Quality (Attributes) over quantity: Minimal essential quality attributes for determining antibody stability in...

Area of Science:

• Biopharmaceutical stability
• Drug product quality
• Therapeutic protein handling

Background:

• Monoclonal antibody (mAb) therapeutics require strict handling to maintain quality attributes (QAs) and ensure patient safety.
• Variations in supply and guidelines necessitate broader handling options to improve logistics and reduce shortages.
• Third parties conduct postproduction handling stability studies (PHSS) to extend mAb handling conditions, but QA standardization is lacking.

Purpose of the Study:

• To review and evaluate 31 postproduction handling stability studies (PHSS) conducted by third parties on monoclonal antibody (mAb) therapeutics.
• To assess the products, extended handling conditions, and quality attributes (QAs) evaluated in these studies.
• To identify variances and trends in PHSS and discuss the need for consensus on essential QAs.

Main Methods:

• Systematic review of 31 third-party postproduction handling stability studies (PHSS) on monoclonal antibody (mAb) therapeutics.
• Evaluation of studied products, extended handling conditions, and assessed quality attributes (QAs).
• Analysis of analytical techniques and study comprehensiveness.

Main Results:

• Significant variance observed in studied QAs, analytical techniques, and study comprehensiveness across the reviewed PHSS.
• A positive trend indicates increasing adherence to industry standards in more recent studies.
• No established consensus on the necessary QAs for PHSS.

Conclusions:

• Consensus on essential quality attributes (QAs) for postproduction handling stability studies (PHSS) is needed.
• A proposal for shared responsibility is presented: manufacturers provide physicochemical data, and pharmacists ensure microbiological stability.
• This shared responsibility model aims to ensure the safe use of mAb products under alternative handling instructions.