Accelerated <scp>CMC</scp> workflows to enable speed to clinic in the <scp>COVID</scp> ‐19 era: A multi‐company view from the biopharmaceutical industry-Reference-Cited by-同舟云学术

Accelerated CMC workflows to enable speed to clinic in the COVID ‐19 era: A multi‐company view from the biopharmaceutical industry

Published:2023-01-20 Issue:2 Volume:39 Page:
ISSN:8756-7938
Container-title:Biotechnology Progress
language:en
Short-container-title:Biotechnology Progress

Author:

Higgins Matthew F.¹,Abu‐Absi Nicholas²,Gontarz Elena³,Gorr Ingo H.⁴,Kaiser Klaus⁵,Patel Pramthesh⁶,Ritacco Frank³,Sheehy Patrick⁷,Thangaraj Balakumar⁸,Gill Tony¹

Affiliation:

1. BioPhorum Development Group London United Kingdom

2. AbbVie Bioresearch Center Worcester MA USA

3. Thermo Fisher Pharma Services St Louis USA

4. Therapeutic Virus Development Boehringer Ingelheim Pharma GmbH & Co. KG Germany

5. Bayer AG Germany

6. GlaxoSmithKline Philadelphia USA

7. Janssen Pharmaceuticals, Inc. Malvern USA

8. Catalent Pharma Solutions Madison USA

Publisher

Wiley

Subject

Biotechnology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/btpr.3321

Reference12 articles.

1. Enabling speed to clinic for monoclonal antibody programs using a pool of clones for IND-enabling toxicity studies

2. Accelerated Preclinical Paths to Support Rapid Development of COVID-19 Therapeutics

3. Developing therapeutic monoclonal antibodies at pandemic pace

4. US Congressional Budget Office.Research and Development in the Pharmaceutical Industry. 2021. Accessed 30/09/2022. Available at:https://www.cbo.gov/publication/57126.

5. A roadmap to AI-driven in silico process development: bioprocessing 4.0 in practice

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