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US / English
Contract Manufacturing
Afton Scientific is a highly-experienced cGMP Contract Manufacturing Organisation (CMO) specialising 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 Sterilisation
- Engineering and Formulation Scale-Up
- Commercial Batch Record Development
- Technology Transfer
- Analytical Support
- Regulatory Filing Assistance
- Label/Pack/Serialisation
We know the market is demanding shorter timelines and smaller scale products. Each of our facilities was built with quality, operational adaptability, and manufacturing capabilities in mind. With these attributes at our core, Afton offers prompt production slots and uncompromising quality.
Afton utilises single-use systems as an easy way to ensure no cross-contamination between product fills. Timelines are also streamlined with these systems as they are kept in stock and have been validated during media fills.
Discover why our cleanrooms are right for your next project
Liquid Vial Filling
Afton’s automated filling lines can support small batches of thousands to tens of thousands with a focus on liquid, clinical, and commercial runs in 2ml -100ml glass and CZ vials. 100% visual inspection of all filled vials via manual or semi-automated inspection. In-house analytical capabilities available to release your product to clinic or market.
Terminal Sterilisation
If your product is not heat stable, there is a regulatory expectation that it will be terminally sterilised. Afton’s terminal sterilisation capabilities include 2ml-100ml vials through moist heat. Our development team will work with you to ensure this is the right fit for your product.
Label/Pack
Whether your clinical product should be shipped bright stock or your commercial product needs custom kitting, we have you covered. Afton has capabilities for individual vial labelling through serialisation/aggregation.
Your Success is Our Success
We focus on the relationship through dedicated teams and frequent client meetings. Through experience, we know that this is the way to a successful product launch. Our “high touch” teams of experts in technical capabilities, engineering, operations, quality control, and quality assurance will scale-up your bench process and guide your team through launch. We measure our success through earning your trust and building an enduring relationship.
Adaptable & Compliant Facilities
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 the release timeline for products 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.
Filling Operations
Our filling operations are supported by in-house component preparation. This includes industry standard vial washing and depyrogenation/ sterilisation in a dry heat oven and closure sterilisation in a steam autoclave. To support our filling operations throughout the process, we also have on-site QC micro and analytical services. Afton’s labs will take your product from start to finish with API/raw material release, in-process testing, and release testing for drug product.
For those companies that have in-house filling capabilities, we also offer our pre-sterilised components in a Ready-To-Fill® format.
Storage Condition
For raw materials and finished product
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