The contract development and manufacturing organisation (CDMO) has added a Bosch ARF 1020 filling machine, and a Seidenader visual inspection station and automatic labelling machine at its Cuxhaven, Germany manufacturing facility. The firm will now be able to fill 7,200 vials per hour with a maximum validated batch size for automatic liquid filling of 30,000 vials.
According to John Shaw, head of business development at Vibalogics, the investment was “significant” and bolsters its aseptic fill and finish capability by around 300% to support demand for early phase biologic products.
“There is a lack of aseptic fill and finish capacity worldwide for live products requiring BSL-2 [Biosafety level] facilities, especially at the small to medium scale,” he told Biopharma-Reporter.com.
While the expansion was therefore driven through lack of availability in the marketplace for fill/finish at such a scale, he added the extra capacity was also brought online in preparation for infectious disease outbreaks.
“The Ebola outbreak [in 2014/15] is a great example of this where a number of companies needed to get clinical trial material available to patients in a very short space of time. We are in a much better place to be able to help with these instances in the future now.”
Fill/finish outsourcing
Many of the larger biologics manufacturers – Eli Lilly, Novartis, Celltrion etc– have signalled their intention of keeping complex biologics manufacturing processes in-house, but according to Shaw, fill and finish activities buck the trend.
“Biologics companies choose to outsource fill and finish activities of this nature due to the highly specialised facilities, equipment and staff required to perform such activities,” he told us.
Furthermore, “for clinical trial material, routine batches are not necessarily required, so it might not make sense for a company to make the investment in this area.”