This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.
Discover how through automation, it is possible to achieve data acquisition, process monitoring and control, and batch record generation, allowing more complex unit operations to be run in cGMP compliant production environments.
This application note demonstrates the performance of the automated ÄKTA™ readyflux single-use filtration system in microfiltration applications. Here, a domain antibody (dAb) expressed in E. coli was recovered from fermentation broth. The dAb-containing sample was clarified (2.5-times concentration) and further washed with three wash volumes, with a recovery of approximately 90% of product in the permeate.
This work describes the capabilities of ÄKTA readyflux when used in ultrafiltration/diafiltration (UF/DF) applications. The process was conducted in an automated manner based on methods created using phases predefined in the UNICORN™ system control software.
This poster describes the studies aimed at characterizing the fluid dynamics of the Allegro STR 1000 bioreactor by measurement and modelling of specific physical parameters known to be critical for mammalian cell culture. More specifically, oxygen transfer rates, mixing times and carbon dioxide stripping rate.
Experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or patient safety.
Examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and understand practical, total solutions.
Addressing the concerns regarding limiting the rapid adoption and implementation of single-use technology has centered on standardizing single-use component extractables data packages to be used for end user risk assessments.
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.
Choosing a supplier with a strong quality and supply track record, as well as broad technology platform and deep bioprocessing expertise, will simplify the entire process. To be a credible partner, they need to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training and the right level of support to bring your capacity online faster.
In deciding which single-use platform to choose, reliability and robustness are fundamental requirements. Beyond process performance, it is important to consider how control systems and automation come into play, how easy it is to implement the platform, and if the design is flexible enough to support varying production volumes.
This contract manufacturer overview highlights their expertise in complex organic synthesis, milling and micronizing, process optimization and scale-up, and more.
In biomanufacturing the only certainty is risk and the only constant is change. Technology is pushing new frontiers, new markets are opening up across the globe, and new competition is creating new levels of urgency—all under the ever more watchful eye of regulators.