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Automation to guide technology shift in aseptic environments

European Pharmaceutical Review

Recently, the European Medicines Agency (EMA) took the lead in pushing for process improvements using technologies already established in other manufacturing sectors. Significance of Annex 1–2022 for implementing Pharma 4.0 One of these key technologies is automation, a recent paper explained. Tanzini et al.

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Single-use technology propelling upstream bioprocessing market expansion

European Pharmaceutical Review

percent between 2022 and 2029. The rising productivity of cell lines has improved the performance of upstream processing with low cost and high process reproducibility, the report explained. A report from Data Bridge Market Research has predicted that the upstream bioprocessing market will value $14,256.78

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Leveraging Data for Predictive & Real-time Bioprocess Performance Improvements

BioPharm

Thu, Sep 8, 2022 11am EST | 8am PST | 4pm BST | 5pm CEST Digitalization & leveraging real-time data are key for biopharma process improvement. Insilico models and soft-sensors boost biopharma performance to unprecedented levels.

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Avoid CMC Challenges by Thinking Slow, Not Fast-Discussions at USP’s Workshop

The FDA Law Blog

Brevig, Senior Regulatory Device and Biologics Expert — On October 26, 2022, US Pharmacopeia (USP) Biologics Stakeholder Forum held a workshop on “Collaborating to solve CMC challenges and support efficient development of lentiviral-mediated CART cell therapies.” By Holly N. Release testing alone is not sufficient.

FDA 59
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Doctoral Capstone Presentations

Blog: Ask a Student Pharmacist

FAQs for sites that provide OT services FAQs for Community Sites with No OT services Capstone Presentations 2023 Expand all + Research Focused Experience Studying the Reliability and Precision of the Intermetacarpal Distance Method in Persons with Thumb Osteoarthritis Research_ Test-Retest Reliability of the GripAble Device Interrater Reliability Measures (..)

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Consistent Measurements from Lab-to-Process Improve Production

ISPE

Consistent Measurements from Lab-to-Process Improve Production. Sat, 10/01/2022 - 06:00. Consistent Measurements from Lab-to-Process Improve Production. 1 October 2022. Trudy Patterson. Sponsored Content. Smooth scale-up requires the use of similar measurement technologies from the lab to full production.

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Oligonucleotides: A Cornerstone for Therapeutics & More

ISPE

Thu, 10/27/2022 - 14:16. November / December 2022. 1 November 2022. In this article, we’ll explore some innovations and improvement opportunities in the science, manufacturing processes, and facilities that produce these therapies. 2 (February 2022): 260. 10 (10 June 2022): 5443–66. Trudy Patterson.