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Adeno-associated virus (AAV) vectors are one of the most popular viral vectors for gene delivery in the treatment of a variety of human diseases. Creative Biogene owns a high-productivity cGMP AAV manufacturing platform and is offering cGMP AAV manufacturing services to our customers. Our professional team has more than 10 years of experience in cGMP AAV development and manufacturing, and we have established a platform which can streamline the process of cGMP AAV manufacturing with a reduced overall cost and timeline. We provide flexible manufacturing processes that will best meet your individual needs. Our goal is to produce and deliver high quality AAVs at sufficient quantities to our global gene therapy clients.
1. Clinical manufacturing for phase I/II/III studies
2. Commercial manufacturing for AAV gene therapy drugs
Our advanced cGMP facilities are designed following EU and US FDA GMP regulations. So far, we have multiple fully equipped process development suites, cGMP clean room suites, quality control suites and aseptic fill/finish suites.
iCELLis 500+ (500m2) Bioreactor System
NevoLine (600m2)
Single-use stirred tank bioreactor 200L
Tangential flow filtration (TFF)
Process development is an indispensable step in cGMP manufacturing for gene therapy drugs. Creative Biogene has a dedicated team with an in-depth experience that can provide you with tailored process development for cGMP manufacturing. Our process development capabilities include upstream process development (USP) and downstream process development (DSP).
Creative Biogene are able to manufacture cGMP AAVs in both adherent and suspension production cell lines. Our scientists will assist you to choose the most suitable cell line based on your AAV serotype of interest, your transgene property and the required AAV amount.
Table 1. Our proprietary AAV production cell lines for Helper-Free Triple Transfection Method
| Cell Line | Culture Property | Manufacturing |
| HEK293-A, HEK293T-A | Adherent | Small scale production |
| HEK293-S, HEK293T-S | Suspension | Large scale production |
We have produced more than 20 batches of cGMP AAVs in multiple serotypes including those serotypes (e.g., AAV4, AAV6) tend to have lower yields.
We offer flexible downstream purification processes based on customers' requirement. These processes include ultracentrifugation, ion exchange chromatography (IEX), anion exchange chromatography (AEX), size-exclusion chromatography (SEC), affinity chromatography, multimodal (or mixed-mode) chromatography etc.
We have multiple independent cGMP production lines with the overall productivity up to 2000L per batch. The maximum AAV yield in a single batch is up to 1E+17 GC or VG.
Creative Biogene has established a robust and reliable quality control system for cGMP manufacturing. Our quality control system provides a wide range of analytical techniques to characterize our cGMP AAVs including identity, purity, content, potency and safety at every stage of the cGMP manufacturing process.
For more information on our cGMP AAV manufacturing services, please contact us at 1-631-626-9181 or info@creative-biogene.com.
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