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Lentiviral Vector One-stop Solution

Cost-effective and robust access from lab to clinic

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With deep understanding of lentiviral vector manufacturing process and experienced leader and front-line personal, GenScript ProBio is providing lentiviral vector one-stop solutions for clients to satisfy needs from preclinical through clinical to commercialization.

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 production system in a dedicated PD lab to satisfy most client’s lentiviral vector process development needs. Successful deliveries over the past year have enabled us to reduce development cycle and streamline processes.

lentiviral vector process development services include:

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

Cell Banking

Working within GMP regulations, GenScript ProBio offers cell banking to customers, ensuring manufacturing fully compliant to GMP and with full characterization. GenScript ProBio cell banks support customers projects move forward smoothly from clinical phase to commercial supply.

lentiviral vector Manufacturing

GenScript ProBio is experienced in manufacturing of lentiviral vectors 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 75CF10
  • High final product titer of 5E7 TU/ml

Manufacturing with suspension system

  • up to 200L manufacturing scales
  • Full ProBio IP cell line
  • Yield improves 4~5 times compared with other commercial cell line
  • ~50% materials cost reduction

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

Analytics Development

GenScript ProBio offers a wide range of testing, which has 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 develop assays tailored to customer’s requirement for specific applications or types of product.

Stability Test

GenScript ProBio provides 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
  • Lentiviral products manufactured under GMP facilities and comprehensive quality assurance

Our customer service representatives are available 24 hours a day, Monday through Friday, to assist you.