Editorial Article: Leveraging technology in quality control: The power of partnership

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Marcelo Shigueru Kamei, Manager of Analytical Development at the Cristália Laboratory

The pharma world is dedicated to developing effective and valuable treatments for patients with an unwavering commitment to the quality of its products. Cristália, Brazil’s homegrown pharma-biotech complex, prides itself in contributing to this same mission. Embracing cutting-edge technology, the Cristália analytical team actively innovates and enhances methodologies that ensure product quality. Here, Marcelo Shigueru Kamei, Manager of Analytical Development at the Cristália Laboratory, reveals how Waters’ harmonized suite of software, hardware, and services has proved invaluable in their operations.

Dedication to quality

Cristália’s bio-industrial complex in São Paulo is one of the most modern facilities in the country. The analytical development sector has its laboratories in a space of 2,450 m² and comprises a team with more than 150 employees, including technicians, trainees, graduates, masters and doctors. These experts develop and validate the analytical methods that are applied to control the quality of pharma products in Cristália’s portfolio with a singular purpose: quality for the final consumer. Analytical methods are exhaustively challenged to ensure that they will be able to unequivocally attest to the necessary quality of the product. In addition to analytical methods, the team provides support for new product innovation and development, generating all essential product registration documents to meet various health agency requirements. Kamei considers his team a great example of championing an ‘all-in’ commitment to the company’s focus on quality, new product development, and innovation.

Cristália’s analytical department has a dedicated set of chromatographers specializing in the latest separation science techniques across a diverse set of products. The park possesses state-of-the-art capacity covering almost every available chromatography technology, be it high or ultra-high-performance, such as ionic separation, gel permeation, separation by normal and reverse phases, as well as detection by various methods of ultraviolet, light scattering, refractive index, fluorescence, aerosol loaded and mass spectrometry.

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Cristália’s analytical department specializes in the latest separation science techniques

Finding a valued partner

Managing a ‘universe of equipment’, as Kamei phrases it, is not an easy task. His lab sought a partner who could efficiently harmonize the operation of all systems, while at the same time could offer Cristália a suite of proven technologies backed by a team of knowledgeable and accessible service and support specialists. This all-encompassing partner needed to have a strong market history, be capable of optimizing generated data, be well-regarded by national and international regulatory agencies, and meet all safety and reliability standards. Additionally, the partner needed to offer some kind of financial savings for the department and be able to deliver good cost-benefit.

The team’s search led them to Waters 

“Waters being a market pioneer in chromatography hardware and software solutions was an added advantage. In addition, the Empower™ Chromatography Data System offers a very versatile data acquisition and processing system that can be used to control even chromatographs from other brands.” Kamei went on to explain: “In the pharmaceutical market, Empower software is synonymous with quality and safety.” Waters' versatile data acquisition and processing system allowed the laboratory to easily control all chromatographs in the area. As a centralized operations and service partner, Waters' integrated methodology empowered the team with agile decision making, which Kamei considers to be a great value addition.

Partnering with Waters has provided another advantage: direct access to a qualified and prompt technical team, a resourceful application team that provides continual staff training, along with a supportive commercial team. While Cristália has continued its service contracts with third parties for other equipment, Kamei states: “The proximity that the Waters team has in relation to our operation is certainly very valuable, they are able to provide solutions that make sense for our needs.” 

A future of endless possibilities

The pharmaceutical industry is quick to adopt new technologies, especially when such changes help improve treatment quality. Cristália shares this attitude as it aims to provide quick and sustainable results. “We develop great partnerships with our third parties and research institutions in the pursuit of technological innovations, new products and treatments,” states Kamei. He adds that actively participating in conferences, events and work groups has been instrumental in understanding the latest technologies. The Cristália team applies these developments not only to their new ventures, but also in upgrades to their core portfolio, either as improvements in their formulations or in their manufacturing processes. 

Kamei notes that currently labs favor ‘classic’ chromatography techniques, but this is likely to change. “I believe that the future is focused on more accurate techniques with less generation of toxic waste,” he elaborates. He hypothesizes that capillary liquid chromatography may potentially take center stage due to its high separation capacity with the added advantage that it generates near-zero levels of solvent residues. As companies seek approval for increasingly complex biomolecules, multidimensional chromatographic techniques for resolving complex separations may also become popular. “When it comes to the science of separations, the possibilities are endless,” concludes Kamei.

Keep your lab at the forefront of science

Learn more about Waters’ comprehensive solutions, industry-leading informatics, and flexible services designed to work in harmony and deliver synergistic value. Take advantage of Waters’ new FlexUP Technology Renewal Program and easily replace your older instruments with state-of-the-art technology to stay protected from obsolescence and its high degree of risk. Whether you have a Waters system or another manufacturer’s, eliminate the issues associated with older instrumentation or software by cost-effectively managing the lifecycle of your laboratory’s assets. Learn more at www.waters.com/FlexUP.