Flexible, High-Quality Aseptic Filling for Clinical & Commercial Needs
ABL-Ascend specializes in fill/finish manufacturing of viral vectors, gene therapies, oncolytics, and other liquid biologics. We offer the flexibility and logistical responsiveness needed to support global clinical trials. Services include comprehensive GMP production or standalone drug product fills.
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We have filled hundreds of GMP gene therapies, vaccines, oncolytic vectors and other immunotherapies.
At our Rockville site, we offer fill/finish under GMP up to Phase I/II using a fully automated Flexicon FPC50W filling machine, qualified up to 3000 vials per batch for 2 mL, 5 mL & 10 mL vials. (Custom vial sizes can be qualified upon request).
We integrate vialing, inspection, labeling, testing, storage and distribution activities to meet the demanding timelines required for the provision of clinical trial materials. We offer one hundred percent in-process weight checks with no impact to the machine throughput.
We operate to Good Manufacturing Practices (GMP) standards and our ISO 9001 quality management system. Our automation systems are installed with grade A Restricted Access Barrier Systems (RABS).
With additional capacity coming online at our Alachua site in H2 2026, we’re able to accommodate big and small fill/finish projects: 200 to 3,000 vials per lot (clinical) and up to 10,000 vials per lot (commercial).
We use pre-sterilized single use components throughout the drug product filling process to eliminate cross contamination risk.
We have filled hundreds of GMP gene therapies, vaccines, oncolytic vectors and other immunotherapies.
At our Rockville site, we offer fill/finish under GMP up to Phase I/II using a fully automated Flexicon FPC50W filling machine, qualified up to 3000 vials per batch for 2 mL, 5 mL & 10 mL vials. (Custom vial sizes can be qualified upon request).
We integrate vialing, inspection, labeling, testing, storage and distribution activities to meet the demanding timelines required for the provision of clinical trial materials. We offer one hundred percent in-process weight checks with no impact to the machine throughput.
We operate to Good Manufacturing Practices (GMP) standards and our ISO 9001 quality management system. Our automation systems are installed with grade A Restricted Access Barrier Systems (RABS).
With additional capacity coming online at our Alachua site in H2 2026, we’re able to accommodate big and small fill/finish projects: 200 to 3,000 vials per lot (clinical) and up to 10,000 vials per lot (commercial).
We use pre-sterilized single use components throughout the drug product filling process to eliminate cross contamination risk.
*Some testing outsourced to partners
In Alachua, Florida we have invested in installing a GENiSYS C third-generation fill-finish system from AST. This innovative filling technology can be configured to your needs and the support while offering benefits like 60-minute cycle times (including aeration).
The GENiSYS C utilizes pre-sterilized, ready-to-use containers and features robotic tub handling and a fully automated filling and closing process to minimize human intervention. Zero-waste processing includes one hundred percent in-process weight checks with no impact to the machine throughput, and end-of-batch filling to avoid product loss. A comprehensive suite of visual and sensor-based quality checks has been customized to maximize yield and quality.
Contact us to discuss your next fill/finish manufacturing project. Complete the form below and a member of our team will be in touch:
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What vial sizes and formats do you support?
We offer 2 mL, 5 mL, and 10 mL vials (Type 1 glass and Crystal Zenith®). Custom configurations up to 100mL vial sizes can be qualified upon request.
What are the supported fill volumes?
Standard fill volumes range from 0.5mL to 9.7mL. Custom dispensing of up to 100mL is possible with additional qualification.
What is the anticipated reject/defect rate?
Our facility maintains industry-low rates of less than 3%, including both mechanical defects and product line loss.
What product types do you specialize in for fill finish manufacturing?
Our experience spans viral vectors (AAV, LVV, AdV, Pox), oncolytics, vaccines, immunotherapies, and protein-based biologics.
How does you ensure sterility and product integrity?
Our fill finish operations include 100% visual inspection, AQL testing, and strict GMP processes. We also partner with trusted analytics providers for specialized tests.
Do you offer hand-filling services? Our Rockville site is qualified for manual fills of cell and virus banks into PETG bottles, conical tubes, or cryovials. However, all DP fills in Rockville are performed using the automated Flexicon machine.
What is your project management approach?
Every project has a dedicated PM who ensures clear communication, risk mitigation, and on-time delivery—from tech transfer to final release.
