Biologics storage

Starting material and biological drug substances should undergo proper biologics storage prior and after biomanufacturing, thus ensuring optimal traceability and stability through a suitable freezing steps and a controlled chain of cold. 

For 20+ years, Clean Cells has provided global customers with secured long-term biologics storage solutions in a GMP environment. Our company thus safeguarded hundreds of cell lines (mammalian, microbial, insect, etc.), virus seeds and stocks (for virus-based products including vaccines)or specific reagents either as the main or a back-up storage site to prevent any risk of destruction of these valuable stored materials.

Complementary to biomanufacturing and biologics testing, the company offers biologics storage services as an integrated approach for the management of drug products and their potential use in patients.

Highest security for valuable material

In a GMP-graded environment, R&D and clinical material are monitored with the highest security in dedicated and restricted areas.

Equipment and facilities are qualified according to standards defined by the competent regulatory bodies (EMA, FDA, ICH) and offer long-term biologics storage solutions. Clean Cells is certified to welcome Biosafety Level (BSL) 1 to 3 and GMO substances.

GMP framework for an optimal traceability

Our cGMP-licensed facilities can accommodate valuable substances, intermediate material and starting material through high biologics storage standards:

  • Continued monitoring of temperature (+4°C; <-20°C; <-80°C; <-145°C)
  • Automatic measurement of nitrogen level and automatic liquid nitrogen filling
  • -80°C freezers,  -20°C freezers, refrigerators
  • Externalized alarm system and back-up power supply system
  • Qualified areas with restricted access
  • Additional data monitoring and documentation (periodic reporting available)
  • Stock separation in two containers on biologics storage site (on demand) 
  • Elevated characterization standards for incoming samples
  • Carrier qualification and selection (systematic inclusion of temperature probes with shipment)

These biologics storage features ensure an optimal traceability of material from receipt to in-house storage to final location. 

Storage

Leaflet

Flyer-Storage_VF

Leaflet

Storage Leaflet

Download via media library

For more information about our storage services, please do not hesitate to contact us.

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