Viral Vector Services

Overview

Viral Vectors are the tools that are commonly used to deliver or transport specific genetic sequences into desired cells in both in vivo and in vitro environments.

Not only do they have the potential to productively infect cells, but also transfer DNA to the host without causing an immune response. Viral vectors, as gene transfer therapy, are designed to be safe by making them incapable of replication and are considered to be the most effective gene manipulation method used worldwide.

Esco Aster offers comprehensive viral vector CDMO services for early-stage research, preclinical phase trial, clinical phase trial, and commercial manufacturing. Our top priority is to identify the best possible solutions, use our expertise, and streamline our platform processes to meet your specific needs.

Our Capabilities

Our services include, but not limited to, the following activities:

Construction of the Plasmids with Gene of Interest (GOI)

Transfection of the Cells

Stable Cell Line Creation

Process Development

Process Characterization

Analytical Development

Quality Control

Technology Transfer

Process Performance Qualification (PPQ)

GMP manufacturing

Construction of the Plasmids with Gene of Interest (GOI)

Simplify your plasmid design work with us. Esco Aster offers well-established platform for plasmid design and construction. Our capabilities include:

  • expression vector design, for CAR constructs: scFv linker and spacer, transmembrane domain, choice of co-stimulatory domain(s)
  • construct optimization for best packaging and expression
  • platform switch guidance (for example from transposon or electroporation system to LV) with option to clone customer’s GOI into our proprietary backbone
  • option to use our proprietary set of helper plasmids
Construction of the Plasmids with Gene of Interest (GOI)

Stable Cell Line Generation

A high-quality and performance production cell line is the critical first step in any biopharmaceutical process. At Esco Aster, we have the ability to generate stable cell lines customized for your needs by implementing state-of-the-art single-cell cloning and high-resolution imager with full documentation to ensure monoclonality and to shorten the time of single cell cloning. We perform the process development with our proprietary bioreactors from lab-scale to manufacturing scale.

Stable Cell Line Generation

Process Development

Esco Aster’s process development service establishes an optimal viral vector production process using the innovative Tide Motion technology to produce high yield and high-quality viral vectors. The optimized lab-scale process will be linearly scaled up to the manufacturing scale per the requirement of the clients.

Procecss Development

Process Characterization

Prior to the process characterization, a scale-down model is established to serve as the representation of the large-scale commercial manufacturing. Due to the linear property of the process scale-up for Tide Motion technology, CelCradle X® system is a perfect scale-down model for process characterization. The scale-down model qualification will be performed first by statically comparison of the process attributes between the scale-down process and the large-scale process. If the manufacturing scale is performed only in CelCradle X® system, the process characterization will use the CelCradle X® system as well.

The process characterization services analyze all the input materials, parameters, and other factors in each unit operation by the subject-matter experts using Ishikawa diagram. Thereafter, risk assessment using the method of Failure Mode and Effective Analysis (FMEA) is performed to understand the Risk Priority Number (RPN) of the process parameters on the Critical Quality Attributes (CQAs) of the drug substance. Potential Critical Process Parameters (PCPPs) as well as the Key Process Parameters (KPPs) will be sorted out for further process characterization studies. The design spaces of the CPPs and KPPs are established by the Design of Experiment (DOE) followed by the verifications.

The process characterization is an iterative process which results in more and more knowledge and understanding of the process as well as the quality attributes. Well-designed Normal Operating Ranges (NOR) and Proven Acceptable Ranges (PAR) of the process parameters ensure both the robustness and the flexibility of the manufacturing process and meet the quality targets of the drug substance and drug product.

Based on the process characterization results, a control strategy of the manufacturing process is established. The control strategy is the foundation of the subsequent Process Performance Qualification (PPQ) and the GMP manufacturing.

Process Characterization

Technology Transfer

Prior to the start of the Process Performance Qualification (PPQ) in GMP facility, technology transfer services ensure the process protocols, Standard Operating Procedures (SOPs), and process control strategy are fully understood by the manufacturing personnel. Master Batch Record (MBS) and Validation Master Plan (VMP) are prepared to ensure the variability and parameters are controlled and sufficient in the face of the rigors of a commercial production environment; to verify parameters established during development are still within the determined design space.

Technology Transfer

Process Performance Qualification (PPQ)

At Esco Aster’s cGMP facility, PPQ services will produce at least 3 consistent batches to validate the process control strategy, process performance and the quality of the viral vectors. Process capability of reproducible commercial manufacturing is evaluated. The documentation and the quality system ensure that the outcomes of the PPQ fully support the subsequent commercial manufacturing and the regulatory filling process.

Process Performance Qualification (PPQ)

cGMP Manufacturing

Esco Aster’s state-of-the-art GMP facility provides the services of viral vector manufacturing for clinical materials and commercial products. The maximum manufacturing capacity using the Tide Motion technology can reach as high as 200 L packed bed volume of BioNOC II carriers, equivalent to 1,000 L daily harvest volume. It will fully meet the production capacity of the commercial manufacturing. Continued Process Verification (CPV) is in place, enabling the detection of variation in the manufacturing process and providing opportunities to proactively control variation and assuring that during routine production the process remains in a state of control.

cGMP Manufacturing

Viral Vector Analytics

We offer a range of assays to characterize your vectors. We analyze the identity, potency, stability and safety of your vector using analytical tools such as flow cytometry, quantitative PCR, digital PCR, ELISA and particle analysis. 

Viral Vector Analytics