Search research articles

ABOUT JoVE

Overview Leadership Blog JoVE Help Center

AUTHORS

Publishing Process Editorial Board Scope & Policies Peer Review FAQ Submit

LIBRARIANS

Testimonials Subscriptions Access Resources Library Advisory Board FAQ

RESEARCH

JoVE Journal Methods Collections JoVE Encyclopedia of Experiments Archive

EDUCATION

JoVE Core JoVE Business JoVE Science Education JoVE Lab Manual Faculty Resource Center Faculty Site

Terms & Conditions of Use

Related Concept Videos

Overview Of Cell Separation And Isolation

Overview Of Cell Separation And Isolation

Cell separation was first achieved in 1964 by S. H. Seal, who separated large tumor cells from the smaller blood cells using filtration. Two years later, Pohl and Hawk performed experiments on how cells respond differently to a nonuniform electric field based on the cell type. Such observations were the inception of cell separation methods, which allow isolating a single cell type from a heterogeneous sample.

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by

Same author

Best Practices for Performing Analytical and Functional Biosimilarity Assessment of Recombinant Monoclonal Antibody Biosimilars.

The AAPS journal·2026

Same author

Impact of color on detectability of fibers in visual inspection.

Journal of pharmaceutical sciences·2025

Same author

Enhanced visualization of colonic polyps using a fluorophore-conjugated claudin-1 antibody in a CPC-APC mouse model.

Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract·2025

Same author

Definition of Particle Visibility Threshold in Parenteral Drug Products-Towards Standardization of Visual Inspection Operator Qualification.

PDA journal of pharmaceutical science and technology·2024

Same author

Piston-driven automated liquid handlers.

SLAS technology·2024

Same author

Container Closure Integrity of a Glass Prefillable Syringe in Deep Frozen Storage Conditions.

Journal of pharmaceutical sciences·2023

Same journal

A PAT-aligned framework for installing and operating particle counting systems to detect pre-limit particle-size distribution shifts in ISO-8 (non-sterile) controlled areas.

PDA journal of pharmaceutical science and technology·2026

Same journal

Using Positive Controls to Define the Defect Detection Range for CCIT Method Development and Validation.

PDA journal of pharmaceutical science and technology·2026

Same journal

Patient-Centric Drug Delivery: Establishing Injection Hold Time Limits for Large Volume Autoinjectors.

PDA journal of pharmaceutical science and technology·2026

Same journal

Gas flow through micro-capillaries â which flow law is most suitable to predict the flow rateÂ through micro-capillaries?

PDA journal of pharmaceutical science and technology·2026

Same journal

Peer Review.

PDA journal of pharmaceutical science and technology·2026

Same journal

In-situ Verification of Disinfection Rotation for Contamination Control.

PDA journal of pharmaceutical science and technology·2026

See all related articles

Search research articles

Related Experiment Video

Updated: Jan 14, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Challenges for Visual Inspection and Particle Control in Cell Therapy Products.

Roman Mathaes¹, Antonio Burazer², Satish K Singh³

¹Clear Solutions Laboratories, Basel, Switzerland; roman.mathaes@clearsolutions-labs.com.

PDA Journal of Pharmaceutical Science and Technology

|October 16, 2025

Summary

This summary is machine-generated.

Controlling particles in cell therapy products is challenging due to their nature as living cell suspensions. This review highlights risks, limitations of current methods, and recommends tailored strategies for particle control in advanced cell therapies.

Keywords:

Advanced therapy medicinal products (ATMPs)Cell therapy Flow imaging microscopy Particulate contamination Regulatory guidance Subvisible particles Visible particles Visual inspection

More Related Videos

Automated Counterflow Centrifugal System for Small-Scale Cell Processing

Automated Counterflow Centrifugal System for Small-Scale Cell Processing

Published on: December 12, 2019

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

Related Experiment Videos

Last Updated: Jan 14, 2026

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Author Spotlight: Microbial Control and Monitoring Strategies for Cleanroom Environments and Cellular Therapies

Published on: March 17, 2023

Automated Counterflow Centrifugal System for Small-Scale Cell Processing

Automated Counterflow Centrifugal System for Small-Scale Cell Processing

Published on: December 12, 2019

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production

Published on: August 18, 2023

Area of Science:

Advanced medicinal products
Cellular therapy manufacturing
Quality control in biopharmaceuticals

Background:

Cell therapy products, comprising living cells in turbid suspensions, present unique manufacturing and quality control challenges.
Traditional methods for visible (VP) and subvisible particle (SvP) detection are often inadequate for these complex products.
Particle generation risks are associated with manufacturing processes, single-use components, and container closure systems.

Purpose of the Study:

To outline distinctive risks of particle generation in autologous and allogeneic cell therapies.
To highlight limitations of existing pharmacopeial methods for particle testing.
To propose optimized particle inspection strategies and emphasize preventative control for cell therapy products.

Main Methods:

Review of current global regulatory requirements for particle testing (USP, Ph. Eur., JP).
Analysis of particle sources in cell therapy manufacturing.
Evaluation of emerging technologies like flow imaging microscopy for SvP characterization.
Proposal of tailored visual inspection strategies for turbid cell suspensions.

Main Results:

Identified three major sources of particles: manufacturing, single-use components, and container closure systems.
Current pharmacopeial methods and traditional inspection approaches have limitations for cell therapy products.
Emerging technologies and tailored strategies are needed for effective particle characterization and control.

Conclusions:

Preventative or preemptive control, supported by risk assessment and raw material control, is the most effective strategy.
Development of cell therapy-specific inspection standards and regulatory alignment is advocated.
Optimized strategies and regulatory harmonization are crucial for consistent global development and patient access to cell therapies.