The new line, planned to start operation in April 2021, is the New Jersey-based CMDO’s third major investment at the site in the past two years, In particular, this will help it cope with an increasing backlog of business as it helps major vaccine manufacturers to scale up production of Covid-19 candidates.

When the installation is complete, Bloomington will have high-speed filling capacity across three vial lines, two syringe lines and a flexible line capable of filling vials, syringes, or cartridges. The US Midwest site, the company said, has “deep expertise” in sterile formulation, with drug substance development and manufacturing and drug product fill-finish capacity, including primary and secondary packaging.

With capacity to produce up to 80 million vials annually under barrier isolator technology and a peristaltic pump filling mechanism, the newest production line is consistent with current good manufacturing practice (CGMP) regulations.

Due to the company’s “considerable experience” in facility and capacity expansions, Catalent said it was able to cut the overall realization time for the project from a typical 18-month timeframe to around  10 months in total, including construction, procurement, installation and CGMP qualification of the new line.

 “The industry has seen an increased demand for vial filling of biologic drugs, which has been compounded by the accelerated development of vaccine and therapeutic candidates to address the COVID-19 pandemic,” said Mike Riley, Catalent’s region president, Biologics, North America. “Continued investment in this capacity will allow us to remain flexible and continue to support the growth of our customers’ programs.”

In late August, Catalent Cell & Gene Therapy, part of the Catalent Biologics network, signed on to provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate, known as AZD1222, from its gene therapy facility in Harmans, Maryland, USA.

The CDMO also has contracts with other potential Covid vaccine makers that have candidates in clinical trials. One of its earliest supply agreements was with Johnson & Johnson (J&J) in April to support the US healthcare giant from its Bloomington site. Catalent is also supporting J&J’s vaccine fill-finish and packaging efforts from its site in Anagni, Italy.

In June, the New Jersey company agreed a collaboration with US biotech Moderna for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based Covid-19 vaccine candidate at Bloomington.

Author: Dede Williams, Freelance Journalist