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Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
Nonclinical development of biopharmaceuticals
1Bayer Schering Pharma AG, Berlin, Germany. andreas.baumann@bayerhealthcare.com
Drug Discovery Today
|October 27, 2009
Summary
Developing biotechnology-derived pharmaceuticals (biologics) requires a unique nonclinical development plan (NDP). This plan differs from small molecule drugs, focusing on safety, pharmacokinetics, and bioanalytics with tailored study designs.
Area of Science:
- Biotechnology
- Pharmaceutical Development
- Toxicology
Background:
- Nonclinical development plans (NDPs) for biotechnology-derived pharmaceuticals (biologics) encompass drug safety, pharmacokinetics (PKs), and bioanalytics.
- Established programs for small molecules often require modification for biologics due to target differences and limited species cross-reactivity.
Purpose of the Study:
- To review the key components of an NDP for biologics.
- To highlight the differences and challenges compared to small molecule drug development.
- To emphasize the need for tailored study designs.
Main Methods:
- Review of nonclinical drug safety (toxicology, safety pharmacology).
- Assessment of nonclinical pharmacokinetics (PKs).
- Evaluation of nonclinical and clinical bioanalytical methods for PK and immunogenicity monitoring.
Main Results:
- Biologics' NDPs necessitate a variety of bioanalytical methods for PK and immune response monitoring in animals and humans.
- Challenges include target differences, limited species cross-reactivity, and applicability of long-term studies.
- Immunogenicity assessment is a critical component.
Conclusions:
- Nonclinical development plans for biologics require a case-by-case approach.
- Scientifically justified, special study designs are crucial to overcome development hurdles.
- Adaptation of standard protocols is essential for successful biologic drug development.
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