Modern Pharmaceutical Manufacturing Calls for Process Analytical Technologies

Today’s drug development process focuses on speed-to-market, continuous and flexible manufacturing, and effective data management while maintaining quality and patient safety. Product portfolios for the life sciences sector are quickly expanding into cell and gene therapy, mRNA therapeutics, CRISPR therapeutics, etc., and new manufacturing technologies and instrumentation are needed to support supply chains and enhance operations.

Process analytical technologies (PAT), new digital strategies, and continuous manufacturing practices are increasingly popular among life science companies to meet patient needs and demand. All help alleviate the challenges with expanded product portfolios by reducing hands-on time and human error, improving inefficient processes, and decreasing operating expenditures while optimizing uptime, agility, and quality.

Veolia Water Technologies & Solutions’ Sievers* instruments allow manufacturers to perform rapid testing and real-time monitoring. This ability provides simpler, more efficient quality control and process monitoring so manufacturers never have to compromise compliance.

Let’s dig deeper into pharmaceutical manufacturing trends to better understand how Veolia’s technology is supporting the evolution of pharmaceutical manufacturing practices.

Meeting market and patient expectations

With the increasing regulatory scrutiny and ever evolving product pipelines in life sciences, companies are strained across quality, sourcing, manufacturing, and supply chains. The pandemic’s effect on the industry reshaped its approach to production and meeting market and patient needs. Manufacturers need agile operations, continuous manufacturing, and digitization to succeed in today’s landscape.

PAT instruments at different stages of the manufacturing process help achieve those traits by controlling quality and achieving quality by design (QbD). These tools enable adaptable, predictive, and efficient operations so manufacturers can keep pace with the production challenges we will continue to see going forward.

Optimizing manufacturing in real-time

For over 30 years, Sievers analytical instruments have proven their reputation for supporting quality and patient safety in pharmaceutical manufacturing with sensitive, robust, and easy-to-use total organic carbon (TOC) analyzers for ultra-pure water (UPW) and water for injection (WFI) testing. Sievers products simplify complex measurements and have evolved to provide comprehensive water quality monitoring, real-time testing, and process monitoring with a portfolio of PAT instruments to serve TOC, conductivity, endotoxin, and bioburden testing.

While water quality monitoring built the foundation of the Sievers Instruments portfolio, the needs of the pharmaceutical industry and partnerships with manufacturers have resulted in expanded applications in cleaning validation, contamination control, rapid microbiological methods, final drug product testing, raw material and intermediate testing, real-time release testing, and extractable and leachable testing. Faster, easier process monitoring tools for bacterial endotoxin testing (BET), bioburden, TOC, and conductivity enable pharmaceutical manufacturers to obtain comprehensive information to support critical release tests and make proactive decisions to mitigate risks.

Veolia’s hands-on approach with the pharmaceutical industry has driven the expanded applications of Sievers Instruments to address challenges and pain points in pharmaceutical manufacturing while maintaining patient safety.

Not only has pharmaceutical manufacturing been challenging in recent years due to evolving therapeutics and product portfolios, but pandemic-related developments, like the ability to rapidly scale production and deploy vaccines and treatments, have set the industry on a new course.

Learn how Sievers analyzers and instruments can help you modernize your manufacturing processes and adapt to today’s pharmaceutical demands. *Trademark of Veolia; May be registered in one or more countries.