Recent advances to accelerate purification process development: A review with a focus on vaccines

Area of Science:

• Biopharmaceutical process development
• Vaccine purification technologies

Background:

• Vaccine development requires stringent safety standards, making it time-consuming and expensive.
• Reducing time-to-market for vaccines is crucial for public health and economic reasons.
• Systematic and efficient process development strategies are needed to accelerate vaccine production.

Purpose of the Study:

• To review downstream process development strategies for (bio)pharmaceutical vaccine purification.
• To discuss and compare high throughput process development (HTPD) and combinatorial approaches.
• To highlight the role of novel modeling tools and artificial intelligence (AI) in process understanding.

Main Methods:

• Review of existing literature on downstream process development in the (bio)pharmaceutical industry.
• Focus on strategies applied to (protein subunit) vaccine purification.
• Discussion of high throughput technologies, statistical and mechanistic modeling, and AI.

Main Results:

• High throughput process development (HTPD), especially model-based HTPD, enables faster screening and increased knowledge.
• Chromatography is a key separation technique in achieving high purity for vaccines.
• Novel modeling tools and AI are increasingly important for data analysis and process understanding.

Conclusions:

• Accelerated process development through HTPD and combinatorial approaches can reduce vaccine time-to-market.
• Advanced modeling and AI are essential for extracting deeper insights from complex process data.
• Optimized downstream processing is critical for efficient and cost-effective vaccine manufacturing.