Contact Menu

Our QbD approach

Quality by Design — from cultivation to commercial batch

We believe quality should not be tested into a product at the end. Quality must be designed into the entire process.

Our QbD approach begins before extraction.

A single botanical sample, still irregular and translucent, waits at the start of a curved pipeline of ten open rings in a dark laboratory space.

01 / 10 Origin

Cultivation

Quality considerations begin in the field, before any material is harvested.

Step 1 of 10, Cultivation: the sample passes through ring 1, which locks and turns luminous; the sample grows smoother and more defined.

02 / 10 Material

Raw-Material Selection

Choosing the right starting material against defined specifications.

Step 2 of 10, Raw-Material Selection: the sample passes through ring 2, which locks and turns luminous; the sample grows smoother and more defined.

03 / 10 Identity

Botanical Authentication

Confirming botanical identity and the correct plant part.

Step 3 of 10, Botanical Authentication: the sample passes through ring 3, which locks and turns luminous; the sample grows smoother and more defined.

04 / 10 Attributes

Defined Quality Attributes

Setting the attributes the finished ingredient must meet.

Step 4 of 10, Defined Quality Attributes: the sample passes through ring 4, which locks and turns luminous; the sample grows smoother and more defined.

05 / 10 Extraction

Extraction Design

Designing the extraction methodology around those attributes.

Step 5 of 10, Extraction Design: the sample passes through ring 5, which locks and turns luminous; the sample grows smoother and more defined.

06 / 10 Parameters

Critical Process Parameters

Identifying and controlling the parameters that matter.

Step 6 of 10, Critical Process Parameters: the sample passes through ring 6, which locks and turns luminous; the sample grows smoother and more defined.

07 / 10 Standardized

Standardization

Bringing the ingredient to its defined specification.

Step 7 of 10, Standardization: the sample passes through ring 7, which locks and turns luminous; the sample grows smoother and more defined.

08 / 10 Analytical

Analytical Verification

Verifying the ingredient against analytical requirements.

Step 8 of 10, Analytical Verification: the sample passes through ring 8, which locks and turns luminous; the sample grows smoother and more defined.

09 / 10 Production

Pilot / Commercial Production

Moving from pilot scale to commercial batches.

Step 9 of 10, Pilot / Commercial Production: the sample passes through ring 9, which locks and turns luminous; the sample grows smoother and more defined.

10 / 10 Released

Batch Release

Releasing each batch against final product specifications.

Batch released

This creates a scientifically controlled pathway from plant material to finished ingredient.

Step 10 of 10, Batch Release: the sample passes through ring 10, which locks and turns luminous; the sample grows smoother and more defined and resolves into a solid, finished ingredient form marked as released.

The ten designed steps

Our QbD approach begins before extraction.

This creates a scientifically controlled pathway from plant material to finished ingredient.

  1. CultivationQuality considerations begin in the field, before any material is harvested.
  2. Raw-Material SelectionChoosing the right starting material against defined specifications.
  3. Botanical AuthenticationConfirming botanical identity and the correct plant part.
  4. Defined Quality AttributesSetting the attributes the finished ingredient must meet.
  5. Extraction DesignDesigning the extraction methodology around those attributes.
  6. Critical Process ParametersIdentifying and controlling the parameters that matter.
  7. StandardizationBringing the ingredient to its defined specification.
  8. Analytical VerificationVerifying the ingredient against analytical requirements.
  9. Pilot / Commercial ProductionMoving from pilot scale to commercial batches.
  10. Batch ReleaseReleasing each batch against final product specifications.

Our team defines and monitors

The controls behind every step

The manufacturing activity may be outsourced. The scientific control is not.

  1. Raw-material specifications
  2. Process parameters
  3. Extraction methodology
  4. Critical Quality Attributes
  5. Critical Process Parameters
  6. In-process controls
  7. Analytical requirements
  8. Batch documentation
  9. Final product specifications

Design quality into your next ingredient.

Start a conversation Our science