M4M™ Lead Op to FIH

Innovative partnership between Crystal Pharmatech and TCG GreenChem

An Optimized Approach to Chemistry, Manufacturing, Controls (CMC)

Within today's pharmaceutical industry, drug development can be categorized into two approaches:

1. Large, fully integrated pharmaceutical companies using a strategic approach.

• Makes the best use of material and mitigates risk

• But often hindered by red tape and over-analysis




2. Biotechs and startup drug developers using a trial-and-error approach.


• Provides agility and a cost-effective budget

• But creates significant risk and uncertainty

The pharmaceutical innovators we encounter are constantly guided down a random walk approach at all stages of drug development. Crystal Pharmatech and TCG GreenChem have developed a unique CMC package that incorporates only the best aspects of both industry approaches.

With M4M™ Lead Op to FIH, our partners can expect a strategic and risk-adverse path from molecule to medicine that is agile and cost-effective.

First Time Right

• Single proposal and CDA

• Consistent Project Manager

• No duplicate analytical development

• Best form, formulation, and process chemistry

Line of Sight

• CMC mapped from lead op to FIH

• Early process chemistry and formulation input

• No random development

• Real-time API prioritization – best use of every gram at every point in time

Centers of Excellence

An experienced leadership team is a vital for maximizing efficiency and effectiveness in drug development from lead optimization to FIH and eventually commercialization.

Crystal Pharmatech and TCG GreenChem have partnered to bring together centers of excellence in:

• Process chemistry

• API form and formulation

• Drug development acceleration

The foundation of these centers of excellence is a leadership team that has already seen and solved every possible challenge a development program can encounter.

M4M™ Approach – Full CMC Package

API Form and Formulation Service Details

Process R&D and API Manufacturing Details

Our Experience Becomes Your Competitive Advantage

Early cohesion between industry-leading Process Chemists, Solid State Experts, and Formulation Specialists gives you:

1. Process and Formulation assessment with limited material

• Guide candidate selection while establishing Phase I complexity and path

2. Line of sight for API and formulation

• Minimize post Phase I delays

• Minimize bridging studies due to formulation changes

3. Condensed timelines and resources

• No more random walk or dart throwing

• No duplication of analytical development

• No "wasted or excess" API batches

• Personalized formulation, no more one-for-all platform formulations

4. Highly experienced leadership team that can rapidly guide strategy for every project