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Items: 3

1.

Control Strategy Approach for a Well-Characterized Vaccine Drug Product.

Kolhe P, Sunasara K, Lewis L, Bailey Piatchek M, Rodriguez R, Arch-Douglas K.

PDA J Pharm Sci Technol. 2019 Sep 13. pii: pdajpst.2018.009415. doi: 10.5731/pdajpst.2018.009415. [Epub ahead of print]

PMID:
31519784
2.

Bivalent rLP2086 (Trumenba®): Development of a well-characterized vaccine through commercialization.

Sunasara K, Cundy J, Srinivasan S, Evans B, Sun W, Cook S, Bortell E, Farley J, Griffin D, Bailey Piatchek M, Arch-Douglas K.

Vaccine. 2018 May 24;36(22):3180-3189. doi: 10.1016/j.vaccine.2017.03.100. Epub 2017 Apr 19.

PMID:
28433330
3.

Support for the revocation of general safety test regulations in biologics license applications.

Evans DM, Thorn JM, Arch-Douglas K, Sperry JB, Thompson B, Davis HL, McCluskie MJ.

Biologicals. 2016 May;44(3):178-81. doi: 10.1016/j.biologicals.2016.02.001. Epub 2016 Mar 17.

PMID:
26996102

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