You need an aseptic filling solution that drives down the vein-to-vein time for autologous cell therapies, gene therapies or personalized medicines.
The Microcell can help you do it. It is a fully automated robotic vial filling machine within a gloveless isolator. It supports a manufacturing model that is safe, flexible and scalable.
The Microcell can fill small, personalized batches of 300 units or less, then switch quickly to the next patient’s therapies. The Microcell makes it possible to process 4 or more patients in an 8-hour shift.
Start-up and decontamination times are 15 minutes or less, saving time in getting the finished therapy to the patient.
As companies look to scale their personalized therapies from the lab to market, they need a model that can scale out. The Microcell is a standard machine that can be deployed quickly. When demand increases, more Microcells can be added to a “multiplex” of machines. Each machine is able to process multiple patients daily.
Since the machine is a standard design and build, acceptance testing and validation becomes a repeatable process.Want to see the full specifications of the Microcell?
Aseptic assurance is the best available because of the Microcell’s gloveless isolator design. Extremely low particle levels are achieved by removing the typical sources of particles, including conveyors, sorting bowls, belts and mouse holes. Creating a completely closed isolator contributes to tighter control over the environment inside.
Aseptic assurance is strengthened by the isolator being glove-free, and removing the biggest particle generator in the room– the operator –from the process.
The Microcell uses single-use product contact materials, including flow paths, filling needles and product bags to eliminate the possibility of cross-contamination. These consumables were carefully developed to reduce the risk to patient and drug product.
While you focus on developing your pharmaceutical science, Vanrx will focus on your manufacturing model. We came from biopharma manufacturing and act as an extension of your own expertise.
Unlike the alternatives, the Microcell comes fully integrated from a single supplier. We have developed it to meet the particular needs of personalized medicines for agility and aseptic assurance.
The simplicity of sourcing and implementing the Microcell makes it easier for innovators and CMOs alike to scale therapies for the clinic and beyond.
The new white paper Aseptic Filling for Personalized Medicines describes a new solution for the aseptic filling of cell and gene therapies, immuno-oncology, mRNA and other modalities where manufacturing creates a therapy for a single patient.Download the white paper