Biosimilars, Oral Biologics, & Continuous Processing: One Virtual Biotech's Strategy
By Anna Rose Welch, Chief Editor, Biosimilar Development
A topic that’s been front of mind for me lately has been what a successful biosimilar market will look like. Of course, there are a number of perspectives on this and quite a few moving parts.
... One of these up-and-coming companies is BiosanaPharma, a virtual biotech out of the Netherlands. The company announced earlier this year that its biosimilar candidate for omalizumab (Xolair) had cleared its Phase 1 trial and is targeted for a comparative efficacy study in 2021. In addition to expanding its biosimilar pipeline in the upcoming years using its 3C continuous counter-current bioprocessing platform, the company also has long-term hopes of bringing the holy grail of all biologics — the oral biologic — to market. I sat down (virtually) with BiosanaPharma CEO, Ard Tijsterman, to discuss the advantages and challenges of being a virtual biotech pursuing biosimilar and novel biologic development.
BiosanaPharma announces successful outcome of comparative phase I study of BP001, a biosimilar candidate to Xolair® (omalizumab)
Ard Tijsterman, CEO of BiosanaPharma:
“We are very proud that we now have successful phase I results for our first biosimilar product. This validates our use of fully-continuous manufacturing for biologics and allows us to move forward in our quest to deliver low cost mAb biosimilars.”
BiosanaPharma (Biosana) and A*STAR’s Bioprocessing Technology Institute (BTI) collaborate to advance continuous bio manufacturing
BiosanaPharma (Biosana) and A*STAR’s Bioprocessing Technology Institute (BTI) signed a research collaboration today to bring continuous biomanufacturing to the next level. Biosana’s proprietary 3C process will be used as the model for:
Downscaling of continuous processing to facilitate fast-track process development for innovator and biosimilar monoclonal antibodies (mAbs),
In-line and at-line process analytical monitoring of continuous process to bring parametric release closer to reality,
Modelling of continuous processing for easy scale up and
High throughput process development of Biosana’s mAb antibody candidates to validate the achieve-
The parties will establish a Joint Laboratory for Continuous Biomanufacturing located at the Centros building in Biopolis, Singapore, where staff from both parties will collaborate to mature and optimize the continuous process. Biosana will incorporate a local entity to support the collaboration.
Last February BiosanaPharma received approval from the Australian Bellberry Human Research Ethics Committee to begin a Phase I clinical trial for a biosimilar version of omalizumab, the first monoclonal antibody (mAb) produced with a fully continuous biomanufacturing process.
In bioprocessing, perhaps the tables are turned. When addressed with continuous bioprocessing I often hear, “we do not want to be the first!” Overcoming technical and regulatory challenges has not outweighed the risk of impacting approval timeline of the drug. However, recently BiosanaPharma announced that they have approval to start a phase I clinical trial for a biosimilar version of omalizumab. This is the first monoclonal antibody produced with a fully continuous biomanufacturing process to go into the clinic! Looking for details, BiosanaPharma claim their “3C process offers a 90% reduction in the cost of developing and manufacturing EMA/FDA quality mAbs. The 3C process is a fully-continuous, small footprint platform...”1.
Biosana Pty Ltd (a 100% subsidiary of BiosanaPharma BV) has received permission from the Australian Bellberry Human Research Ethics Committee HREC to start a phase I clinical trial of their first pipeline product. The trial consists of a bioequivalence double- blind, randomized, two-parallel-group phase I study of a humanized anti-immunoglobulin E mono- clonal antibody ‘BP001’ as lyophilized powder formulation compared with the standard omalizumab (Xolair®) lyophilized powder formulation in healthy male volunteers.