With deep understanding of lentivirus manufacturing process and experienced leader and front-line personal, GenScript is providing lentivirus 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 has developed adherent production system in a dedicated PD lab to satisfy most client’s lentivirus process development needs. Successful deliveries over the past year have enabled us to reduce development cycle and streamline processes.
Lentivirus process development services include:
- Upstream process development
- Downstream process development
- Lab-scale lentivirus manufacturing for process validation
- Process scale-up
Working within GMP regulations, GenScript offers cell banking to customers, ensuring manufacturing fully compliant to GMP and with full characterization. GenScript cell banks support customers projects move forward smoothly from clinical phase to commercial supply.
GenScript is experienced in manufacturing of lentiviral vectors adopting adherent production system, providing customers with quality products for preclinical, clinical and commercial supply.
GenScript 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 validated.
GenScript 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 includes BSA, benzonase, host cell protein, host cell DNA, residual plasmid, SV40, functional titer, sterility, endotoxin, mycoplasma, etc.
GenScript also develop assays tailored to customer’s requirement for specific applications or types of product.
GenScript 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