Europe’s Biologic Manufacturing Capacity Shows Potential, According to CPhI Report

The second part of CPhI’s annual report has projected that the biologic manufacturing capacity of Europe will exceed that of the United States by 2023, as a result of the rising number of commercially approved biologics.

Looking at the near- and medium-term trends in the industry, Dawn Ecker (director of bioTRAK Database Services with BioProcess Technology Group) and Emil W. Ciurczak (president of Doramaxx Consulting) forecast the ability of the biologics industry to meet and keep pace with manufacturing capacity requirements. Additionally, Ecker and Ciurczak evaluate quality control in bio, particularly focusing on critical quality attributes in biosimilars.

Through an analysis of the global biopharma industry’s production, Ecker projects that over the next four years, Europe will have increased its biologics manufacturing capacity by 15%. Additionally, Asia is expected to experience substantial growth to the year 2023, with key drivers of the growth in both regions being slated as government initiatives and tax incentives, which have been seen in countries such as Ireland, Singapore, and South Korea.

“Our analysis shows the 2018 mammalian cell culture supply to be nearly 4400 kL and we predict it will grow to nearly 6400 kL by 2023, a five-year growth rate of 8%,” said Ecker in a press release about the report on Oct. 29, 2019. “Currently, product companies control over 70% of the installed mammalian cell culture capacity, but this is predicted to drop to 65% by 2023, with CMO capacity increasing 6%, and hybrid companies increasing 1%, respectively.”

Biosimilars are also anticipated to be a driver for future capacity demand, according to the analysis discussed in the report and explored by Ciurczak. Particularly, Ciurczak has noted in the report that there is a potentially accentuated risk of hazardous side products in biosimilar production, as a result of unknown proteins.

“All impurities in APIs are critical, but with biological impurities (often proteins, not seen previously), the stakes are potentially higher. Not only are there potential long-term carcinogenicity and mutagenicity dangers, but, with unknown proteins, there are also potential immediate allergic reactions,” stated Ciurczak in the press release. “Long-term use of bio-drugs, such as insulin, which could be used for decades, could be of high risk without proper quality control, as even the smallest impurity could do harm to the patient over these extended periods of time.”

In his prediction for the future, Ciurczak revealed that he expects regulatory harmonization in the assessment of CQAs for biologics. The common goal of this harmonization in Ciurczak’s opinion will be to expedite production time and the resultant time-to-market.

“Our experts suggest that biologics manufacturing is evolving in conjunction with the development of new and exciting bio-products, which we hope will be of fantastic benefit to sufferers of rare diseases,” commented CPhI brand director Europe, Orhan Caglayan, in the press release. “These findings are particularly striking given the introduction of the BioProduction Congress at this year’s event, which will concentrate on the manufacturing and processing of biopharmaceuticals.” 

Source: CPhI