Mammalian Manufacturing – Abzena

Mammalian Manufacturing

From Cell Line Development to Fill/Finish

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.

  • Extensive cell line development capabilities in royalty free CHO lines or SP2/0 and NS0
  • Master and working cell banking
  • Full cGMP manufacturing utilising the latest advances in single use technology

antibody3Cell Line Development

Abzena’s variety of manufacturing cell line development packages are designed to produce high yielding cGMP ready clonal cell lines ready for in house manufacture or transfer to external contract manufacturers. Abzena also specialise in development of biosimilar cell lines in CHO, NS0, Sp2/0 or other suitable lines with enhanced PQA assessment. Read More >>

antibody3Cell Banking

Master and Working Cell Banks are produced in Abzena’s cGMP production area and storage is provided with independent validated monitoring. Abzena also manages the full testing and characterisation requirements for cell lines prior to production of clinical material. Read More >>

antibody3Process Development

Abzena has expertise in both upstream and downstream process development. Process development services can stand alone or can be integrated into preclinical and clinical manufacturing projects with focus on improving yield at each stage of development by optimizing each step in the process. Read More >>

antibody3Manufacturing Capabilities

Abzena provides cGMP production and purification for recombinant proteins and antibodies for use in preclinical and phase I and II clinical trials. Abzena has extensive experience in the use of single-use technology which provides flexibility in the production process. Abzena’s manufacturing capacity runs from 1 to 15000 L in batch, fed batch and perfusion runs. Read More >>

antibody3Analytical Capabilities

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. Read More >>

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