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.

Comparison of A(H3N2) Neutralizing Antibody Responses Elicited by 2018-2019 Season Quadrivalent Influenza Vaccines Derived from Eggs, Cells, and Recombinant Hemagglutinin.

Autor: Wang W; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Alvarado-Facundo E; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Vassell R; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Collins L; Defense Health Agency- Immunization Healthcare Division, Falls Church, Virginia, USA.; Walter Reed National Military Medical Center, Bethesda, Maryland, USA., Colombo RE; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA.; Madigan Army Medical Center, Fort Lewis, Washington, USA., Ganesan A; Walter Reed National Military Medical Center, Bethesda, Maryland, USA.; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA., Geaney C; Walter Reed National Military Medical Center, Bethesda, Maryland, USA., Hrncir D; Defense Health Agency- Immunization Healthcare Division Regional Office, Lackland AFB, Texas, USA., Lalani T; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA.; Naval Medical Center, Portsmouth, Virginia., Markelz AE; Brooke Army Medical Center, Fort Sam Houston, Texas, USA., Maves RC; Division of Infectious Diseases, Naval Medical Center, San Diego, California, USA., McClenathan B; Defense Health Agency- Immunization Healthcare Division Regional Office, Ft. Bragg, North Carolina, USA., Mende K; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA.; Brooke Army Medical Center, Fort Sam Houston, Texas, USA., Richard SA; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA., Schofield C; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Madigan Army Medical Center, Fort Lewis, Washington, USA., Seshadri S; Defense Health Agency- Immunization Healthcare Division, Falls Church, Virginia, USA., Spooner C; Defense Health Agency- Immunization Healthcare Division, Falls Church, Virginia, USA., Utz GC; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA.; Division of Infectious Diseases, Naval Medical Center, San Diego, California, USA., Warkentien TE; Naval Medical Center, Portsmouth, Virginia., Levine M; Influenza Division, Centers for Disease Control and Prevention, Atlanta Georgia, USA., Coles CL; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.; Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc., Bethesda, Maryland, USA., Burgess TH; Infectious Diseases Clinical Research Program, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA., Eichelberger M; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA., Weiss CD; Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.

Publikováno v: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2021 Dec 06; Vol. 73 (11), pp. e4312-e4320.

The Novel HDAC Inhibitor OBP-801 Promotes MHC Class I Presentation Through LMP2 Upregulation, Enhancing the PD-1-Targeting Therapy in Clear Cell Renal Cell Carcinoma.

Autor: Narukawa, Tsukasa^1,2 (AUTHOR) tnarukaw@koto.kpu-m.ac.jp, Yasuda, Shusuke¹ (AUTHOR) m-hori@koto.kpu-m.ac.jp, Horinaka, Mano¹ (AUTHOR) ktaniguc@koto.kpu-m.ac.jp, Taniguchi, Keiko¹ (AUTHOR) miemori@koto.kpu-m.ac.jp, Tsujikawa, Takahiro³ (AUTHOR) tu-ji@koto.kpu-m.ac.jp, Morita, Mie¹ (AUTHOR) tsakai@koto.kpu-m.ac.jp, Ukimura, Osamu² (AUTHOR), Sakai, Toshiyuki¹ (AUTHOR)

Publikováno v: Cancers. Dec2024, Vol. 16 Issue 23, p4058. 16p.

Assisted death for prisoners and forensic patients: complexity and controversy illustrated by four recent cases.

Autor: Jones, Roland M.^1,2 (AUTHOR) roland.jones@camh.ca, Simpson, Alexander I. F.^1,2 (AUTHOR)

Publikováno v: BJPsych Bulletin. Oct2024, Vol. 48 Issue 5, p300-305. 6p.

Signs and terminologies in cutaneous manifestations of substance abuse.

Autor: Murugan, Kalaiarasi¹ (AUTHOR), Sivakumar, Aravind¹ (AUTHOR) aravinddermat@gmail.com

Publikováno v: Indian Journal of Dermatology, Venereology & Leprology. Sep/Oct2024, Vol. 90 Issue 5, p1-5. 5p.