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Killer Artificial Antigen Presenting Cells KaAPC for Efficient In Vitro Depletion of Human Antigen-specific T Cells

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Published on: August 11, 2014

Containment challenges in HPAPI manufacture for ADC generation.

Elizabeth Dunny¹, Imelda O'Connor², Jonathan Bones³

¹The National Institute for Bioprocessing Research and Training, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, A94 X099, Ireland.

Drug Discovery Today

|March 11, 2017

Summary

Manufacturing antibody-drug conjugates (ADCs) requires significant containment investment due to potent cytotoxic payloads. This analysis reviews containment strategies and regulatory challenges for active pharmaceutical ingredient (API) production.

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HLA-Ig Based Artificial Antigen Presenting Cells for Efficient ex vivo Expansion of Human CTL

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Published on: April 11, 2011

Area of Science:

Pharmaceutical Manufacturing
Oncology Therapeutics
Chemical Engineering

Background:

Antibody-drug conjugates (ADCs) combine antibody specificity with cytotoxic payloads for targeted cancer therapy.
The high potency of ADC payloads presents significant manufacturing challenges for active pharmaceutical ingredient (API) producers.
Operator and environmental safety necessitate substantial investment in containment technologies.

Purpose of the Study:

To examine varying approaches to high-potency compound classification and containment control.
To provide an overview of containment strategies applicable to ADC payload manufacturing.
To address the health and safety regulatory landscape for cytotoxic payload production.

Main Methods:

Review of industry attitudes towards high-potency categorization and containment.
Overview of containment strategies in facility design, powder handling, purification, analysis, and cleaning.
Consideration of regulatory challenges in cytotoxic payload manufacturing.

Main Results:

Divergent perspectives exist regarding the classification of highly potent compounds.
Established containment strategies are adaptable for ADC payload manufacturing processes.
Regulatory compliance for cytotoxic payload production involves complex health and safety considerations.

Conclusions:

Effective containment is paramount for the safe and compliant manufacturing of ADC cytotoxic payloads.
Standardized containment approaches can mitigate risks associated with potent API production.
Addressing regulatory nuances is crucial for advancing ADC therapeutic development.