Challenges to overcome in the CAR T manufacturing process include lengthy production times 11 21 days), product variability associated with open handling steps, and high manufacturing costs Here we examine and evaluate individual CAR T cell unit operations, commercial reagents, and equipment with process closure potential to develop an improved workflow and increase product consistency.
The traditional method of big batch manufacturing must change as companies move away from the one-size-fits-all blockbuster model toward more innovative, targeted biologics that deliver better outcomes.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective.
Building a bioprocessing facility is usually a complicated process and requires partnering with not only drug developers, but also many different experts in various industries.
Why new biopharma processing technology and automated processing is key to driving down costs and boosting facility efficiency.
A growing number of biologic manufacturers are adopting new fill-finish technologies, including single-use systems, pre-filled syringes, and automated fill-finish systems. When doing so it is critical to also consider the cost-benefit tradeoffs.
Demand to increase speed and flexibility while maintaining sterility spurs the adoption of novel technologies and materials, all of which introduce new challenges.
Single-use technology is well-established and made its way into commercial licensed facilities, but there is more innovation in this field which will enhance its versatility into new markets and technologies.
The concept of optionality is key to staying flexible in biomanufacturing by keeping your options open and having multiple pathways to take while navigating through this highly uncertain environment.
As the biopharma industry identifies faster and more efficient ways to deliver drugs to patients, such as break-through and fast track designations for accelerated approval, these progresses create pressure on both large and small drug manufacturers. As development timelines shorten, decisions related to drug commercialization need to be taken earlier, when key results are not yet available. And deciding on the scale and type of facility to build without complete data can create substantial risks with costly consequences.
Helping your cell therapies succeed through our reach and resources.
Genderless AseptiQuik® L Connectors enable quick and easy sterile connections, in large-volume, high-flow production environments. The largeformat, 3/4" and 1" genderless design simplifies system integration and minimizes the risk of operator error. The connectors’ robust construction provides reliable performance without the need for clamps, fixtures or tube welders. Biopharmaceutical manufacturers benefit from interchangeable 3/4” and 1” flow solutions for full-scale bioprocessing production environments with the quality and market availability they expect from the leader in single-use connection technology.
Genderless AseptiQuik® L Connectors enable quick and easy sterile connections, in large-volume, high-flow production environments. The largeformat, 3/4" and 1" genderless design simplifies system integration and minimizes the risk of operator error.
PODs coupled with LifeAire Systems’ purification technology offers extreme cleanliness and stability of the air in G-CON‘s prefabricated cleanrooms. This is achieved with LifeAire’s proven and patented multi-stage filtration systems built within the POD, eliminating all toxic airborne pathogens within critical space environments on a single pass. LifeAire’s new, transformational and proven technology provides deliverables that exceed GMP metrics that have been recognized as toxic to living cell culture.