Upstream utilising ambr® technology
Abzena utilise the latest ambr® technology so different media can be screened against temperature shifts, impeller speeds, CO and pH to produce a more robust process and understand important process parameters increasing the speed of upstream development. From 15-2000L the reactors are geometrically similar, so data obtained is comparable from lab to plant.
Bench-scale fermentations are designed by Abzena to identify the upper and lower limits for each parameter (according to current ICH guidelines) that will be suitable as a laboratory scale process for use in later phase development for retrospective validation of the upstream process.
Once bench-scale tests are completed Abzena produces a development cell bank ready for fermentations to assess cell line stability for protein productivity and quality).
Abzena produces a robust, consistent and scalable process with the goals of maintaining yield, purity and quality of the drug substance.
Optimisation of the purification process includes:
- Capture, Ion Exchange and SEC Chromatography
- Viral reduction
Abzena’s purification development activities are performed in parallel with upstream and assay development activities.
Working with Abzena
Abzena’s mammalian manufacturing services are tailored for each project to ensure that the objectives are met or exceeded. Experienced project teams are assigned to each study focusing on progressing projects through to results in the minimum amount of time. Our clients widely regard us as professional and attentive partners who deliver quality results.
To get more information, a quote or to schedule a teleconference please contact us.