Drug Substance (DS)

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)