Afton Scientific
Charlottesville | Charlottesville,, United States of America
Overview
Company details and contact information.
About
Afton Scientific is a highly-experienced cGMP CMO specializing in sterile injectables. We can Formulate, Aseptically Fill, Label, and Package your small-batch parenterals. Our customers include major global pharmaceutical companies and emerging biotechs. Sterile manufacturing services offered Clinical Trial and Commercial Drug Products Both Small and Large Molecule Inspected by Both CDER and CBER International Standards – FDA, PMDA, MHRA, and EMA Terminal Sterilization Engineering and Formulation Scale-Up Commercial Batch Record Development Technology Transfer Analytical Support Regulatory Filing Assistance Label/Pack/Serialization Our flexibility allows us to get client projects on the schedule as quickly as possible and maintain robust regulatory compliance. Quality assurance and in-house analytical services allow us control over product release timelines to ensure that products hit the market or clinic on time. Our facilities can handle vial sizes from 2mL – 100mL and batch sizes from thousands to tens of thousands making us an ideal fit for small-run commercial drugs and clinical trial materials. About Afton Scientific, LLC Afton Scientific is a U.S.-based CDMO specializing in aseptic fill-finish for biologics and small molecule products, with more than 20 years of manufacturing excellence. We are early technology adopters, and our newest capability reflects that commitment: a state-of-the-art, Annex 1–compliant isolator-based filling line supporting vials, syringes, and cartridges, purpose-built to meet the highest standards in sterile manufacturing and position our partners for global market access. What sets Afton apart is how we work. Our clients have direct access to experienced leadership and technical teams from day one. We embed ourselves in your program, bring deep technical expertise, and stay close through every stage of development and manufacturing. With available capacity today, a growing facility footprint, and a culture built around solving hard problems, Afton is ready to support your program now and as it scales.
- Website
- https://aftonscientific.com
- Phone
- 1 434 979 3737
- Address
- 2030 Avon Court, Charlottesville VA 22902-8722, United States of America | 2020 Avon Ct., Charlottesville, VA 22902, United States of America
Products
Products and media connected to this company.
New Isolator Filling Line
Afton's new Groninger/SKAN isolator-based filling line supports vial, pre-filled syringe, and cartridge formats across biologics, monoclonal antibodies, small m...