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Innovation & Regulation: Not a Zero Sum Game

A Letter from Clara Caminada, VP of Process Analytics

Regulation is a double-edged sword. With one edge it protects millions of people from poor manufacturing processes and unethical practices. With the other edge it burdens companies with stringent requirements, clear inefficiencies, and exorbitant costs. With globalization, each edge of the sword is getting exponentially sharper.

The words regulation and innovation are not often used in the same sentence. Innovation can be stifled by constraints, and regulation is by definition about enforcing constraints. When forced together, regulation and innovation would seem to play a zero-sum game.

Innovation may be more difficult in heavily regulated industries, but a partnership between innovation and regulation is incredibly advantageous. Regulation sets a high bar and innovation works to meet and exceed it.

We seek not only to seamlessly integrate into the infrastructure of today, but also to anticipate the possibilities of tomorrow.

Whether aspiring to fulfill the needs of the U.S. FDA’s PAT initiative or ICH’s more recent Q12 guideline, Hamilton is a key partner to the biopharmaceutical industry as we seek to achieve the high expectations of developing drugs faster, cheaper, and in ever-increasing quantities.

Back in 1989, Hamilton Process Analytics (PA) was just a small lab tasked with finding ways to leverage Hamilton’s innovative glass expertise for new markets and applications. Now in 2021, Hamilton PA finds itself a leader in process sensor innovation, developing new measurement technologies that help increase yields, lower costs, and yes, enable compliance with new biotechnology regulations and guidances.

This innovative spirit permeates throughout all of Hamilton PA. From the research scientists looking for new and improved ways to measure critical process parameters, to product managers envisioning the future of intelligent sensor platforms, to production managers leading efforts to move into lean manufacturing, Hamilton pushes the envelope. We seek not only to seamlessly integrate into the infrastructure of today, but also to anticipate the possibilities of tomorrow.

Every Hamilton business unit seeks to be “the measure of excellence” in their market. For Hamilton PA that means pushing for one customer-focused innovation after another, striving for a future where biopharma-ceutical drugs continue to make the world a place where we all thrive.

I hope that as you look through this book you feel the sense of excellence and problem-solving innovation that drives us every day.

Thanks for reading,

Clara

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