Perspectives

What are the most significant manufacturing hurdles in biopharma and how can they be addressed?

Jun. 30, 2025

What are the most significant manufacturing hurdles in biopharma and how can they be addressed?

In June Pharma’s Almanac roundtables, Dr. Wei Guo, Senior Vice President, Head of Global Manufacturing, WuXi Biologics, shared her insights on manufacturing hurdles in biopharma and how they can be addressed. Learn more, click here.

From the perspective of a contract research, development, and manufacturing organization (CRDMO), the biopharma industry faces three significant challenges in scaling from lab to market: process scalability, regulatory complexity, and supply chain resilience.

Scalability: Scaling up from small-scale to commercial production risks process drift, impacting product quality. Solutions including continuous manufacturing and process intensification (e.g., high-density cell cultures) reduce scale-up timelines while maintaining consistency. By combining the benefits of single-use technology with a scale-out strategy (increasing the number of bioreactors used in parallel), WuXi Biologics can effectively address scale-up risks, enabling rapid growth that aligns directly with demand, while also supporting emergency production and accommodating various process types.

Regulatory agility: The emerging modalities and delivery systems, such as antibody–drug conjugates (ADCs) and autoinjectors, impose new demands for specialized expertise and GMP adherence. To navigate these complexities, companies must proactively build interdisciplinary teams to accumulate institutional knowledge, ideally established early in development cycles to ensure seamless integration of quality systems and regulatory alignment.

Supply chain vulnerabilities: Geopolitical disruptions pose uncertainty and threaten timelines. Diversifying suppliers with different priorities in speed and cost for the initial and secondary launch can be helpful. With facilities in Ireland, Germany, the United States, Singapore, and China, we offer our global clients access to a reliable and premier-quality global supply chain network. By implementing a global dual sourcing strategy, WuXi Biologics ensures that materials can be sourced and products can be manufactured at multiple locations across the world.

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