作者：Elizabeth A. Poore^a ; ¹ ; Dawn K. Slifka^a ; ¹ ; Hans-Peter Raué ; ^b ; Archana Thomas^b ; Erika Hammarlund^b ; Benjamin K. Quintel^a ; Lindsay L. Torrey^a ; Ariel M. Slifka^a ; Justin M. Richner^d ; Melissa E. Dubois^a ; Lawrence P. Johnson^c ; Michael S. Diamond^d ; ^e ; ^f ; ^g ; Mark K. Slifka^a ; ^b ; Ian J. Amanna^a ; ^{iamanna@najittech.com}

关键词：BDS ; bulk drug substance ; BPL ; β-propiolactone ; cGMP ; current good manufacturing practices ; DENV ; dengue virus ; DP ; drug product ; Env ; envelope protein ; FFA ; focus forming assay ; GLP ; good laboratory practices ; H2O2 ; hydrogen peroxide ; IVRP ; in vitro relative potency ; JEV ; Japanese encephalitis virus ; LOD ; limit of detection ; MAb ; monoclonal antibody ; MCB ; master cell bank ; MOI ; multiplicity of infection ; MVB ; master virus bank ; NT50 ; 50% neutralizing titer ; PFU ; plaque forming unit ; PPV ; porcin

刊名：Vaccine

出版年：2017

作者：Pablo F. Cé ; spedes^a ; ¹ ; Emma Rey-Jurado^a ; ¹ ; Janyra A. Espinoza^a ; Claudia A. Rivera^a ; Gisela Canedo-Marroquí ; n^a ; Susan M. Bueno^a ; Alexis M. Kalergis^a ; ^b ; ^c ; ^{akalergis@bio.puc.cl}

关键词：BAL ; bronchoalveolar lavage ; BCG ; Bacillus Calmette et Guerin ; CFUs ; colony-forming units ; cGMP ; current Good Manufacturing Practices ; hRSV ; human respiratory syncytial virus ; FI-hRSV ; formalin-inactivated hRSV ; HI-hRSV ; heat-inactivated hRSV ; FACS ; fluorescence activated cell sorting

刊名：Vaccine

出版年：2017

作者：Renaud Jacquemart ; ^{Renaud@natrixseparations.com} ; Melissa Vandersluis¹ ; Mochao Zhao¹ ; Karan Sukhija¹ ; Navneet Sidhu¹ ; Jim Stout¹

关键词：DSP ; downstream process ; USP ; upstream process ; CoG ; cost of goods ; OpEx ; operating expense ; CapEx ; capital expense ; cGMP ; current good manufacturing practice ; HCP ; host cell protein ; EBA ; expanded bed adsorption ; SMB ; simulated moving bed ; MV ; membrane volume ; FT ; flow through ; B&E ; bind and elute ; PAT ; process analytical technology ; FDA ; Food and Drug Administration ; EMA ; European Medicines Agency

刊名：Computational and Structural Biotechnology Journal

出版年：2016

作者：Teó ; filo Vasconcelos^a ; ^b ; ^c ; ^d ; Sara Marques^e ; José ; das Neves^c ; ^d ; Bruno Sarmento^c ; ^d ; ^f ; ^{Bruno.sarmento@ineb.up.pt" class="auth_mail" title="E-mail the corresponding author}

关键词：ASES ; Aerosol solvent extraction system ; BCS ; Biopharmaceutical classification system ; DMSO ; Dimethyl sulfoxide ; DSC ; Differential Scanning Calorimetry ; EMA ; European Medicines Agency ; EU ; European Union ; FDA ; Food and Drug Administration ; GAS ; Gaseous antisolvent ; GMP ; Good manufacturing practices ; HME ; Hot melt extrusion ; HPC ; hydroxypropylcellulose ; HPMC ; Hydroxypropyl methylcellulose ; HPMCAS ; Hydroxypropyl methylcellulose acetate succinate ; ICH ; International Conference Harmonization ; N.A.

