Great Bay Bio’s CHO-K1 catalog medium AlfaMedX-K1 has successfully completed Drug Master File (DMF) filing with the U.S. Food and Drug Administration (FDA). DMF Number: 42995. This milestone marks another significant achievement in Great Bay Bio’s global expansion and commercialization journey, following the company’s ISO 9001:2015 certification.

With the DMF filing, AlfaMedX-K1 provides practical advantages for global customers: when used in FDA regulatory submissions for new drug applications, the DMF number can be directly referenced, greatly shortening product review and evaluation time, simplifying submission packages, and accelerating drug approval and market entry.

▲ AlfaMedX-K1, a CHO-K1 Catalog Medium, Completes FDA DMF Filing

AlfaMedX-K1, developed on Great Bay Bio’s AlfaMedX platform, leverages AI-driven analysis and predictive modeling of extensive experimental datasets to optimize medium composition and culture conditions. This catalog medium is specifically designed for CHO-K1 cell lines, supporting enhanced cell growth and improved protein expression.

Comparative experimental data show that AlfaMedX-K1 demonstrates core advantages in CHO-K1 cell culture. When benchmarked against 17 commonly used commercial media, it consistently delivers excellent expression performance and broad adaptability across cell lines producing monoclonal antibodies, bispecific antibodies, and fusion proteins.

· Monoclonal Antibody (mAb)

·Bispecific Antibody (BsAb)

· Fusion Protein

Key features for CHO-K1 cell lines (growth factor–free):

• Excellent Expression: Protein expression levels are comparable to leading international commercial media, with some critical indicators exceeding benchmarks, helping improve biologics production efficiency.

• Broad Versatility: Compatible with multiple biologics modalities, including fusion proteins, monoclonal antibodies, and bispecific antibodies, offering extensive industrial application potential.