Quality by Design
ICH Q8 / Q9 / Q11
Digital twin

The Chitin Lab, a working digital twin of the process

Move a setpoint and watch the design space, the capability index and the quality attributes respond. The co-pilot in the corner can read the live state of this page and reason about it with you.

QTPP to control strategy
ICH Q8 style, end to end
Monte Carlo capability
Cpk under real control noise
Reaction cascade
LPMO to GH18 to GH20 to GlcNAc
Digital twin
Every unit operation, live
Quality by Design

QTPP, risk, design space and control strategy

The four ICH Q8 artefacts, connected. Change a setpoint in the design space and the capability analysis rebuilds from a Monte Carlo over your stated control noise.

Conversion response surface, pH against temperatureshaded region meets 90 %
pH 5.5pH 6.5pH 7.5pH 8.530405060Dashed box: proven acceptable range. Marker: current setpoint.
Conversion
59.9 %
In-spec probability
0.0 %
Cpk
-4.66
Colour
18 APHA

Capability is a 400 run Monte Carlo over the stated pH and temperature control noise. Cpk at or above 1.33 is the usual bar for a validated commercial process.

Enzymology

Kinetics bench

Michaelis-Menten and Lineweaver-Burk for the chitinolytic system, with the inhibition modes that actually limit an industrial hydrolysis.

Initial rate against colloidal chitin concentration
0102031410%3%6%9%12%Km 1.50%v0 (U/mL)
Lineweaver-Burk (1/v vs 1/[S])
Derived constants
Apparent Vmax
38.86 U/mL
Km (set)
1.50 % w/v
kcat/Km index
12.99
Rate at 1.5% substrate
19.49 U/mL

Anchored to 38.98 U/mL at 1.5% colloidal chitin, pH 7.0, 44 C (DOI 10.1007/s11356-022-22166-x). Inhibition terms are illustrative.

Classic Michaelis-Menten hyperbola.