Information Request Email, February 18, 2014 - ALPROLIX

From: Denise Schultz [mailto:Denise.Schultz@biogenidec.com]  
Sent: Tuesday, February 18, 2014 1:30 PM 
To: Huang, Ellen (CBER) 
Subject: RE: Information request BLA 125444 - Visual inspection

Hi Ellen,

I’m so sorry for the delay.  Yesterday was a Company holiday so I’ve been trying to catch up with -(b)(4)- 
today on your visual inspection question.
 I am still trying to pull together the specific information you are looking for.

-(b)(4)- does not normally share their SOPs so I am trying to cull the appropriate information for you. 
 I have some additional clarifying questions for them and I know it is now evening in -(b)(4)-.
 I will definitely have something to you by Friday, if not earlier.
 I am unfortunately -----------(b)(6)----------, but will keep pushing folks as much as I can.

As for your other clarifying question:
 1.   You stated that the transport of filled products to the lyophilizer is performed by placing -(b)(4)-
 ----------------------------(b)(4)-------------------------. Can you please clarify if the 
 loading onto the ----(b)(4)---- is a manual or automated process?

I can confirm that the vials are loaded ----(b)(4)---- onto the cart. 

Please let me know if you need more information.

Kind regards, 
 Denise

From: Huang, Ellen (CBER) [mailto:Ellen.Huang@fda.hhs.gov]  
 Sent: Friday, February 14, 2014 4:49 PM 
 To: Denise Schultz 
 Subject: RE: Information request BLA 125444 - Visual inspection

Denise,

Thanks! And stay warm!

Ellen

From: Denise Schultz [mailto:Denise.Schultz@biogenidec.com]  
 Sent: Friday, February 14, 2014 4:31 PM 
 To: Huang, Ellen (CBER); Suzanne Stella 
 Cc: Thompson, Edward 
 Subject: RE: Information request BLA 125444 - Visual inspection

Hi Ellen,

No problem, I will get this answer for you in addition to the visual inspection question.

Regards, 
 Denise

From: Huang, Ellen (CBER) [mailto:Ellen.Huang@fda.hhs.gov]  
 Sent: Friday, February 14, 2014 4:29 PM 
 To: Suzanne Stella; Denise Schultz 
 Cc: Thompson, Edward 
 Subject: RE: Information request BLA 125444 - Visual inspection

Denise

I have one more question for you.
 1.   You stated that the transport of filled products to the lyophilizer is performed by placing -(b)(4)-
 ----------------------------(b)(4)----------------------------. Can you please clarify if the 
 loading onto the ---(b)(4)--- is a manual or automated process?

Thanks,
 Ellen Huang
 Consumer Safety Officer
 FDA/CBER/OCBQ/DMPQ/MRBII
 1401 Rockville Pike, HFM-676
 Rockville, MD 20852
 Phone: 301.827.7199
 Fax: 301.827.3536
 Email: ellen.huang@fda.hhs.gov

 

From: Suzanne Stella [mailto:suzanne.stella@biogenidec.com]  
 Sent: Thursday, February 13, 2014 7:01 PM 
 To: Huang, Ellen (CBER) 
 Cc: Thompson, Edward; Denise Schultz 
 Subject: Information request BLA 125444 - Visual inspection

Hi Ellen,

Sorry to be so late getting back to you today, but I just got my power back!.  I have been informed that 
 we should be able to provide the information regarding the training of individuals for the 100% 
 inspection process at -(b)(4)- by Monday.  Denise will be send  this along -------------(b)(6)-------------.

I hope you all stay safe during this storm that is going your way next!

Sue

Suzanne Stella
 Biogen Idec
 Director, Regulatory CMC
 5000 Davis Drive
 Research Triangle Park, NC 27709
 P: 919-993-1121
 C: ----(b)(6)----
