Cytovance® Biologics Congratulates Siwa Biotech on Commercial Medical Device Approval

Cytovance® Biologics announces Siwa Biotech’s receipt of FDA licensure of Anti-Fya and Anti-Fyb recombinant monoclonal Blood Grouping Reagents. These reagents were developed and manufactured by Siwa Biotech Corp. and filled by Cytovance®. In 2018, Cytovance® completed a successful Pre-Licensing Inspection (PLI) by the FDA in support of these products with no form 483 issued.

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 “This is a major accomplishment for both companies as it is the first commercial products for both Siwa and Cytovance.” Dr. Yan Wang, CEO of Cytovance commented.  “We look forward to our continued relationship with Siwa Biotech as they now enter the marketplace.” 

“Access to the manufacturing and other technical services provided by Cytovance has been important in bringing these products to market. We look forward to our continued working relationship with Cytovance.” Dr. William Canfield, CEO and Chairman of Siwa Biotech Corp. 

About Cytovance Biologics

Cytovance Biologics is a privately held contract development manufacturing company specializing in the cGMP production of therapeutic proteins and antibodies from mammalian cell culture, microbial fermentation, transgenic processes, and small scale "flex suite" programs. In addition, Cytovance offers process development services, cell line development, purification development, stability testing, and regulatory support services, all from its Oklahoma City state-of-the-art facilities.

For more information, please contact: 

Lonnie Barish

VP, Business Development, Cytovance Biologics

lbarish@cytovance.com