GMP Manufacturing — API / Drug Product

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GMP Manufacturing — API / Drug Product

The Challenge

Fast-Track Clinical Supplies for Multiple APIs and Drug Products

The Barriers

  • Simultaneous development activities and execution of processes for 2 unique drug substances and 4 drug product lots
  • Coordination of sourcing, setup, technology transfer, batch records, familiarization, etc.
  • Accelerated schedule based on positive data points
  • Tight timelines

API & Drug Product Manufacturing Services

  • Recalculate API batch sizes for optimal speed
  • Assess equipment trains for suitability
  • Develop flexible drug product suite utilization agreement
  • Modify and create batch records (2 API and 4 drug product/packaging)
  • Set up coordination teams at multiple locations
  • Initiate technology and materials transfer
  • Facilitate Quality Audit by sponsor of 2nd Avista location
  • Establish sample shipment plan to eliminate transfer of analytical methods
  • Utilize Avista’s microbiology facility when incumbent MET lab couldn’t meet time requirements
  • Undertake ad-hoc formulation development in parallel for product with unexpectedly low clinical dose, including qualification of new equipment and additional analytical method development
  • All cGMP activities completed November to early January

API / DP Synthesis

  • 2 APIs synthesized, 1 lot each
    • API 1: 5 GMP steps, yielded ~0.5 kg of API
    • API 2: 1 non-GMP and 3 GMP steps, yielded ~1.5 kg of API
  • 4 Drug Product lots manufactured and packaged
    • API 1: Powder in bottle – pediatric use
    • API 1: 7,787 capsules packaged in ~300 bottles
    • API 2: 9,751 capsules packaged in ~370 bottles
    • API 3: 28,997 capsules packaged in ~398 bottles
  • All API and Drug Product lots placed on stability storage for testing

The Outcome

  • Coordinated activities across multiple locations
  • Anticipated scope and timing changes based on clinical trial requirements and proactively worked with client to maximize flexibility
  • Modified delivery to meet client’s timeline with initial small batch followed by full quantities for each program
  • Met the client’s accelerated schedule while delivering quality products and results

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