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
- Design and implement a short-term triage shipping plan
- Evaluate a liquid formulation to ship at refrigerated temperatures
- Reduce incidence of vial breakage
- Create a transport validation strategy and design
- 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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