Assistance from Pre-clinical to Clinical
Adherent & Suspension Platforms
Well noticed the challenges in viral vector production, GenScript ProBio is dedicated to developing technologies in viral vector manufacturing. Currently, GenScript ProBio has established robust platform to manufacture Lentiviral vector, using either adherent culture or suspension culture. We are also providing cell banking, process development and essential Quality Control (QC) services to cover all your needs from pre-clinical to clinical phases.
Working within GMP regulations, GenScript ProBio offers cell bank manufacturing service to customers, ensuring manufacturing fully 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
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:
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.
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
Manufacturing with suspension system
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.
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