Related Experiment Video
Updated: May 6, 2026
10:16
Transient Expression in Red Beet of a Biopharmaceutical Candidate Vaccine for Type-1 Diabetes
Published on: March 19, 2019
7.2K
Beyond Side Effect: Immuno-Ethical Risk Analysis of Animal-Derived Ingredients in Pharmaceuticals
Yedi Herdiana1, Dolih Gozali1, Norisca Aliza Putriana1
1Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia.
Risk Management and Healthcare Policy
|March 4, 2026
Summary
Animal-derived ingredients in drugs pose risks like alpha-gal syndrome (AGS) and ethical conflicts. Developing animal-free alternatives (AFAs) is crucial, but challenges in scalability and cost remain for wider adoption.
Area of Science:
- Biomedical Science
- Pharmaceutical Science
- Bioethics
Background:
- Animal-derived ingredients (ADIs) constitute a significant portion of prescription drugs, presenting risks such as alpha-gal syndrome (AGS), ethical-religious concerns, and supply chain opacity.
- The reliance on ADIs necessitates a thorough evaluation and the promotion of animal-free alternatives (AFAs) in pharmaceutical development.
Purpose of the Study:
- To critically review the persistence of ADIs in pharmaceuticals.
- To analyze the risks associated with ADIs, including biological (e.g., AGS) and religious (e.g., Halal) factors.
- To evaluate the progress and challenges of developing and implementing AFAs.
Main Methods:
- A comprehensive literature review synthesizing evidence from biomedical, regulatory, and ethical domains.
- Development of a dual risk stratification framework integrating immunological profiles (galactose-α-1,3-galactose epitope) and Halal jurisprudential criteria.
- Assessment of existing AFAs (plant-based, recombinant, synthetic) and supporting regulatory initiatives.
Main Results:
- ADIs remain prevalent due to their functional, regulatory, and biocompatibility benefits in medical products.
- A dual risk framework effectively categorizes pharmaceutical ingredients based on immunological and religious criteria.
- While AFAs are advancing, significant hurdles in scalability, cost-effectiveness, and bioequivalence persist.
Conclusions:
- The transition to AFAs is essential for patient safety, ethical considerations, and supply chain transparency.
- Overcoming challenges in AFA development and implementation requires a unified scientific, ethical, and religious framework.
- Accelerating the adoption of safe, inclusive AFAs is critical for patient autonomy and well-being.
Related Concept Videos
01:28Preclinical Development: Overview
4.8K
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...
4.8K
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
631
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
631
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
252
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
252
01:28Drug Products: Biologics, Biosimilars and Interchangeables
371
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...
371
01:19Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence
242
Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
242
01:23Toxicity Testing in Animals
222
Toxicity tests in animals are grounded on two main assumptions: first, the effects observed in laboratory animals can be extrapolated to humans, especially when adjusted for body surface area; second, high-dose exposure in animals is essential to identify potential human hazards from lower doses. This is based on the quantal dose-response concept, which faces the challenge of extrapolating results from relatively few test animals to much larger human populations. For example, a 0.01% incidence...
222