV manufacture. Observing…

Guidelines for Developing a High Cell Density Cryopreservation Process

Biopharmaceutical manufacturers are leveraging several approaches to intensify processes with a goal of improving efficiency and productivity and reducing costs — all while ensuring the highest quality standards. The upstream workflow offers several opportunities to apply next generation technologies and methods to achieve these important goals. In this white paper we discuss integration of high cell density cryopreservation (HCDC) in the seed train and explore key considerations for developing a cryopreservation process including choice of cryoprotectant and freezing techniques. Use…

Strategies for the Development of a High Throughput Octet® Bio-Layer Interferometry Method to Measure Pharmacokinetics of Monoclonal Antibodies in Preclinical Animal Models

Therapeutic antibodies are developed to treat various diseases, including cancers, immunological disorders, and infectious diseases. The safety and efficacy of these therapeutic molecules may be influenced by the way they interact with the body. Therefore, it is vital to understand how a body reacts to a biopharmaceutical after administration. Pharmacokinetic studies (PK) measure the variations of drug levels in the body as a function of time and are an essential part of the drug development process. Properly designed PK studies…

Selecting the Best Transfection Method – When to Use Transfection Reagents, Viral Transduction or Electroporation

No single delivery method is ideal for all situations, but researchers may routinely employ a suboptimal approach for the sake of familiarity or to avoid any start-up costs associated with new methods. In this white paper, we will describe three methods (chemical, electroporation and viral transduction) and highlight the Mirus Bio TransIT® transfection reagents and Ingenio® EZporator® Electroporation System, which are both easy to use and cost-effective.

Keys to Establishing a Robust Mammalian Cell Line Development (CLD) Platform

Risk management and the establishment of a robust mammalian cell line development (CLD) platform is key in the effort to bring biologics into the clinic as quickly as possible while also achieving high productivity and maintaining expected product quality. Utilizing the same mammalian cell platform early in the lead molecule discovery efforts as that used for eventual GMP production provides critical manufacturability and developability data while also delivering consistent cell culture growth characteristics and product quality and titer information to…

The Critical Role of Predictive Bioreactor Characterization in Pharmaceutical Process-based Upscaling

In bioreactors, microorganisms or cell cultures produce complex therapeutic proteins and other biopharmaceuticals. The industrial production of those active pharmaceutical ingredients usually involves a seed train: the cells are run through many cultivation systems, which become larger with each passage (Upstream Process). An adequate number of cells for the inoculation of large-scale production bioreactors of 10,000 liters or more is generated. A prominent example from the growing mammalian cell culture processing sector is the upstream production process of monoclonal antibodies.…

Optimizing Feed Strategies with Cellvento® ModiFeed Prime Comp: A Scalable Process

Development of upstream processes, that maximize productivity without increasing complexity, relies on the right combination of medium and feed and the ability to maintain tight control of culture conditions. In fed-batch mode, cells are initially grown in a relatively lean production medium followed by regular feed supplementation to achieve the desired product yield. This App Note presents an optimized feeding strategy and demonstrates how a new, easy-to-hydrate, single-part, pH neutral feed can support optimal cell growth and high productivity of…

Intensifying Upstream Processing and the Implications for Media Management

Process intensification offers many benefits but implementing PI can introduce an unexpected challenge of managing larger media volumes. This whitepaper covers the implications of media management when developing PI strategies. Key Learning Objectives: Gain the tools and knowledge needed to confidently assess intensification options with a focus on media management for new or existing facilities. Follow the media journey from prep to use, exploring potential logistical pitfalls in the management of increased media volumes associated with process intensification. See how…

3M™ Harvest RC Chromatographic Clarifier Beta Testing Series Summary

Frost & Sullivan invited a panel of industry leaders and key opinion leaders in pharmaceutical bioprocessing to participate in a new and unique thought leadership forum, the Virtual Think Tank (VTT) Early Access series. Each VTT panel, comprising professionals from pharmaceutical companies, contract development and manufacturing organizations (CDMOs), and 3M Company, discussed the new 3M™ Harvest RC Chromatographic clarification technology following participation in a beta test program that allowed them early access to work with the product and provide hands-on…