Simtra BioPharma Solutions

What differentiates Simtra BioPharma Solutions lies in what we know, what we do, and who we are: - Deep-rooted expertise in sterile injectables - Collaborative approach designed to meet clients where they are in the process - Talented, dedicated professionals who bring passion and precision to every project - Strategic investments and partnerships aimed at creating a more efficient and integrated manufacturing process for our clients From clinical to commercial, explore our full range of service offerings in the video below and visit our website to learn more: https://lnkd.in/gMeNrWrP #MadeForThis #CDMO #Manufacturing #Simtra

Antibody-drug conjugates (ADCs) are revolutionizing cancer treatment—but their complexity makes manufacturing a challenge. Because the antibody is generally less stable than the small-molecule cytotoxic agent, approximately 90% of commercially available ADCs are manufactured as lyophilized powders that are reconstituted at the point of care. Our latest white paper, authored by Greg Sacha, Ph.D., breaks down the essential role of lyophilization in the development and manufacture of ADCs, and how Simtra BioPharma Solutions ensures that the lyophilization process is optimized to ensure safety and efficacy. Download the full paper: https://lnkd.in/gcpWyZfh #ADCs #Lyophilization #Innovation #Simtra

We are executing a bold, dual-continent expansion strategy – building matching capacity and capabilities at our Bloomington, Indiana and Halle, Germany locations. We’ve recently acquired a 65-acre campus in Bloomington, Indiana, with more than 300,000 square feet of available space for expansion under-roof, continued to execute construction to expand our existing Bloomington site with a 150,000-square-foot state-of-the-art building, and opened a 20,000-square-foot building at our facility in Halle, Germany.   Helping our clients bring innovative new medicines to patients around the world and growing our investments in local communities is an integral part of our commitment to excellence.   See how we’re expanding our operations locally and making a #GlobalImpact below or visit our website for more information: simtra.com #CDMO

At Simtra BioPharma Solutions, we’re committed to advancing pharmaceutical science through collaboration and innovation. Last week, our own Jayasree Srinivasan, Ph.D. moderated a keynote session at the AAPS PharmSci360 conference, featuring Dr. Raj Suryanarayanan on the topic of “Excipient Phase Behavior in Frozen and Freeze-Dried Systems – Potential Implications on Drug Stability.”   The presentation explored the complex interplay between formulation variables and processing conditions during freeze-drying. Key takeaways included: - Understanding how excipient phase behavior impacts the stability of active pharmaceutical ingredients - Strategies for controlling crystallization tendencies during processing - Analytical techniques for monitoring phase transitions in frozen and freeze-dried systems - Approaches to confer multifunctionality to excipients   Events like PharmSci360 highlight the importance of deep scientific understanding in developing robust, stable drug products. Thank you to Dr. Suryanarayanan and Dr. Srinivasan for sharing your expertise and to everyone who joined the discussion! #AAPS #PharmSci360 #Lyophilization #Simtra #Innovation

Simtra BioPharma Solutions was featured in Pharma Manufacturing about our expanding sterile injectable manufacturing footprint in the U.S. and Europe to better serve customers and patients worldwide. This investment strengthens our ability to deliver high-quality injectable medicines and supports our vision to be the premier CDMO for injectable products. Read the full article here: https://lnkd.in/gxUNhUer

November is #DiabetesAwarenessMonth – an important time to reflect on how we can all help improve the lives of those affected by this chronic condition. At Simtra BioPharma Solutions, we’re committed to doing our part by partnering with innovators to help ensure that life-changing sterile injectable therapies reach the patients who need them most.  

Wrapping up #WorldQualityWeek, we are proud to congratulate Simtra BioPharma Solutions’ Brooke Wise, PMP, for earning the Veeva Hero Award! Your commitment to “Think Differently” and drive for continuous improvement is inspiring to elevate quality and innovation every day. 

Our Global Senior Scientist, Development & Pre-Commercial Services, Greg Sacha, and Research Scientist II, Jayasree Srinivasan, Ph.D., were part of a team of industry experts that received the 2025 AAPS PharmSciTech High Impact Article Award at PharmSci 360.     The team's paper titled “Best Practices and Guidelines (2022) for Scale-Up and Tech Transfer in Freeze-Drying Based on Case Studies. Part 1: Challenges During Scale Up and Transfer” has become a trusted resource for the industry. It dives into practical solutions and modeling approaches for overcoming scale-up and tech transfer challenges—and has had roughly 9,500 downloads.    Congratulations, Greg and Jayasree!    Read the full paper: https://lnkd.in/gkrsyd5n      American Association of Pharmaceutical Scientists (AAPS) | @aapscomms #Madeforthis #CDMO #Manufacturing #Simtra

At World ADC San Diego last week, our Chief Commercial Officer & Head of Business Development, Mike Schaefers joined a global community dedicated to advancing the latest in cancer treatment and finding ways to bring medical innovation to as many patients as quickly as possible. Here are a few of his observations about the future of development for antibody drug conjugates (ADCs): • With a huge pipeline of more than 3,300 ADCs in preclinical and clinical development, expect ~ 20 ADC products to be submitted for FDA approval in 2026 and 2027. • For rare and orphan diseases, AOCs (antibody oligonucleotide conjugates) are gaining traction, particularly in muscle, CNS, and cancer indications. • Right now, Asian nations, especially China and India, are driving ~50% of the global ADC clinical pipeline. • Lyophilized products—complex to develop—are still the first path to get ADCs administered to patients. Nearly all FDA-approved ADCs are formulated as lyophilized products. Providing regional capacities in development and fill/finish, reducing complexity, increasing efficiency and speeding up timelines are going to make all of the above possible—and that’s why we’re proud of our recent capacity and capability expansions as well as our alliance with MilliporeSigma.   To learn more about the alliance, visit: https://lnkd.in/gDSme8Kc