Detailed Product Review
BLA ref. number:
Kurt Brorson, Ph.D. /“(. i”,,
Kathryn Stein, Ph.D.
BLA Receipt date:
lnfliximab (cA2) is a chimeric anti-TNFa mAb.
produced by -_ w
:Ils transfected with genomic expression constructs
and VJ, exons and human yl and K exons.
It is purified
to near homogeneity by standard chromatography
technology and will be
in a lyophilized
It has a high affinity (Ka = 10’0 M-l) for TNFa
and is specific for human and chimp TNF. The proposed indication
parenteral use in Crohn’s disease patients, with the mechanism of action
believed to be clearance of pro-inflammatory
TNF and possibly deletion of
aberrantly activated mTNF+ T cells.
Overall Conclusions and Recommendations:
In general, the manufacturing
process of cA2 at Centocor BV is well controlled.
and potency are tight and the consistency
lots within specifications.
product manufacture at -
is also controlled.
In general, most
issues were resolved during the IND stage. All product
raised in the review of the BLA have been resolved (see amendments)
for their resolution are in place.
Reviewer’s note: Reviewers notes are bolded, action items are listed at end.
Where there is no reviewer’s note the process and testing is deemed to be
acceptable by the reviewer. Adobe photoshop scans integrated
in text are
stamped with BLA number and volume.
Detailed review table of contents:
I Drug Substance
1. Description and Characterization
3. Method of Manufacture
4. Process ‘Controls
5. Reference Standards
II Drug Product