The selection of lead candidates in the development of therapeutic monoclonal antibodies (mAbs) is a critical decision. Designing a mAb that exhibits all the desired biological and pharmaceutical properties is challenging, and therefore, this process is primarily empirical. The classification of monoclonal antibodies (mAbs) based on their binding behavior can be a valuable tool for selecting promising candidates for further development. Such classification often involves grouping mAbs with similar epitope binding regions, which are known to share similar biological functions.…

Achieving process consistency is a critical goal in cell culture and fermentation operations. However, one common challenge in these processes is the accumulation of air bubbles on oxygen sensors. This can cause severe signal noise, which in turn can mask the true oxygen level, complicating process control and leading to variability. To avoid this issue, robust aeration control is crucial. You can improve growth, productivity, and product quality by ensuring adequate oxygen supply to cells. However, air bubbles on oxygen…

A major advantage of magnetically coupled agitators is the hermetic separation of the sterile vessel interior from the agitator motor. As no mechanical seal system is required, the risk of contamination entailed by such a system is avoided. There is no requirement to lubricate the seal and no need for energy-intensive pure steam condensate: a sign of the climate friendliness of magnetic mixing technology! Elimination of steam lubrication reduces CO2 footprint Steam generation requires a lot of energy, usually from…

Characterizing LVV stability just got a whole lot easier. As a developer of genetic therapies, do you find yourself struggling with the complexity of lentiviral vectors (LVV)? If so, you’re not alone. Compared to protein biologics, LVVs can be more difficult and expensive to manufacture. The scarcity of LVV material also makes scale-up difficult and adds additional complexity when qualifying subvisible particles, the most indicative critical quality attribute for biologic stability. But what if there was a way to overcome…

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…

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…

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…

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…

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.