Before your mAb therapy reaches a patient, it is important to ensure product safety and efficacy. This includes understanding the effects of environmental conditions—temperature, humidity, light, container interactions—on your mAb. We offer a full portfolio of lot release and stability testing services performed to GMP guidelines. While others may provide data points, we combine full data with regulatory guidance required for clinical submission.
Assays are available to suit your development phase, including:
- Raw Materials
- Unprocessed Bulk
- Purified Bulk (Drug Substance)
- Final Product (Drug Product)