May 18, 2017

Fast Trak Services: a collaborative project to accelerate downstream biosimilar process development

Biosimilars represent an innovative solution that can benefit both patients and healthcare systems  by reducing the burden of rising treatment costs. To improve the availability, price and access of  medicines, many countries are implementing strategies to establish their own production capacity.

To support this development, mAbxience, a Spanish biotechnology company specialized in research,  development, and manufacture of biosimilar drugs, is committed to provide the manufacturing of highquality  products and processes that meet regulatory and technical requirements in all countries where  it operates, using cutting edge single-use technology. Currently, mAbxience has sales contracts in more  than 70 countries.

One of the biosimilar specialties present in mAbxience pipeline constitutes an Fc-fusion protein, with  a molecular weight of Mr 150 000 and an isoelectric point of < 5, for which a first-generation process  was established by a third-party contract manufacturing organization (CMO). The molecule exhibits  monoclonal antibody (mAb) behavior, however, with a challenging glycosylation profile and complex  tertiary and quaternary structures. Consequently, low product recovery and purity were obtained in  the first-generation purification process. In addition, the purification protocols were poorly suited for  manufacturing scale.

With the aim of improving the first-generation process to reach the manufacturability and purity  required to produce material for phase I clinical trials, mAbxience contacted the Fast Trak Services team to initiate a collaborative project. This case study demonstrates the optimization of the  downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein. The optimization work was conducted by Fast Trak scientists. Process optimization focused  on improving the affinity chromatography (AF) capture step as well as the intermediate purification and polishing steps, using hydrophobic interaction chromatography (HIC) and anion exchange chromatography (AIEX), respectively, keeping the same process materials. In addition, a purification scheme more suitable for manufacturing scale was to be established.

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