Where ingredients transcend passive roles to become active enablers

THE pharmaceutical industry's future hinges on two foundational pillars: Active Pharmaceutical Ingredients (APIs), which deliver therapeutic effects, and a vast spectrum of excipients functional ingredients that ensure stability, manufacturability, bioavailability, and patient acceptability.

- DR SUPRIYA SHIDHAYE

Once relegated to passive roles, excipients now perform specialised functions as stabilisers, preservatives, solubilisers, binders, disintegrants, taste-maskers, colourants, and advanced delivery vehicles such as stimuli-responsive polymers and nanocarriers. Breakthroughs in biotechnology and artificial intelligence (AI), combined with the surge of student-led research, are revolutionising both APIs and excipients, enabling precision medicines, sustainable manufacturing, and superior patient outcomes.

Active Pharmaceutical Ingredients: Biotech and AI Accelerate Discovery

Recent advances in biotechnology have transformed API development. Recombinant DNA techniques, microbial fermentation, and mammalian cell culture now enable efficient production of complex biologics including monoclonal antibodies, vaccines, and gene therapies with high purity and consistency. Single-use bioreactors and continuous bioprocessing platforms minimise contamination risk and allow rapid scale-up for emerging therapies. Meanwhile, AI-driven synthesis planning has reduced development timelines by up to 50%: machine learning models predict optimal synthetic routes, reaction conditions, and yields, while automated robotic platforms execute multi-step syntheses with minimal human intervention. These integrated Al-biotech approaches accelerate candidate identification and process optimisation, cutting both cost and time to clinic.

Excipients as Multifunctional Ingredients

Excipients—constituting up to 90% of many solid dosage forms—have evolved into multifunctional ingredients that actively shape drug performance. Key functional classes include:

Stabilisers & Preservatives: Bio-based antioxidants and antimicrobial peptides derived via fermentation protect APIs from chemical degradation and microbial contamination, replacing or augmenting traditional synthetic additives.