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Assessing the stability-indicating properties of alternative potency assays for inactivated influenza vaccine.

Autor: Ekimov A; Department of New Technologies, Federal State Unitary Enterprise (FSUE), Saint-Petersburg Scientific Research Institute of Vaccines and Serums (SPbSRIVS), Federal Medical-Biological Agency (FMBA) of Russia, Saint-Petersburg 198320, Russian Federation. Electronic address: a.a.ekimov@niivs.ru., Arunachalam AB; Global Analytical Sciences, R&D Sanofi, 1 Discovery Dr, Swiftwater, PA 18370, USA. Electronic address: arun.arunachalam@sanofi.com., Blake T; Global Analytical Sciences, R&D Sanofi, 1 Discovery Dr, Swiftwater, PA 18370, USA. Electronic address: taylor.blake@sanofi.com., Bodle J; Technical Development and Global Process Innovation, Seqirus Ltd, 63 Poplar Rd, Parkville, Victoria 3052, Australia. Electronic address: Jesse.Bodle@seqirus.com., Couzens L; Division of Biological Standards and Quality Control (DBSQC), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), US Food & Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, United States of America. Electronic address: laura.couzens@fda.hhs.gov., Dubey S; Standards Lifecycle, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar EN6 3QG, UK. Electronic address: Sitara.Dubey@nibsc.org., Eichelberger M; Division of Biological Standards and Quality Control (DBSQC), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), US Food & Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, United States of America. Electronic address: maryna.eichelberger@fda.hhs.gov., Engelhardt OG; Vaccines, Scientific Research & Innovation, Medicines and Healthcare products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar EN6 3QG, UK. Electronic address: Othmar.Engelhardt@nibsc.org., Gubinelli F; Standards Lifecycle, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar EN6 3QG, UK. Electronic address: Francesco.Gubinelli@nibsc.org., Joshi M; Division of Biological Standards and Quality Control (DBSQC), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), US Food & Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, United States of America. Electronic address: Manju.Joshi@fda.hhs.gov., Melnyk D; Division of Biological Standards and Quality Control (DBSQC), Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), US Food & Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, United States of America. Electronic address: Darya.melnyk@fda.hhs.gov., Palladino G; Preclinical Research, Seqirus, 50 Hampshire Street, 9th Floor Cambridge, MA 02139, United States of America. Electronic address: Giuseppe.Palladino@Seqirus.com., Rigsby P; Analytical and Biological Sciences, Scientific Research & Innovation, Medicines and Healthcare Products Regulatory Agency, Blanche Lane, South Mimms, Potters Bar EN6 3QG, UK. Electronic address: peter.rigsby@nibsc.org., Rockman S; Technical Development and Global Process Innovation, Seqirus Ltd, 63 Poplar Rd, Parkville, Victoria 3052, Australia. Electronic address: Steve.Rockman@seqirus.com., Savina N; Department of New Technologies, Federal State Unitary Enterprise (FSUE), Saint-Petersburg Scientific Research Institute of Vaccines and Serums (SPbSRIVS), Federal Medical-Biological Agency (FMBA) of Russia, Saint-Petersburg 198320, Russian Federation. Electronic address: n.n.savina@niivs.ru., Smith E; Analytical CMC, Vaccine mRNA Center of Excellence, Sanofi, 200 West Street, Waltham, MA 02451, United States of America. Electronic address: elena.smith@sanofi.com., Gilchrist SAN; S Gilchrist Consulting Services Inc, 8 Covebank Crescent, Brampton, ON L6P 2X5, Canada. Electronic address: shawngilchrist@sympatico.ca.

Publikováno v: Vaccine [Vaccine] 2023 Jul 19; Vol. 41 (32), pp. 4639-4647. Date of Electronic Publication: 2023 Jun 19.

Preclinical development of the quadrivalent meningococcal (ACYW) tetanus toxoid conjugate vaccine, MenQuadfi®.

Autor: Kensinger R; BioProcess R&D, Sanofi Pasteur, 1 Discovery Dr, Swiftwater, PA, 18370, USA. richard.kensinger@gmail.com., Arunachalam AB; Analytical Sciences, R&D Sanofi Pasteur, 1 Discovery Dr, PA, 18370, Swiftwater, USA.

Publikováno v: Glycoconjugate journal [Glycoconj J] 2022 Jun; Vol. 39 (3), pp. 381-392. Date of Electronic Publication: 2022 Apr 20.

Unique features of a recombinant haemagglutinin influenza vaccine that influence vaccine performance.

Autor: Arunachalam AB; Analytical Sciences, R&D Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA, 18370, USA. Arun.Arunachalam@sanofi.com., Post P; Regulatory Affairs, Protein Sciences, a Sanofi Company, 1000 Research Parkway, Meriden, CT, 06450, USA., Rudin D; Global Medical Affairs, Sanofi Pasteur, 1 Discovery Drive, Swiftwater, PA, 18370, USA.

Publikováno v: NPJ vaccines [NPJ Vaccines] 2021 Dec 02; Vol. 6 (1), pp. 144. Date of Electronic Publication: 2021 Dec 02.