Related Experiment Video
Updated: Dec 15, 2025

Author Spotlight: Advancing Cell Therapy Manufacturing with Dissolvable Microcarriers
Published on: July 7, 2023
Formulation of Cell-Based Medicinal Products: A Question of Life or Death?
Karin H Hoogendoorn1, Daan J A Crommelin2, Wim Jiskoot3
1Leiden University Medical Center, Hospital Pharmacy, Interdivisional GMP Facility, Albinusdreef 2, 2333 ZA Leiden, the Netherlands.
Abstract:
The formulation of cell-based medicinal products (CBMPs) poses major challenges because of their complexity, heterogeneity, interaction with their environment (e.g., the formulation buffer, interfaces), and susceptibility to degradation. These challenges can be quality, safety, and efficacy related. In this commentary we discuss the current status in formulation strategies of off-the-shelf and non-off-the-shelf (patient-specific) CBMPs and highlight advantages and disadvantages of each strategy. Analytical tools for the characterization and stability assessment of CBMP formulations are addressed as well. Finally, we discuss unmet needs and make some recommendations regarding the formulation of CBMPs.
Related Concept Videos
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Clinically Relevant Drug Product Specifications: Methods of Establishment
Drug Products: Biologics, Biosimilars and Interchangeables
Cell Lines
Biopharmaceutical Factors Influencing Drug Product Design: Overview

