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Aurora Manufacturing Facility

Our 65,000 sq. ft. manufacturing facility in Aurora, OH, USA includes a 12,000 sq. ft. excipient processing center, 3,000 sq. ft. for repackaging, 35,000 sq. ft. warehouse, 8,000 sq. ft. office, 8,000 sq. ft. manufacturing area, and 1,000 sq. ft. quality control and R&D laboratory.
  • Manufacturing
  • Excipient processing
  • Warehousing and distribution
  • Excipient processing

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 2008 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