Aurora Manufacturing Facility
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 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