Downstream Processing Technologies/Capturing and Final Purification : Opportunities for Innovation, Change, and...

Area of Science:

• Biopharmaceutical Manufacturing
• Protein Purification
• Downstream Processing (DSP)

Background:

• Upstream process optimization has shifted the bottleneck to purification, increasing manufacturing costs.
• Economical drivers necessitate debottlenecking downstream processes for efficient biomanufacturing.

Purpose of the Study:

• To review traditional and emerging protein purification strategies for recombinant biopharmaceuticals.
• To address innovations and challenges in downstream processing, focusing on antibodies.
• To discuss integrated upstream/downstream processing (USP/DSP) strategies and enabling technologies.

Main Methods:

• Review of chromatographic and non-chromatographic separation techniques.
• Analysis of integrated continuous processing strategies.
• Evaluation of automation, high-throughput screening (HTS), design of experiments (DOE), and modeling/simulation in DSP.

Main Results:

• Significant innovations exist in protein purification, including multi-modal chromatography and single-use technologies.
• Integrated USP/DSP strategies and advanced analytics (HTS, DOE) enhance process understanding and efficiency.
• Emerging trends like 3D printing and nanotechnology offer future potential for DSP optimization.

Conclusions:

• Holistically efficient and economical downstream processing remains a key challenge in biopharmaceutical production.
• Adoption of advanced technologies and integrated strategies is crucial for overcoming DSP bottlenecks.
• Continuous innovation in purification methods is vital for the future growth of the biopharmaceutical industry.