Time-saving benefit a factor in decision to go disposable, says Avid Image: iStock/phong_ek
Related tags: Peregrine, Avid, Single-use, Bioreactors, Stainless steel, Bavituximab, MAb
The changeover time between batches is significantly quicker using disposable equipment, says Avid Bioservices whose new biomanufacturing facility boasts several 1,000L single-use bioreactors.
Last week , Avid Bioservices – the contract biomanufacturing arm of Peregrine Pharmaceuticals – formally announced the completion of its new facility in Tustin, California, which it hopes will bring the firm an additional $40m in contract revenue each year.
The plant more than doubles Avid’s manufacturing capacity, and is equipped with single-use equipment - rather than stainless steel as in Avid’s prior production space – housing multiple 1,000L bioreactors with room to accommodate 2,000L disposable systems.
Single-use has been criticised by some biopharma firms for the huge cost of the systems, especially in commercial manufacture but CFO Paul Lytle said last week that “in terms of our manufacturing contracts, the manufacturing fees are fairly consistent, whether it’s in stainless steel or it’s in single-use bioreactors.”
Discussing Q3 2016 results, he told investors that “in terms of the cost structure, a significant portion of the cost structure is really built into labour and whether you are doing it with our traditional facility or with the single-use, the cost structure is fairly similar from a human resource standpoint.”
But where single-use stands out is in the changeover time between batches, he continued. “Single-use is much quicker, so we can shrink the amount of time between manufacturing runs and potentially drive a lot more output out of a single-use facility.”
Vice President, Business Development Stephen Worsley added the disposable nature of the site the plant, known as the Myford facility, “was completed for a fraction of the cost of building comparable facilities.”
Biopharma-Reporter.com asked Avid about the total costs of manufacturing batches in the different systems, but we were told this remains confidential002E
In 2011, Peregrine ran a product comparability project which demonstrated the ability to make the same product in single-use bioreactors and stainless steel with a high level of comparability, the results of which were submitted to the US Food and Drug Administration (FDA).
Along with contract manufacturing, the site was commissioned in order to make Peregrine’s own monoclonal antibody candidate, bavituximab.
However, the firm recently announced it was halting a Phase III trial of the mAb in combination with a chemotherapy – known as SUNRISE – after analysis showed that its drug combined with docetaxel did not perform better than docetaxel alone.
CEO Steven King said last week that while the results of the trial were “unfortunate,” it is “by no means the end of the programme.”
“At this point, our goal for the study is to obtain data from the trial that can potentially be critical in how we move the chemotherapy combination programme forward,” he said.
“As we generate this data, we will be able to share it at the appropriate time in the future. As for advancing the program, we are as excited and confident as ever about the immuno oncology combination potential of bavituximab.”