PEIpro®-HQ

Therapeutic virus production

  • The unique PEI suitable for production of clinical batches and use in GMP processes
  • Perfectly suited for therapeutic virus production
  • Synthetic reagent free of any animal-origin components
  • Manufactured according to a well-established process
  • Fully characterized product with extensive Quality Controls
  • Supplied with appropriate Documentation
  • Robust and long shelf life

Specifications

Reagent

PEIpro®-HQ

Molecule delivered

DNA

Applications

Production of clinical grade viruses and proteins
Suitable for use in GMP processes

Cell types

Adherent or suspension HEK-293 and HEK-293T cells and derivatives grown in synthetic serum-free medium

Number of transfections

1 Liter of PEIpro®-HQ is sufficient to transfect on average 500 Liters of cell culture

Storage

4 °C, for at least 2 years

Provided with

Certificate of Analysis
Certificate of Origin
Batch Production Documentation
Non-Hazardous Product Statement

Summary

Advanced therapy medicinal products (ATMPs) including gene therapy and cell therapy medicines have emerged as promising treatments for various diseases. These therapies involve the introduction of therapeutic DNA into patient’s body or patient’s cells. This process is often accomplished by the use of viral vectors. Raw materials used for the manufacturing of these viral vectors need to be manufactured according to a robust and reproducible process, with appropriate Quality Controls.

PEIpro®-HQ is a highly qualified grade of PEIpro® reagent, especially developed for the production of clinical batches of viral vectors, such as Adenovirus, Adeno Associated virus (AAV) and lentivirus, in addition to proteins. This reagent is a linear Polyethylenimine (PEI) based transfection reagent widely used for the development of large-scale bioproduction processes in adherent or suspension HEK-293 or HEK-293T cells grown in synthetic serum-free media. The PEIpro®-HQ grade is supplied with appropriate Quality Controls and documentation allowing its use as a qualified raw material in GMP processes for the manufacturing of clinical batches of therapeutic products.

File icone Read the article published in GEN: Simplifying the Efficient Clinical-Grade Production of Viruses

Ordering information

Reference NumberAmount of reagent
301-4004 x 100 ml
301-01K10 x 100 ml
301-01L1 x 1 L

Larger quantities are available upon request.

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Manufactured according to a well-established process

PEIpro®-HQ is a fully synthetic reagent free of any animal-origin components. PEIpro®-HQ is manufactured and formulated using a well-established and controlled manufacturing process (Fig. 1), allowing the reproducible supply of remarkably high quality product meeting very stringent release specifications.

PEIpro-HQ - Manufacturing-process
Fig. 1: Manufacturing process of PEIpro®-HQ reagent

Each lot of PEIpro®-HQ is provided with a Batch Production Documentation that contains a comprehensive summary of the manufacturing process and the quality controls, which makes PEIpro®-HQ perfectly suitable for use as a qualified raw material for the production of clinical batches of viruses and proteins in GMP processes.

PEIpro®-HQ is an optimized and selected PEI, truly deacylated, with an extremely low polymer chain length variation and formulated at 1 mg/ml in water.

Fully characterized Product with extensive Quality Controls

Recently, there is an increase in regulatory scrutiny for reagents used as raw material in the production of viruses for early-phase clinical trials. Along with the recent increase in biopharmaceutical funding in gene therapy, it is now mandatory to meet higher levels of quality compliance at earlier stages of clinical development. With its extensive Quality Controls PEIpro®-HQ fully answers these needs.

The quality of PEIpro®-HQ is continuously assessed during the manufacturing process with suitable control testing. An extensive number of Quality Controls are performed on both the bulk material and the formulated product to assess identity, potency, safety and purity of PEIpro®-HQ (Table 1).

Indeed, PEIpro®-HQ is tested to ensure complete sterility, absence of mycoplasma and very low level of bacterial endotoxins following pharmacopoeia standards. Impurity profile, residual organic solvent and heavy metal content are also tested to assess the purity of the reagent. Moreover, a standardized transfection assay is performed with a suspension HEK-293 cell line in serum-free medium to ensure the reliability and reproducibility of the transfection efficiency under conditions that are suitable for virus production.

PEIpro®-HQ is released with a Certificate of Analysis including the results of the Quality Controls. A full list of QCs is available upon request (Contact the Technical Support).

PEIpro®-HQ is also supplied with a Certificate of Origin confirming the absence of components of animal origin and a Non-Hazardous Product Statement.

PEIpro-HQ - highly-qualified grade of PEIpro
Table 1: PEIpro®-HQ is a highly qualified grade of PEIpro® reagent. The quality of PEIpro® and PEIpro®-HQ are continuously assessed during the manufacturing process with suitable control testing. In comparison to PEIpro®, a more extensive number of quality controls are performed on both the bulk material and the formulated product to assess identity, purity, safety, and potency.

Especially developed for therapeutic virus production

PEIpro®-HQ combines an exceptional quality grade with robust transfection efficiency. PEIpro-HQ® is currently used for the production of large quantities of viral vectors, including Adenovirus, Adeno Associated Virus (AAV) and lentivirus. PEIpro®-HQ is suitable for use in mammalian cells such as HEK-293 and HEK-293T grown adherently or in suspension in both serum containing media or synthetic chemically defined media. PEIpro®-HQ can be used in all types of cell culture vessels, single used bioreactors (SUB), WAVE bags and fixed bed bioreactors such as iCELLIS®. Following PEIpro®-HQ mediated transient transfection, lentivirus titers routinely reach up to 10^14 VG/ml.

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A Recognized Quality Management System

Polyplus-transfection® has been awarded ISO 9001 Quality Management System Certification since 2002, ensuring that the company has established reliable and effective processes for manufacturing, quality controls, distribution and customer support.

Our customers are invited to audit Polyplus-transfection® in order to qualify our company as a supplier of raw materials used in the manufacturing of clinical grade therapeutic products. Please contact us if you would like to perform an audit of our Quality Management System.

Stability of the reagents

Polyplus-transfection®’s reagents have a robust and long shelf life of a minimum of two years, ideal for timely completion of GMP production processes.