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# FDA Tells Revance to Qualify New Working Cell Bank
- URL: https://www.fdaweb.com/fda-tells-revance-to-qualify-new-working-cell-bank/
- Published: 2022-01-19T12:00:00.000Z
- Updated: 2026-09-14T17:29:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150960

FDA has told Revance Therapeutics that to address a recent BLA complete response letter on DaxibotulinumtoxinA for Injection, indicated for treating glabellar lines, will require qualification of a new working cell bank (WCB). The qualification, which the company says is in progress, will need to be verified by a reinspection of the firm’s manufacturing facility.

Based on FDA meeting minutes from last month, Revance says it will need to qualify its new WCB by producing three consecutive drug substance lots and one drug product lot. The company says it plans to submit the new WCB qualification package as part of its BLA resubmission as soon as possible. Once the resubmission is accepted by FDA, it has up to six months to complete its reinspection and review.

In 10/2021, FDA released a [7/2/2021-dated FDA-483](https://www.fda.gov/media/153014/download?ref=fdaweb.com) with five inspection observations issued following a  
6/21-7/2/2021 inspection at the firm’s Newark, CA drug substance and drug product manufacturing facility. The inspection observations were: 

- current release and stability cell bank testing methods are insufficient to monitor quality and shelf-life of working cell bank;
- the current manufacturing process is not the process proposed for licensure;
- the firm’s quality unit lacks the responsibility and authority for the control, review, and approval of outsourced activities, which includes defining the responsibilities and communication processes for quality-related activities in a written agreement;
- actual yield and percentages of theoretical yield, indicators of process performance, are not determined after each appropriate phase of manufacturing for a redacted drug product; and
- the responsibilities and procedures applicable to the quality control unit are not always in writing.

DaxibotulinumtoxinA is the company’s next-generation neuromodulator product that “combines a proprietary stabilizing peptide excipient with a highly purified botulinum toxin that does not contain human or animal-based components,” Revance says. DaxibotulinumtoxinA is also being evaluated in the full upper face, including glabellar lines, forehead lines and crow’s feet, as well as in two therapeutic indications — cervical dystonia and adult upper limb spasticity.