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Croda Launches "BioXPro™" Advanced Purified Amino Acid Series to Support Stable Biopharmaceutical Manufacturing and Formulation Processes

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Croda Japan Co., Ltd. has launched "BioXPro™", a series of highly purified amino acids designed as excipients for biopharmaceuticals. This product line aims to stabilize manufacturing and formulation processes by reducing variability originating from raw materials. BioXPro™ combines Croda's purification technology with expertise from Amino GmbH, ensuring low levels of metals, elemental impurities, and endotoxins. The series includes four types: Arginine, Arginine Hydrochloride, Histidine, and Histidine Hydrochloride, complying with major pharmacopoeias in Japan, the US, Europe, and China. It is suitable for various applications from R&D to commercial scale, including cell culture, viral inactivation, purification, pH adjustment, buffering, stabilization, and viscosity reduction in final formulations. Croda will showcase BioXPro™ and other products at CPHI Japan 2026 in Tokyo Big Sight from April 21-23, 2026.

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Frequently Asked Questions

Q: What is the primary purpose of the newly launched BioXPro series?
A: It is designed as a series of highly purified amino acids to support stable biopharmaceutical manufacturing and formulation processes.
Q: Who are the partners involved in the development of the BioXPro series?
A: The series is designed by combining Croda's purification technology with insights gained through a partnership with Amino GmbH.
Q: What are the four types of amino acids offered in the BioXPro series lineup?
A: The series offers Arginine, Arginine Hydrochloride, Histidine, and Histidine Hydrochloride.
Q: Which pharmacopoeias do the BioXPro series amino acids comply with?
A: They comply with major pharmacopoeias in Japan, the United States, Europe, and China.
Q: In which process areas can the BioXPro series be utilized?
A: They can be used in cell culture media design, viral inactivation, purification, and final formulation stabilization.