Atara Bio

Transport Simulation, Shipper Qualification, and a Comprehensive Validation Plan Support Multi-Country Filings for a Biotherapeutic Protein

Challenge

During the clinical development phase for one of its novel T-cell immunotherapies, Atara Biotherapeutics engaged Modality Solutions to revise its logistics process to ensure better product stability through the cold chain.

Objectives

  1. Design and implement a short-term triage shipping plan
  2. Evaluate a liquid formulation to ship at refrigerated temperatures
  3. Reduce incidence of vial breakage
  4. Create a transport validation strategy and design
  5. Support regulatory filings in US & Europe

Results

See how Modality’s Cold Chain Engineering™ experts provided short-term shipping solutions and a transport validation and shipper qualification strategy to optimize Atara’s cold chain.

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