Gene therapy final fill
Progressing from the drug substance to the final injectable drug product requires final packaging vials and stoppers that meet a number of quality requirements. Avantor fulfills these demands, giving you confidence and peace of mind in your final gene therapy product.
ISO-Certified environments critical to gene therapy final fill
To meet final fill requirements, products must be prepared in an ISO Class 5 environment and meet USP71, USP85 and USP758 requirements to be sterile, pyrogen-free and particulate-free. They must also be validated for use in storage of frozen or lyophilized drug product and for compatibility with the protein and excipients in final formulation.
We offer a range of excipients that are used in drug product formulation — including adjuvants, stabilizers, preservatives and bulking agents — and production water processed and meeting testing requirements in accordance with USP Water-for-Injection (WFI) regulations used in drug product manufacturing and as a diluent.
Explore solutions for gene therapy final fill
Avantor is the only open-architecture, single-use provider to offer complete design, manufacturing and logistics to support every stage of your biomanufacturing process—wherever your operations are located across the globe. Our global capabilities and supply chain and quality programs are designed to give the peace of mind so you can focus your time on producing critical therapies, quickly and safely.
Avantor manufacturers and distributes biopharmaceutical products and excipients providing structured choice and risk mitigation – for biopharmaceutical development, pilot scale and commercial manufacturing.
Learn how Avantor Services bioprocessing specialists can help optimize your upstream and downstream operations.
Explore product choices for gene therapy final fill
- Mammalian Bottles
- Mammalian Buffers
- Mammalian Carbohydrates & Sugars
- Mammalian Detergents, Surfactants & Preservatives
- Mammalian Filtration Systems
- Mammalian Microbial Detection
- Mammalian Mycoplasma Detection
- Mammalian Salts and other Production Chemicals
- Mammalian Water
- Microbial Bottles
- Microbial Carbohydrates & Sugars
- Microbial Detergents, Surfactants & Preservatives
- Microbial Filtration Systems
- Microbial Microbial Detection
- Microbial Mycoplasma Detection
- Microbial Salts and other Production Chemicals
- Microbial Virus Extraction, Amplification & Detection
- Microbial Water
- Vials & Stoppers
Ready to maximize production efficiency?
Our Bioprocessing Solutions team is here to help.