Biologics Testing - Creative Biolabs

A biological assay is a procedure for determining the efficacy of a pharmaceutically active substance in a formulated product or bulk material by observing their effects on living animals (in vivo) or tissues (in vitro), which produce detailed information about the biological activity of a drug substance. Biological assays also include the detection of biohazards, the quality assessment of mixtures, their impact on the surrounding environment, and the assessment of the environmental impact and safety assessment of new technologies and facilities.

With expertise in the field of oncology immunotherapy, Creative Biolabs offers the most comprehensive portfolio of customized biologics testing services throughout the drug development cycle. The development, optimization, validation and performance of our biological / potency assays are carried out in accordance with GMP regulations. Validation strategies are based on international guidelines and recommendations (e.g., ICH, US-FDA, ISO, EMEA).

Biologics Testing Services Available

Bioassays
Biomarker Development ADCC, CDC, and ADCP Immunoassay Immune Checkpoint Assays FcR Binding Assay Tissue Cross-Reactivity Studies Immune Cells Function Assay Immuno-Oncology Assays

Structure and Biochemical
Primary Structure Characterization Biophysical Characterization Post-Translational Modification(PTM) Forced Degradation Studies Charge Variant Analysis Size Variants Analysis

Endotoxin Testing
Endotoxin Detection Service Endotoxin Removal Service LPS Analysis Service

Our Guarantees

✔ Follow the guidelines of health authorities including the FDA and the European Medicines Agency (EMA)
✔ Perform comprehensive biologics safety testing, including cell and molecular biology as well as microbiology
✔ Pharmacological identification based on major pharmacopoeia and regulatory guidelines
✔ Provide regulatory and security consulting as well as customize analysis development

Creative Biolabs’ team of scientists are dedicated to ensureing the most appropriate method based on the project to address the needs of clients. For more information on biologics testing, please contact us immediately.