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Related Concept Videos

Affinity Chromatography01:03

Affinity Chromatography

Affinity chromatography is a powerful technique extensively utilized for separating and purifying specific biomolecules from complex mixtures. It capitalizes on the highly selective binding between an analyte and its counterpart, such as antibody-antigen interactions. The counterpart is immobilized on the stationary phase, forming an affinity column. The stationary phase typically consists of solid support, such as agarose or porous glass beads, immobilizing the affinity ligand. The mobile...

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Leachables Analysis from a Closed Connected Single-Use mAb Purification Process.

Alfred Haglind1, Emil Håkansson2, Nils Wallménius2

  • 1Cytiva, Bjorkgatan 30, 75323 Uppsala, Sweden alfred.haglind@cytiva.com.

PDA Journal of Pharmaceutical Science and Technology
|December 26, 2024
PubMed
Summary
This summary is machine-generated.

This study tracked leachables during monoclonal antibody purification using single-use systems. Most leachables were removed during the process, except for those originating from final storage components.

Keywords:
BiomanufacturingExtractables and leachablesExtractables and leachables testingLeachable screeningSingle-use bioreactormAb

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Analytical Chemistry

Background:

  • Single-use systems (SUS) are increasingly used in biopharmaceutical manufacturing.
  • Understanding leachables and extractables (L&E) is critical for process safety and product quality.
  • Monoclonal antibody (mAb) purification relies heavily on chromatography and filtration steps.

Purpose of the Study:

  • To screen and identify leachables throughout a closed, connected mAb purification process.
  • To compare identified leachables with extractables data from process equipment.
  • To evaluate the fate of leachables during different stages of the mAb purification.

Main Methods:

  • Utilized high-throughput screening methods including HS-GC-MS, GC-MS, and LC-QToF/ESI (positive and negative modes).
  • Collected samples from perfusion culture to final storage bags across two parallel purification processes.
  • Correlated identified leachables with extractables data from mapped single-use equipment.

Main Results:

  • A broad spectrum of leachables was detected, with many compounds predicted by extractables mapping.
  • Common leachables such as ethylene glycols and laurolactam were identified, showing dynamic changes during the process.
  • The purification process demonstrated 'sink' capacities, effectively removing most leachables shortly after their release.

Conclusions:

  • The study confirms that single-use equipment is a source of leachables in mAb purification.
  • The mAb purification process effectively removes the majority of leachables, validating risk assessment assumptions.
  • Leachables associated with final product contact materials (storage bags) persist, highlighting the importance of final step material assessment.