刊名：Advanced Drug Delivery Reviews

出版年：2016

作者：Kathryn M. Camp^a ; ¹ ; ^{campkm@od.nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Danuta Krotoski^b ; ^{krotoskd@mail.nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Melissa A. Parisi^b ; ^{parisima@mail.nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Katrina A. Gwinn^c ; ^{gwinnk@ninds.nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Bruce H. Cohen^d ; ^{bcohen@chmca.org" class="auth_mail" title="E-mail the corresponding author} ; Christine S. Cox^e ; ^{outreach@mitoaction.org" class="auth_mail" title="E-mail the corresponding author} ; Gregory M. Enns^f ; ^{genns@stanford.edu" class="auth_mail" title="E-mail the corresponding author} ; Marni J. Falk^g ; ^{falkm@email.chop.edu" class="auth_mail" title="E-mail the corresponding author} ; Amy C. Goldstein^h ; ^{amy.goldstein@chp.edu" class="auth_mail" title="E-mail the corresponding author} ; Rashmi Gopal-Srivastavaⁱ ; ^{rashmi.gopal-srivastava@nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Grá ; inne S. Gorman^j ; ^{grainne.gorman@newcastle.ac.uk" class="auth_mail" title="E-mail the corresponding author} ; Stephen P. Hersh^k ; ^{hershs@starpower.net" class="auth_mail" title="E-mail the corresponding author} ; Michio Hirano^l ; ^{mh29@cumc.columbia.edu" class="auth_mail" title="E-mail the corresponding author} ; Freddie Ann Hoffman^m ; ^{fhoffman@heterogeneity-LLC.com" class="auth_mail" title="E-mail the corresponding author} ; Amel Karaaⁿ ; ^{akaraa@mgh.harvard.edu" class="auth_mail" title="E-mail the corresponding author} ; Erin L. MacLeod^o ; ^{emacleod@childrensnational.org" class="auth_mail" title="E-mail the corresponding author} ; Robert McFarland^j ; ^{robert.mcfarland@newcastle.ac.uk" class="auth_mail" title="E-mail the corresponding author} ; Charles Mohan^p ; ^{chuckm@umdf.org" class="auth_mail" title="E-mail the corresponding author} ; Andrew E. Mulberg^q ; ² ; ^{amulberg@amicusrx.com" class="auth_mail" title="E-mail the corresponding author} ; Joanne C. Odenkirchen^c ; ^{jo21x@nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Sumit Parikh^r ; ^{parikhs@ccf.org" class="auth_mail" title="E-mail the corresponding author} ; Patricia J. Rutherford^s ; ^{triciarutherford@vitaflo.co.uk" class="auth_mail" title="E-mail the corresponding author} ; Shawne K. Suggs-Anderson^t ; ^{shawne.suggs-anderson@fda.hhs.gov" class="auth_mail" title="E-mail the corresponding author} ; W.H. Wilson Tang^u ; ^{tangw@ccf.org" class="auth_mail" title="E-mail the corresponding author} ; Jerry Vockley^v ; ^{gerard.vockley@chp.edu" class="auth_mail" title="E-mail the corresponding author} ; Lynne A. Wolfe^w ; ^{lynne.wolfe@nih.gov" class="auth_mail" title="E-mail the corresponding author} ; Steven Yannicelli^x ; ^{steven.yannicelli@nutricia.com" class="auth_mail" title="E-mail the corresponding author} ; Philip E. Yeske^p ; ^{philip.yeske@umdf.org" class="auth_mail" title="E-mail the corresponding author} ; Paul M. Coates^a ; ^{coatesp@od.nih.gov" class="auth_mail" title="E-mail the corresponding author}

