GMP Cell Bank Manufacturing

A fully characterized, well-documented, homogeneous Master Cell Bank (MCB) and Working Cell Bank (WCB) critically impacts the safety, speed and success of your process.

Drawing on extensive contract research (CRO) experience, we have expanded our service offering to include cell bank manufacturing. Our unique Good Manufacturing Practice (GMP) Licensed mammalian cell bank manufacturing service enables closed system processing in sterile single use systems.

A Fast Solution: From Vial Thaw to Release in 5 Months

Our GMP Cell Bank manufacturing services are complemented by core expertise in cell bank characterization for mammalian suspension cells (CHO, HEK293, HELA, SP2/0). See how working with our team makes GMP- and ICH Q5A/Q5D guideline-compliant production of up to 500 vials possible from thaw to release by Qualified Person (QP) in just five months.

Safe Closed System Manufacturing

Our built-for-purpose 260m2 GMP cleanroom facility is fully dedicated to mammalian cell lines in suspension, manufactured using serum-free, animal component free media for applications in monoclonal antibody (mAB), new biological entity, vaccine and gene therapy products. The closed manufacturing system is fully nutrient broth qualified for added process safety and sterility assurance.

 

Our IMP (MIA) licensed custom-built facility features:

  • Grade A isolator for initial cell recovery.

  • Closed systems for serial expansion using BIOSTAT® RM Bioreactors or MYCap® fluid transfer system for shake flasks.

  • Aseptic connections for sterile, reliable processes using Biowelder® and Biosealer®.

  • Automated filling with capacity to fill ~500 vials in 20 minutes using fill-it.

  • Storage & distribution  (LN2 vapour phase).

Reliable, Fully Integrated Service Solutions from Start to Finish

Customers gain time and quality advantages from access to our global GMP purpose-built suites dedicated to mammalian cell bank manufacturing. When further integrated with our CellcaCHO cell line expression platform and biosafety testing services, including MCB characterization and genetic stability testing, the timeline from DNA to MCB is accelerated to 10 months.

And because our offer has been built to support every step of the production process, we also offer systems for the storage and transport of intermediate and finished products.

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