Simtra BioPharma Solutions, a contract development and manufacturing organization with facilities in Halle/Westfalen, Germany, and Bloomington, Ind., in the United States, said it has completed construction on a new production manufacturing building at its Germany campus (1). This expands the production area at that site by 1800 square meters (19,400 square feet) to a total of nearly 12,000 square meters (130,000 square feet).
Increased presence on two continents
Key Takeaways
- Simtra BioPharma Solutions has expanded its Germany site by 1800 square meters, adding sterile fill/finish capacity for vials and prefilled syringes and creating 150 jobs.
- The new facility enhances Simtra's capabilities in large-scale vial filling and introduces prefilled syringe tech at the Halle site to meet global injectable demand.
- The expansion follows recent strategic moves, including a $250 million investment in the US and a Merck KGaA alliance to support bioconjugate and ADC manufacturing.
By adding the new production building, Simtra said in a press release, the company hopes to strengthen its presence in the sterile injectables field in Europe as well as North America (1). Simtra expects strong demand on both the prefilled syringe and vial fill/finish service lines once production begins at the facility.
“With this expansion in Halle, we are in a great position to help our clients accelerate development of new therapies, such as targeted cancer treatments, and deliver these critical drugs to patients sooner,” said Franco Negron, CEO of Simtra BioPharma Solutions, in the press release (1). “With the opening of this new facility, we are delivering on our promise to our customers. This state-of-the-art facility further builds out our expertise in large-scale vial filling for liquid and lyophilized products, as well as prefilled syringes, which is a new technology for our Halle site.”
Simtra making moves
In February 2024, Simtra said it was investing more than $250 million to expand its sterile fill/finish manufacturing campus in Bloomington, which was one of the company’s first major moves after Advent International’s and Warburg Pincus’ acquisition of Baxter’s BioPharma Solutions business in October 2023, resulting in the adoption of the Simtra name (2).
More recently, in June 2025, Simtra announced a strategic alliance with the Life Science division of Merck KGaA, Darmstadt, Germany—which is known as MilliporeSigma in the US and Canada—to assist companies in the biopharmaceutical industry seeking solutions related to antibody-drug conjugates and bioconjugates, including linker and payload manufacturing, drug product formulation development, and fill/finish services (3).
Sterile injectables challenges
Ahead of the Drug, Chemical, & Associated Technologies Association (DCAT) Week 2025 in New York City, Lidia Serina, PhD, head of Development Services at Simtra, spoke with BioPharm International® about the key challenges in aseptic processing for sterile injectables (4).
"In parallel to the digitalization environment, we are also improving the way we do technology transfer … from when we receive a molecule and a process from a client [to when] we transfer this knowledge onto our aseptic filling lines … we need to make sure that we understand the critical process parameters [and] the quality attributes of the molecule, so we are actually able to keep the stability of this molecule along the manufacturing process [even to] the patient, right when we ship the product to the patient," Serina said in the interview (4).
Click here to watch the full video interview with Serina.
Simtra said the expansion at the Germany site will create 150 new jobs (1). Along with the construction of the building comes the addition of four new freeze dryers, bringing the total at that site to 15.
References
1. Simtra BioPharma Solutions. Simtra BioPharma Solutions Expands Halle/Westfalen, Germany Facility with the Addition of a New Production Building. Press Release. June 30, 2025.
2. Simtra BioPharma Solutions. Simtra BioPharma Solutions Announces $250+ Million Investment to Expand Sterile Fill/Finish Manufacturing Site in Bloomington, Indiana. Press Release. Feb. 28, 2024.
3. Simtra BioPharma Solutions. Simtra BioPharma Solutions and MilliporeSigma Announce Strategic Alliance for Antibody Drug Conjugates Drug Substance and Drug Product Manufacturing Services. Press Release. June 11, 2025.
4. Mirasol, F. DCAT Week 2025: Maintaining Aseptic Integrity and Stability in Sterile Injectable Manufacturing. BioPharmInternational.com, March 18, 2025.
