June 2, 2019
Contract development and manufacturing organization (CDMO) 3P Biopharmaceuticals will scale-up the manufacture of Affibody’s candidate ABY-035 for psoriasis.
Swedish biopharma firm Affibody has been working with 3P since 2017 and has now secured the CDMO to transfer and scale-up the process developed prior to execution of the first GMP manufacturing batches for its candidate ABY-035.
3P will also carry out process characterization and validation ahead of commercial manufacture.
Image: iStock/metamorworks
“Currently the collaboration is based on GMP manufacturing for Ph II clinical trials and from there on we will work together for further Phase III clinical trials to commercial supply,” a spokesperson from 3P told this publication.
The service will be performed using 3P’s current capabilities, which includes the production of proteins using its microbial expression system based on E. coli.
According to the firm, E. coli expression suits Affibody’s candidate as “the molecule is small size, highly stable and requires no refolding.”
Financial details of the deal have not been divulged.
Affibody itself is a firm focused on bringing biotherapeutics to market based on its Albumod technology, which binds molecules to albumin to extend their circulatory half-life.
“The Albumod platform is based on a 5 kDa small albumin binding domain (ABD), and enables modified and enhanced pharmacokinetics, offering the same distribution profile as albumin, and in addition gives the potential of enhanced targeting of inflammation through albumin association,” Affibody claims.
The firm also says its platform offers several advantages over other targeted approaches including -specific binding and extended half-life, excellent tox profile and high tumor uptake, and biodistribution flexibility and good tissue penetration to reach targets that are difficult to reach for antibodies.
“The small size of both the Affibody molecules and Albumod gives the opportunity for superior sub cutaneous formulation, with ten times higher dose per injection volume, compared to MAbs [monoclonal antibodies],” the firm says.
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