Fill-finish roundup: News from INCOG, Recipharm, WuXi Bio

INCOG BioPharma completes installation of a filling line in Indiana, Recipharm invests in Lab+ filling technology in France, and WuXi Biologics expands its fill-finish capacity and capability in China. Welcome to our fill-finish roundup.

First up is contract development manufacturing organization (CDMO) INCOG, which specializes in sterile injectables. The firm has completed the installation of its OPTIMA multi-use production filling line at its Fishers, Indiana plant.

“The OPTIMA multi-use line serves as our highly customized, injectable therapy ‘bottling line’ at our Fishers, Indiana facility. In our filling suite number one, the filling line resides within a completely sealed, barrier isolator system to maintain a sterile environment for filling and finish of vials/syringes/cartridges,” a spokesperson for INCOG told BioProcess Insider.

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“[The] line processes up to 9,000 units per hour and has 100% in-process controls that measure and monitor each unit to ensure fill volume and proper sealing specifications are met while simultaneously maximizing yield. When we think about high-value biologics, this feature was designed specifically to capture every drop of product that we can to maximize value for our biopharma customers.”

INCOG claims that the installation of the filling line means that its headquarters will be GMP operational and able to manufacture drug products for its customers before the end of this year.

Recipharm

Up next is another CDMO, which has scaled up its sterile filling capabilities by investing in Lab+ technology used for low volume blow-fill-seal (BFS) filling at its plant in Kaysersberg, France.

According to Recipharm, Lab+ is a suitable option for BFS projects that need smaller volumes as it has a throughput speed of 2,000 doses per hour and is flexible in design. Furthermore, the technology has a streamlined tooling changeover process enabling it to be easily adapted for various products and dosage designs.

“By investing in new BFS technologies like Lab+, we are able to fully support our customers through both Phase I and II clinical projects,” Yves Buelens, site manager at Recipharm said.

“This new machinery means we can make small batches and removes the need to dedicate a whole filling line to one project. We can offer a system that is new, and rare on the market, allowing our customers to design and test their products, to see how they will look and react in a BFS system. The new Lab+ technology supports proof-of-concept, feasibility batches (cGMP & non-cGMP) and clinical I and II batches.”

The company announced last June that it has signed a Memorandum of Understanding (MoU) for the fill-finish of biotherapeutics and vaccines in Morocco, which is expected to be fully operational by 2023.

WuXi Biologics

Last but certainly not least is WuXi Bio who has announced that its drug product facility entitled DP8 and located in Hangzhou, China has completed its first batch of GMP production. DP8 is a single-use-system-based facility that features sterile filling technology with two segregated filling lines, and also an aseptic formulation isolator used to prepare alum-adjuvanted vaccines.

The CDMO said that it also has messenger RNA (mRNA) and lipid nanoparticle (LNP) encapsulation technologies, which has a processing capacity of 10 L per hour. Furthermore, the facility can provide flexible dosage forms.

“The successful first batch of GMP manufacturing at our DP8 facility represents an important milestone for WuXi Biologics, Chris Chen, CEO of WuXi Biologics said.

“It demonstrates that we can provide our customers with a stronger foundation to deliver drug product – including mRNA LNP – within our global manufacturing network. We look forward to supporting more partners on their paths to commercialization for the benefit of patients worldwide as we continue to expand our capabilities and capacity for end-to-end integrated drug product solutions.”

In June 2022, the company opened a drug product facility in Wuxi, China increasing pre-filled syringes (PFS) capacity to 17 million units annually.