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Lonza on the fate of leachables during biotechnology drug substance downstream processing

Ahead of his presentation at Extractables & Leachables USA 2017, we spoke with Michael Jahn, Head of Forensic Chemistry, Drug Product Services at the Lonza about the fate of leachables during biotechnology drug substance downstream processing, the importance of discussing results of projects and studies with peers and more.

Your presentation looks at the fate of leachables during biotechnology drug substance downstream processing; can you provide us with a brief overview of what your presentation will look into?

Throughout biotechnology drug substance (DS) downstream processing leachables are introduced via contact of the DS with polymeric surfaces. To evaluate the resulting safety concern for patients it is important to have knowledge about the clearance factors of those leaching compounds during the further downstream processing steps.

For two key steps of monoclonal antibody (mAb) downstream processing - ultrafiltration / diafiltration (UFDF) and protein-A affinity liquid chromatography (ALC) - the clearance of organic and elemental model compounds was investigated. The clearance of the organic model compounds was depending on their polarity; un-polar compounds were retarded within the mAb containing fractions, whereas compounds with high polarity displayed high clearance. Also elemental model compounds showed variable clearance; mainly they were cleared at high rates, but some elements (Mo, Se, Ag) were retained within the mAb containing fractions.

It can be concluded that the theoretical prediction of clearance factors for downstream processing steps based on ideal clearance behaviour leads to too optimistic estimation of the fate of leachables. They might not be sufficiently removed from the DS, but rather be administered into patients without appropriate safety concern prediction.

How important is it to evaluate and discuss results of research projects and case studies, such as your presentation, with peers and colleagues in the same industry at E&L USA?

It is important because E&L work is performed entirely for patients’ safety. Therefore an exchange between the experts in the field will increase awareness and safety standards and by this reduce patients’ risk with regard to leachables.

What are you most looking forward to at E&L USA 2017 in May?

I am looking forward to networking opportunities and to lively discussions, which will be guaranteed considering the exciting agenda.

Michael will be presenting as part of the E&L in biopharmaceutical manufacturing session at Extractables & Leachables USA 2017 this May alongside representatives from Triad Scientific Solutions, PPD, NIBRT, Sartorius Stedim and VR Analytical.

Book your ticket to join these esteemed companies, plus Becton Dickinson, GlaxoSmithKline, B.Braun, AbbVie, Novo Nordisk, the FDA and more this May now.