Simtra BioPharma Solutions expands sterile manufacturing footprint in US and Europe

Two years after becoming an independently owned company, New Jersey-headquartered Simtra BioPharma Solutions is expanding its capacity and service offerings in the United States and Europe. The contract development and manufacturing organization (CDMO), which focuses on sterile injectables, is building the infrastructure to support pharma and biotech customers at its facilities in Bloomington, Indiana and Halle/Westfalen, Germany.  

While Simtra currently produces almost 200 million sterile units annually and manufactures six of the 17 approved antibody-drug conjugates (ADCs) globally, the CDMO is investing in a dual-continent growth strategy at its Bloomington and Halle/Westfalen sites to meet the growing demand for complex, high-value therapies.

Overall, the company is looking to expand its manufacturing footprint from 11 fill-finish lines to 18 lines and will add about 1,000 new jobs to its workforce of approximately 3,000 employees by 2028.

“We’re playing a critical role in all sectors of the market that is growing — GLP-1s, vaccines, oncology medicines, and ADCs,” CEO Franco Negron told Pharma Manufacturing. “We’re an important part of the supply chain for our customers who come to us because we can deal with difficult molecules and high volume.”

Simtra has emerged as a strategic partner for its customers with a specialized technical expertise in the global biopharma ecosystem, according to Negron, who touted the CDMO’s “world-renown” capabilities in lyophilization and capital investments of more than $500 million since 2023.

Making targeted investments

At its Bloomington campus, Simtra has added a flexible clinical line for prefilled syringes as well as liquid and lyophilized vials, while constructing a new 153,000-square-foot production facility that will include the installation of at least six additional isolator filling lines. The first new line will be a high-speed isolator vial filling line equipped with three lyophilizers dedicated to highly potent molecules — such as ADCs — and is slated to be operational in 2027.

The move follows the company’s previously announced $250 million construction project at its Bloomington campus. In July, Simtra announced that it bought a 65-acre property in Bloomington from medical device maker Cook Group. The site includes a former GE manufacturing facility with more than 300,000 square feet of space and is located near Simtra’s existing manufacturing operations.

Negron said Simtra’s decision to purchase the 65 acres in Bloomington predated the threat of tariffs from the Trump administration and is a further investment in its hub in Indiana. The intention is to leverage this new site to establish Simtra as one of the first CDMOs to offer commercial-scale drug product manufacturing of ADCs in the U.S., he contends.

“Our Halle site in Germany is a world-recognized, high-potency ADC manufacturer,” Negron said. “It was quite evident we needed to bring the expertise of Halle to North America.”     

In July, Simtra completed the construction of a new $100 million production building at its manufacturing site in Germany. The expansion adds approximately 19,400 square feet of new production space, bringing the site’s total footprint to nearly 130,000 square feet. The CDMO also added a $14 million conjugation and purification suite for ADCs, while the new building includes two high-speed isolator lines — one for syringes and one for liquid and lyophilized vials.

Simtra’s Halle investment will support increased demand for fill-finish services, particularly for prefilled syringes and high-potency vial production. The site now includes 15 freeze dryers — four added as part of the expansion — used to preserve the stability of sensitive molecules during drug manufacturing.

In June, Simtra inked a five-year strategic alliance with MilliporeSigma, the U.S. and Canada Life Science business of Germany’s Merck KGaA, to support the manufacturing of ADCs. The collaboration combines Simtra’s sterile injectable expertise with MilliporeSigma’s capabilities in bioconjugation and payload manufacturing.

Under the agreement, ADC drug substance produced by MilliporeSigma will be transferred directly to Simtra for fill-finish, offering customers a turnkey solution. 

“CDMOs used to be an afterthought,” Negron said. “We’re a purpose-driven partner. We play a critical role in bringing important bioproducts to the patients of our customers. It’s a big shift and with that comes capital investment and significant growth. Where we are today is beginning to reap the benefits.”