Capability
Aseptic Processing CDMOs
Compare CDMOs with validated aseptic processing capabilities. Filter by isolation technology, cleanroom classification, and sterility assurance approach.
329 companies listed
About Aseptic Processing
Aseptic processing is the manufacturing of sterile drug products without terminal sterilization. The product is sterilized by filtration (0.22 micron) and filled into pre-sterilized containers in classified clean environments. This technique is essential for biologics, proteins, and other heat-sensitive products that cannot withstand autoclaving.
The sterility assurance strategy defines CDMO capability. Modern approaches use isolator technology (closed systems with HEPA-filtered air, vaporized hydrogen peroxide decontamination) for the highest contamination control. Older approaches use RABS (Restricted Access Barrier Systems) or conventional cleanrooms. FDA and EMA increasingly favor isolator-based systems for new facilities.
Companies (329)
Lifecore Biomedical
United States
Lifecore Biomedical (Nasdaq: LFCR) is a fully integrated CDMO headquartered in Chaska, Minnesota, specializing in sterile injectable drug product development and manufacturing. The company has over 40 years of experience in aseptic fill/finish, with particular expertise in highly viscous formulations. Lifecore is also a premium producer of non-animal-sourced sodium hyaluronate.
Sterile Fill/FinishSterile InjectableFill/Finish (Vials)
Made Scientific
United States
Made Scientific is a US-based cell therapy CDMO specializing in development and GMP manufacturing of cell-based therapies including T cells, NK cells, HSCs, MSCs, iPSCs, and TILs. The company provides services from pre-clinical support through Phase I-III clinical trials and commercial enablement, including process and analytical development, GMP cell banking, drug product manufacture, aseptic fill and finish, and QC lot release and stability testing. FDA-registered with FEI number and operations including API manufacture, analysis, labeling, manufacturing, and packaging.
Cell & Gene TherapyCell TherapyAnalytical Services
Frequently Asked Questions
What is the difference between isolators and RABS?+
Isolators are completely sealed enclosures with HEPA-filtered air supply and H2O2 decontamination between batches. Personnel never enter the isolator environment. RABS (Restricted Access Barrier Systems) use physical barriers but share air with the surrounding cleanroom and allow limited interventions through glove ports or open doors (active vs passive RABS). Isolators provide superior sterility assurance but require longer setup times and higher capital investment.
How do CDMOs validate their aseptic process?+
Aseptic process validation requires: media fill (process simulation) studies where sterile growth medium is filled in place of product, with the goal of zero contaminated units. FDA requires a minimum of three consecutive successful media fills. Environmental monitoring data, personnel qualification (gowning, aseptic technique), and equipment qualification are also required components of the validation package.
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