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FectoVIR?-AAV GMP

貨號 102000006 售價(元) 詢價
規(guī)格 100ML CAS號
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Reagent

FectoVIR?-AAV GMP

Molecule delivered

Plasmid DNA and co-delivery of several plasmid DNA

Applications

GMP compliant Recombinant AAV virus production

Virus types

Adeno-Associated Viruses (AAV)

Cell types

Mammalian producer cell lines (HEK-293, HEK-293 derivatives) grown in suspension cultures

Number of transfections

100 mL of FectoVIR?-AAV transfection reagent is sufficient to transfect on average 50 L of cell culture

Storage

Store FectoVIR?-AAV GMP at 5 °C ± 3°C.
Expiry date is indicated in the certificate of analysis (available in "My account") and on the product.

Provided with

Protocol
Certificate of Compliance
Certificate of Analysis
Certificate of Origin
Non-Hazardous Product Statement


AAV Gene therapy manufacturers must meet regulatory requirements across their manufacturing process to ensure patient safety. This includes all starting materials, excipients and ancillary materials used to create the therapeutic AAV particle, because they can have an effect on the final product.

Transfection reagents are ancillary materials, which are used during the manufacturing but are not intended to be present in the final drug product.

AAV manufacturers expect their raw material suppliers to comply with regulatory agencies by upholding to the highest quality standards and aligning with CMC guidelines.

At Polyplus, we do not compromise on quality or performance. FectoVIR?-AAV GMP is a premium transfection reagent that ensures:

  • Patient safety. FectoVIR?-AAV GMP manufacturing strictly follows the ICH Q7 & Part II GMP guidelines. It is manufactured in compliance with the most stringent guidelines for the use of raw material (Eudralex Vol 4 Part II, Annex 1).
  • Robust & reliable aseptic manufacturing. FectoVIR?-AAV GMP is produced following a robust and aseptic manufacturing process to guarantee quality of each batch and ensure batch to batch consistency.
  • Manufacturing cost-effectiveness. FectoVIR?-AAV GMP is the scaled duplicate of FectoVIR-AAV to guarantee similar AAV production yield during process development for large scale GMP manufacturing and commercialization.
  • Accelerated time to market. FectoVIR?-AAV GMP is intended to increase transfection performance and industrial scalability to expand the number of doses per production batch to treat more patients.


產(chǎn)品訂購信息

產(chǎn)品

規(guī)格

貨號

PElpro轉(zhuǎn)染試劑

1.5ML

101000017

PElpro轉(zhuǎn)染試劑

10ML

101000033

PElpro轉(zhuǎn)染試劑

100ML

101000026

PElpro-HQ 轉(zhuǎn)染試劑

100ML

101000052

PElpro-HQ 轉(zhuǎn)染試劑

1L

101000039

PEIpro-GMP 轉(zhuǎn)染試劑

300 mL bag

102000005

PEIpro-GMP 轉(zhuǎn)染試劑

1L bag

102000001

PEIpro-GMP 轉(zhuǎn)染試劑

100 mL bottle

102000002

PEIpro-GMP 轉(zhuǎn)染試劑

10 x 10 mlL. bottles

102000011

FectoVIR-AAV 轉(zhuǎn)染試劑

1ML

101000044

FectoVIR-AAV 轉(zhuǎn)染試劑

10ML

101000022

FectoVIR-AAV 轉(zhuǎn)染試劑

100ML

101000004

FectoVIR-AAV GMP 轉(zhuǎn)染試劑

100ML

102000006

FectoVIR-AAV GMP 轉(zhuǎn)染試劑

1L

102000009