Drug Product (DP)

At SGS, we offer a comprehensive testing service for the drug product (DP) phase of production. With over 25 years experience in GMP assays, we can support an array of essential tests to evaluate the quality, safety and efficacy of biologic products. We support all types of manufacturers to ensure confidence in the safety and effectiveness of your biologic product.

Services our biosafety team can offer

Identity:

Vector identity – Sanger sequencing

Qualification assay:

Vector particle concentration
Infectious particle titer
Infectivity/particle ratio

Batch release assay:

Bacterial endotoxin
Osmolality
pH
Extractable volume
Vector aggregates
Sterility
Appearance

Replication competent tests:

Replication competent adeno-associate virus (AAV)
Replication competent lentivirus (RCL)

Why work with SGS?

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

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

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 to learn more about drug product testing.