ADC Therapeutics’ recently approved cancer treatment Zynlonta will be commercially manufactured by Avid Bioservices in Tustin, California.
Contract development manufacturing organization (CDMO) Avid Bioservices will manufacture the monoclonal antibody portion of the antibody-drug conjugate (ADC) Zynlonta (loncastuximab tesirine), which received US Food and Drug Administration (FDA) approval in April.
Avid has provided ADC Therapeutics with clinical manufacturing services since 2017. However, the firm will now undertake commercial manufacturing activities for Zynlonta, which is used to treat patients with relapsed or refractory large B-cell lymphoma.
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“Commercial manufacturing of Zynlonta will take place on our Tustin, California campus within our Myford North facility, which successfully completed the pre-license inspection in February 2021,” a spokesman for Avid told BioProcess Insider. “This facility is dedicated to single-use-technologies with various scales ranging from multiple 200 L to multiple 2,000 L single-use bioreactors.”
Avid did not comment on the financials associated with the deal and said it is unable to disclose the volume of Zynlonta it aims to produce.
Howeverm the firm said while a scale-up is not “necessary to meet the current demands associated with the Zynlonta commercial manufacturing deal […] Avid is currently executing a two-phase expansion of its Myford facility.”
The firm initiated a $15 million expansion of its Myford, California facility last November and the CDMO kicked off its second phase in February 2021 estimated to cost $45 to $55 million.
According to Avid, the first phase of this expansion “is expected to come online in early 2022,” adding that “it involves the addition of a second purification suite and will increase our Myford North facility capacity.”
He continued: “The second phase (Myford South) […] involves the addition of a second manufacturing train with both upstream and downstream processing suites within the Myford facility. Once completed, the total bioreactor capacity at the facility (Myford North and South) will exceed 20,000 L.”
Avid did not disclose a time-limit for this deal.