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Aurora Manufacturing Facility

Core Capabilities

  • Supply of excipients down-packed in controlled and segregated environments to meet analytical and biological requirements
  • Custom finished goods packaging configurations including OEM packaging and labeling
  • Manufacturing, purification, crystallization, blending and finishing of high purity chemicals to customized specifications
     

Industry Segments and Applications

  • Biopharma
  • Cell culture
  • Diagnostics
  • Dehydrated culture media
  • Chemical distribution

Major Products

  • Excipients
  • High-purity chemicals such as buffers, amino acids, salts, and specialty chemicals

Primary Functions

  • Repackaging of excipients
  • Manufacture of high-purity chemicals
  • Custom testing and packaging of chemicals (VWR and OEM) (5g to 159 kg)
  • Testing, storage, manufacturing, and packaging of chemicals to meet customer requirements

Quality Systems

  • Excipients are ISO 9001 and EXCiPACT certified
  • All products meet established quality system requirements

Quality Control Capabilities and Instrumentation

  • Biological testing (Rnase, Dnase, Protease, Phosphatase, Endotoxin, Bioburden)
  • UV-VIS, Atomic Absorption, FTIR, TLC, Polarimeter, Autotitrator, Karl Fischer, LOD, Melting Point, Column Chromatography
  • Offsite by approved labs: HPLC, GC/MS, NMR, ICP

Supply Chain Management

  • Full supply chain traceability, global strategic sourcing, formalized qualification, full lot traceability, and supplier rating and audit program