Closely-held Simtra BioPharma Solutions, a premier contract development and manufacturing organization with more than 65 years of sterile injectable manufacturing experience, offers world-class cGMP sterile fill/finish, technical expertise, quality service, and a uniquely collaborative approach to meeting the challenges inherent in manufacturing parenteral products.
“Manufacturing and commercializing parenteral products presents any number of challenges such as formulation issues, upscaling from clinical to commercial production, surges in demand, and patent expiry, so as a manufacturing and development partner with a 65-year legacy of craftsmanship and expertise, Simtra BioPharma Solutions not only delivers tailored innovative solutions to these types of challenges but it has a global reputation for exceptional execution,” Franco Negron, Chief Executive Officer of Simtra BioPharma Solutions, says in an interview with BioTuesdays.
Simtra BioPharma Solutions offers drug delivery platforms and clinical to commercial stage contract manufacturing services to pharmaceutical and biotechnology companies seeking to bring products to market. Accommodating clinical to commercial scale and multiple drug types, the organization delivers expertise across cytotoxics, highly potent compounds, biologics, and small molecules and diluents for reconstruction. Aiming to maximize the quality of product and speed to market for its global customer base Simtra BioPharma Solutions’ services include formulation and development, lyophilization optimization, rapid technology transfer, fill/finish operations, specialized containment, analytical services, and global regulatory support.
Mr. Negron explains that cookie-cutter solutions are inefficient because navigating the pathway to commercialization is different for every molecule. Simtra BioPharma Solutions has the technical expertise, capacity, and capability to respond to all aspects of the development and manufacturing process with its uniquely collaborative, tailor-made approach that draws on decades of handling a multitude of molecule types with various toxicity profiles and a world-class singular focus on sterile injectables, he says. The Simtra BioPharma Solutions team of industry leaders work tirelessly to overcome the hurdles that pharmaceutical and biotechnology companies face adding value with a reliable, relentless commitment to quality and compliance, Mr. Negron adds.
“Simtra BioPharma Solutions plays a critical role with global companies of varying sizes and manufacturing capabilities,” Mr. Negron contends. “We are uniquely positioned to complement the internal manufacturing processes of large organizations with continuity of supply for example,” he says. “And, for those customers who don’t have a supply chain, we can fulfill that need because we have the processes, systems, and business infrastructure in place to support them and deliver the development and manufacturing services they require to achieve their commercialization goals.”
Formerly Baxter BioPharma Solutions, the organization was acquired by Advent International, a global private equity investor, and Warburg Pincus, a global growth investor on October 2, 2023 for $4.25 billion.
Simtra BioPharma Solutions is comprised of a team of 1700 with manufacturing sites in Bloomington, Indiana and Halle/Westfalen, Germany. The facility in Bloomington recently announced a $50 million client-dedicated prefilled syringe line rendering it one of the largest suppliers of prefilled syringes worldwide. The facility in Halle, Germany, is currently undergoing a $100 million expansion which will add a high-speed syringe line and a vial line with two 40 square meter lyophilizers. There are plans for more facility expansions to be announced over the next few months and a new corporate headquarters to be established in New Jersey.
“The reaction to the acquisition of Simtra BioPharma Solutions by these two highly experienced investors within the healthcare space has been extremely positive,” Mr. Negron points out. “Together, we are well-positioned to spearhead the next chapter, augmenting the legacy and reputation that the team has built as part of Baxter.”
Currently, Simtra BioPharma Solutions is formalizing its development services function with immediate plans to expand its drug development offering. “We will continue to pull from our rich history of project successes, lessons learned, as well as our deep scientific and technical knowledge to grow mission-critical services and deliver customized, versatile solutions for pharmaceutical and biotechnology companies,” Mr. Negron indicates.
Looking forward, Mr. Negron says to facilitate drug development expansion plans across a variety of therapeutic areas including oncology, metabolic disease, and infectious disease, among others, Simtra Biopharma Solutions is investing in growing its team of world-class talent. “Many of our people have been with us for more than 20 years and they are passionate about bringing vital healthcare solutions to patients worldwide,” he notes. “We are proactively adding to our team by recruiting and training top industry leaders ahead of future demand, reinforcing our commitment to customer excellence and our reputation as the premier source for knowledge, expertise, and delivery of uncompromisingly high quality sterile injectables.”
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