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Challenges for Cell-Based Medicinal Products From a Pharmaceutical Product Perspective
Dhananjay Jere1, Ahmad S Sediq1, Jörg Huwyler2
1Drug Product Services, Lonza AG, Hochbergerstrasse 60G, 4057 Basel, Switzerland.
Journal of Pharmaceutical Sciences
|December 11, 2020
Summary
This review addresses challenges in developing and manufacturing cell-therapy medicinal products (CBMPs). It highlights issues with product quality, stability, and particulate contamination, crucial for patient safety.
Area of Science:
- Pharmaceutical Sciences
- Biotechnology
- Regenerative Medicine
Background:
- Advanced therapy medicinal products (ATMPs) show promise for treating intractable diseases.
- Cell-therapy medicinal products (CBMPs) face unique stability and quality challenges due to their cellular nature.
- Parenteral preparations of CBMPs require careful consideration of drug product aspects.
Purpose of the Study:
- To review open questions and problems in the development, manufacturing, and testing of CBMPs.
- To discuss pharmaceutical drug product considerations for CBMPs.
- To highlight challenges related to safety, storage, handling, particulates, and container closure systems.
Main Methods:
- Literature review focusing on pharmaceutical development of CBMPs.
- Analysis of quality attributes and analytical methods for CBMPs.
- Discussion of challenges in particulate detection and control.
Main Results:
- CBMPs present significant stability and quality issues impacting their therapeutic potential.
- Particulate contamination is a critical concern as CBMPs cannot be sterile filtered.
- Existing analytical methods may not be suitable for detecting particulates in CBMPs due to their inherent nature.
Conclusions:
- Addressing development, manufacturing, and testing challenges is vital for safe and effective CBMPs.
- Robust analytical strategies are needed to ensure the quality and safety of CBMPs, particularly regarding particulates.
- Further research into suitable analytical methods for particulate analysis in CBMPs is essential.
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