Technical feasibility

SECTION I: Testing

 

1

Has the R & D result been tested?

YES

x

NO

 

 

The following question is replied according to the reply in question 1

 

If yes

 

1a

In what mode has the result been tested?

•             Prototype

•             Pilot Application

•             Alpha/BETA testing

 

Animal studies

 

 

 

1b. Please describe and discuss the testing results
The formula is able to deliver the active ingredient up to one week. Pharmacokinetic studies in rabbit models detected steady INF release for 10 days after subcutaneous injection administration of the nanointerferon formulation.

 

If no:

 

1c

Describe what type of testing does the R&D result need?
Detailed comment

 

 

 

1d. What is the time needed for testing?
 
1e. What is the cost needed for testing?
 

 

 

SECTION 2: Current Stage of Development

 

2a

To what extent does the development team have technical resources for supporting the production of a new product? (Researchers, human resources, hardware, etc. )
It is a shared patent with PannonPharma Ltd. The partners are able to provide the necessary technical resources.

 

 

2b

What are the technical issues that need to be tackled for full deployment, if needed?
The method is now developed for laboratory conditions, the task of increasing the technology to industrial sizes.

 

 

2c

What additional technical resources are needed for the production of this new product?
Nothing special, PannonPharma Ltd. has the necessary technical resources.

 

2d

Overall assessment of the current stage of technical development.
The invention is a novel method of core-shell nanoparticle preparation of protein drugs or protein-bound active compounds, which provides a relatively easy and inexpensive way to formulate sustained release products. Industrial-scale manufacturing is in progress.

 

 

 

SECTION 3: Deployment

3a

Define the demands for large scale production in terms of
  • Materials
No special material is required, they have the necessary active substance (interferon).

 

 

  • technologies, tools, machineries
 

 

 

  • Staff effort
 

 

 

 

 

 

SECTION 4: Overall Assessment

 

1

What is you overall assessment of the technical feasibility of the research result?
The invention is a novel method of core-shell nanoparticle preparation of protein drugs or protein-bound active compounds, which provides a relatively easy and inexpensive way to formulate sustained release products.

 

 

 

 

 

 

 

KEYWORDS QUANTITATIVE ASSESSMENT (0-5).

 

Please put X as appropriate. 1 2 3 4 5
Adequacy of testing activity undertaken so far         X
Adequacy and availability of technical resources of the development team         X
Current development stage         X
Overall technical feasibility         X

 

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