Boehringer Ingelheim Enhances Biopharmaceutical Contract Manufacturing Services In China

Boehringer Ingelheim’s biopharmaceutical facility in Shanghai, China, meets the conditions to participate in a regulatory reform promoting segmented manufacturing of biological products by the local authorities. The reform, led by the Chinese medicine authority NMPA (National Medical Products Administration), aims at enhancing control, efficiency, and flexibility in the production process. As one of the few contract manufacturing organizations qualified for the pilot period, Boehringer Ingelheim BioXcellence is expanding its service portfolio in China, offering distinct service packages for different segments in biopharmaceutical production and enabling the sustainable global supply of medications to patients.

Segmented manufacturing refers to the division of a production process into distinct, manageable segments or stages, each focusing on a specific part of the entire process. In the biopharmaceutical industry, it allows for the manufacturing of different components of medicines in separate facilities, potentially in various countries.

Boehringer Ingelheim BioXcellence in Shanghai is at the forefront of the reform due to its expertise and global supply capabilities. As a pilot site in the Chinese Market Authorization Holder reform since 2016, the site has been working closely with the local government. It meets stringent regulatory standards and is characterized by a robust quality management system. Strategically located in Shanghai’s biopharmaceutical ecosystem, the site has been producing innovative therapies for more than seven years. With its comprehensive manufacturing and packaging capabilities, the site is fully equipped to support a segmented manufacturing approach and is prepared for segment-by-segment tech transfer and commercial launch in China.

“We can build on our more than 40 years of experience with this segmented manufacturing business model, as it is well established in the U.S. and the EU. Now we’re eager to roll out this concept in China to better serve our customers’ needs, by enhancing a reliable and sustainable global supply of life-changing biopharmaceutical medicines to patients in need,” Andrea Rothmaler, Head of Boehringer Ingelheim’s contract manufacturing arm, BioXcellence, underlines the impact for the biotech community.

This regulatory reform strengthens Boehringer Ingelheim BioXcellence's position, enabling it to offer more tailored solutions to its customers. The new level of flexibility reinforces the company’s Chinese business model, allowing it to serve both local-for-local and local-for-global supplies of biopharmaceuticals. Hereby, Boehringer Ingelheim BioXcellence™ reaffirms its dedication to reliable and sustainable supply chain solutions for its partners worldwide.

About Boehringer Ingelheim
Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry’s top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. More than 53,500 employees serve over 130 markets to build a healthier, more sustainable, and equitable tomorrow.

For more information, visit www.boehringer-ingelheim.com.

About Boehringer Ingelheim BioXcellence
Building on this, Boehringer Ingelheim BioXcellence collaborates with partners to reliably supply biopharmaceutical therapies. The companies’ extensive experience in their contract development and manufacturing has resulted in supplying more than 45 commercial products to patients in need worldwide. It operates a global manufacturing network in key technologies such as mammalian and microbial, turning biologic innovations into commercial successes.

For more information, visit www.bioxcellence.com.