Safety Testing of (Bio-)Pharmaceuticals, Biologics & ATMPs

BSL BIOSERVICE supports your drug development project in all phases from early development to commercialization. Our services during development include ADME, IND-enabling toxicology / PK studies, immunotoxicology, immunogenicity, microbiology and clinical sample analysis. In late-phase and after market approval, we provide bioassays for batch release.

In support of IND and later-stage regulatory submissions for new chemical (NCE) or biological entities (NBE) we provide full nonclinical development programs. On the basis of more than 30 years of experience we are guiding your project with highest flexibility and efficiency to IND and beyond.

In close cooperation with our partner Eurofins BioPharma Product Testing Munich our services for the biological testing of Biopharmaceuticals, Biologics and ATMPs include

Preclinical Assessment

• Metabolism
• Drug Interaction
• Permeability & Transport
• ADME in vivo (radio-labelled & non radio-labelled substances)

Pharmacology

• Pharmacodynamics
• Pharmacokinetics/Toxicokinetics
• Safety Pharmacology

Toxicology

• Cytotoxicity, Phototoxicity in vitro
• Acute Toxicity
• Subacute, Subchronic, Chronic Toxicity
• Carcinogenicity
• Developmental & Reproductive Toxicity (DART)
• Sensitization
• Genetic Toxicology
• Immunotoxicity
• Immunogenicity
• Bioanalytics
• in vitro Dermal Absorbtion & Toxicology
• Testing of Media Fills