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Applying UHPLC-HRAM MS/MS Method to Assess Host Cell Protein Clearance during the Purification Process Development of Therapeutic mAbs.

• Authors : Kiyonami, Reiko¹ (AUTHOR) ; Melani, Rafael² (AUTHOR) ; Chen, Ying³ (AUTHOR)

Subjects: *ION exchange resins; *GREEN business; *MONOCLONAL antibodies

• Source: International Journal of Molecular Sciences. Sep2024, Vol. 25 Issue 17, p9687. 11p.

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Process development and quality attributes for the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanomedicine delivery: a state-of-the-art review.

• Authors : Pardeshi, Sagar R.¹ (AUTHOR); Deshmukh, Nilesh S.² (AUTHOR); Telange, Darshan R.³ (AUTHOR)

• Source: Future Journal of Pharmaceutical Sciences. 11/7/2023, Vol. 9 Issue 1, p1-31. 31p.

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Application of inline variable pathlength technology for rapid determination of dynamic binding capacity in downstream process development of biopharmaceuticals.

• Authors : Bhangale, Rashmi P.¹ (AUTHOR) ; Ye, Rui¹ (AUTHOR); Lindsey, Thomas B.¹ (AUTHOR)

Subjects: *PROCESS capability; *BIOPHARMACEUTICS; *CHIMERIC proteins

• Source: Biotechnology Progress. Mar2022, Vol. 38 Issue 2, p1-9. 9p.

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Process development in the QbD paradigm: Role of process integration in process optimization for production of biotherapeutics.

• Authors : Rathore AS; Dept. of Chemical Engineering, Indian Institute of Technology, Hauz Khas, New Delhi, India.; Pathak M

Subjects: Biopharmaceutics*; Granulocyte Colony-Stimulating Factor/Granulocyte Colony-Stimulating Factor/Granulocyte Colony-Stimulating Factor/*biosynthesis; Chromatography, High Pressure Liquid

• Source: Biotechnology progress [Biotechnol Prog] 2016 Mar; Vol. 32 (2), pp. 355-62. Date of Electronic Publication: 2015 Dec 07.Publisher: Wiley-Blackwell Country of Publication: United States NLM ID: 8506292 Publication Model: Print-Electronic Cited Medium: Internet ISSN:

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Exploiting mAb structure characteristics for a directed QbD implementation in early process development.

• Authors : Karlberg, Micael¹; von Stosch, Moritz¹; Glassey, Jarka¹

Subjects: *BIOPHARMACEUTICS; *MONOCLONAL antibodies; *PRODUCT quality

• Source: Critical Reviews in Biotechnology. Sep2018, Vol. 38 Issue 6, p957-970. 14p.

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Characterization of TAP Ambr 250 disposable bioreactors, as a reliable scale-down model for biologics process development.

• Authors : Xu, Ping¹; Clark, Colleen¹; Ryder, Todd¹

Subjects: *BIOLOGICALS; *BIOREACTORS; *CELL growth

• Source: Biotechnology Progress. Mar/Apr2017, Vol. 33 Issue 2, p478-489. 12p.

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Optimization-based framework for resin selection strategies in biopharmaceutical purification process development.

• Authors : Liu, Songsong^1,2,3; Gerontas, Spyridon¹; Gruber, David⁴

Subjects: *GUMS & resins; *PLANT exudates; *SEPARATION (Technology)

• Source: Biotechnology Progress. Jul/Aug2017, Vol. 33 Issue 4, p1116-1126. 11p.

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Downstream process development strategies for effective bioprocesses: Trends, progress, and combinatorial approaches.

• Authors : Baumann, Pascal¹ ; Hubbuch, Jürgen¹

• Source: Engineering in Life Sciences. Nov2017, Vol. 17 Issue 11, p1142-1158. 17p.

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Strategic assay deployment as a method for countering analytical bottlenecks in high throughput process development: Case studies in ion exchange chromatography.

• Authors : Konstantinidis, Spyridon¹; Heldin, Eva²; Chhatre, Sunil¹

Subjects: *ION exchange chromatography; *BIOPHARMACEUTICS; *FACTORIAL experiment designs

• Source: Biotechnology Progress. Sep2012, Vol. 28 Issue 5, p1292-1302. 11p. 1 Diagram, 5 Charts, 3 Graphs.

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Use of uniform designs in combination with neural networks for viral infection process development.

• Authors : Buenno, Laís Hara¹; Rocha, José Celso¹; Leme, Jaci²

Subjects: *ARTIFICIAL neural networks; *VIRUS diseases; *RABIES

• Source: Biotechnology Progress. Mar2015, Vol. 31 Issue 2, p532-540. 9p.

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