JN International Medical Corporation

Lincoln, NE, United States

JN International Medical Corporation

Lincoln, NE, United States
SEARCH FILTERS
Time filter
Source Type

Gudlavalleti S.K.,JN International Medical Corporation | Crawford E.N.,JN International Medical Corporation | Tran N.N.,JN International Medical Corporation | Orten D.J.,JN International Medical Corporation | And 2 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2015

The ability to accurately measure and report trace amounts of residual formaldehyde impurity in a vaccine product is not only critical in the product release but also a regulatory requirement. In many bacterial or viral vaccine manufacturing procedures, formaldehyde is used either at a live culture inactivation step or at a protein de-toxification step or at both. Reported here is a validated and improved C18-UPLC method (developed based on previously published C-8 HPLC method) to determine the traces of formaldehyde process impurity in a liquid form Neisseria meningitidis A/C/Y/W-135-DT conjugate vaccine formulated in isotonic aqueous 1× PBS. UPLC C-18 column and the conditions described distinctly resolved the 2,4-DNPH-HCHO adduct from the un-reacted 2,4-DNPH as detected by TUV detector at 360. nm. This method was shown to be compatible with PBS formulation and extremely sensitive (with a quantitation limit of 0.05. ppm) and aided to determine formaldehyde contamination sources by evaluating the in-process materials as a track-down analysis. Final nanogram levels of formaldehyde in the formulated single dose vialed vaccine mainly originated from the diphtheria toxoid carrier protein used in the production of the conjugate vaccine, whereas relative contribution from polysaccharide API was minimal. © 2015 Elsevier B.V.


Trademark
JN International Medical Corporation | Date: 2012-10-13

Adjuvants for use with vaccines.


Trademark
JN International Medical Corporation | Date: 2012-10-01

Adjuvants for use with vaccines.


Trademark
JN International Medical Corporation | Date: 2012-10-01

Adjuvants for use with vaccines.


PubMed | JN International Medical Corporation
Type: | Journal: Journal of pharmaceutical and biomedical analysis | Year: 2015

The ability to accurately measure and report trace amounts of residual formaldehyde impurity in a vaccine product is not only critical in the product release but also a regulatory requirement. In many bacterial or viral vaccine manufacturing procedures, formaldehyde is used either at a live culture inactivation step or at a protein de-toxification step or at both. Reported here is a validated and improved C18-UPLC method (developed based on previously published C-8 HPLC method) to determine the traces of formaldehyde process impurity in a liquid form Neisseria meningitidis A/C/Y/W-135-DT conjugate vaccine formulated in isotonic aqueous 1 PBS. UPLC C-18 column and the conditions described distinctly resolved the 2,4-DNPH-HCHO adduct from the un-reacted 2,4-DNPH as detected by TUV detector at 360 nm. This method was shown to be compatible with PBS formulation and extremely sensitive (with a quantitation limit of 0.05 ppm) and aided to determine formaldehyde contamination sources by evaluating the in-process materials as a track-down analysis. Final nanogram levels of formaldehyde in the formulated single dose vialed vaccine mainly originated from the diphtheria toxoid carrier protein used in the production of the conjugate vaccine, whereas relative contribution from polysaccharide API was minimal.

Loading JN International Medical Corporation collaborators
Loading JN International Medical Corporation collaborators