关键词：ACMG ; American College of Medical Genetics and Genomics ; ATP ; adenosine triphosphate ; CDE ; common data elements ; cGMP ; current good manufacturing practices ; CNS ; central nervous system ; CoQ10 ; coenzyme Q10 ; CPEO ; chronic progressive external ophthalmoplegia ; DSHEA ; Dietary Supplement Health and Education Act of 1994 ; FDA ; U.S. Food and Drug Administration ; FFDCA ; Federal Food ; Drug ; and Cosmetic Act ; GMDI ; Genetic Metabolic Dietitians International ; FSDU ; Food for Special Dietary Use ; IEM ; inbor

刊名：Molecular Genetics and Metabolism

出版年：2016

作者：Janak B. Valaki^a ; ^b ; ^{janakvalaki@gmail.com" class="auth_mail" title="E-mail the corresponding author} ; Pravin P. Rathod^c ; C.D. Sankhavara^d

关键词：Sustainability ; Bio dielectric fluid ; Material removal rate (MRR) ; Surface roughness (SR) ; Surface hardness (SH) ; Sustainable EDM

刊名：Journal of Manufacturing Processes

出版年：2016

作者：Franç ; oise Aubrit ^{francoise.aubrit@valneva.com" class="auth_mail" title="E-mail the corresponding author} ; Fabien Perugi ^{fabien.perugi@valneva.com" class="auth_mail" title="E-mail the corresponding author} ; Arnaud Lé ; on ^{arnaud.leon@valneva.com" class="auth_mail" title="E-mail the corresponding author} ; Fabienne Gué ; henneux ^{fabienne.guehenneux@valneva.com" class="auth_mail" title="E-mail the corresponding author} ; Patrick Champion-Arnaud ^{championarnaud@yahoo.fr" class="auth_mail" title="E-mail the corresponding author} ; Mehdi Lahmar ; ^{mehdi.lahmar@valneva.com" class="auth_mail" title="E-mail the corresponding author} ; Klaus Schwamborn ^{klaus.schwamborn@valneva.com" class="auth_mail" title="E-mail the corresponding author}

关键词：BSE ; bovine spongiform encephalopathy ; CAP ; CEVEC'samniocyte production ; CEF ; chicken embryo fibroblast ; DNA ; deoxyribonucleic acid ; EP ; European Pharmacopeia ; FBS ; fetal bovine serum ; GCCP ; good cell culture practice ; GMP ; good manufacturing practices ; HCD ; host cell DNA ; HEK ; human embryonic kidney ; MCB ; master cell bank ; MDCK ; Madin Darby canine kidney ; MRC ; Medical Research Council ; NRA ; national regulatory authority ; PERT ; product-enhanced reverse transcriptase ; RA ; regulatory agency ; RMK

刊名：Vaccine

出版年：2015

作者：Tuan Mohd Rosli Tuan Hassan^a ; Mohd Rafi Yaacob^b ; Nik Kamaruzaman Abdullatiff^c

关键词：Indigenous ; Entrepreneurs&rsquo ; best practices ; SMEs ; wood-based products

刊名：Procedia - Social and Behavioral Sciences

出版年：21 February, 2014

作者：Lindsey Childress ; PharmD ; Andrea Gay ; PharmD ; Atanaz Zargar ; PharmD ; Matthew K. Ito ; PharmD ; FCCP ; FNLA ; ^{itom@ohsu.edu}

关键词：Food and Drug Administration ; Dietary supplements ; Hyperlipidemia ; Red yeast rice ; Statins

刊名：Journal of Clinical Lipidology

出版年：2013

作者：B. Laverdet^a ; ¹ ; L. Micallef^a ; ¹ ; C. Lebreton^b ; J. Mollard^c ; J.-J. Lataillade^d ; B. Coulomb^e ; A. Desmouliè ; re^a ; ^{alexis.desmouliere@unilim.fr" class="auth_mail}

关键词：Mesenchymal stem cells ; Tissue repair ; (Myo)fibroblasts ; Reconstituted skin

刊名：Pathologie Biologie

出版年：April, 2014