Croda launches highly purified amino acid series "BioXPro™" to support stable manufacturing and formulation processes for biopharmaceuticals.

Croda Japan Co., Ltd. (Headquarters: Shinjuku-ku, Tokyo; Representative Director: Liu Yongchuan) has started offering "BioXPro™," a series of highly purified amino acids as additives for biopharmaceuticals.

In the development and manufacturing of biopharmaceuticals, challenges arise from variability in raw materials and difficulties in quality control as processes become more sophisticated and scale up. Croda is committed to providing solutions that support manufacturing and formulation processes from the perspective of raw material design to address these issues.

Click here for the highly purified amino acid series "BioXPro™" product web page. Croda's approach to raw materials for stable operation BioXPro™ is an amino acid series designed by combining Croda's long-cultivated advanced purification technology with insights gained through a partnership with Amino GmbH. By managing low levels of metals, elemental impurities, and endotoxins, it contributes to meeting the quality requirements demanded at each stage and reducing lot-to-lot variability.

The aim is to support stable operations in manufacturing processes and formulation design by considering quality from the raw material design stage.

*For background and details of the partnership, please refer to our news release. Amino acid lineup covering research and development to commercial manufacturing The BioXPro™ series offers four types: "Arginine," "Arginine Hydrochloride," "Histidine," and "Histidine Hydrochloride." They comply with major pharmacopoeias in Japan, the US, Europe, and China, allowing selection according to application and purpose from research and development stages to commercial scale.

Main process areas supported by BioXPro™ BioXPro™ is intended for use in various processes in biopharmaceutical manufacturing and formulation, not limited to specific steps.

Medium design in cell culture processes

Process support in viral inactivation and purification processes

pH adjustment, buffering capacity, and stabilization in final formulations

Optimization of formulation characteristics such as viscosity reduction

Flexible utilization is possible depending on the characteristics required at each stage.

Croda's initiatives in the biopharmaceutical field Croda is expanding its raw materials and solutions for the entire biopharmaceutical process, not just providing pharmaceutical additives. We offer proposals from the perspective of stable supply and quality consistency, addressing challenges at each stage such as cell culture, purification, and formulation. BioXPro™ is positioned as part of these ongoing efforts in the biopharmaceutical field.

Exhibition at CPHI Japan 2026 Croda will exhibit at CPHI Japan 2026, held at Tokyo Big Sight from Tuesday, April 21 to Thursday, April 23, 2026. At our booth, in addition to new products such as "BioXPro™" for biopharmaceuticals, we will introduce solutions for a wide range of pharmaceutical fields, from small molecule drugs to vaccines and DDS. During the exhibition, we will also disseminate information on raw material selection and process design for biopharmaceutical manufacturing through technical seminars.

Click here for the exhibition web page. Looking ahead Croda will continue to provide value to a wide range of pharmaceutical fields, including biopharmaceuticals, small molecule drugs, vaccines, and DDS, centered on advanced purification technology, thereby supporting pharmaceutical development and manufacturing.

Croda Japan Co., Ltd.

[Headquarters] Shinjuku Park Tower 11F, 3-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo

[Inquiries] 03-6258-1912

pharma.japan@croda.com

[Public Relations] Nakae, Yamane

[Website] https://www.croda.com