Regulatory Open Forum

Since you don't have any prior history of stability of this product, the FDA's expectation is that you concurrently monitor the stability of the clinical batch (i.e. being dosed in FIH study) while the study is ongoing. Why not dose the technical batch and monitor the stability of this lot? BTW, the clinical batch should adhere to the phase 1 cGMP guidance.
https://www.fda.gov/media/70975/download

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GRSAOnline
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Original Message:
Sent: 03-Jul-2020 03:45
From: Roy Jamieson
Subject: FTIH clinical batch - Stability setdown

Hi all,

I'd appreciate any insight into peoples views on the following situation based on precedent if possible;

• FTIH clinical study of a sterile IV infusion product (lyophilised powder for reconstitution in a vial)
• Due to lack of drug substance (DS) proposing not to set-down on stability the 1st clinical batch to be dosed in humans
• Setting down & monitoring the Technical GMP batch on stability - identical DS/formulation/vial, similar scale and likely identical process
• Shelf-life will be set and supported by technical batch - fully representative of the clinical batch
• 
  
• I've not come across the situation where 1st GMP clinical sterile product batch is not placed on stability but maybe i'm being too conservative.

Is there any specific guidance out there that recommends setdown of 1st clinical batch?

Any thoughts or builds welcome.

Kind regards,
Roy Jamieson (BPharm Hons)

Regulatory CMC Consultant
Jamieson Combinations AB

E: roy.jamieson@btinternet.com
T: +46 (0)70 8467411