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
- Aseptic preparations
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.