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Vaccines, Blood & Biologics

Memorandum, May 23, 2011 - Anascorp


Our STN:  125335/0
Rare Disease Therapeutics, Inc.
Attention:  Ms. Jennifer Spinella
May 23, 2011
By email
Dear Ms. Spinella:
We are reviewing your resubmission to your biologics license application for Centruroides (Scorpion) Immune F(ab)2 Intravenous (Equine).  We determined that the following information is necessary to continue our review:
  1. With regard to your response to CR item 8, please indicate where in your CR response the mixing validation data might be found.
  2. With regard to your response to CR item 14, please clarify the statement that “hold times for other process reagents, such as ----------------------------------------------------(b)(4)--------------------------------------------”. Please provide a list of all process reagents and their relevant hold times, as well as data validating those hold times.
  3. With regard to your response to CR item 28, please indicate where in the submission data might be found to demonstrate robustness of the nanofiltration step.  This data should evaluate the effect of parameters such as ------------(b)(4)------------ on the nanofiltration process.
  4. With regard to your response to CR item 30, please note that viral inactivation cannot be claimed if the process has not been adequately validated; this typically involves studies on the inactivation kinetics.  Please clarify your statement that "the requested and more recent viral removal data is provided above". Specifically, we are requesting kinetic studies on the heat inactivation step for ------------(b)(4)------------.
  5. With regard to your response to CR item 34, a glycine range of ----(b)(4)---- mg/vial indicates fill volumes ranging from -----(b)(4)----.  It also appears that most of your lots fall within one standard deviation from the mean glycine or sucrose content, with apparent outliers.  Please justify setting your specifications within three standard deviation of the mean glycine and sucrose content.
  6. With reference to your response to CR item 36, please justify storage at -(b)(4)- considering your long-term stability studies are performed at 25 °C (b)(4) °C.
  7. With reference to your response to CR item 82, please note that our request was for you to ‘preclude introduction of adventitious agents into your manufacturing stream’.  The tests described in 9 CFR 113.53 include tests in addition to those for ---(b)(4)-----.  Please implement testing of your equine plasma pools for adventitious agents according to 9 CFR 113.53(c).
The review of this submission is on-going and issues may be added, expanded upon, or modified as we continue to review this submission. Please submit your response to this information request as an amendment to this file by June 1, 2011. If you anticipate you will not be able to respond by this date, please contact the Agency immediately so a new response date can be identified.
If we determine that your response to this information request constitutes a major amendment, we will notify you in writing. 
The action due date for this file is August 3, 2011.
If you have any questions, please contact me at (301)827-6157.
Debbie Cordaro
Regulatory Project Manager

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