End-to-end donor screening and manufacturing controls: complementary quality-based strategies to minimize patient risk for donor-derived microbiome therapeutics.

Autor: Goldsmith J; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA., Tomkovich S; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA., Auniņš JG; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA., McGovern BH; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA., Mahoney JC; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA., Hasson BR; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA., McChalicher CWJ; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA., Ege DS; Product Development, Quality, and Supply (PDQS), Seres Therapeutics, Inc., Cambridge, MA, USA.

Publikováno v: Gut microbes [Gut Microbes] 2024 Jan-Dec; Vol. 16 (1), pp. 2402550. Date of Electronic Publication: 2024 Sep 18.

SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection.

Autor: Feuerstadt P; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Louie TJ; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Lashner B; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Wang EEL; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Diao L; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Bryant JA; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Sims M; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Kraft CS; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Cohen SH; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Berenson CS; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Korman LY; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Ford CB; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Litcofsky KD; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Lombardo MJ; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Wortman JR; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Wu H; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Auniņš JG; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., McChalicher CWJ; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Winkler JA; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., McGovern BH; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Trucksis M; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., Henn MR; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.)., von Moltke L; From Yale University School of Medicine, New Haven, and PACT Gastroenterology Center, Hamden - both in Connecticut (P.F.); the University of Calgary and Foothills Medical Centre, Calgary, AB, Canada (T.J.L.); Cleveland Clinic, Cleveland (B.L.); Seres Therapeutics, Cambridge, MA (E.E.L.W., L.D., J.A.B., C.B.F., M.-J.L., K.D.L., J.R.W., H.W., J.G.A., C.W.J.M., J.A.W., B.H.M., M.T., M.R.H., L.M.); Beaumont Hospital, Royal Oak, Royal Oak, and Oakland University William Beaumont School of Medicine, Rochester - both in Michigan (M.S.); Emory University, Atlanta (C.S.K.); the University of California, Davis, Davis (S.H.C.); the University at Buffalo and Veterans Affairs Western New York Healthcare System - both in Buffalo (C.S.B.); and Capital Digestive Care, Washington, DC (L.Y.K.).

Publikováno v: The New England journal of medicine [N Engl J Med] 2022 Jan 20; Vol. 386 (3), pp. 220-229.