0:00 Hello, everyone. Good morning, good afternoon. My name is Mike Pipis, and I'm the Regional Business Manager here at SGS Glasgow. Today, I'll be talking about how we can support vaccine manufacturers with our QC GMP testing, specifically biosafety testing.
0:20 I'll give you a background about who SGS is, what makes up our global network, and then go into detail about what we can do here at SGS Glasgow, our centre of excellence with full biosafety capabilities, and why you might want to work with us.
0:42 Our Health Science network includes over 25 labs serving more than 5000 customers across 11 countries with decades of experience. This slide illustrates our drug development network setup.
1:05 The centre of excellence for biosafety is in Glasgow. This standalone lab serves all corners of the world. I'll provide more details later about what each of our sites can support.
1:21 As this slide and graph show, we can support any type of biologic from the start of its life cycle through to leachables and extractables within our network.
1:37 This slide highlights some of our standout labs. Our biopharmaceutical labs in the US, located in Michigan and Chicago, support QC release testing. Our standalone biosafety site in Glasgow works closely with our sites in Belgium, which conduct QC release testing for biologic medicines released within the European Union.
2:16 Post-Brexit, we can serve all types of products. Today, we're focusing on vaccines, but we have decades of experience with biosimilars, monoclonal antibodies, and cell and gene therapy.
2:35 We've broken down the type of support we offer across the four typical stages in the manufacturing cycle for biologics and vaccines.
2:53 Starting with the cell virus bank and starting material phase, we conduct testing according to FDA and European Pharmacopoeia guidelines. This includes microbial contaminants, adventitious virus detection, specific virus detection, identity and genetic stability testing, and retrovirus detection.
3:23 For microbial contaminants, we test for Mycoplasma via culture or GPCR, mycobacteria, Spiroplasma, and sterility. Adventitious virus detection includes in vitro tests like the 28-day in vitro test. We also perform 9 CFR testing by qPCR and specific virus detection using over 300 GMP validated qPCR assays.
4:03 Under specific bio detection, we have MAP and HAP testing, identity and genetic stability testing using methods like NAT, RAPD, karyology, Southern blot, and retrovirus detection. The F-PERT assay, discovered by Doctor Archie Lovett and his group in the late 90s, is one of our in-house expertise areas.
4:49 For bulk harvest, we conduct similar testing panels, including microbial contaminants, adventitious virus detection, specific virus detection, identity, and retrovirus detection. Each bulk harvest or master cell bank needs to be tested separately.
5:18 In the drug substance area, we test for residual impurities like wholesale DNA, wholesale protein residuals, residual reagents like benzonase or BSA, residual plasmid DNA, and endotoxin. We also conduct genetic stability and integrity testing using Southern blot, nucleic acid sequencing, or gene copy number by qPCR.
5:59 Replication competent virus assays are tested depending on the product type. For vaccines, this isn't particularly applicable, but it is for gene therapy. We also test for vector concentration, infectivity, particle ratio, or vector copy number.
6:25 In the drug product manufacturing process, we work closely with our Brussels group for release assays required within the European Union. These include bacterial endotoxin, osmolality, pH, vector aggregate stability, and more.
7:01 Focusing on SGS Glasgow, we have an excellent audit history. We've been audited by the USFDA in 2015 and receive regular audits by the MHRA for GLP and GMP compliance. The FDA and MHRA have mutual recognition, so no further FDA audit is needed due to the mutual recognition of GMP certificates.
7:43 We have a platform of GMP validated assays developed according to US Pharmacopoeia or ICH Q2 R2 guidelines. Method validation includes accuracy, precision, limit of detection, limit of quantitation, specificity, linearity in range, robustness, and system suitability.
8:28 Our team and site history date back to the mid-90s when Q-One Biotech developed GMP biosafety testing technologies for vaccines. Various new virus detection systems were set up, and a team of senior managers created a new CRO, Vitrology, in 2007. Vitrology was later acquired by SGS.
9:14 During the COVID pandemic, SGS Glasgow played a central role, releasing over 4 billion doses of the COVID vaccine and supporting the Oxford AZ consortium. I'll provide more details on how that testing took place.
9:45 SGS Glasgow and SGS Wavre supported vaccine manufacturing and testing during the pandemic. This included media testing for the Master Cell Bank production, Master Viral Bank
testing, and Working Cell Bank testing. The 2020 vaccine development and batch release testing for clinical trials involved 1000-litre bioreactors, with each batch creating 500 doses.
10:47 Testing was conducted on the bulk harvest drug substance, purified vaccine, and drug product. This was done at two sites, including SGS Glasgow. We expanded our facility to 6000 square meters to respond to the COVID-19 pandemic.
11:23 Why work with SGS? In summary, we have over 97% on-time delivery across all departments this year. Our scientific expertise includes pioneering biosafety testing in the 1990s, and our team has worked together for over 25 years. Doctor Archie Lovatt, our scientific director, has been nominated as one of the top 100 most influential people in drug development and manufacturing.
12:43 The drug development group serves over 5,000 clients world-wide, so we are well versed in dealing with many customer types. We offer GMP CoAs and a detailed final report free of charge. This report provides incredible detail on sample preparation, methods, and more.
15:41 These are my contact details and my team's contact details. I hope I introduced something new to you today. If you have any questions or need support, please reach out. Thank you for your time.
