DIR 200

Fermentation and processing of recombinant proteins using genetically modified Pichia pastoris

Licence details

Licence number:
DIR 200
Licence status:
Limited and controlled

Cauldron Molecules Pty Ltd

Parent organism:

Pichia pastoris

Modified trait:

Production of animal proteins

Licence issue date:

This licence authorises Cauldron Molecules Pty Ltd to conduct fermentation trial of a genetically modified (GM) yeast for the production of specific animal proteins in Australia.

The trial is to assess and optimise the fermentation process and characterise GM yeast during production of animal proteins. Yeast will be genetically modified to express one type of protein from cow’s milk, chicken egg or spider silk. GM yeast would be cultured in several batches in closed fermentation vessels over five years.

GM yeast will not be used, sold or otherwise disposed of for any purpose, which would involve or result in their use as food for humans. However, killed GM yeast may be used as a soil conditioner or in animal feed preparation.

The RARMP concluded that the trial poses negligible risks to people or the environment. However, as this is a trial under limited and controlled conditions, licence conditions have been imposed to:

  • restrict when and where the trial can take place
  • limit the size of the trial
  • restrict the spread and persistence of the GM yeast.

The risk analysis for this application was carried out in accordance with the Regulator’s Risk Analysis Framework.

Date application received:
RARMP open for public consultation:
RARMP closed for public consultation:


Licence decision - notification

Outlines the Regulator’s decision to issue a licence following the assessment of this application.

Licence decision - Q&A

FAQs on the licence application and the Regulator’s decision to issue a licence for this application.

Risk assessment and risk management plan - summary

A summary of the Risk Assessment and Risk Management Plan prepared as part of the assessment of this application. It provides a brief description of the licence application, the risk assessment and risk management plan.

Risk assessment and risk management plan - full version

The final risk assessment and management plan prepared to support the Regulator's decision. It describes the GMO(s) and proposed work with the GMO(s) and provides an assessment of potential risks posed by the GMO(s). It also includes a summary of submissions received during the public consultation process.

Licence conditions

Sets out the licence conditions imposed by the Regulator, including the licence holder’s general and specific obligations and reporting requirements.

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