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Over 20 IND Track Records
Adherent & Suspension Platforms
Well noticed the challenges in viral vector production, ProBio is dedicated to developing technologies and establishes robust platform to manufacture Lentiviral vector, using either adherent culture or suspension culture. The services include cell banking, process development and essential Quality Control (QC), LVV production, which cover all your needs from pre-clinical to commercial phases.
Cell Banking
Lentiviral vector production working within GMP regulations, ProBio offers cell bank manufacturing service to customers, ensuring manufacturing fully Lentiviral vector 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
Process Development (PD)
Smooth transition from early stage research through clinic to market demands for stable, scalable and robust manufacturing process. ProBio has developed adherent system, as well as suspension 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:
Analytical Development Services
ProBio offers a wide range of assays, which have been developed and optimized, to ensure quality Lentiviral vector in the dedicated assay lab. The analytical support for customers includes analytical development, qualification, validation and transfer, which is also essential in CMC study and BLA for regulatory filings.
Key assays available in ProBio includes BSA, benzonase, host cell protein, host cell DNA, residual plasmid, SV40, functional titer, sterility, endotoxin, mycoplasma, etc.
ProBio also develops assays tailored to customers’ requirements for specific applications or types of product.
Lentiviral Vector Manufacturing
ProBio is experienced in manufacturing of lentiviral vector adopting both adherent system and suspension system, providing customers with quality products for preclinical, clinical and commercial supply.
Manufacturing with adherent system
Manufacturing with suspension system
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
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