ASEPTIC VIAL FILLING
ASEPTIC VIAL FILLING
Symbiosis is a specialist in the sterile filling of pharmaceuticals into vials. Vial filling has been our core area of technical and regulatory expertise since we opened our MHRA-licensed FDA inspected manufacturing facility in Scotland in 2012.
If you require a manufacturing partner to aseptically fill a liquid or lyophilised drug product into vials, then rest assured that your drug development project will be in safe hands at Symbiosis.
No matter what vial size your project dictates, from 0.5mL to 100mL, our experienced team can support your project with all small-volume parenteral dosage sizes. Our batch sizes range from hundreds to thousands so are ideal if you need clinical trial materials or low volume commercial supplies.
We can also offer our clients rapid access to manufacturing slots along with fast QA release of batches and therefore a quicker route to the achievement of clinic trial milestones and to meet the tightest of deadlines.
IN-HOUSE VIAL FILLING CAPABILITY
Our in-house vial filling capability enables us to fill bulk volumes under 100 litres per batch, including products that require aseptic liquid filling and specialist lyophilisation. This may also include the manufacture of the following products using our dedicated cleanrooms:
- Vaccines
- Biologics including antibodies
- Advanced therapy medicinal products (ATMP)
- DNA antibody-Drug Conjugates (ADCs)
- Viral vectors for gene therapies
- Proteins
- Peptides
- Cytotoxic, cytostatic and highly potent APIs
- Small molecules
WORLD-CLASS CMO
As you would expect from a world-class CMO, our vial filling capability is supported by in-house vial washing and depyrogenation and component preparation services. All pharmaceutical production is undertaken within our purpose-built GMP-licensed facility, which was specifically designed for the aseptic manufacturing of sterile drug products on this scale.
Working with biotech and speciality pharmaceutical clients across the globe, our aseptic filling capabilities cater for the increasing demand for small-scale sterile injectable products intended for use in clinical trials or licensed commercial supply.
Regulatory compliance and the highest levels of technical capability are at the heart of everything we do, yet our agility also gives our biotech and speciality pharmaceutical clients rapid access to manufacturing slots. This focus on quality combined with operational flexibility is what sets Symbiosis apart from other CMOs.
If you are planning a vial filling project, then please contact our team today. Even if the deadline is tight, our team will make every effort to help achieve your milestones and timelines.
