Our
Expertise
We leverage our own development experiences into helping your team have the most streamlined experience possible.
Our
Experience
Our teams of experts across the globe have exceptional experience
60+ Years
with biologics
30+ Years
with cell therapy
20+ Years
with AAV/gene therapy
Government
contracts experience
Full Service
and support experience
60+ Years
with biologics
30+ Years
with cell therapy
20+ Years
with AAV/gene therapy
Government
contracts experience
Full Service
and support experience
We love working with your team to find the right level of support for:
- Chemistry, manufacturing & controls (CMC)
- Process design
- Process feasibility
- Upstream & downstream process development
- Assay development & qualification
- Master & working cell & virus banks
- Scale-up & engineering run(s)
- GMP bulk drug substance
- GMP aseptic fill/finish
- Analytical lot release testing
- ICH stability testing
- Regulatory guidance & filing
If you do not see what you need here, please reach out and have a chat with us via business@ascend-adv.com
Specialized support for your team
When we had trouble finding a CDMO, we became one! Our offer includes specialized support for your team from early stage through to commercialization and fill/finish.
Let’s work together to build the future of advanced medicines!
Platform Innovation
One of our most critical differentiators is the unmatched flexibility of our technical platform solutions and the range of technologies we use. Together we can conduct side-by-side comparisons of your platform operations with ours to ensure the best aspects are carried forward. Optimization of the process is then achieved using design of experiment (DoE) methodology. These services are specialized for AAV processes.
Formulation
We perform high throughput and focused formulation screening to deliver the best formulation for any target product profile. Focused on AAV, these high-end, low volume analytical methods and automated rebuffering decrease the starting material needed. Close collaboration with the downstream processing team enables a smoother transition to manufacturing with in-use testing services to assess the suitability of preclinical and clinical dosing procedures.
Scalable Manufacturing
When your upstream process is optimized, we can scale into larger bioreactors to provide the amount of product needed from 2L to 500L for a range of modalities. For gene therapy customers only, try our EpyQ® AAV production system with 2 plasmids instead of 3 to increase quality and lower cost with no impact to scale. And tailor your downstream processing workflows with the option for in-house fill/finish in two of our United States locations.
Process Development
Having a wide range of bioreactor sizes and options like shake flasks, stirred tank reactors, and small-scale systems enables streamlined design of experiment workflows and scale up verification. We work with you to quickly identify optimal conditions for your AAV vector manufacturing, oncolytics, immunotherapies or vaccines.
Analytics & Testing
At all locations, we have world-leading analytics systems in place. Our library of off the shelf and custom assays is designed for the integrity of each process. For AAV projects, we complete VG/mL; %full capsid measurements; encapsidated genome length (NGS); particle aggregation; visible and sub-visible particles; potency; and levels of packaged contaminant DNA (plasmid and host cell derived).
In House Fill-Finish
One of our most critical differentiators is the unmatched flexibility of our technical platform solutions and the range of technologies we use. Together we can conduct side-by-side comparisons of your platform operations with ours to ensure the best aspects are carried forward. Optimization of the process is then achieved using design of experiment (DoE) methodology. These services are specialized for AAV processes.
In Partnership with
ELISA Test Kits by ABL
ABL has a strong core of expertise to help advance your candidate vaccines and therapeutics. Our p24 enzyme-linked immunosorbent assays (ELISA) kits are sold off the shelf to support your analytical biochemistry needs. Originally developed for HIV titer determination, the kits have evolved into a critical tool for the quantification of lentiviral vector (LVV) titers in cell and gene therapy applications.
Cell & Virus Banking by ABL
In our GMP facility in Rockville, MD we offer suspension and adherent cell expansion capabilities for preclinical and Ph I/II clinical trials. Virus seed banking up to BSL-2; mycoplasma & sterility standard release criteria and in-house cold storage with 24/7 alarm monitoring complement this offer.
Oncolytics by ABL
Our Rockville facility has diversified capacity, including a variety of suspension and adherent production platforms to manufacture novel oncolytic therapies. Our full scale capabilities include the ability to work with vaccinia, MVA, HSV, Adenovirus, and more.
Immunology & Vaccines by ABL
The ABL team has more than five decades of custom research and product development experience for vaccines. A flexible platform offer is supported by a knowledgeable staff and a rigorous quality perspective to mitigate even the most daunting problems encountered in society.
Government Partnerships by ABL
For 60+ years, ABL has supported the US Government’s mission to prevent, treat, and diagnose infectious diseases. We act as a translational solutions integrator to support biotechnology product development including vaccines, medical countermeasures, as well as therapeutics against infectious disease, cancer, neurological disorders and other indications.
