Moving from research-grade towards market-grade Advanced Therapy Medicinal Products (ATMPs): Encouraging quality culture in non-GxP environments

Moving from research-grade towards market-grade Advanced Therapy Medicinal Products (ATMPs): Encouraging quality culture in non-GxP environments

In response to the global push for expediting the release of new drugs and treatments, research entities must align themselves with pharmaceutical and biotech companies by embracing GxP compliance.

Universities predominantly contribute to scientific knowledge through published articles. Typically, the quality of this data is ensured by holding researchers accountable for the integrity and reliability of their findings. As of now, the primary quality control checkpoint remains the peer review process conducted by scientific journals.

However, despite the transparency required by certain journals and the voluntary sharing of research team data, the challenge of reproducibility persists, hindering the development of potential treatments. Achieving the desired level of reproducibility necessitates the implementation of specific quality measures. In addition to ensuring basic data integrity, biomedical research teams should consider methods validation, equipment qualification for nonclinical confirmatory activities, and the analysis of clinical samples.

It's understandable if compliance with GxP regulations appears to limit the flexibility typically enjoyed by research laboratories and is perceived as costly. Nevertheless, adopting key quality concepts that align with the discovery aspect of research can enhance data integrity in terms of robustness and reproducibility, essential for progressing to clinical phases. Moreover, it reduces the need for repetitive work and minimizes resource wastage.

Therefore, quality assurance policies in academic environments should extend from teaching to research, incorporating practices like Good Laboratory Practice (GLP), Good Documentation Practice (GDocP), Computerized System Assurance (CSA), and fundamental principles of data integrity. These principles encompass nine core data attributes known as Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available, forming the acronym ALCOA+. Adhering to these principles during data collection, recording, analysis, reporting, storage, and retrieval guarantees an elevated level of research quality, facilitating the practical application of research results. Applying each attribute to various research phases, whether in basic lab work, clinical trials, or epidemiological studies, requires a thorough understanding of definitions, indications, and implementation.

Partnering with Rescop, a trusted validation partner in GxP-related industries, can help organizations navigate the complex landscape of compliance and quality assurance. Rescop offers expert guidance and tailored solutions, allowing organizations to streamline processes, ensure data accuracy, and minimize compliance-related challenges. By collaborating with Rescop, organizations can enhance research quality, reduce compliance risks, and accelerate the development of groundbreaking treatments.

It's worth noting that this gradual adaptation to the regulatory environment not only benefits research organizations but also has the potential to groom a generation of technically adept future entrepreneurs in the biomedical industry.


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