|
Cell Banking
The manufacture of biopharmaceuticals requires
a constant supply of equivalent cells which can be used over the
life span of the manufactured product. Avecia has been manufacturing
microbial cell lines to cGMP standards for over ten years and
has a dedicated Microbial Cell Bank facility and team who are
responsible for the manufacture of Master and Working Cell Banks
as per regulatory guidelines outlined in ICH A5B and Q5D
Avecia can offer Master and Working Cell Banking
services in support of current Avecia programmes or contracted
as an individual project. Our Microbial Cell Bank facility supports
manufacture of cGMP cell lines for use in production of Phase
I, II and III API for clinical trials, product launch and market
supply.
Avecia cell banking programme is able to provide:
- Dedicated FDA and MHRA inspected GMP Cell Bank facility operating
to EU guidelines.
- Extensive experience in the manufacture of cGMP Master and
Working cell banks using a range of microbial expression systems
including E. coli and yeast species.
- Comprehensive Environmental Monitoring service performed
throughout production of GMP cell lines.
- Qualification by characterisation and testing for all newly
manufactured cell lines.
- Long term stability programme to ensure cell line has retained
its retention for consistent production capacity during storage.
- Short and long term storage of manufactured Cell Banks in
qualified low temperature freezers and liquid nitrogen dewars
which are controlled, secured and continuously monitored.
- Quality approved documentation system used throughout the
manufacturing process.
Process
creation
|
|
