Implementation of chemometrics, design of experiments, and neural network analysis for prior process knowledge assessment, failure modes and effect analysis, scale‐down model development, and process characterization for a chromatographic purification of <scp>Teriparatide</scp>-Reference-Cited by-同舟云学术

Implementation of chemometrics, design of experiments, and neural network analysis for prior process knowledge assessment, failure modes and effect analysis, scale‐down model development, and process characterization for a chromatographic purification of Teriparatide

Published:2022-04-07 Issue:3 Volume:38 Page:
ISSN:8756-7938
Container-title:Biotechnology Progress
language:en
Short-container-title:Biotechnology Progress

Author:

Pathak Mili¹^ORCID,Pokhriyal Prashant¹^ORCID,Gandhi Irshad¹,Khambhampaty Sridevi¹

Affiliation:

1. R&D, Intas Pharmaceuticals Ltd. (Biopharma Division) Ahmedabad Gujarat India

Publisher

Wiley

Subject

Biotechnology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/btpr.3252

Reference41 articles.

1. Quality attributes of recombinant therapeutic proteins: An assessment of impact on safety and efficacy as part of a quality by design development approach

2. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Pharmaceutical development. Q8 (2R) As revised in August;2009.

3. Quality by design – a review;Kengar M;PharmaTutor,2019

4. FDA Draft Guidance Process Validation: General Principles and Practices;2008.

5. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8 (R2).2009.

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