WEBINAR

Automated Colony Counter: Successful Validation Experience of an Eight Company User Group

Rapid Micro Biosystems® is proud to partner with industry expert Vaishali Shah of Kite Pharma to share her first-hand experience successfully validating and implementing an automated colony counter, our Growth Direct® System.

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Topics include:

  • Why an automated colony counter was crucial for their CAR T-cell therapy production
  • Why the Growth Direct® System was chosen
  • The validation approach taken, summarizing:
    • TTR comparison
    • IOQ approach
    • PQ and manual visual count comparability
    • PQ performance
    • EM method qualification/comparability with current method

Vaishali Shah_Headshot

Vaishali Shah, Head of Quality Systems and Compliance at Kite Pharma, has collected, in the past 25 years, extensive technical and leadership experience in pharmaceutical/biotechnology quality with a focus on microbiology, and most recently in commercial cell therapy microbiology. Her expertise is in process microbial control strategies and setting up microbiology labs using the latest rapid microbial detection techniques while upholding regulatory requirements on equipment qualification and method validation. She holds a Master’s Degree in Microbiology from Sardar Patel University, India.