Herpesvirus Manufacturing
Specialised services for Herpesvirus–based vectors, for use in gene therapies, oncolytic therapies and vaccines.
The Challenge For Developers
The large size & fragile enveloped structure of Herpesviruses makes sterile filtration impractical and therefore requires aseptic processing from start to finish in specialized BSL-2 facilities.
Our Solution
Specialised development and manufacturing services for Herpesvirus–based vectors, designed for clients with products where viral stability, aseptic processing, and genetic fidelity are critical. With ABL-Ascend you can also expect:
- End‑to‑end program oversight with technical PIs and experienced PMs
- Support for government‑funded, early‑stage, and commercial‑stage programs
Upstream Process Development
Expertise with Complementation‑Dependent & Oncolytic Herpesvirus
- Ability to work with client cell line of choice, including packaging cell lines.
- Experience troubleshooting low‑titer, high‑complexity Herpesvirus constructs, including:
Capability to scale in suspension or adherent cells
- Adherent platform from iCELLis™ Nano to iCELLis™ 500.
- Suspension platform up to 2x 200L.
Closed, Aseptic Manufacturing
Herpesvirus’s large (~150–200 nm), fragile, enveloped structure makes sterile filtration impractical. Ascend therefore provides:
- Fully closed aseptic upstream and downstream operations, from infection through final sterile fill.
- Processes qualified to operate without terminal sterile filtration, supported by aseptic process simulation to confirm aseptic integrity from cell thaw to drug product vial.
- Manufacturing approaches adapted from our long experience with Pox and other complex large, enveloped viruses.
This ensures clients’ Herpesvirus programs can progress without compromising yield or product safety requirements.
Downstream Processing & Purification
We provide a robust purification train designed around the sensitivity and size of Herpesvirus:
- Fully closed TFF system includes
- Gamma-irradiated, ready-to-process filters.
- Custom designed fully enclosed, single-use flow path
- 0.2 µm vent filter
- Sterile sampling manifold
- Flexible, custom designed single-use assemblies
- Low sheer process adapted to project viral integrity
Our DSP team has developed Herpesvirus specific learnings that reduce loss during large scale concentration and minimise shear damage.
Full Analytical Support for Herpesvirus
Safety & Quality
– Endotoxin
– Sterility
– Replication Competence
– Adventitious Agents
– Mycoplasma & Mycobacteria
Purity
– Process Residuals (HC protein & DNA; nuclease, BSA)
– Aggregation
– Residual DNA Sizing/Identity
Concentration, Potency & Identity
– Physical Titer
– Infectious Titer
– Functional Titer
– Capsid ID
– Viral Protein ID
– Vector Genome Integrity
Integrity & Composition
– pH
– Osmolarity
– Appearance
– Extractable Volume
– Subvisible Particles
Safety & Quality
– Endotoxin
– Sterility
– Replication Competence
– Adventitious Agents
– Mycoplasma & Mycobacteria
Purity
– Process Residuals (HC protein & DNA; nuclease, BSA)
– Aggregation
– Residual DNA Sizing/Identity
Concentration, Potency & Identity
– Physical Titer
– Infectious Titer
– Functional Titer
– Capsid ID
– Viral Protein ID
– Vector Genome Integrity
Integrity & Composition
– pH
– Osmolarity
– Appearance
– Extractable Volume
– Subvisible Particles
Ready to speak to a member of the team about your Herpesvirus development or manufacturing needs?
Please contact us using the form below and a member of our team will be in touch.
HSV Form
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