Manufacturing Facility

Manufacturing Facility

Manufacturing Facility

  • Accellta operates a fully equipped top-tier manufacturing facility designed according to GMP guidelines for industrial manufacturing of cells. The facility includes over 550 sqm of clean room (88 sqm), QC laboratories, research laboratories and offices located at the Technion in Haifa, Israel.
  • Accellta’s facility is the company main production site, it has the highest technological and methodological standards in the fields of various cells and related cell products.
  • Unique to the industry, Accellta's hybrid model allows partners/customers to execute manufacturing activities without the need for facility ownership or reliance on contract manufacturing organizations (CMOs). 
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Facility Design

Facility Design

Cleanroom classification

ISO 5, ISO 7, ISO 8 / BSL2 / GMP cleanrooms with class A biological and laminar hoods (grade A, B, C) Validated HVAC system.

Accompanying units:

In house quality control laboratories or cooperating with sub contractors Cool and cold storage (-20◦c,-80◦c) Monitored General GMP storage areas.
24/7 supervised cryo facility (-196◦c)
UPS and generator backup

For more information about manufacturing facility services

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Infrastructures

HVAC
dedicated OSA, FFUs, VRF-based AC
Gas
Medical grade vacuum and gas system (CO2, O2, N2, Air)
Control
Alan Bradley PLC, Wonderware HMI and SMS alerts
Autoclave - Fedegari 2-sided
Purified type II water - Millipore Reference
Power - 125KVA generator backup and UPS
IP HD camera for remote monitoring

Type of services

  • Product development
  • Cell banking
  • Product manufacturing
  • Process development (R&D or Clean Room)
  • Fill-&-finish
  • Cryopreservation

Quality Management

  • Regulatory compliance and highest quality processes and products.
  • Written standard procedures for documentation control
  • Gowning and behavior in aseptic environment
  • Deviations and investigations handling, cleaning procedures, and environmental monitoring.
  • Records are kept in order to provide full traceability of manufactured products.
  • Training on SOP’s and GMP subjects

Project Management

Project manager is assigned to each client project, guaranteeing uncomplicated, timely and efficient project handling.

Optional services

  • Procurement of gowning, disposable, production materials, reagents, etc.
  • Offices
  • Training client production teams on Accellta SOP’s for working in clean rooms
  • 24/7 availability

Facility Team

Highly skilled operational teams ready to satisfy the needs of each client

Regulatory compliance

  • Compassionate treatments
  • Phase 1 + 2 clinical trails

Our quality system includes

  • HVAC equipment validation
  • Equipment validation, calibration and preventive maintenance
  • Change control management

For more information about manufacturing facility services

Please fill the required field.
Please fill the required field.

Atlas of Human Pluripotent Stem Cells

978 1 61779 548 0

Editors:

Michal Amit, Joseph Itskovitz-Eldor

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Accelerating stem cell technologies

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