Personalised Medicine: From Genomics to 3D-Printed Pharmaceuticals
B. Navya Sree
Arya College of Pharmacy, India.
Saif Bin Salim
Arya College of Pharmacy, India.
Mohd Abdul Kareem
Arya College of Pharmacy, India.
M. Srikanth
Arya College of Pharmacy, India.
AVS Rajeswari
Department of Pharmaceutics, Arya College of Pharmacy, India.
*Author to whom correspondence should be addressed.
Abstract
Personalised medicine (PM) is a patient-specific approach to treatment that integrates genetic, epigenomic, and clinical data. PM has the potential to transform traditional medical practice by tailoring therapies to individual genetic profiles. The significant advantages and limitations must be carefully considered. Manufacturers are using drug repurposing, biomarker-driven R&D, and collaborations with diagnostics and IT sectors. Personalised medicine not only enhances therapeutic precision but also advances preventive care through polygenic risk scores and early biomarker detection. The integration of digital health tools, including wearables and telemedicine, further supports patient-specific monitoring. Real-world examples, such as FDA-approved targeted therapies and CAR-T cells, illustrate its transformative potential. Innovations such as CRISPR-based interventions, AI-driven decision support, and personalised vaccines are highlighted. Liquid biopsy, single-cell omics, artificial intelligence, and healthcare digitalisation, further supporting its implementation, are cutting-edge tools. The Quality by Design (QbD) principles for safe, consistent, and effective production of personalised 3D-printed tablets have been explained. Critical material attributes (CMAs), critical process parameters (CPPs), and critical quality attributes (CQAs) together enable regulatory-compliant manufacturing by ensuring drug dosage accuracy, content uniformity, dissolution control, and robust production conditions. Beyond treatment, it raises ethical considerations related to data privacy and equitable access. Although cost-intensive, it reduces long-term healthcare burdens by minimising adverse reactions.
Keywords: Genomics, bioinformatics, next-generation sequencing, Artificial Intelligence, personalised medicine, 3D printing, quality by design