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1

The pharmaceutical study work of process development for gene

recombinant virus manufacturing which we can do

The process development of cell culture, cell banking Include

The process development of cell culture

Cell banking (Master and Working Cell Banks)

The stability study on cell passage

The adaptation of cell to suspension with Serum Free Media (SFM)

The process development of virus amplification, Master and Working Virus Seeds banking Include

The process development of virus amplification

Virus seeds banking(Master and Working Virus Seeds lots)

The stability study on virus generation times of amplification

Virus strain monoclonal screening

The process development of virus purification, Pre-clinical / toxicological batch manufacturing Include

The process development of virus purification

The study on virus preservation solution formulation

Pre-clinical / toxicological batch manufacturing for animal test

IND batches (n=3, Drug Substance and Drug Product) manufacturing

Clinical trials sample manufacturingInclude

The sample manufacturing for clinical trials of stage I, II, III or IV

Can also include process improvement, process change, process validation, etc.

Product stability research

Including the stability study on three batches of DS (bulk) or DP (preparation)

Preparation of a CMC regulatory dossier for CFDA Include

CMC regulatory dossier for CFDA IND application and approval

Declare new drug certificate,Declare process change,Declare GMP certification

2The types of viral vector which we can produce

Adenovirus

Amplification with HEK293 cells (adherent), HER096 cells (suspension) or the other cells customers provided.

Introduction of adenovirus

Adenoviruses are medium-sized (70-90nm), non-enveloped viruses containing double-stranded DNA. Virus packaged by transfecting HEK 293 cells with adenoviral-based vectors is capable of infecting dividing and nondividing cells. Depending on the genetic modification, adenovirus vectors retain packaging signal sequence, remove the viral protein coding sequence,not only to increase the packing capacity of exogenous gene, and to reduce the cytotoxicity and immune response, thereby gaining greater security of gene delivery system.

Adenovirus packaging system features: not integrated into the host cell genome; without insertion mutation; effectively amplify to obtain high titer and high purity of adenovirus.

Adenovirus technical specification

Customers provide adenovirus seeds, our company will amplify them in the cell and evaluate single cell yield of the virus. According to customer requirements to small scale production or pilot production, small scale production can abtain 1012~1013 vps virus, pilot production can get 1014~1015 vps virus by the NBS bioreactor or WAVE bioreactor.

Lentivirus

Amplification with 293T cells

Introduction of Lentivirus

Lentivirus belongs to the retrovirus family. Most of the lentiviral vectors presently in use are HIV-derived vectors. The cis- and trans-acting factors of lentiviruses are often on separate

plasmid vectors, with packaging being provided in trans. The vector constructs contain the viral cis elements, packaging sequences, the Rev response element (RRE), and a transgene.

Replacement of the HIV envelope glycoprotein with VSV-G provides a broad host-range for the vector. The virulence genes in the Lentivirus have been removed and replaced by exogenous gene, so it belongs to pseudovirions. It can integrate transgene sequence to the cellular genome through the cis effect components.

Lentivirus packaging system features: 1. the exogenous gene expression level high and stable; 2. high transfection efficiency, infecting dividing and nondividing cell; 3.easy to operate, easy to prepare a large number of high titer viruses; 4. viral genome can be integrated into the cellular genome, easy to build stable cell lines.

Lentivirus technical specifications

Customers provide a complete set of Lentivirus plasmid vector (expression vector, packaging systems), our company can optimize conditions to transfect, or customers may only provide expression vector, by our packaging systems. We can abtain107~ 108TU/ml virus.

Vaccinia virus

Amplification with Hela cells (adherent, suspension), BHK-21 cells or to the other cells customers provided.

Introduction of vaccinia virus

The vaccinia viruses are the largest known DNA viruses and are distinguished from other viruses by their ability to replicate entirely in the cytoplasm of infected cells. The core contains a 200-kilobase pairs (kbp), double-stranded DNA genome and is surrounded by a lipoprotein core membrane, a diameter of 300-400 nm.

Vaccinia virus packaging system characteristics: 1. can accept as much as 25 kb of exogenousDNA, making it useful for expressing large eukaryotic and prokaryotic genes; 2. exogenous genes are integrated stably into the viral genome, resulting in efficient replication and expression of biologically active molecules.3.the host range is extensive; 4. not integrated into the host cell genome.

Vaccinia virus technical specification

Customers provide vaccinia virus seeds. According to customer requirements to small scale production or pilot production, we can abtain 1011 ~ 1012 pfu virus.

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