Application of machine learning methods to pathogen safety evaluation in biological manufacturing processes

Author:

Panjwani Shyam1ORCID,Cui Ivan1,Spetsieris Konstantinos1,Mleczko Michal1,Wang Wensheng2,Zou June X.2,Anwaruzzaman Mohammad2,Liu Shawn2,Canales Roger3,Hesse Oliver4

Affiliation:

1. Engineering & Technology Bayer Pharmaceuticals Berkeley California USA

2. Pharma Biotech ‐ Pathogen Safety Bayer Pharmaceuticals Berkeley California USA

3. Bayer Business Services ‐ Pharma R&D ITO Bayer Pharmaceuticals Berkeley California USA

4. Pharma Biotech ‐ Lab Automation & Data Management Bayer Pharmaceuticals Berkeley California USA

Publisher

Wiley

Subject

Biotechnology

Reference21 articles.

1. Proceedings of the 2017 Viral Clearance Symposium, Session 4: Submission Strategies

2. GalbraithD.ICH Q5A. ICH Quality Guidelines 2017. 311‐335.https://onlinelibrary.wiley.com/doi/abs/10.1002/9781118971147.ch10

3. ASTM E2888‐12 Standard Practice for Process for Inactivation of Rodent Retrovirus by pH. West Conshohocken PA2012.

4. PAT — a framework for innovative pharmaceutical development manufacturing and quality assurance In: FDA ed2004.

5. Q8(R2) pharmaceutical development. In: FDA ed2009.

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