Mol2Med™ First-Time-Right 3-STEP Approach

Crystal Pharmatech are a specialized CRO/CDMO focused on Solid State Research, Pre-Formulation, Formulation Development and Manufacturing.  Our strength is our focus and expertise in these specialties and the outcome for the client is the following Mol2Med™ Integrated Services: First-Time-Right 3-STEP Approach, designed to expedite small molecule lead compounds or preclinical candidates into Phase I and beyond, with unparalleled efficiency and precision. This First-Time-Right 3-step approach begins at the lead optimization/PCC stage:

Step 1: Developability Assessment

• Our approach determines the physicochemical properties of all lead candidates to find the most “developable” lead, benchmarking against a series of industry standards and providing a high-level approach for achieving the most probable success in GLP Tox and FIH. For a given preclinical candidate (PCC), this will also help to determine whether a free form or salt, and a conventional formulation using crystalline form or amorphous solid dispersion should be selected for further development.

Step 2: Solid Form Screening/Selection and Pre-Formulation

• Our approach begins with comprehensive screening and selection of the optimal crystalline form for the API. Subsequently, we develop an optimal preclinical formulation to support PK/PD and GLP Tox animal studies.

Step 3: Formulation Development and CTM Manufacturing

• API-specific "First-time-right" strategy that yields the best formulation for Phase I and subsequent Clinical Studies. This allows Pre-Market Formulation and Final-Market Formulation late-stage development to focus on process optimization and scale up, without the need for significant formulation change and hence the need for human PK bridging studies.

• Contrast this to the traditional “fit-for-purpose” method (for example, powder in a capsule or prototype capsule or tablet), which requires human PK bridging studies after significant re-formulation. This results in significant additional cost and time.

This innovative approach guarantees a robust API form and a scalable manufacturing process, culminating in a First-Time-Right formulation for Phase I. Streamlining the transition to future clinical studies upon Phase I success, our First-Time-Right approach sets the foundation for optimized drug development and success beyond.