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Fit For Purpose Development

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  • Fit-for-Purpose

Fit-for-Purpose Development in Drug Substance Development

We at Zasya Life Sciences, adopt this philosophy to deliver efficient, scalable, and cost-effective solutions without compromising quality for Fit-for-Purpose Development in Drug Substance Development

Key Principles of Fit-for-Purpose Development

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Phase-Appropriate Strategies

– Early-phase development focuses on speed and flexibility to generate materials for preclinical studies and initial clinical trials.
– Late-phase development emphasizes scalability, robustness, and regulatory readiness to support commercial manufacturing.
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Risk-Based Approach

Employing a thorough risk assessment ensures that resources are focused on the most critical aspects of process development, enabling optimal decision-making.
Accurate Results

Efficient Use of Resources

Leveraging minimalistic yet effective experimental designs, we prioritize cost-efficiency while delivering high-quality outcomes.

Zasya’s Approach to Fit-for-Purpose Drug Substance Development

Route Selection and Feasibility Studies

- Systematic evaluation of multiple synthetic routes to identify the most efficient, scalable, and sustainable pathway.
- Early identification of potential risks, including scale-up challenges, impurities, and environmental factors.

Process Optimization

- Development of robust processes tailored to meet yield, purity, and scalability requirements.
- Implementation of innovative methodologies, including flow chemistry, photochemistry, and biocatalysis, to streamline production.

Analytical Support

- Fit-for-purpose analytical methods are developed and validated for monitoring critical process parameters.
- State-of-the-art techniques, such as NMR (including 19F NMR), HPLC, LC-MS, and sensure precise characterization.

Regulatory Alignment

Processes are designed with a clear understanding of regulatory expectations, ensuring seamless transition through clinical phases to commercial manufacturing.

Scalability and Tech Transfer

Expertise in scaling up processes from gram to kilogram levels, ensuring smooth technology transfer to GMP facilities when required.

Advantages of Fit-for-Purpose Development with Zasya

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Speed and Agility
Accelerating timelines for early-phase projects while maintaining flexibility for iterative development.
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Cost-Efficiency
Optimized use of resources to minimize waste and reduce overall project costs.
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Tailored Solutions
Customized processes addressing unique compound requirements and therapeutic goals.
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Quality and Compliance
Deliverables meet stringent quality standards with a clear pathway to regulatory approval.

Enabling Your Drug Discovery Journey

At Zasya Life Sciences, fit-for-purpose development is more than just a strategy—it’s a commitment to delivering value-driven solutions that empower your drug discovery and development programs. Our comprehensive expertise ensures that every molecule we develop is optimized for its intended purpose, from preclinical exploration to market readiness.

Let us partner with you to bring efficiency, innovation, and success to your next drug development project.

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