FDA 483 for Catalent behind CRL for Regeneron

The inspection at the Bloomington, Indiana site resulted in three observations and is believed to be the cause of the rejection of Regeneron’s aflibercept 8 mg last month.

The US Food and Drug Administration (FDA) published the Form 483 (below) with three observations last week, following an inspection in April and May at Catalent’s Bloomington site.

The Agency criticized the failure of the contract development and manufacturing organization (CDMO) to follow written and process control procedures, citing various issues with aseptic handling.

DepositPhotos/dusanpetkovic

The second observation said Catalent’s equipment validation in support of manufacture was inadequate, while the third observation slammed the failure to satisfactorily maintain and clean equipment.

Like many manufacturers, Catalent is no stranger to 483s citing GMP deficiencies. The Bloomington site received a 483 last year, as did a facility in Brussels, Belgium.

However, this latest 483 was noted first by Bloomberg, then confirmed by other press outlets, as the cause of a complete response letter (CRL) for the 8 mg dosage of Regeneron’s wet age-related macular degeneration (wAMD) drug Eylea (aflibercept).

Regeneron wrote on June 27 the FDA’s CRL was issued “due to an ongoing review of inspection findings at a third-party filler.”

Regeneron added it “is committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with wAMD, diabetic macular edema (DME) and diabetic retinopathy (DR) as quickly as possible.”

Catalent Indiana, LLC, Bloo… by Dan Stanton