Allaboard! AnalyticalInsightsfasttrack yourTime toMarket · Contact: Joke De Gelder,...

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Transcript of Allaboard! AnalyticalInsightsfasttrack yourTime toMarket · Contact: Joke De Gelder,...

Contact: Joke De Gelder, joke.degelder@anacura.com presentation Tuesday June 19th, 3 pm

Eddy Ruijter, eddy.ruijter@anacura.com BOS CMC Basel, booth 27

Standardized approach

Risk mitigation

Knowledge

GMP prospectExpectations

Product

Timelines Customise

You

typical DS trackValidation

Forced degradation

Method optimisation

Solubility

Validation

Forced degradation

Method optimisation

Solubility Stability modelling

Pre-validation

anacura DS track

Time

All aboard! Analytical Insights fast track your Time to Market

Stability modelling: DP tablet example

Applications

• DS/DP stability indication

• Formulation selection

• Packaging selection (performance/cost)

• Avoid reformulations

• Extended shelf-life claim in filing

Theory

• Humidity corrected Arrhenius equation: a

kinetic understanding of degradation

ln k = ln A – (Ea / RT) + (B * RH)

• Isoconversion time = time needed to reach

the specification limit

• Identical pathways to failure

Efficient and effective drug development starts with sharing goals, expected timelines, product

information and with creating customized solutions.

Stability of formulations is an important aspect throughout product development. The stability

modelling using the ASAP technology is employed at several points throughout the drug

development phases, supporting quick DS stability checks, formulation selection, packaging

selection and extended shelf-life claims.

At anacura we have developed a process with smart

integration of forced degradation studies, solubility testing,

method optimisation, stability modelling using ASAP studies

and pre-validation. The integrated approach results in higher

quality and avoids rework.

An ASAP stability study takes 4-10 weeks from protocol design

to report, which is significantly shorter than traditional

development stability studies. The outcome is a shelf life

prediction, which allows fast descisions on needed revisions

in the production process. This risk mitigation pays off in the

next phases of drug development.

Creating the model

In ASAPprime® software:

Data of the major degradant:

Model evaluation:

R² > 0.9

Q² > 0.7

Study setup

Early DS development track

Predicted shelf-life

• At 25°C/60%RH for 0.4 years with 97%

probability at a degradant specification of

0.30%w_w

• At 5°C for 2 year with 98% probability at a

degradant specification of 0.30%w_w

Excipients Predicted water uptake

In ASAPdesignTM software:

• Broad range of T and RH conditions

(min. 5)

• Determine ‘the plane’

Stress testing

Packaging HDPE bottles selected

as preferred packaging (cost-related)

Excipient composition table

combined with database

information on excipient water

uptake.

• RH: use of saturated salt

• Continous logging of T and RH

in proximity of the samples

• Immediate appearance

evaluation after pulling

• Storage of pulled samples at

5°C, protected from moisture

• Comparative appearance of all

conditions

• Combined LC runs to minimize

inter-day variability

Packaging selection

Humidity of the packaging headspace

Water uptake of the formulation

Development stability

Viewpoint