Related Experiment Video
Updated: Dec 2, 2025
09:44
Author Spotlight: Advancing Cell Therapy Manufacturing with Dissolvable Microcarriers
Published on: July 7, 2023
4.5K
Developing cell therapies as drug products.
Rachele Ciccocioppo1, Patrizia Comoli2, Giuseppe Astori3
1Gastroenterology Unit, Department of Medicine, A.O.U.I. Policlinico G.B. Rossi & University of Verona, Verona, Italy.
British Journal of Pharmacology
|November 3, 2020
Summary
Advanced therapy medicinal products, including cell-based therapies, offer new hope for treating serious diseases like cancer. While over 50 products are authorized, challenges remain in developing these innovative cellular treatments.
Area of Science:
- Biomedical Science
- Regenerative Medicine
- Immunology
Background:
- Global regulatory frameworks have evolved over 20 years to address challenges in assessing cellular products as therapeutics.
- Advanced Therapy Medicinal Products (ATMPs) encompass diverse cell types, often combined with gene and tissue engineering.
- These therapies hold potential for treating severe conditions like cancers, infections, and inflammatory diseases.
Purpose of the Study:
- To provide an overview of the advantages and challenges in developing cell-based therapies.
- To discuss key players and the legal framework governing cell therapies.
- To highlight specific cell types and their therapeutic applications.
Main Methods:
- Literature review and analysis of regulatory frameworks.
- Examination of market-authorized cell-based products.
- Discussion of specific cell therapy examples and their mechanisms.
Main Results:
- Over 50 cell-based products have achieved market authorization globally.
- Chimeric antigen receptor T-cells are used for leukemia and solid tumors.
- Lymphocytes show potential as antimicrobial agents, and mesenchymal stem/stromal cells are relevant in regenerative medicine, immunology, and oncology.
Conclusions:
- Cell-based therapies represent a significant advancement in medicine, with growing regulatory acceptance and therapeutic success.
- Ongoing research and development are crucial to overcome remaining challenges and expand the application of these innovative treatments.
- The diverse applications of cell therapies, from oncology to regenerative medicine, underscore their transformative potential.
Related Concept Videos
01:28Preclinical Development: Overview
5.6K
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
5.6K
01:11Clinical Trials: Overview
4.3K
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
4.3K
01:28Drug Products: Biologics, Biosimilars and Interchangeables
138
Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
138
01:29Clinically Relevant Drug Product Specifications: Methods of Establishment
96
Product specifications define the acceptable quality of a pharmaceutical product by ensuring identity, purity, potency, and strength. These specifications serve as benchmarks during development, manufacturing, and post-approval quality control. Clinically relevant specifications are particularly important because they directly relate to a drug's safety and efficacy in clinical use.Dissolution studies are critical biopharmaceutic tools that link in vitro behavior to in vivo performance. They...
96
01:26Drug Discovery: Overview
10.6K
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
10.6K
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
114
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
114