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Current challenges in biotherapeutic particles manufacturing.

Mafalda G Moleirinho1,2, Ricardo J S Silva1, Paula M Alves1,2

  • 1IBET, Instituto de Biologia Experimental e Tecnológica, Apartado, Oeiras, Portugal.

Expert Opinion on Biological Therapy
|November 28, 2019
PubMed
Summary

Manufacturing complex biotherapeutics like viruses and extracellular vesicles faces challenges in dosage and purity. Innovations focus on integrated, continuous processes and advanced analytical methods for efficient production.

Keywords:
Extracellular vesiclesgene-therapymanufacturingpurificationvaccines; viral vectorsvirus-like particles

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Therapeutic Particle Production
  • Downstream Processing

Background:

  • The biopharmaceutical industry faces significant challenges in manufacturing complex biotherapeutics, including viruses, virus-like particles, and extracellular vesicles.
  • Despite demonstrated therapeutic potential in gene therapy, oncolytic therapy, and tumor vaccines, challenges persist in achieving high dosages and purity.
  • The expanding pipeline of complex therapeutic particles necessitates advanced manufacturing tools and capacity.

Purpose of the Study:

  • To review current challenges in biopharmaceutical manufacturing of therapeutic particles.
  • To highlight recent developments and innovations in downstream processing for virus, virus-like particles, and extracellular vesicles.
  • To discuss the implementation of continuous and integrated manufacturing processes.

Main Methods:

  • Review of current literature on biotherapeutic particle manufacturing.
  • Description of various unit operations and downstream trains for purification.
  • Analysis of innovations in purification steps, focusing on continuous and integrated approaches.

Main Results:

  • Identified key challenges in achieving high dosage and purity for complex biotherapeutics.
  • Described purification strategies for viruses, virus-like particles, and extracellular vesicles.
  • Highlighted innovations in purification, emphasizing continuous and integrated process implementation.

Conclusions:

  • The industry requires manufacturing platforms with fewer unit operations, higher yields, and reduced costs.
  • Advanced analytical methods are crucial to support continuous integrated operations and single-use technologies.
  • There is a clear need for enhanced manufacturing capacity and advanced tools to meet the growing demand for complex therapeutic particles.