Partnership to strengthen Saudi biopharmaceutical manufacturing

Batavia Biosciences, a leading contract development and manufacturing organization, is expanding its partnership with PrexPharma, an emerging player in the Saudi Arabian biopharmaceutical sector. This collaboration marks a pivotal step in driving the growth of biopharmaceutical products, including biosimilars and recombinant proteins, within the Saudi market.

PrexPharma, the first commercial parental biomanufacturing facility in the MENA region, is aligned with Saudi Arabia’s Vision 2030. The company’s mission to advance local R&D, create job opportunities, and improve patient access to essential medicines is integral to the nation’s shift toward a non-oil-based economy.

As part of this expanded partnership, Batavia Biosciences will provide support in product registration and local manufacturing for several biopharmaceutical products. Batavia will conduct in-depth reviews of product dossiers to ensure compliance with Saudi Food and Drug Authority (SFDA) regulations and evaluate the manufacturability of these products at PrexPharma’s facilities.

A dedicated team within Batavia, led by an experienced senior expert, will oversee the project, bringing extensive expertise in R&D, technology transfer, and regulatory compliance. This team will thoroughly review critical documentation, such as product dossiers, quality assurance records, and GMP compliance documents, ensuring an efficient and comprehensive evaluation process.

“PrexPharma selected Batavia Biosciences for our proven expertise in developing a wide range of biological products, our experience in technology transfer, and our success in meeting regulatory standards across the EMA and FDA. Our ability to assess manufacturability, including cost of goods (COGs) and scalability, positions us as a key partner for PrexPharma’s biopharmaceutical growth,” said Ahd Hamidi, Strategic Partnership Director at Batavia Biosciences.

“This partnership goes beyond fulfilling immediate regulatory requirements; it is a long-term collaboration aimed at supporting Saudi Arabia’s local biomanufacturing industry. By combining our expertise, we are committed to accelerating PrexPharma’s expansion within the MENA region and internationally.”

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