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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Vaccines

Meeting Minutes, November 30, 2009 - Flublok

 

Meeting Date:                       November 30, 2009
Meeting Time:                       1 – 2 PM
Meeting Location:                 Woodmont Office Complex, Conference Room 300N
File:                                        BLA 125285
Product Name:                       Flublok
Sponsor:                                 Protein Science Corporation (PSC)
                                               
 
FDA Attendees:
Wellington Sun, Jerry Weir, Cynthia Nolletti, Maryna Eichelberger, Matthew Sandbulte, Arifa Khan, Deborah Trout, Rajesh Gupta, Rakesh Pandey, Katherine Matrakas, Timothy Fritz
 
Purpose of Meeting:
 
To identify outstanding Chemistry, Manufacturing and Control (CMC) issues associated with Protein Sciences Corporation’s (PSC) Biologics License Application for FluBlok (STN 125285) and determine the timeframe for resolving these issues.
 
Discussion: 
 
The review team members were asked to provide a list of the outstanding CMC issues. The issues included:
 
  • Fill validation
  • Container closure testing
  • Residual Tween-20 validation
  • -----b(4)---------------------------
  • Lack of manufacturing consistency (e.g., recent failed lots without identification of root cause)
  • --b(4)-------------------- information
  • Format of the lot release protocol (trivalent bulk or final fill)
  • All items from CBER’s November 6, 2009 Information Request
 
The review team members were asked how long it would take to review this information once submitted by PSC. The review team members indicated that it should not take long to review this information but that PSC had not provided a timeframe for when this information would be submitted and, depending upon the information submitted by PSC, the reviews could require additional time.
 
The review team was asked whether there were any additional issues to be addressed. Three issues were raised:
  • It was noted that PSC recently had 3 lots of rH1 fail (either Out of Specification or Out of Trend) which raised concerns regarding PSC’s ability to manufacture product consistently.
  • It was also noted that, from their comments at the recent VRBPAC meeting, PSC might be planning ---b(4)------ studies to address the concern regarding -------b(4)---------------------- and that PSC would need to consult with CBER on the design of these studies.
  • The possibility was raised that PSC would need to repeat their clinical lot consistency study and that PSC may need to collect additional safety data. However, this could be requested as a post-marketing commitment.
 
Action Items
 
A list of the outstanding issues should be sent to PSC as soon as possible with a request for when PSC expected to submit a response.