LIFE SCIENCES LIFE INSPIRED, QUALITY DRIVEN QUANTITATIVE PCR (qPCR) SERVICES BIOLOGICS SGS provides a wide range of qPCR testing services to meet your preclinical and clinical requirements. Our scientists have over 20 years’ experience in setting the current biopharmaceutical industry standards for the development and validation of qPCR assays for virus detection. All qPCR assays are validated to ICHQ2 guidelines, GMP compliant, and performed on ABI 7900HT systems using TaqMan technology, in accordance with criteria required for maintaining 21CFR part 11 compliance. CONFORMATORY DETECTION UTILISING QPCR FOR NGS HUMAN VIRUSES PORCINE VIRUSES Human immunodeficiency Human T-cell lymphotropic virus Porcine adenovirus West Nile virus virus (HIV-1,HIV2) (Proviral) (HTLV-1, HTLV-2) (Proviral) Human immunodeficiency Human T-cell lymphotropic virus Porcine circovirus (Types 1/2/3) Bornavirus virus (HIV-1,HIV2) ( RNA) (HTLV-1, HTLV-2) (RNA) Human papillomavirus (Types Human Herpes simplex virus Porcine parvovirus Hantaviruses (SEOV/SNV) 6,11.16,18, 31, 33, 52 and 58) (Types 1/2) Eguine encephalomyelitis Human Hepatitis viruses Porcine lymphotropic Human herpes Viruses (3/6/7/8) virus (A/B/C) herpesvirus (Types 1/2/3) (Types EEEV/WEEV/VEEV) Human cytomegalovirus Human Simian virus 40& SV40 Porcine cytomegalovirus Swine Torque tenovirus (hCMV) LTA Human Parvovirus B19/4/5 & Human Adenovirus & Human Swinepox virus Rabies virus Erythrovirus V9 Adeno Associated Virus Human polyomavirus Human Parainfluenza Virus Porcine haemagglutinating (Typse BK/JC/WU/KI/ Pseuodorabies virus (Types 1/2/3) MCPyV/6/7/9/TS PyV encephalomyelitis virus Human Respiratory Syncytial Transmissible gastroenteritis Epstein-Barr virus Porcine rotavirus (Types A/C) Virus (Types A and B) virus Human Enterovirus Varicella-zoster Virus Porcine Teschovirus Classical swine fever virus Human Rhinovirus Human Bocavirus Procine Hokovirus/Bocavirus African Swine Fever virus Measles virus & Subacute Swine vesicular diesease Rubella virus (Rubella) Hepatitis E sclerosing panencephalitis virus virus Swine encephalomyocarditis Mumps virus Human Torque tenovirus Reovirus /Types 1/2/3 virus Human coronavirus (HCoV) Types 229E, OC43, HKU1, Influenza A/C NL63 and SARS-CoV-2 Positive Viral Pathogen detection obtained using NGS testing methods can be verified utilising ICH Q2 validated Real Time Polymerase Chain Reaction (PCR) assays which are available for all Human, Porcine, Bovine, Avian, Duck, Simian, Murine and Bacterial pathogens listed. BOVINE VIRUSES AVIAN/DUCK VIRUSES Bovine herpes virus Bovine polyomavirus (BPyV) Duck Adenovirus (DAdV) Duck circovirus (Types 1&4) Bovine parvovirus types Bovine respiratory syncitial virus Avian Encephalomyelitis virus Duck Hepatitis B virus 1/2/3 Bovine parainfluenza virus Bovine bocavirus Chicken Parvovirus (ChPV) Duck hepatitis virus (Type 1) Type3 Bovine Rotavirus Bovine Epizootic Hemorrhagic Avian Reovirus Duck picornavirus (Type A and C) Disease virus Avian leukosis virus Bovine Hokovirus Bovine Adenovirus Duck virus enteritis (Types A/B/C/D/E/J) Bovine viral diarrhea virus Bovine Adeno Associated Virus Chicken Anaemia virus Goose parvovirus (Types 1/2/3) Bovine Enterovirus Bovine Astrovirus Avian influenza virus Infectious bronchitis virus Bovine Norovirus Blue tongue virus Moscovy Duck parvovirus Vesivirus Positive Viral Pathogen detection obtained using NGS testing methods can be verified utilising ICH Q2 validated Real Time Polymerase Chain Reaction (PCR) assays which are available for all Human, Porcine, Bovine, Avian, Duck, Simian, Murine and Bacterial pathogens listed. SIMIAN VIRUSES MURINE/INSECT VIRUSES BACTERIAL Simian cytomegalovirus Minute virus of mice Mycobacterium species Ecotropic, Polytropic & Xenotropic murine Mycoplasma Species Rhesus cytomegalovirus leukaemia virus Simian foamy virus Flock house virus Chlamydia species Simian retrovirus Nodamura virus Treponema pallidum (Types 1/2/3/4/5) Squirrel monkey retrovirus Boolarra virus Neissera gonorrhoeae Simian Adenovirus Pariacoto virus Leptospiraceae Simian Immunodeficiency virus Cache valley virus Simian T-cell leukaemia virus types 1 and Sf-Rhabdovirus 2 (STLV-1 and STLV-2) Positive Viral Pathogen detection obtained using NGS testing methods can be verified utilising ICH Q2 validated Real Time Polymerase Chain Reaction (PCR) assays which are available for all Human, Porcine, Bovine, Avian, Duck, Simian, Murine and Bacterial pathogens listed. ABOUT SGS • Raw material and bulk harvest For any of your biologics, we help SGS provides a comprehensive range testing (sterility, mycoplasma, you comply with the global regulatory of biosafety services such as: virology, viruses and other potential biological guidelines and testing requirements. cell and molecular biology as well as contaminants) Our team of experienced scientists microbiology and electron microscopy. • Final product testing for residual DNA have over 20+ years’ experience in Health Authorities, including the US and other process related impurities GMP, FDA, EP, ICH compliant validated assays. FDA and the EMA, require companies to • Regulatory and safety consultancy undergo safety testing to demonstrate services that all cell banks, viral banks, raw Global network • Custom development of assays materials of animal origin, bulk harvests, Rapid turnaround times and batches of clinical drug are free of bacteria, fungi, mycoplasma, viruses and SGS’s global centre of excellence Data management and Reporting other potential contaminants. for cell bank characterization & virus SGS helps clients by ensuring product testing is located in the United Kingdom safety in satisfying these regulatory and provides services with ultimate requirements through a large range reliability, highest GLP/cGMP quality & CONTACT US of validated assays and develops new scientific expertise. As trailblazers in the +44 (0)141 952 0022 services in the following areas: development of the biosafety testing industry, our SGS Vitrology team in [email protected] • Cell bank and virus seeds Glasgow have developed and validated characterization per the major www.sgs.com/lifescience novel nucleic acid technologies, such compendia, regulatory and ICH as real-time PCR, RAPD, Sequencing, www.sgs.com/Linkedin-life guidelines Non-radioactive Southern Blotting, Next Generation Sequencing (NGS). WWW.SGS.COM © SGS Group Management SA – 2020 – All rights reserved - SGS is a registered trademark of Group Management SA – 2020 © SGS Group Management SA.