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)