Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Has any clinical and commercial biological drug product used filter needles to resolve visible particle issues?

Visible particles are often occasionally observed and specification for biological products is often: essentially free from visible particles. However visible particles are often product related and a intrinsic part of a biological product, and often are opportunistic. Filter needles (5 um pore size) seem to be able to remove visible particles.

Is there any commercial or clinical drug products use filter needles to remove visible particles? what are the regulatory hurdles for using the filter needles to remove visible particles in biological products?

This message was posted by a user wishing to remain anonymous

This is for subcutaneous (SC) injection. Any comments and information will be appreciated
Original Message:
Sent: 05-Nov-2019 10:09
From: Anonymous Member
Subject: Has any clinical and commercial biological drug product used filter needles to resolve visible particle issues?

This message was posted by a user wishing to remain anonymous

Has any clinical and commercial biological drug product used filter needles to resolve visible particle issues?

Visible particles are often occasionally observed and specification for biological products is often: essentially free from visible particles. However visible particles are often product related and a intrinsic part of a biological product, and often are opportunistic. Filter needles (5 um pore size) seem to be able to remove visible particles.

Is there any commercial or clinical drug products use filter needles to remove visible particles? what are the regulatory hurdles for using the filter needles to remove visible particles in biological products?

I can only comment that I was involved a few years back with a particulate issue for a commercial product that had just been approved. This was for a small molecule - so not a biologic. We had made our launch batches when the particulate issue was observed.  We asked FDA if we could include filtering instructions with the launch materials as we continued to investigate, but FDA said no.

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Tom
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 08-Nov-2019 08:50
From: Anonymous Member
Subject: Has any clinical and commercial biological drug product used filter needles to resolve visible particle issues?

This message was posted by a user wishing to remain anonymous

This is for subcutaneous (SC) injection. Any comments and information will be appreciated
Original Message:
Sent: 05-Nov-2019 10:09
From: Anonymous Member
Subject: Has any clinical and commercial biological drug product used filter needles to resolve visible particle issues?

This message was posted by a user wishing to remain anonymous

Has any clinical and commercial biological drug product used filter needles to resolve visible particle issues?

Visible particles are often occasionally observed and specification for biological products is often: essentially free from visible particles. However visible particles are often product related and a intrinsic part of a biological product, and often are opportunistic. Filter needles (5 um pore size) seem to be able to remove visible particles.

Is there any commercial or clinical drug products use filter needles to remove visible particles? what are the regulatory hurdles for using the filter needles to remove visible particles in biological products?