Simtra BioPharma Solutions Expands U.S. Presence with Focus on ADC Manufacturing

Simtra BioPharma Solutions, a contract development and manufacturing organization (CDMO) specializing in injectable biologics, has announced plans for a significant expansion of its operations in Bloomington, Indiana. The move comes as part of a broader industry trend towards increased capacity for antibody-drug conjugates (ADCs) and other complex biologics.

Strategic Land Acquisition and Facility Expansion

Simtra has purchased a 65-acre property adjacent to its existing fill-finish facility in Bloomington, providing over 300,000 square feet of usable space for future development. While specific details of the project are still under evaluation, the company has indicated its intention to design and install new manufacturing lines at the site.

A key focus of this expansion will be the establishment of Simtra's first U.S. commercial-scale capacity for injectable oncology medicines, with a particular emphasis on ADCs. If realized, this development could position Simtra as the first CDMO to offer commercial-scale drug product manufacturing of ADCs in the United States.

The new facility is slated to include isolator-based vial and prefilled syringe lines, enhancing Simtra's capabilities in sterile drug product manufacturing. This expansion complements an ongoing $250 million project at the Bloomington site, announced in February, which involves the construction of a 150,000-square-foot building housing high-speed automated isolator filling lines and lyophilization capabilities.

Strategic Partnerships and Global Expansion

Simtra's growth strategy extends beyond its U.S. operations. The company recently completed a $100 million production building at its site in Halle Westfalen, Germany, and is investing an additional $14 million in a conjugation and purification suite at the same location.

In a move to strengthen its position in the ADC market, Simtra has entered into a five-year partnership with Merck KGaA's MilliporeSigma. This collaboration aims to create a comprehensive offering for pharmaceutical companies requiring ADC production services. Under the agreement, MilliporeSigma will handle bioconjugation steps at facilities in St. Louis or Madison, Wisconsin, while Simtra will oversee drug product formulation and fill-finish operations.

Industry-wide Focus on ADC Manufacturing

Simtra's expansion is part of a broader industry trend towards increased ADC manufacturing capacity. Other recent developments in this space include:

• Swiss CDMO Carbogen's 25.5 million Swiss franc ($31 million) investment, in partnership with an unnamed Japanese company, to equip two of its facilities for commercial production of linkers used in ADCs.
• API specialist Veranova's $20 million investment at its Devens, Massachusetts campus to build new bioconjugation capacity for ADCs and other bioconjugate drugs.

These investments reflect the growing importance of ADCs in the pharmaceutical industry, particularly in oncology applications, and highlight the increasing demand for specialized manufacturing capabilities in this sector.