Welcome to SGS. Confirm your location for an enhanced experience: USA
Welcome to SGS. Confirm your location for an enhanced experience: USA
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What are you looking for?

Drug Substance (DS)

Drug substance (DS) and product specific validations (PPV) from SGS help you to bring products to market efficiently.

We are industry experts in GMP DS testing, with more than 25 years of experience in drug substance (DS) and product specific validations (PPV). Based on where your biologic will be marketed, our in-house experts can tailor the necessary assays to allow for over 94% on time delivery of a GMP final report of Certificate of Analysis (CoA).

Services our biosafety team can offer:

Identity:

  • Sanger sequencing – vector identity

Residual impurities:

  • Residual host cell DNA/RNA (USP <1126/1127>, Pharm.Eur.2.6.21 & Pharm.Eur.2.6.35)
  • Residual host cell protein (USP <1126/1127>, Pharm.Eur.2.6.36)
  • Residual reagents, e.g. Benzonase, bovine serum albumin (BSA) etc.
  • Residual plasmid DNA
  • Endotoxin (<USP 85>, Pharm.Eur.2.6.12)

Genetic stability and integrity:

  • Genetic characterization by Southern Blot
  • Nucleic acid sequencing (DNA & RNA) next generation sequencing and Sanger sequencing
  • Gene copy number by quantitative polymerase chain reaction (qPCR)

Replication competent virus:

  • Replication competent adeno-associated virus (AAV)
  • Replication competent lentivirus (RCL)
  • Replication competent adenovirus (RCA)

Other DS assays:

  • Vector concentration/infectious particle titer
  • Infectivity/particle ratio
  • Vector copy number by quantitative polymerase chain reaction (qPCR)

Why work with SGS?

Central Lab Services

Scientific expertise

· Our scientists pioneered biosafety testing in the 1990s

· They have spent over 25 years working together as a cohesive group to develop, validate and run GMP
lot release assays

· Our extensive expertise has contributed to our being recognized as a world leader in biopharmaceutical
testing services
SGS Glasgow

A recognized team of experts

· Pioneered real-time PCR and PERT technology for biologics testing

· The Medicine Maker 2015 and 2016 – Top 100 Most Influential People in Drug Development and Manufacturing

· Scottish Life Sciences 2023 Leadership Award Winner

· US Pharm. Panel of Experts – Viral Vaccines and Cell Banking
Three Scientists Working in Laboratory

Quality

· Multiple successful audits by large pharma and experienced biotechs, including the FDA

· GMP CoAs or final reports – 10+ pages providing detailed info on sample prep, method, validity criteria, results/conclusion, audit steps

· Reports are templated and carefully audited to ensure no errors
Contact us for more information on drug substance testing.
  • Groupe SGS France

29 Avenue Aristide Briand,

Cedex, 94111,

Arcueil, Val-de-Marne,

France