Nutraceuticals CRAMS

- from strain development to on-market needs

 

Production and development of probiotics according to the Customer’s needs.

Flexible model; may start from sourcing of the strain or from ready-to-go process obtained from the Customer.

The work is done as a service and all IPR belongs to the Customer.

 

FEASIBILITY STUDY

STRAIN DEVELOPMENT

VERIFICATION

INSTALLATION STAGE

MANUFACTURING

DELIVERY

 

1.Feasibility Study

The following steps are included in the feasibility study:

1. Evaluation of requested properties vs. a suitable in vitro screen

2. Elucidation of the methods for strain development

3. Cultivation properties vs. probiotic properties; detailed planning

Duration: about 4 weeks

Deliverables: report and detailed project plan

 

2. Strain Development

The aim of the strain development project is to obtain a strain with desired probiotic properties.

Development options

  • strain
  • process
  • upscaling
  • analytics
  • markers

Duration: 2-4 months

Deliverables: report, strains, lyophilized powder for trials with CoA, characterization

 

3. Verification

The verification stage includes:

1. Strain identity: DNA analysis, metabolic analysis, cultivation properties compared to the parent strain

2. Performance of strain characteristics tests according to EFSA regulation:

  1. Unique identification and genetic stability
  2. Toxins and virulence factors
  3. Toxicological studies if not QPS strain
  4. Antibiotic resistance (MIC values)
  5. Microbial studies

3. Stability of the strain, accelerated and real time studies

Duration: 6 weeks for accelerated study

Deliverables: Report

 

4.  Installation stage

The process will be installed to obtain robust commercial production. The following steps are studied and evaluated at the Installation stage:

1. Media components of industrial grade

2. Inoculation rate

3. Fermentation parameters

4. Drying of the cell mass

To study the above-mentioned parameters, affecting fermentation, we perform two sets of trials and test/optimize
the identified parameters at 200 L scale in the pilot laboratory.

 

5. Manufacturing

Fermentation package:

- fermentation of cell mass, frozen/lyophilized/spray-dried product

- standard analysis; viability, microbiological purity, water content

 

6. Delivery

Delivery with Certificate of Analysis and other relevant certificates

 

Please ask us to offer a solution for your individual needs for custom manufacturing and for new product development.

 

 

 

Microbial fermentation

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