Operations
Manufacturing—
  • Cell Culture;
  • Fermentation;
  • Contamination Reduction;
  • Purification;
  • Fill Finish;

Aseptic Processing—

Media fills—

Sterility failures—

  • Root Cause Analysis and Deviation Resolution;
  • Production scale;

Preclinical—

GMP clinical development—

GMP production (commercial/large scale)—

  • Process Capability Analysis (CPA);
  • Scale-up process;

Process transfer—

Tech transfer—

Commercialization—

  • Batch record and SOP drafting and revision.

Facilities—

  • Planning;
  • Start-up;
  • Capital utilization optimization;
  • Implementation of multi-product facility operations;
  • Evaluation and application of US and European requirements.

Supply chain—

  • Raw materials sourcing;
  • Warehouse layout and organization;
  • Materials management and staging.
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