The world's leading healthcare brands trust Element’s industry-leading expertise in aseptic liquid and sterile-fill finish manufacturing of conventional and biologic drugs.
Our team of experts have a proven track record of helping clients compress time to clinic, rapidly employing our R&D engineering and clinical small-scale aseptic liquid and sterile fill-finish solutions for engineering test studies, clinicals, and aseptic small-scale commercial manufacturing to deliver materials while other contract development and manufacturing organizations (CDMOs) are still scheduling their facilities.
Aseptic manufacturing and sterile fill finish for biologics and conventional drugs is a complex and highly specialized discipline that requires purpose-built facilities, equipment and processes, meticulous planning and careful execution, and a highly skilled and experienced team. Element’s comprehensive suite of industry-leading aseptic manufacturing solutions are built upon best-in-class operations and processes, along with an unwavering commitment to quality and compliance. Our resolute dedication to quality and compliance has resulted in an excellent reputation with the Center for Drug Evaluation Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Veterinary Medicine (CVM), and the Office of Generic Drugs (OGD) of the US Food & Drug Administration (FDA) and European Medicines Agency (EMA) counterparts, as well as with local FDA and Drug Enforcement Agency (DEA) district offices.
Rigorous quality and compliance-driven aseptic manufacturing processes and facility design
Element’s sterile manufacturing facilities have been purposefully constructed and designed to ensure sterility and completely eliminate opportunities for contamination, allowing our experts to safely deliver drug product that has been manufactured to the highest standards as quickly as possible. Additionally, our facilities have been engineered to provide clients with an opportunity to view all work being done in the ISO Class 5/Class and aseptic core remotely or in close proximity.
Numerous conventional and biologic drug products pose an increased risk of infection or harm to patients solely due to their route of administration, particularly those which are administered through parenteral, ophthalmic, otic, or inhaled routes. FDA requires drug products be supplied as sterile products when delivered by these routes of administration. As more complex parenteral, ophthalmic, and otic drug products make their way into clinics and patient populations, a collaborative partnership with a trusted aseptic processing and sterile fill-finish CDMO will be critical to successfully bringing therapies to market. Successfully navigate challenging process considerations and ensure compliance to rigorous regulatory requirements by leveraging Element’s comprehensive suite of CDMO capabilities, along with our deep bench of regulatory, industry, and scientific expertise.
R&D engineering and clinical small-scale manufacturing solutions for various drug delivery systems
- Vial filling of liquid small volume parenterals (SVP) in clear and amber glass vials (1ml to 100ml)
- Aseptic fills via flex bags
Comprehensive aseptic manufacturing and sterile fill finish for a variety of finished dosage forms
- Otic and ophthalmic aseptic fills (up to 100ml)
- Topicals, semi-solids (creams, gels, ointments) and non-aseptic liquid fills (up to 100ml)
- Potent compounds
- Controlled substances (DEA classes II-V)
- Compounding pharmacy drugs and medication
The Element advantage
Element offers comprehensive sterile fill-finish solutions tailor-made to support clinical studies, compounding pharmacies, and small-scale batches, including small bulk fills. Additionally, our toll manufacturing services can be implemented to protect manufacturing know-how and trade secrets. Our sole concern is getting your product safely into the clinic as quickly as possible, solving tough problems and supporting clinical manufacturing with consistently reliable quality results. For more information about Element’s aseptic manufacturing and sterile fill finish services for biologics and conventional drugs, including media fill and media chase, or to request a quote, contact us today.
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