Recipharm Launches New Fully Operational Modular Sterile Filling System in Germany

Recipharm, a Stockholm, Sweden-based contract development and manufacturing organization (CDMO), announced on Feb. 5, 2025 that a new and advanced modular sterile filling system, which performs aseptic filling within a Grade A isolator, is now fully operational and operates in full compliance with good manufacturing practice (GMP) standards. The system is tailored for process development and is located at the company’s facility in Wasserburg, Germany (1).

According to the company, the system’s interchangeable modules supporting various product types, such as syringes and vials, help to increase flexibility, and an additional pre-filled syringe module that is included with the installation broadens the capabilities of the system even further (1).

Recipharm said the filling line can deliver anywhere from 500 to 50,000 units per batch, making it useful for all development phases (1). The system is also designed to limit loss of high-value products to less than 500 mL, preserving material for clinical trials and ultimately providing cost savings.

“With this unit, we offer our clients a flexible, high-quality and GMP-compliant solution for their development and clinical production needs,” Gregor Kawaletz, Recipharm chief commercial officer, said in the press release (1). “This installation reflects our commitment to investing in innovative technologies that enable faster and more efficient pharmaceutical development.”

Installation was performed during the summer of 2024, and the system has already successfully completed its first production run for a leading biotech company, although Recipharm did not identify that company by name.

In their summation of key trends for the pharmaceutical industry at the beginning of 2025, Pharmapack and CPHI said that the ongoing demand for glucagon-like peptide-1 (GLP-1) drugs would cause aseptic filling capacity to be “tied up” in these drugs’ clinical filling needs, especially with generic GLP-1s entering the market in 2025 (2). This, Pharmapack said, could cause delays in the clinical filling of other therapies with smaller volumes.

“The result is that we will see biotechs widening supplier networks and potentially even Big Pharma searching for new partners for GLP-1s,” Pharmapack said at the time. “Consequentially, contract and device filling is predicted to be a rapid growth area.”

Pharmaceutical Technology®’s coverage of Pharmapack 2025 can be viewed here.

As part of its CPHI Milan coverage in October 2024, Pharmaceutical Technology® had the opportunity to speak to Uwe Hanenberg, Recipharm head of product implementation, about trends, technological advancements, and industry investments (3).

In that interview, Hanenberg predicted the increased need for efficient commercial production capabilities in 2025, specifically noting the burgeoning popularity of GLP-1 diabetes and weight loss drugs.

“There will come further big products. And that is certainly not to be executed on an existing tablet line or blister line,” Hanenberg said at the time (3). “That is something where you need more investment … I expect to see announcement on investment in high-potent capabilities, especially in [the] CDMO space, anything that is related to completion of offerings to reach an integrated solution, which means I expect a further consolidation of the CDMO market. Then I expect a very significant investment in continuous manufacturing. There are big companies who have a commitment to produce, in future, 50–80% of all new launches on continuous manufacturing.”

Watch the full interview with Hanenberg here.

References

1. Recipharm. Recipharm Expands Aseptic Filling Capabilities for Process Development, Pilot Scale and Clinical Supply. Press Release. Feb. 5, 2025.
2. Mirasol, F. Pharmapack Reports on Key Trends for 2025. PharmTech.com, Jan. 16, 2025.
3. Thomas, F. CPHI Milan 2024: Trends in Oral Solid Dosage Forms. PharmTech.com, Oct. 8, 2024.