A New Era in Viral & Non-Viral Drug Product Manufacturing
With the manufacturing, packaging and quality control capabilities that you need available at scale, Emergent CDMO’s in-house drug product support services for clinical and commercial manufacturing help pave the way for your biotherapeutic or vaccine success. Flexible fill lines, single-use technologies, a large (and growing) production footprint, viral and non-viral platforms — an entire suite of capabilities from Emergent are ready to support your drug product manufacturing initiative. Plus, our size, adaptability, and expertise ideally position us to meet your needs as they evolve.
Our viral drug product manufacturing facility in Rockville, MD is home to the groninger® INTEGRA, a state-of-the-art high-speed fill/finish line. The INTEGRA offers integrated isolator technology and Biosafety Level 2 (BSL2) capabilities, in conjunction with an automated inspection, labeling, and packaging line, ideal for large scale fill/finish manufacturing of viral biotherapeutics and vaccines. The INTEGRA is an integral part of our strategic investment plan to support biopharma innovators in the fight against life-threatening viral diseases. Learn More
Vanrx Overview
The Vanrx SA25 Aseptic Filling Workcell is a state-of-the-art isolator fill line, providing our clients with a high level of sterility assurance and flexibility through an automated handling, filling, and closing process, designed to minimize line losses. If you have a high-value product and require a small-to-moderate batch size, the Vanrx may be the right fit for your program.
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groninger® FlexPro 50
The groninger® FlexPro 50, located at our Camden site in Baltimore, MD is a state-of-the-art filling suite, utilizing isolator-based technology for the aseptic processing of drug products in pre-sterilized ready-to-use (RTU) syringes, vials, and cartridges. An inline lyophilizer minimizes user intervention through an automated lyophilization loading system. The FlexPro 50 enhances Emergent CDMO's commitment to providing excellence in aseptic fill/finish to meet biopharmas’ diverse needs. Learn more
Development Services Center Overview
Our Development Services Center for Excellence in Gaithersburg, MD offers drug substance and drug product process development, analytical development, lab-scale manufacturing, and early-phase GMP release and stability testing. To learn more about Emergent CDMO's development services, take a 3D Virtual Tour of our Gaithersburg facility.
Navigating Annex 1 for Early Phase Sterile Fill Finish in Clinical Supplies
November 21st 2024Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity testing to meet stringent European Union standards. The guide provides a comprehensive look at key elements such as PUPSIT, critical zone controls, and monitoring and training for aseptic processes.
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.
Ensuring Quality from the Start: Raw Materials Testing Support
November 21st 2024Raw Materials are the foundation of every biopharma product. Our ultimate guide highlights how our testing support can help you establish purity, identity, and quality standards, ensuring a smooth manufacturing process and adherence to regulatory requirements.
Ensure the Safety of Allogeneic Therapies with Advanced qPCR Testing
November 21st 2024Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ensuring comprehensive safety in every stage of the allogeneic therapy pipeline. Protect your products – and your patients- with industry-leading sensitivity and specificity.
