DNA Sequencing Services - WuXi AppTec

1 Essential data analysis for product development and regulatory submissionDNA Sequencing ServicesILLUSTRATION:DNA double helix3/0053 emaN/ledoM tsnI1_lx7 POP_05qeSdtS_31_10E_MEGp500 InstrumentpGEMMay 20,2011 04:48PM, EDTS/N G:42 A:43 T:42 20,2011 05:12PM, 1479 to 14191 Pk1 Loc:1456 Cap:13 Version HiSQV Bases: 1020 Plate Name: pGEM-05-20 Printed on: Tue May 24,2011 02:15PM, EDTS equence Data Page 1 of 2 TYAAWWWGGGGGCGAATTCGAGCTCGGTACCCGGGGATCC TCTAGAGTCGACCTGCAGGCATGCAAGCTT170 GASTATTCTATAGTGTCACCTAAATAGCTTGGCGTAATCA TGGTCATAGCTGTTTCCTGTGTGAAATTGT71140 TATCCGCTCACAATTCCACACAACATACGAGCCGGAAGCA TAAAGTGTAAAGCCTGGGGTGCCTAATGAG141210 TGAGCTAACTCACATTAATTGCGTTGCGCTCACTGCCCGC TTTCCAGTCGGGAAACCTGTCGTGCCAGCT211280 GCATTAATGAATCGGCCAACGCGCGGGGAGAGGCGGTTTG CGTATTGGGCGCTCTTCCGCTTCCTCGCTC281350 ACTGACTCGCTGCGCTCGGTCGTTCGGCTGCGGCGAGCGG TATCAGCTCACTCAAAGGCGGTAATACGGT351420 TATCCACAGAATCAGGGGATAACGCAGGAAAGAACATGTG AGCAAAAGGCCAGCAAAAGGCCAGGAACCG421490 TAAAAAGGCCGCGTTGCTGGCGTTTTTCCATAGGCTCCGC CCCCCTGACGAGCATCACAAAAATCGACGC491560 TCAAGTCAGAGGTGGCGAAACCCGACAGGACTATAAAGAT ACCAGGCGTTTCCCCCTGGAAGCTCCCTCG561630

2 TGCGCTCTCCTGTTCCGACCCTGCCGCTTACCGGATACCT GTCCGCCTTTCTCCCTTCGGGAAGCGTGGC631700 GCTTTCTCATAGCTCACGCTGTAGGTATCTCAGTTCGGTG TAGGTCGTTCGCTCCAAGCTGGGCTGTGTG701770 CACGAACCCCCCGTTCAGCCCGACCGCTGCGCCTTATCCG GTAACTATCGTCTTGAGTCCAACCCGGTAA771840 Additional Related ServicesO ered by wuxi AppTec Cell Line Development & Engineering Cell Line Identi cation GMP Cell Banking & Characterization Lot Release Testing Stability StudiesProduct Types SupportedRecombinant Protein Therapeutic Monoclonal Antibody Plasmid or Viral Gene Therapy VaccineDNA Sequencing in Support ofBiopharmaceutical Product DevelopmentWuXi AppTec o ers R&D, GLP and GMP DNA Sequencing Services from early-stage development to GMP lot release of clinical and commercial Development and CloningDNA Sequencing is commonly used to con rm the integrity of a gene cloned into a plasmid or viral vector prior to transfection into a producer cell line or infection in the case of viral vaccines.

3 In addition, Sequencing of the entire plasmid or viral construct is also required for many therapeutic or vaccine product regulatory submissions. Genetic Stability of Producer Cell LinesFor protein therapeutics, determining genetic stability of the producer cell line is also a regulatory ling necessity. wuxi AppTec s DNA Sequencing and molecular biology laboratories in Philadelphia o er support with the following studies on the Master Cell Bank and the End of Production Cells: Genomic DNA Sequencing (gene and anking regions) RT-PCR cDNA Sequencing (mRNA/message integrity) Construct DNA sequencingIn addition to DNA Sequencing , the molecular biology lab can support other genetic stability studies, including Southern and Northern Blotting and qPCR for copy number determination.

4 25-year history with an expert support team, including six with 80 years combined molecular biology and virology experience. Experience from analyzing a wide range of vectors from di erent virus families, including: adenovirus, herpesvirus, etc. Ability to sequence viruses with high GC content and complexity. Industry-standard platforms (next generation and capillary electrophoresis) for speed and optimized data Generation Technology Industry-Leading TechnologiesAdvanced Sequencing platforms are utilized by wuxi AppTec to meet your speci c project needs. Our expert teams are fully trained on a wide range of technologies including: Life Technologies (Ion Proton , Ion PGM ) and Illumina (HiSeq 2000/2500, MiSeq, Genome Analyzer IIX).

5 Next-Generation Data Analysis and Bioinformatics Raw data analysis to meet stringent quality criteria. Accurate Sequencing data assembly using validatedcommercial software. Structural variant identi cation. Sanger Sequencing available for gap closure (if required).Whole Virus / Vector SequencingMapping and con rming the sequence of large viral vectors or virus (over 10,000 bp) is a requirement of current EMA and FDA regulations. Whether you are developing a viral vaccine or a gene therapy product, our next-generation Sequencing technologies can provide rapid, extensive, and cost-e ective means of Sequencing large addition, the Sequencing platforms allow for multiple samples to be sequenced simultaneously ideal for discovery/development programs when the need to sequence several plasmid or virus vectors is Sequencing ServicesWuXi AppTec utilizes Life Technologies and Illumina Sequencing systems for the following applications.

