Preclinical Development Clinical Supply Commercial Contract Manufacturing GET STARTED Our Customers Leadership Our Facilities Our Mission Our Products Careers Outreach FAQs OUR FACILITIES At Exelead, service is state of the art Exelead operates a 56,000-square-foot pharmaceutical manufacturing facility in Indianapolis, Indiana and employs a staff of 170. Our company has a worldwide reputation for handling contract manufacturing and contract filling for small to mid-size pharma clients—especially those serving small or rare disease populations. We also help clients with manufacturing and fulfillment during the clinical trial process. Our facilities play a large role in helping us fulfill that mission, by offering a flexible, scalable manufacturing environment capable of running multiple production lines simultaneously. We specialize in LNP and PEGylated formulations, and we have the staff and verification processes in place to support these complex products. Exelead has experience contract vial filling and manufacturing the following types of products: Lipid Nanoparticles (LNPs) Liposomal Complexes Pegylated Molecules Oligonucleotides (mRNA, siRNA, RNAi, saRNA, DNA, Duplexes) Small Molecules Buffers/Diluents Suspensions Aseptic preparations Proteins Antibiotics Our manufacturing operations utilize clean rooms qualified to GMP and ISO standards. To ensure quality, consistency, and compliance, we employ: Aseptic Processing and Filling areas designed, maintained and operated to meet ISO 5 (Grade A) standards for environmental control Barrier filling technology to ensure product sterility during filling and capping operations. Small Scale Formulation areas designed, maintained and operated to meet ISO 8 (Grade C) standards for environmental control Equipment washing and support areas designed, maintained and operated to meet ISO 8 (Grade C) local protection standards for environmental control Proceduralized, standardized methodologies for HEPA recertification Daily environmental monitoring of facilities, personnel and equipment to continuously verify that the facility is in a state of microbial/particulate control Process/product specific bio-burden monitoring plans to ensure manufacturing process control Annual environmental baseline monitoring to detect changes in the site microbial profile and confirm continuing effectiveness of sanitization agents and procedures For more information about our manufacturing facilities, or to schedule a tour, contact us. © 2021 Exelead 6925 Guion Rd Indianapolis, IN 46268 LinkedIn About Us News Privacy Resources Careers Visitor Information CONTACT US 1-317-347-2800