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March 2017

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Subject:
From:
"Mazzeo (R&D), Tony" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 24 Mar 2017 16:12:35 +0000
Content-Type:
text/plain
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text/plain (117 lines)
Hi Henry,
  We'll eventually be filing in US, EU, Japan, and then everywhere else sometime later.
Tony


-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Henry Madden
Sent: Wednesday, March 22, 2017 2:34 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] stability study batches for drug substance

Hi Anthony,
Are you hoping to register in the USA, Europe or some other region, we have worked for the European registration only and I could share my experiences on that but you maybe registering in the US only, let me know Regards, Henry Madden Chanelle Group Ireland

________________________________________
From: Pharmaceutical Stability Discussion Group [[log in to unmask]] on behalf of Mazzeo (R&D), Tony [[log in to unmask]]
Sent: 22 March 2017 16:34
To: [log in to unmask]
Subject: [PSDGLIST] stability study batches for drug substance

Hello stabilitarians,

I am not sure my last message got through so I am sending it again to see if I can get a response.

Does anyone have any experience with filing an NDA using pilot scale drug substance batches (primary stability batches) that were manufactured at a site that was not the commercial manufacturing site. Or having one of the three primary batches from a manufacturing site that was not the commercial site?

If, so, did you run into any issues with the ICH country reviewers or non-ICH reviewers?

I would appreciate hearing about your experiences.

Thanks
Tony




Anthony R. Mazzeo, Ph.D.
Senior Principal Scientist
Analytical and Bioanalytical Operations Pharmaceutical Development Department

Bristol-Myers Squibb Company
1 Squibb Drive
New Brunswick, New Jersey 08903-0191
USA

Ph: 732-227-7044
[log in to unmask]




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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.

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Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.DISCLAIMER: The information transmitted is intended for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, retransmission, dissemination or other use of, or taking of any action reliance upon this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the material from any computer.
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=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community.   Please take a second to visit our sponsors' web sites and say thank you for their support of this service.


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.
________________________________
 This message (including any attachments) may contain confidential, proprietary, privileged and/or private information. The information is intended to be for the use of the individual or entity designated above. If you are not the intended recipient of this message, please notify the sender immediately, and delete the message and any attachments. Any disclosure, reproduction, distribution or other use of this message or any attachments by an individual or entity other than the intended recipient is prohibited.

=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community.   Please take a second to visit our sponsors' web sites and say thank you for their support of this service.


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

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