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

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

In the development and manufacturing of biopharmaceuticals, challenges arise from raw material variability and difficulties in quality control due to process sophistication and scale-up. Croda addresses these issues by providing solutions that support manufacturing and formulation processes from a raw material design perspective.

BioXPro™ is an amino acid series designed by combining Croda's long-standing 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 quality requirements at each stage and reducing lot-to-lot variability.

The goal is to support stable operations in manufacturing 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 for 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 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.

Cell culture media design

Process support in viral inactivation and purification steps

pH adjustment, buffering, and stabilization in final formulations

Optimization of formulation properties 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 excipients. We offer proposals from the perspective of stable supply and quality consistency, while addressing challenges in 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 April 21 (Tuesday) to 23 (Thursday), 2026. At the exhibition booth, we will introduce solutions for a wide range of pharmaceutical fields, from small molecule drugs to vaccines and DDS, in addition to biopharmaceutical products including the new "BioXPro™". During the exhibition, we will also disseminate information on raw material selection and process design concepts in biopharmaceutical manufacturing through technical seminars.

Looking Ahead

Croda will continue to support pharmaceutical development and manufacturing by providing value to a wide range of pharmaceutical fields, including biopharmaceuticals, small molecule drugs, vaccines, and DDS, centered on advanced purification technology.

Croda Japan Co., Ltd.

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

[Contact] 03-6258-1912

pharma.japan@croda.com

[Public Relations] Nakae, Yamane

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