TY - JOUR
T1 - Current challenges in biotherapeutic particles manufacturing
AU - Moleirinho, Mafalda G.
AU - Silva, Ricardo J.S.
AU - Alves, Paula M.
AU - Carrondo, Manuel J.T.
AU - Peixoto, Cristina
PY - 2019/1/1
Y1 - 2019/1/1
N2 - Introduction: The development of novel complex biotherapeutics led to new challenges in biopharmaceutical industry. The potential of these particles has been demonstrated by the approval of several products, in the different fields of gene therapy, oncolytic therapy, and tumor vaccines. However, their manufacturing still presents challenges related to the high dosages and purity required. Areas covered: The main challenges that biopharmaceutical industry faces today and the most recent developments in the manufacturing of different biotherapeutic particles are reported here. Several unit operations and downstream trains to purify virus, virus-like particles and extracellular vesicles are described. Innovations on the different purification steps are also highlighted with an eye on the implementation of continuous and integrated processes. Expert opinion: Manufacturing platforms that consist of a low number of unit operations, with higher-yielding processes and reduced costs will be highly appreciated by the industry. The pipeline of complex therapeutic particles is expanding and there is a clear need for advanced tools and manufacturing capacity. The use of single-use technologies, as well as continuous integrated operations, are gaining ground in the biopharmaceutical industry and should be supported by more accurate and faster analytical methods.
AB - Introduction: The development of novel complex biotherapeutics led to new challenges in biopharmaceutical industry. The potential of these particles has been demonstrated by the approval of several products, in the different fields of gene therapy, oncolytic therapy, and tumor vaccines. However, their manufacturing still presents challenges related to the high dosages and purity required. Areas covered: The main challenges that biopharmaceutical industry faces today and the most recent developments in the manufacturing of different biotherapeutic particles are reported here. Several unit operations and downstream trains to purify virus, virus-like particles and extracellular vesicles are described. Innovations on the different purification steps are also highlighted with an eye on the implementation of continuous and integrated processes. Expert opinion: Manufacturing platforms that consist of a low number of unit operations, with higher-yielding processes and reduced costs will be highly appreciated by the industry. The pipeline of complex therapeutic particles is expanding and there is a clear need for advanced tools and manufacturing capacity. The use of single-use technologies, as well as continuous integrated operations, are gaining ground in the biopharmaceutical industry and should be supported by more accurate and faster analytical methods.
KW - Extracellular vesicles
KW - gene-therapy
KW - manufacturing
KW - purification
KW - vaccines; viral vectors
KW - virus-like particles
UR - http://www.scopus.com/inward/record.url?scp=85076057453&partnerID=8YFLogxK
U2 - 10.1080/14712598.2020.1693541
DO - 10.1080/14712598.2020.1693541
M3 - Review article
C2 - 31773998
AN - SCOPUS:85076057453
SN - 1471-2598
JO - Expert Opinion on Biological Therapy
JF - Expert Opinion on Biological Therapy
ER -