Adeno-associated Viral Vector Production Services

Overview

Adeno-associated Viral Vector Production Services

Adeno-associated virus (AAV) has been an increasingly essential viral vector for gene therapy and cell therapy. At Esco Aster, we bring forth world-class AAV packaging services for all projects, large and small.

We support small-scale AAV packaging for in vitro experimentation, large-scale AAV packaging vital for successful research studies, and services which are designed to go all the way to cGMP production for clinical trials and commercial manufacturing.

OUR SERVICES

In recent years, we have witnessed an abrupt increase in the number of gene therapies in both pre-clinical and clinical studies, proposing a rousing trend pointing to the feasible development of treatments for medical conditions such as Leukemia, Hemophilia B, Thalassemia, Spinal Muscular Atrophy, Muscular Dystrophy, and many more. So, the demand for viral vector manufacturing facilities that can cater to the needs for cost-effective and skillful preclinical, clinical and commercial development for gene therapies is very much needed.

As a CRO, CRDMO, Esco Aster provides viral vector production services in varying grades--research/preclinical clinical, and commercial, respectively. Choosing and producing the best viral vectors to be used for your desired applications can be difficult, but we are here to help every step of the way!

Research / Preclinical Grade

Clinical Grade

Commercial-Grade

Research-grade AAV
Production Services

Esco Aster’s team of scientific experts will work with you to guarantee that you receive AAV service that is customized to your research at every stage, meeting your needs quickly and efficiently. The features of this service comprise of:

  • Safer, helper-independent AAV vector with helper-free expression system
  • Thoroughly clarified and purified AAV vector with Esco Aster’s proprietary extraction method
  • Several options of purification method to match your application/s
  • Scale-up development for future commercial manufacturing
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Researh-grade Adenoviral Vector Production Services

AAV’s Upstream Bioprocessing Platform

At Esco Aster, we consider many variables for adeno-associated virus (AAV) upstream bioprocess development. Within each step there are many ways to optimize and refine your process--a process that works, and a process that holds the promise of harvesting great results!

Feature Transfection Sf9/Baculovirus Producer Cell Line HSV Co-Infection
Specialized Raw Materials
  • Plasmids
  • Cell banks (E. coli and mammalian)
  • Serum (for adherent processes)
  • MBIIC (baculovirus infected insect cells), cell bank
  • Helper virus (e.g. Adenovirus)
  • Producer cell bank
  • Helper virus cell bank
  • Cell banks (HSV banks and AAV production)
  • HSV viral banks
Scalability Concerns
  • Efficiency/time sensitivity of transfection can limit scale
  • Suspension culture process
  • Size of MBIIC (MOI strategy)
  • Adherent culture process
  • Size of helper virus bank (MOI strategy)
  • Adherent culture process
  • Size of the viral banks
Impurity Profile Concerns
  • Residual Plasmid DNA Serum components
  • Endogenous virus
  • Baculovirus
  • Wild-type Adenovirus
  • Cell Line Components
  • HSV and genetic components
Cell Culture System
  • Adherent or
  • Suspension
  • Suspension
  • Adherent or
  • Suspension
  • Adherent or
  • Suspension
Time Consideration
  • Generation of Plasmids
  • Cloning of baculovirus
  • Generation/qualification) of MBIICs
  • Cloning of producer cell line
  • Generation/qualification of banks
  • Cloning of HSV vector and viral banking
  • Generation and Qualification

Also available via client's technology transfer protocol

Clinical-grade AAV
Production Services

AAV vectors can transduce into proliferating cells and impart long-term expression. Furthermore, AAV vectors have very low immunogenicity. For these reasons, interest in the use of AAV vectors in gene therapy is rapidly growing. As each serotype shows different characteristics and tissue specificity, AAV vectors are expected to transduce target genes efficiently into heart, liver, muscle, retina, and central nervous system tissues.

  • Project Initiation: We will be requiring plasmid DNA (transfer plasmid, packaging plasmids) and a producer cell line
  • Deliverables: We will deliver AAV vector, manufacturing report, and certificate of analysis

Moreover, we use a validated assay for measuring physical titer (genome copies) for all AAV packaging services. Titering is performed using qPCR with primers targeting the ITRs present in the viral genome and quantified by comparison to a standard curve of a plasmid sample of known concentration.

Clinical-grade AAV Production Services

Commercial-grade AAV
Production Services

Esco Aster’s state-of-the-art cGMP 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 macrocarriers, 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.

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Commercial-grade Adenoviral Vector Production Services

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.

Adenoviral Vectors