CDMO-浦珠生物

CDMO

Introduction:

Pracgen’s virus technical team is composed of virology experts with decades of industry experience. We have developed protocols for both adherent and serum-free suspension lentivirus production, and the latter method eliminates the need to examine exogenous serum residues. Serum-free suspension lentivirus production makes the process safer and greatly increases yields. Furthermore, all of our virus production processes strictly comply with GMP production requirements, and the virus titer can reach 1e7 TU/mL, representing top global industries standards. Pracgen’s high-quality lentiviruses feature extraordinary purity and stability, and as such are increasingly being recognized by our valued partners and clients.

Procedure:

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Advantages:

Stable

Stable adherent and suspension production process
Virus stability is high; can remain stable for over 1 year
China and US IND application experience
High efficiency

virus purification is completed within 8 hours with high efficiency
Virus purification yield is high; overall yield of more than 20%
Transfection efficiency is high; the initial virus titer is over 1x107 TU/ml, and virus titer after purification is above 1x109 TU/ml.
We offer continuous, scalable production; and each batch meet minimum 1,000 human dosage
Safety

serum-free, avoiding the need to inspection for exogenous serum factors

More Info:

Service information

Item	Content
Lentivirus packaging	There are two cell culture methods, namely, suspension culture and adherent culture, with virus titer over 1×106TU/ml, fast purification, high yield and good quality. Pracgen provides research and clinical grade viruses to customers.
Retrovirus packaging	Two kinds of retrovirus packaging services: transient packaging and stable expression, with high titer expression over 1×106 TU/ml, the retroviral transduction efficiency is as high as 80%, which can be used in the field of cell therapy such as CAR-T and CAR-NK, exerting little effect on the activity of immune cells.
AAV packaging	It has suspension packaging cell lines. AAV packaging and purification methods can be developed according to customer processes. The world's leading bioreactor is used for cell culture and virus packaging.
Oncolytic virus production	Host cell lines are made from traceable institution. The three-level cell bank meets the IND application requirements. There are two cell culture methods, namely, suspension culture and adherent culture. Purification process development, optimization and pilot scale production are available.

Process development service content and price

Name	Cycle	Delivery standard	Price
Cell line screening	2-3 months	Meet ChP requirements	Quote
Three-level cell bank establishment	3-4 weeks	Meet ChP requirements
Cell culture process development and validation	3-4 months	Subject to contract
Purification process development and validation	1.5-3 months	Subject to contract
Formulation development	1.5-2 months	Subject to contract
Study on stability of preparation	6 months – 2 years	Subject to contract
Test methodology development	Depending on method	Meet ChP requirements
Test methodology validation	Depending on method	Meet ChP requirements

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