The Crucial Role of Analytical Development in IMPD Projects

Sponsored by Prasfarma

In the highly regulated world of pharmaceuticals, analytical development plays a pivotal role in Investigational Medicinal Product Dossier (IMPD) projects.

These projects are critical for obtaining clinical trial authorization and ensuring the safety, efficacy, and quality of investigational medicinal products (IMPs). A robust analytical follow-up is essential, as it not only guarantees compliance with regulatory requirements but also supports the ongoing development of novel therapies.

Ensuring Quality and Safety Through Robust Analytical Methods

One of the most fundamental aspects of analytical development in IMPD projects is the establishment of robust analytical methods. These methods must be meticulously designed to ensure that IMPs meet the highest quality and safety standards. Since IMPs are intended for human use in clinical trials, their analysis must adhere to the same rigorous requirements as fully registered medicines.

Regulatory authorities, such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), expect IMPs to comply with stringent quality control measures. This includes validation of analytical methods, impurity profiling, stability studies, and characterization of the active pharmaceutical ingredient (API). Without a strong analytical foundation, obtaining regulatory approval for clinical trials can be challenging, potentially delaying the development of life-saving treatments.

Challenges in IMPD Projects

Despite the importance of analytical follow-up, IMPD projects come with unique challenges:

• First-time Manufacturing of Products: Many IMPs are being produced for the first time, meaning there is limited prior experience with their manufacturing processes. This requires extensive method development and validation to establish the necessary analytical parameters.

• Limited Availability of Product: Some investigational products involve high- cost active ingredients, making it difficult to allocate large quantities for analytical testing. Analytical strategies must be optimized to minimize sample consumption while still providing accurate and reliable data.

• Lack of Stability Data: Because IMPs are in the early stages of development, there is often little to no stability data available. To mitigate risks, companies must conduct comprehensive risk assessments and provide well-justified stability testing plans to regulatory authorities.

Given these challenges, a flexible and adaptive analytical approach is essential to ensuring compliance while facilitating the development of innovative therapies.

Prasfarma’s Proposal: A Flexible Approach to Analytical Development

At Prasfarma, we recognize the complexities involved in analytical development for IMPD projects. Our approach is designed to be both adaptive and customer-centric, allowing us to meet the diverse needs of our clients while maintaining regulatory compliance.

• Flexibility to Adapt to Customer Needs: Each IMP is unique, requiring tailored analytical solutions. We work closely with our clients to design customized strategies that address their specific challenges and objectives.

• Stepwise Validation Approach: Given the evolving nature of IMPs, we implement a scalated validation strategy. Instead of locking validation criteria from the outset, we adopt a step-by-step approach, refining methods as new data emerges. This ensures that the final product meets the required specifications while maintaining the agility needed in early-stage development.

By combining scientific expertise, regulatory knowledge, and a commitment to innovation, Prasfarma stands as a leader in analytical development for IMPD projects. Our solutions empower pharmaceutical companies to bring groundbreaking therapies to market efficiently and safely, ultimately improving patient outcomes worldwide.

Connect with the Prasfarma team at CDMO Live 2025