Bio Elpida Processes of Prokaryote Cell Culture or Fermentation
Production of attenuated living bacteria or of heat inactivated bacteria
Production of Active Pharmaceutical Ingredients (API)
Bio Elpida has developed processes of prokaryotes cell culture and fermentation
that favours the use of single-use closed systems
. This type of production ensures culture volume of up to 25l.
Bio Elpida also proposes prokaryotes cell culture and fermentation using Erlenmeyer
in shakers and CO2
incubators. These are particularly suited for the production of smaller volumes or for pre-culture prior to inoculation of larger volumes.
Bio Elpida is also equipped with an autoclave that allows the heat inactivation of bacterial cultures.
These processes allow the production of:
- Attenuated living bacteria,
- Heat inactivated bacteria,
- Supernatant containing biologically molecules and/or proteins of interest.
All operations are performed in a GMP zone
compliant with current standards for the production of API. This production zone has been declared to the ANSM (French Medical Regulatory Agency). Therefore, it allows the production of API and pharmaceutical release by our the qualified person
Upstream step – Culture
For upstream steps, Bio Elpida recommends a Single-Use approach
The techniques used are adapted to cell suspensions as well as adhesive cells. The culture volume will depend on the project and can range from small volumes (100ml) to the manufacturing of pre-industrial clinical batches (20l or more depending of the technology).
In addition, Bio Elpida proposes to optimise culture conditions
, including medium composition.
Downstream step – Purification of API
Bio Elpida can also organise and/or participate in all downstream steps necessary to the "production"
of antibodies or proteins of interest obtained by cell fermentation or cell culture:
- Clarification by classical techniques such as filtration and cycles of ultra-filtrations
- Purification by liquid chromatography of antibodies and of protein of interest with equipments that are compatible with development and also with the manufacturing of pre-clinical or phase I/II clinical batches
- Inactivation and sterilisation with viral inactivation by ultrafiltration/diafiltration, nanofiltration or chemical inactivation (solvent, detergent, pH…)
All these operations can be performed in the pharmaceutical zone.