Home » CGT CDMO » Lentiviral Vector CDMO Services » Lentiviral Vector One-stop Solution

We are ready to provide

Stages Regular CMC FAST CMC – Adh. FDA/EMA IND Ready CMC
Packaging Test
Cell Banking
Process Development (PD) NA NA
Verification Runs NA
Engineering run
Analytical Development (AD)/Project Specific Qualification (PSQ) NA
Pilot Scale Production
Stability Study

Cell Banking

Lentivirus production working within GMP regulations, GenScript ProBio offers cell bank manufacturing service to customers, ensuring manufacturing fully Lentivirus production compliant to GMP and with full characterization. Our cell banks support customers’ projects move forward smoothly from clinical phase to commercialization.

We also have our own cell banks ready for lentiviral vector production

  • MCB and WCB for HEK293T, for adherent culture
  • ProBio proprietary cell line PowerSTM-293T for suspension culture

Process Development (PD)

Smooth transition from early stage research through clinic to market demands for stable, scalable and robust manufacturing process. GenScript ProBio has developed adherent culture system, as well as suspension culture system in a dedicated PD lab, and is experienced in developing and optimizing process of customer’s projects. Successful deliveries over the past year have enabled us to reduce development cycle and streamline processes.

Process development services include:

  • Upstream process development
  • Downstream process development
  • Lab-scale viral vector manufacturing for process validation
  • Process scale-up

Analytical Development Services

GenScript ProBio offers a wide range of assays, which have been developed and optimized, to ensure quality lentiviral products in the dedicated assay lab. The analytical support for customers includes analytical development, qualification, validation and transfer, which is also essential in CMC study for regulatory filings.

Key assays available in GenScript ProBio includes BSA, benzonase, host cell protein, host cell DNA, residual plasmid, SV40, functional titer, sterility, endotoxin, mycoplasma, etc.

GenScript ProBio also develops assays tailored to customers’ requirements for specific applications or types of product.

Lentiviral Vector Manufacturing

GenScript ProBio is experienced in manufacturing of lentiviral vector adopting both adherent production system and suspension system, providing customers with quality products for preclinical, clinical and commercial supply.

Manufacturing with adherent system

  • The largest manufacturing scales is 50CF10

Manufacturing with suspension system

  • up to 200L manufacturing scale
  • Proprietary cell line PowerSTM-293T
  • Yield improves 4~5 times compared with other commercial cell line
  • ~50% material cost reduction

GenScript ProBio manufactures Lentiviral vector with well-established process in highly-controlled manufacturing suites, performs testing to control the quality of product, including identity, purity, safety, potency, etc. Under strict and comprehensive quality oversight, all materials are well controlled, deviations are investigated and documented, and facilities with equipment are qualified.

Stability Test

GenScript ProBio provides influencing factor, accelerated and long-term stability studies according to ICH guidelines to monitor product integrity over time. Different factors, such as light, heat, humidity, are examined to determine influence of external factors on the active ingredients

Expect MORE from One-Stop Solutions

  • Ready to start your project once contract is in place
  • Optimized and well-controlled manufacturing process for the most cost-effective options to speed up to clinic
  • Fully developed and qualified analytical methods supporting regulatory filing
  • LVV packaging and lentiviral products manufactured under GMP facilities and comprehensive quality assurance

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