"AI, Automation & Analytics: A new era of modern microbiology testing!"

Pharmaceutical manufacturing is undergoing a paradigm shift.

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As the industry moves towards complex biologics, personalised therapies, and stringent global compliance, the role of microbiological quality control (QC) is being redefined. Once seen as a back-end process, microbial QC has now become a strategic function, balancing speed, safety, and sustainability. Diwakar Sharma, Country Head, Industrial Applications, India & Neighbouring Markets, bioMérieux shares how QC labs are evolving into digital, data-driven command centres that power business success. Edited excerpts:

What has changed in pharma manufacturing that makes microbial QC more business-critical than ever?

The entire landscape of pharma manufacturing has transformed. We've shifted from traditional formulations to complex biologics, biosimilars and sterile injectables—all of which are far more sensitive to contamination. With these modalities, the margin for error is extremely small. A single contamination event can affect patient safety and result in significant financial losses.

Speed to market has also become a key differentiator. Any delay in QC—especially in sterility or release testing—directly impacts batch release and revenue. At the same time, regulators are insisting on faster, more transparent, and data-integrity-driven QC workflows. So, QC today isn't just about compliance. It's a business-critical function that ensures operational continuity, regulatory trust, and market competitiveness.

Where do most QC workflows break down today—time, traceability, or team coordination?

It's usually a combination of all three. Time is an obvious challenge—traditional sterility testing can take up to 14 days, keeping inventory on hold. Traceability suffers when teams rely on manual logbooks or partially digitised systems, which are prone to transcription errors. And team coordination becomes difficult when QC, QA and manufacturing operate in silos.