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)
Bryllan
United States
Bryllan is a US-based CDMO specializing in the production and filling of potent and cytotoxic compounds, with a focus on aseptic powder and liquid filling for complex drug and device combination products. The company operates a high-containment, state-of-the-art facility in Brighton, Michigan, supporting both clinical and commercial supply of ADCs and other cytotoxic products.
Formulation DevelopmentFill/Finish (Vials)Fill/Finish (Syringes)
BSP Pharmaceuticals
Italy
BSP Pharmaceuticals is an Italian CDMO specializing in cytotoxic, ADC (antibody-drug conjugate), and non-cytotoxic sterile injectable manufacturing. The company provides development, clinical, and commercial supply services including API synthesis, ADC conjugation and fill/finish, and oral solid dose manufacturing, with FDA and EMA approved facilities near Rome.
Small Molecule APISmall Molecule Drug ProductOral Solid Dose
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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