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.
PODs provide the environments for the entire upstream and downstream process for a state of the art gene therapy facility.
Flexible and modular facility designs that can be built in a factory, shipped to the site and then rapidly assembled have been recognized and are being addressed by innovative suppliers.
Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.
The plug-and-play nature of single-use enables you to incorporate new technologies and innovations into the process workflow as they become available. But beyond the flexibility of the single-use platform, you need to consider a range of other factors to ensure your capacity can will meet your long-term needs.
If you have decided to add capacity in-house, you need to consider which location enables you to most efficiently and effectively meet demand. Having knowledge of the local operating environment as well as regulatory considerations is vital. Where you don’t have this knowledge in-house, finding a supplier with first-hand experience of operating in a region can help fast track your project.
In selecting a biomanufacturing platform, it's necessary to properly understand what the industry needs are and what aspects of the drug development and clinical pathway you intend to support with your new manufacturing capacity. Having a rigorous selection and assessment criteria will ensure you make the right decision.
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.