Freudenberg Expands Biopharm Product Portfolio with Addition of Custom Single-Use Assemblies

Editor's note: this story was originally published on BioPharmInternational.com.

On Aug. 1, 2024, Freudenberg Medical announced an expansion to its biopharma product portfolio, which now includes custom single-use assemblies. The assemblies will be combined with the company’s expertise in silicone extrusion and molding. Included in the new offerings are single-use Y-connector manifolds, tubing assemblies, and bottle cap assemblies with multiple inlets/outlets. Both labs and current good manufacturing practice (CGMP) bioprocesses commonly use bottlecap assemblies with Y-connector tubing for critical fluid transfer applications, according to the company in a press release.

The assemblies are cleanroom manufactured according to customer specifications. Among the advantages, Y-connector overmolds offer unobstructed flow within a critical fluid path and can prevent leaks from occurring. Leaks are commonly seen with standard fluid couplings, fittings, and connectors, according to Freudenberg. “Validated production processes with proven process capabilities will continuously ensure consistent overmolding of Y-manifolds on customer-specified tube ends,” the company stated in the press release.

The expanded biopharma portfolio complements the company’s existing PharmaFocus Premium product line containing high purity, platinum-cured silicone tubing and sanitary ends for single-use systems. The company’s tubing, molded components, and systems are used in bioprocessing, biotechnology, lab processes, GMP manufacturing, small batch processes, and cell and gene therapy as well as for the production of messenger RNA, biosimilars, and regenerative proteins.

The company’s other expansion activities include a $50 million investment in a new Hemoteq AG production facility in Aachen, Germany, to expand its coatings business (1) and a $25 million investment to establish a manufacturing site in Costa Rica (2). The expansion in Germany, which Freudenberg announced in June 2024 will triple its manufacturing footprint with a new 130,000-ft² facility in Alsdorf, near the existing site. The new facility houses ISO Class 7 cleanrooms, laboratories, and offices and will serve as a hub for R&D and production as well as drive innovation in medical coatings (1).

The new Costa Rica facility, announced in February 2024, is slated to come online in the beginning of 2025 and will be dedicated to assembling high-volume minimally invasive catheters for electrophysiology, vascular and structural heart therapies, and other medical devices requiring high-precision manual assembly. The first phase of construction comprises a build on 50,000 ft² and the facility will house three ISO 7 cleanrooms. The company also expects to add another 50,000 ft² to the site within three years of its opening. This added construction will quadruple Freudenberg’s total footprint in Costa Rica (2).

Of the Germany site expansion, Mark Ostwald, CEO of Freudenberg Medical, said in a company press release issued at the time, "The convergence of medical devices and drugs is inspiring a new generation of innovative products that fundamentally improve patients’ outcomes. With this innovation driven investment, we are strengthening our position as a strategic partner to our customers, offering vertically integrated solutions along the entire supply chain" (1).

Meanwhile, Róger Gómez, vice-president/general manager of Freudenberg Medical in Costa Rica, said of the Costa Rica facility expansion at the time it was announced, “The investment in this new site underlines Freudenberg Medical’s confidence in Costa Rica as an integral part of our global growth strategy. In the next three years, we will triple the number of employees from the current 300 to over 900 team members. Committed to diversity and inclusion, we offer equal opportunities to all” (2).

References

1. Freudenberg Medical. Freudenberg Medical Expands Coatings Business with New Production Facility. Press Release, June 11, 2024.
2. Freudenberg Medical. Freudenberg Medical Establishes Second Production Facility in Costa Rica. Press Release, Feb. 14, 2024.

Source: Freudenberg Medical