#USA #ADCs #sterile injectables #Simtra BioPharma Solutions #Bloomington, Indiana

Simtra BioPharma Solutions Expands Global Manufacturing

Simtra BioPharma Solutions, a prominent contract development and manufacturing organization (CDMO), is making significant strides in expanding its global manufacturing footprint to cater to the increasing demand for sterile injectables. This leap in capability follows its transition into an independent company in 2023.

The company is pursuing an ambitious dual-continent expansion strategy, focusing on enhancing its operations in North America and Europe. At its Bloomington, Indiana facility, Simtra has recently introduced a flexible clinical line specifically for prefilled syringes and liquid/lyophilized vials. Additionally, a new production facility is under construction that will incorporate three industrial-scale sterile filling lines housed within isolators. Notably, Simtra has acquired a large 65-acre site nearby that boasts over 300,000 square feet available for future development. Among the plans for this campus, the installation of at least six more isolator filling lines is set to take place, with the first line—a high-speed isolator for vial filling equipped with three lyophilizers dedicated to highly potent molecules—expected to become operational by 2027.

Simtra's expansion efforts are mirrored at its site in Halle/Westfalen, Germany, where the company has added a cutting-edge conjugation and purification suite. A new building was inaugurated, featuring two high-speed isolator lines catering to the production of syringes and liquid/lyophilized vials. These strategic investments are a testament to Simtra's commitment to delivering top-notch sterile manufacturing solutions across major global markets.

Franco Negron, CEO of Simtra BioPharma Solutions, emphasizes the company’s mission: "Our purpose is clear to bring vital injectable products to customers and their patients worldwide. By expanding capacity and service offerings in both the United States and Europe, we are building the infrastructure needed to support innovation and reliability, now and for the future."

Simtra’s growth strategy aligns closely with therapeutic areas that are in high demand, particularly oncology therapies. Currently, the company produces nearly 200 million sterile units annually and is responsible for the manufacturing of six out of the seventeen approved antibody-drug conjugates (ADCs) worldwide.

A significant advantage for Simtra lies in its unified operational capabilities across North America and the European Union. This synergy enables customers to create robust, end-to-end supply chains tailored to their target markets. The company offers integrated development services that encompass formulation and lyophilization development, alongside its technology transfer capabilities, aiding clients from pre-commercial stages through to full-scale launches and beyond.

With over 65 years of rich experience in sterile manufacturing and the nimbleness of an independent entity, Simtra is strategically positioned to merge deep technical expertise with a proactive approach towards innovation and growth. Negron adds, "Our integrated approach, cross-functional expertise, and continuity of project management help accelerate readiness for commercialization. From the outset, products are designed for high-quality manufacturing to maximize yields and facilitate scalability, saving time and costs."

About Simtra BioPharma Solutions

Simtra BioPharma Solutions is a global contract development and manufacturing organization (CDMO), focusing exclusively on sterile injectables. The company leverages over 65 years of manufacturing know-how, a solid global reach, and an impressive quality record to assist pharmaceutical and biotech innovators in delivering complex medicines to patients. With facilities located in Bloomington, Indiana, USA, and Halle/Westfalen, Germany, Simtra continues to play a crucial role in the biopharma landscape.

For more details, visit www.simtra.com.