Experimental validation of a parenteral permitted daily exposure value for cleaning-induced degradants from recombinant therapeutic proteins with in vitro immunogenicity assays.

Autor: Cohen JR; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States. Electronic address: jcohen02@amgen.com., Joubert MK; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States., Tabassum S; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States., Capili A; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States., Carreon J; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States., Xiang C; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States., Prabhu S; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States., Merlo A; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States., Mytych D; The Department of Clinical Immunology, Amgen Inc., Thousand Oaks, CA 91320, United States., Dolan DG; The Department of Environmental Health and Safety, Amgen Inc., Thousand Oaks, CA 91320, United States., Kouda R; The Department of Process Development, Amgen Inc., One Amgen Center Dr., Thousand Oaks, CA 91320, United States. Electronic address: rkouda@amgen.com.

Publikováno v: Journal of pharmaceutical sciences [J Pharm Sci] 2024 Oct 28. Date of Electronic Publication: 2024 Oct 28.

Assessment of the Immunogenicity Potential for Oligonucleotide-Based Drugs.

Autor: Henry SP; Ionis Pharmaceuticals, Inc., Carlsbad, California, USA., Arfvidsson C; Clinical Pharmacology & Safety Sciences, Astra Zeneca, Mölndal, Sweden., Arrington J; Arrowhead Pharmaceuticals, Pasadena, California, USA., Canadi J; F. Hoffmann-La Roche Ltd., Basel, Switzerland., Crowe D; Disc Medicine, Cambridge, Massachusetts, USA., Gupta S; Amgen, Thousand Oaks, California, USA., Lohmann S; Roche Pharma Research & Early Development, Roche Innovation Center Munich, Penzberg, Germany., Massonnet B; F. Hoffmann-La Roche Ltd., Basel, Switzerland., Mytych D; Amgen, Thousand Oaks, California, USA., Rogers T; SNBL USA, Everett, Washington, USA., Rogers H; CDER, FDA, Silver Spring, Maryland, USA., Stebbins C; ADC Therapeutics, San Mateo, California, USA., Stovold C; Astra Zeneca, Cambridge, United Kingdom., Verthelyi D; CDER, FDA, Silver Spring, Maryland, USA., Vigil A; Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany., Xuan C; Alnylam, Cambridge, Massachusetts, USA., Xu Y; Intellia Therapeutics, Cambridge, Massachusetts, USA., Yu R; Ionis Pharmaceuticals, Inc., Carlsbad, California, USA., Klem T; Homology Medicines, Bedford, Massachusetts, USA (formerly with Sarepta Therapeutics Headquarters, Cambridge, Massachusetts, USA).

Publikováno v: Nucleic acid therapeutics [Nucleic Acid Ther] 2022 Oct; Vol. 32 (5), pp. 369-377. Date of Electronic Publication: 2022 Sep 29.

Treatment Persistence and Switching Patterns of Adalimumab Biosimilar ABP 501 in European Patients with Rheumatologic Diseases.

Autor: Jin, Ran¹ (AUTHOR) rjin01@amgen.com, Kruppert, Silvia² (AUTHOR), Scholz, Florian² (AUTHOR), Bardoulat, Isabelle³ (AUTHOR), Karzazi, Khalil³ (AUTHOR), Morand, Francois³ (AUTHOR), Kricorian, Greg¹ (AUTHOR), Collier, David¹ (AUTHOR), Kay, Jonathan⁴ (AUTHOR)

Publikováno v: Rheumatology & Therapy. Jun2024, Vol. 11 Issue 3, p523-537. 15p.

P815: PHARMACOKINETIC AND PHARMACODYNAMIC SIMILARITY OF ABP 959 AND ECULIZUMAB REFERENCE PRODUCT: UNBOUND ECULIZUMAB AND CH50 FROM THE RANDOMIZED, DOUBLE‐BLIND, SINGLE‐DOSE STUDY IN HEALTHY VOLUNTEERS.

Autor: Hanes, V., Pan, J., Mytych, D., Chow, V.

Publikováno v: HemaSphere; 2022 Supplement 3, Vol. 6, p709-710, 2p

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