Key Benefits include:
- Gravimetric powder filling: 100% weight verification and faster cycle times with high-precision dosing
- Scalable technology: Identical systems used in our fully-automated, higher-speed machines.
- Handles and fills the most challenging powders (including delicate biologics, spray-dried and freeze-dried, blends, micro-spheres and engineered particles)
- Reduces drug development lead-times by enabling formulators to bypass the need for excipients with the associated benefit of avoiding the need for excipient compatibility tests.
- Fills syringes, vials, cartridges, capsules and custom containers
- Isolator ready: Aseptic, GMP design
- Entry-level system: Cost-effective, with short lead-times.
- Suitable for spray dried and lyophilised powders
- Autoclavable dispensing head
- Tool-less disassembly for cleaning and sterilisation
- Suitable for VHP environments
- Ultra-compact and portable: Use inside existing isolators, RABS, LAF’s and down-flow booths.**
** Subject to size of enclosure
Reducing drug development lead times
This Gravimetric Filler helps customers significantly reduce drug development lead times: The system handles very challenging powders, avoiding the need for costly and time-consuming 'formulation development' which is traditionally needed to enable filling of powders with poor flow properties. Customers achieve 'first-in-human' (FIH) milestones typically 2-3 months faster, knowing sooner if their new drug will work or not. This results in a quicker launch, with a faster return on investment and ability to develop more products with the freed-up capacity.
Smaller Doses
The Gravimetric Filler can dose very small quantities of powder; the need for smaller doses is driven by the development of high-potency drugs and desire to administer drugs in pure API form.
Scalable for total life-cycle support
A key challenge in a new drug programme is ensuring early-stage manufacturing processes are applicable to commercial production. The Gravimetric Filler's narrow design means multiple modules can be installed side-by-side to create a multi-lane solution, however, the core process remains the same, avoiding the need to develop and validate costly new technologies which add time and risk.
Minimal drug product required and zero waste
In early stages of a new development, very low quantities of API are available as manufacture is carried out with lab-scale methods. The filler works with very small quantities of powder. Just 2-3 grams is sufficient to enable doses to be created for administration to patients or for other development tests. Unused powder can be recovered, meaning zero waste.
Improved product quality and patient safety
The fillers gravimetric system means that every dose is verified and any doses outside limits are rejected. Precision weighing enables tighter tolerances, meaning smaller doses can be dispensed. This is essential for high-potency drugs, where inaccurate dosing poses risks to patient safety.
Enables filling of biologics and engineered particles
The Gravimetric Filler enables dosing of new drugs in a form previously not possible. Delicate, ‘long-chain’ biologics and ‘engineered’ particles made with technologies such as spray-drying are typically unsuitable for volumetric dosing, but can be dosed successfully with Fill2Weight.
