Automated In-Vitro Testing

Automate Your PhysChem Benchwork to De-Risk Your API

Better datasets for better decisions early in development

There is a new standard for measuring the physicochemical properties of your drug earlier in the development timeline to prevent backwards and inefficient decisions on your way to in vivo and FIH studies.

At early stages of drug development, a limited supply of API historically made it a challenge to gather sufficient data to guide candidate selection in vivo studies. 

This resulted in:

• Uncertainty with estimated physicochemical properties

• Guesswork and parallel studies to understand kinetic solubility

• Costly delays in decision-making

A Novel Path to Sprint from Molecule to Medicine

Earlier than ever before in the development timeline, biotechs can achieve a comprehensive understanding of their molecule's physicochemical properties. Using material-sparing automation, Crystal Pharmatech guides their partners towards smarter decisions before more time and money is invested in their development process.

If your API benchwork is not utilizing advanced automation, 

you are wasting API and time to receive less accurate results.

Automated and Accurate Measurements of pKa, Log P/D

A thorough understanding of the drug's pKa and Log P, determined through pH and UV metric titration methods, will:

• Guide a fundamental understanding of solid-state interactions and the overall crystalline form

• Allow for more accurate prediction of physical, chemical, and biological in vivo predictions

• Direct better formulation decisions and avoid costly mistakes when given solubility under different pH conditions

Automated Dissolution and Permeability Determination

Understanding the preliminary metabolism and absorption profile of a compound, is critical to optimize API usage in vivo studies. 

We input biorelevant solubility measurements and predicted permeability into our in silico modelling software. This provides a predicted human PK and guides formulation development.

In volumes as low as 2mL, it is possible to utilize minimal amounts of API to evaluate:

• Dissolution (intrinsic or regular) at RT or 37°C

• Solubility determination at RT or 37°C

• Effect of particle size on the formulation stability and solubility

• Stability profile (up to 40°C)

• Polymorphic change over time

• Excipient and salt screening

• Simultaneous solubility and permeability over time across an artificial PAMPA membrane at RT or 37°C

To overcome the challenge of limited API supply, we use Pion's MicroDiss to determine biorelevant dissolution across numerous media and pH ranges. This platform helps us gain a comprehensive understanding of the kinetic solubility of your molecule in different media, which minimizes the amount of animal studies needed to move to FIH.

Benchwork - In Vivo - In Silico - First in Human

Crystal Pharmatech leverages these powerful automations to provide the benchwork needed to run human PK simulations. Our novel path from molecule to medicine provides our biotech partners with a more comprehensive understanding of their molecule to make proactive decisions throughout all stages of development.