Abzena has extensive experience in cGMP and non-GMP production for recombinant proteins, antibodies, conjugates, gene therapy, and cell therapy products for preclinical and clinical materials. Abzena’s expertise in employing single-use technology allows for rapid turnaround times and cost effective solutions.
Abzena can performs in silico assessments to identify a number of potential sequence liabilities which, if not addressed, could lead to manufacturing challenges at a later stage. The presence of any identiﬁed liability sites can be investigated further using our extensive bioanalytical capabilities and, if needed, removed using our comprehensive protein engineering technologies.
Cell Line Development
Abzena has over 10 years experience developing cell lines for customers and has completed over 50 projects, expressing biologics ranging from antibodies to fusion proteins. Multiple cell lines developed by Abzena have progressed through to product manufacture and are currently being assessed in clinical trials. Combining cell line development with GMP manufacturing can save 4-5 months to IND.
Abzena produces Master and Working Cell Banks in its cGMP production area in 100, 200 and 300 vial configurations.
- Cell bank generation
- Cell bank characterisation
- Cell bank storage
Abzena utilise the latest ambr® technology so different medias can be screened against temperature shifts, impeller speeds, CO and pH to produce a more robust process and understand important process parameters increasing speed of upstream development.
For downstream Abzena produces a robust, consistent and scalable process with the goals of maintaining yield, purity and quality of the drug substance.
Abzena’s biopharmaceutical manufacturing facilities located in San Diego, California, US provides world-class cGMP manufacturing utilizing single use technology for cost effective manufacturing.
Preclinical, phase I and phase II clinical trials
Abzena provides cGMP production and purification for recombinant proteins and antibodies for use in preclinical and phase I and II clinical trials.
Abzena’s manufacturing capacity runs from 1 to 500L with higher availability in batch, fed batch and perfusion runs.
Abzena have begun the installation of a new 500 L BIOSTAT® STR, single-use bioreactor, as part of a series of significant investments in its San Diego process development and manufacturing operations.
Analytics, Quality & Project Management
Abzena has standard platform assays and the methods used for in-process testing and release of drug substance are qualified. The qualification examines a number of parameters based on applicable ICH guidance to show assay specificity, linearity and variability.
Abzena has an established System of Quality in order to meet the quality and regulatory requirements of products manufactured for Phase I and II clinical trials meeting US and EU regulatory standards.
Abzena’s manufacturing solutions 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. Abzena’s clients widely regard us as professional and attentive partners who deliver quality results.