Plant Molecular Farming (PMF) is an innovative biotechnological approach that employs genetically modified plants to produce high-value compounds, such as pharmaceuticals,

Chapter 1. Introduction

Background of Study

Plant Molecular Farming (PMF) is an innovative biotechnological approach that employs genetically modified plants to produce high-value compounds, such as pharmaceuticals, vaccines, and industrial enzymes. This technology provides a cost-effective, scalable, and sustainable alternative to traditional biomanufacturing methods. PMF holds the potential to revolutionize the pharmaceutical industry by enabling localized production, reducing reliance on traditional manufacturing hubs, and lowering production costs.

Globally, PMF has achieved significant advancements in both high-income countries (HICs) and lower- and middle-income countries (LMICs). For example, Protalix Biotherapeutics in Israel and iBio in the USA have successfully developed plant-based therapeutic proteins. In the UK, Leaf Expression Systems, and in Canada, Medicago, have pioneered PMF for vaccine production. Likewise, LMICs such as South Africa’s Cape BioPharms and Thailand’s Baiya Phytofarms have showcased the viability of PMF in diverse economic settings, demonstrating its adaptability and potential for global health impact.

Consider including a table summarizing the companies, their active PMFs, products, and current regulatory statuses.

Malaysia, with its robust agricultural sector and emerging biotechnology industry, is well-positioned to adopt and advance PMF. However, the regulatory framework governing PMF in Malaysia is still evolving, presenting both opportunities and challenges. Developing comprehensive regulatory perspectives is essential for the safe, efficient, and sustainable implementation of PMF in the Malaysian context.

2. Literature Review

Regulatory Acts and Guidelines for PMF

• Biosafety Act
• Good Agricultural Practices (GAP)
• Good Manufacturing Practices (GMP)
• Additional regulatory measures specific to PMF applications (to be elaborated).

Global Advancements in PMF

PMF has gained attention for its ability to produce recombinant proteins in plants for various applications, including therapeutic proteins and vaccines. For example, Protalix Biotherapeutics has commercialized taliglucerase alfa, a treatment for Gaucher disease, using carrot cells. iBio in the USA has developed plant-based influenza vaccines, demonstrating PMF`s scalability and rapid production capabilities.

Regulatory Frameworks in High-Income Countries

HICs have established robust regulatory systems to oversee PMF. For instance:

• Leaf Expression Systems (UK): Operates under stringent EU regulations to ensure biosafety and efficacy.
• Medicago (Canada): Collaborates with Health Canada to meet regulatory requirements for its COVID-19 vaccine.

PMF in Lower- and Middle-Income Countries

LMICs have successfully adapted PMF to address local health needs. For example:

• Cape BioPharms (South Africa): Focuses on affordable vaccine production.
• Baiya Phytofarms (Thailand): Produces plant-based biopharmaceuticals targeting regional health issues.

Regulatory Challenges

The regulatory complexity of PMF arises from the need to address:

• Biosafety
• Environmental impact
• Intellectual property (IP) rights
• Public health standards

Studies by Sparrow et al. (2013) and Ma et al. (2020) highlight the necessity of adaptable frameworks that promote innovation while ensuring safety and compliance.

Malaysia’s Regulatory Landscape

Malaysian regulations for GMOs, governed by the Ministry of Health and the Department of Agriculture, currently lack specific provisions for PMF. While BiotechCorp Malaysia provides general GMO policies, detailed guidelines for PMF remain underdeveloped.

Gap in Literature

Existing research primarily focuses on GMO regulations, leaving a gap in understanding the specific regulatory needs for PMF in Malaysia. This study aims to bridge this gap by analyzing the regulatory landscape and providing targeted recommendations.

3. Problem Statement

Despite its potential, Malaysia’s regulatory framework is insufficient to address the unique requirements of PMF. Existing GMO regulations are too broad to address the biosafety, environmental, and commercial considerations of PMF. This ambiguity hampers innovation, public health safety, and economic growth opportunities.

4. Significance of Study

1. Policy Development: Provides evidence-based recommendations for a comprehensive PMF regulatory framework.
2. Economic Impact: Attracts investments, fosters industry growth, and creates high-skilled jobs.
3. Public Health: Enhances healthcare capabilities through affordable local production of vaccines and therapeutics.
4. Environmental Sustainability: Ensures biosafety and sustainable agricultural practices.
5. Global Competitiveness: Aligns regulations with international standards, facilitating trade and collaboration.

5. Objectives

1. Analyze Malaysia’s existing GMO regulatory framework and its applicability to PMF.
2. Identify key regulatory gaps and challenges specific to PMF.
3. Propose a comprehensive PMF regulatory model aligned with international standards.
4. Assess stakeholder perspectives on PMF regulation in Malaysia.
5. Develop policy recommendations to balance innovation, biosafety, and public health.

6. Research Questions

1. What are the existing regulatory frameworks for GMOs in Malaysia, and how do they apply to PMF?
2. What regulatory gaps hinder the development of PMF in Malaysia?
3. How can Malaysia develop a PMF-specific regulatory framework that aligns with international standards?
4. What are stakeholder perspectives on PMF regulation in Malaysia?
5. How can Malaysia balance innovation, biosafety, and public health within its PMF framework?