Mammalian Manufacturing Process Development
- Abzena’s runs purification development activities in parallel with upstream and assay development activities to minimise time scales
- Aim to improve yield with optimisation of each step in the upsteam and downstream process
Upstream Process Development
Abzena develops a practical, robust, reproducible and scalable cell culture process suitable for clinical production. Abzena performs a series of bench studies examining growth and productivity performance under set basic parameters such as nutrient analysis, pH and dO2 in order to optimise the production procedure.
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 test are completed Abzena produces a development cell bank ready for 5 – 20 L scale fermentations to assess cell line stability (with regard to protein productivity and quality) through:
- Growth curve analysis
- Seeding density (split ratio/defined)
- Extended passage – also suitable for larger scale cGMP production
- Derivation of expansion format
- Cell/product performance data (cell count and viability, WB and ELISA)
- Seed pool generation
Downsteam Process Development
Abzena produces a robust, consistent and scalable process with the goals of maintaining yield, purity and quality of the drug substance.
During the programme to develop and scale-up the purification process the studies are based upon established data and include, as a minimum, analysis of:
- Impurity removal
- Product stability
- Process consistency
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.