Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear group,

Hope you all are doing well and staying safe!

I was hoping to get a guidance on the stage at which WCB needs to be established in a biosimilar development program. Is it acceptable for clinical trial material to be manufactured either from MCB or WCB? which regulation or guidance can I refer to in this regard?

Thanks in advance for the help!

When to generate a WCB, I'd personally say is more of a commercial and risk management decision. For a Phase I EU IMPD it is acknowledged by the EMA that a WCB might not yet be available. Take into account that, changing to a WCB during further process development or for MAA application might result in changes in the product quality profile. It would be advantageous to have the interbatch product stability and comparability with the originator question settled. Furthermore, whether the application is made with a MCB or WCB viral safety must be established by viral characterization as well as studies on the viral removal efficiency of the DSP suite.

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal_en-0.pdf

Have a great application!

------------------------------
Luis Peña-Ortiz
Munich
Germany
------------------------------

Original Message:
Sent: 03-Jul-2021 03:39
From: Anonymous Member
Subject: WCB Establishment during biosimilar development

This message was posted by a user wishing to remain anonymous

Dear group,

Hope you all are doing well and staying safe!

I was hoping to get a guidance on the stage at which WCB needs to be established in a biosimilar development program. Is it acceptable for clinical trial material to be manufactured either from MCB or WCB? which regulation or guidance can I refer to in this regard?

Thanks in advance for the help!

This message was posted by a user wishing to remain anonymous

Hello Luis,
Thank you very much for your insights.

Original Message:
Sent: 07-Jul-2021 03:42
From: Luis Peña-Ortiz
Subject: WCB Establishment during biosimilar development

When to generate a WCB, I'd personally say is more of a commercial and risk management decision. For a Phase I EU IMPD it is acknowledged by the EMA that a WCB might not yet be available. Take into account that, changing to a WCB during further process development or for MAA application might result in changes in the product quality profile. It would be advantageous to have the interbatch product stability and comparability with the originator question settled. Furthermore, whether the application is made with a MCB or WCB viral safety must be established by viral characterization as well as studies on the viral removal efficiency of the DSP suite.

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-requirements-quality-documentation-concerning-biological-investigational-medicinal_en-0.pdf

Have a great application!

------------------------------
Luis Peña-Ortiz
Munich
Germany

Original Message:
Sent: 03-Jul-2021 03:39
From: Anonymous Member
Subject: WCB Establishment during biosimilar development

This message was posted by a user wishing to remain anonymous

Dear group,

Hope you all are doing well and staying safe!

I was hoping to get a guidance on the stage at which WCB needs to be established in a biosimilar development program. Is it acceptable for clinical trial material to be manufactured either from MCB or WCB? which regulation or guidance can I refer to in this regard?

Thanks in advance for the help!