Cell Therapy services Delivered.

Cell therapy services: Customized Cell Collections

Getting the right starting material is crucial to developing your CAR-T and other cell immunotherapies. Excellos will deliver your specified cell types, healthy and ready for scale-up, under cGMP conditions. With over 250K active blood donors you get the diversity and selections that match your requirements, without costly new donor characterization. Want more? Using our network (including San Diego Blood Bank) we can rapidly expand your collection.

Choose what matters to you

Donor Management Services – We design the donor pool that matches your requirements.
Selection – Specify donor HLA, gender, age, medical history, genetic disorder(s), and more.
Recruitment and Collection – Utilize fully consented, IRB-approved donors for apheresis, whole blood, or cord-blood collection.
Configuration – Choose guaranteed cell count or volume, fresh or frozen.

Features:

Rapid Quotes – Most quotes available within 10 days of receiving your parameters.
Fast Delivery – Overnight shipping of collected samples.

Cell Therapy Services: Cell Isolation

With your customized donor samples collected, Excellos can enrich, isolate, and preserve specified cell populations. These screened cell populations are ready for genetic modification by transfection/transduction. Isolated immune cells commonly specified may include T-cells, Natural Killer cells (NK), or CD34+ cells.

Customized To Meet Your Demands

Isolation/Enrichment—Negative and positive processes give you maximum yield.
Technology—Choose magnetic or FACs platforms for the best flexibility and purity.
Selection—We can use standardized selection markers or your custom antibody.
Analysis—Cell count and viability using an NC-200 or your specified system to validate purity and yield.
Cryopreservation—Use your formulation or ours, and based on the thaw protocol, we can provide you viability data.

Features:

ISO-7 cGMP cleanrooms.
cGMP manufacturing facilities meet regulatory and safety requirements.

Cell Therapy Services: EXCELLOS 360

Ready to go deeper on cell characterization? Advance past typical cell and donor screening to create a comprehensive immune cell profile for each donor as well as an assessment of the metabolic and effector potential of their cells. See beyond surface markers too.

EXCELLOS 360

Improve clinical outcomes.
Lower safety liability by making therapies effective in lower dosages.
Reduce the cost of goods associated with cell and gene therapy manufacturing.

Features:

Proprietary panels.
Pre and post-testing of isolation/enrichment.
Cell viability and scale-up potential.

Cell Therapy Services: Process Development and cGMP Manufacturing

Now that you have the best donated cellular material, it is time to optimize your cell therapy process for cGMP manufacturing. We offer R&D services including process development and cGMP production for Phase I through Commercial manufacturing.

Custom Manufacturing to Your Specifications

Donor Management Services—We design the donor pool that matches your requirements.
cGMP Manufacturing facilities meet regulatory and safety requirements.
Manufacturing by Design (MBD) scales processes to increase efficiencies and lower costs.
Full QA oversight and documentation.

Features:

Customized assay and process development.
Technology transfer (hardware, know-how, QC, compliance).
Cell isolation, transduction and expansion.
Harvest, cryopreservation and storage.
Stability testing.
Full documentation.
ISO 7 cleanrooms.

Cell Therapy Services: Quality Assurance and Regulatory

With Excellos Quality Assurance (QA) and Regulatory teams at your side, you get standardized procedures, control measures, and documentation that delivers a consistent, reproducible product to meet regulatory requirements.

Quality by Design (QBD) methodology matches patients’ needs with your product quality profile. Control strategies are implemented to support regulatory filings, while the product is managed throughout its lifecycle for continuous improvement opportunities.
Regulatory Affairs provides you advice on regulatory requirements, develops the regulatory strategy for your product lifecycle, assists in document preparation, and with you, interfaces with relevant regulatory agencies.

Accreditation and Licensure

California license for the production of biologics.
Tissue bank license.
cGMP-qualified cleanrooms.
IRB-approved donor consents and collection protocols.