6 Adventitious agent detection via its AgentSCREEN and AgentID Services Biomarker development for R&D, preclinical and clinical studies Whole genome and transcriptome Sequencing Exome Sequencing wuxi AppTec is a Life Technologies Certi ed Service Provider Capillary Electrophoresis[Sanger Method] For R&D, GLP or GMP genetic stability and gene integrity and vector construct Sequencing , wuxi AppTec utilizes the Applied Biosystems (ABI) 3500 system (24 capillary). Along with ABI PCR instrumentation, we can provide a wide variety of Sequencing applications that meet your exacting quality standards. Experience & Program Features3/0053 emaN/ledoM tsnI1_lx7 POP_05qeSdtS_31_10E_MEGp500 InstrumentpGEMMay 20,2011 04:48PM, EDTS/N G:42 A:43 T:42 20,2011 05:12PM, 1479 to 14191 Pk1 Loc:1456 Cap:13 Version HiSQV Bases: 1020 Plate Name: pGEM-05-20 Printed on: Tue May 24,2011 02.

7 15PM, EDTS equence Data Page 1 of 2 TYAAWWWGGGGGCGAATTCGAGCTCGGTACCCGGGGATCC TCTAGAGTCGACCTGCAGGCATGCAAGCTT170 GASTATTCTATAGTGTCACCTAAATAGCTTGGCGTAATCA TGGTCATAGCTGTTTCCTGTGTGAAATTGT71140 TATCCGCTCACAATTCCACACAACATACGAGCCGGAAGCA TAAAGTGTAAAGCCTGGGGTGCCTAATGAG141210 TGAGCTAACTCACATTAATTGCGTTGCGCTCACTGCCCGC TTTCCAGTCGGGAAACCTGTCGTGCCAGCT211280 GCATTAATGAATCGGCCAACGCGCGGGGAGAGGCGGTTTG CGTATTGGGCGCTCTTCCGCTTCCTCGCTC281350 ACTGACTCGCTGCGCTCGGTCGTTCGGCTGCGGCGAGCGG TATCAGCTCACTCAAAGGCGGTAATACGGT351420 TATCCACAGAATCAGGGGATAACGCAGGAAAGAACATGTG AGCAAAAGGCCAGCAAAAGGCCAGGAACCG421490 TAAAAAGGCCGCGTTGCTGGCGTTTTTCCATAGGCTCCGC CCCCCTGACGAGCATCACAAAAATCGACGC491560 TCAAGTCAGAGGTGGCGAAACCCGACAGGACTATAAAGAT ACCAGGCGTTTCCCCCTGGAAGCTCCCTCG561630 TGCGCTCTCCTGTTCCGACCCTGCCGCTTACCGGATACCT GTCCGCCTTTCTCCCTTCGGGAAGCGTGGC631700 GCTTTCTCATAGCTCACGCTGTAGGTATCTCAGTTCGGTG TAGGTCGTTCGCTCCAAGCTGGGCTGTGTG701770 CACGAACCCCCCGTTCAGCCCGACCGCTGCGCCTTATCCG GTAACTATCGTCTTGAGTCCAACCCGGTAA771840 Additional Related ServicesO ered by wuxi AppTec Cell Line Development & Engineering Cell Line Identi cation GMP Cell Banking & Characterization Lot Release Testing Stability StudiesProduct Types SupportedRecombinant Protein Therapeutic Monoclonal Antibody Plasmid or Viral Gene Therapy VaccineDNA Sequencing in Support ofBiopharmaceutical Product DevelopmentWuXi AppTec o ers R&D.

8 GLP and GMP DNA Sequencing Services from early-stage development to GMP lot release of clinical and commercial Development and CloningDNA Sequencing is commonly used to con rm the integrity of a gene cloned into a plasmid or viral vector prior to transfection into a producer cell line or infection in the case of viral vaccines. In addition, Sequencing of the entire plasmid or viral construct is also required for many therapeutic or vaccine product regulatory submissions. Genetic Stability of Producer Cell LinesFor protein therapeutics, determining genetic stability of the producer cell line is also a regulatory ling necessity. wuxi AppTec s DNA Sequencing and molecular biology laboratories in Philadelphia o er support with the following studies on the Master Cell Bank and the End of Production Cells: Genomic DNA Sequencing (gene and anking regions) RT-PCR cDNA Sequencing (mRNA/message integrity) Construct DNA sequencingIn addition to DNA Sequencing , the molecular biology lab can support other genetic stability studies, including Southern and Northern Blotting and qPCR for copy number determination.

9 25-year history with an expert support team, including six with 80 years combined molecular biology and virology experience. Experience from analyzing a wide range of vectors from di erent virus families, including: adenovirus, herpesvirus, etc. Ability to sequence viruses with high GC content and complexity. Industry-standard platforms (next generation and capillary electrophoresis) for speed and optimized data Generation Technology Industry-Leading TechnologiesAdvanced Sequencing platforms are utilized by wuxi AppTec to meet your speci c project needs. Our expert teams are fully trained on a wide range of technologies including: Life Technologies (Ion Proton , Ion PGM ) and Illumina (HiSeq 2000/2500, MiSeq, Genome Analyzer IIX).

10 Next-Generation Data Analysis and Bioinformatics Raw data analysis to meet stringent quality criteria. Accurate Sequencing data assembly using validatedcommercial software. Structural variant identi cation. Sanger Sequencing available for gap closure (if required).Whole Virus / Vector SequencingMapping and con rming the sequence of large viral vectors or virus (over 10,000 bp) is a requirement of current EMA and FDA regulations. Whether you are developing a viral vaccine or a gene therapy product, our next-generation Sequencing technologies can provide rapid, extensive, and cost-e ective means of Sequencing large addition, the Sequencing platforms allow for multiple samples to be sequenced simultaneously ideal for discovery/development programs when the need to sequence several plasmid or virus vectors is Sequencing ServicesWuXi AppTec utilizes Life Technologies and Illumina Sequencing systems for the following applications.