Latest Post

May 03, 2021

Understanding Particles and Their Impact to Biologics and Biosimilars

Particles in an injectable drug product represent a huge risk not only to patient safety &ndash; but also to a drug company&rsquo;s reputation and bottom line. Presence of visible or sub-visible particles has been one of the most common reasons for recalls. According to the <em>FDA Recalls, Market Withdrawals, &amp; Safety Alerts</em> database, 23 of 59 (39%) recalls, market withdrawals, and safety alerts between 2018 and 2020 were due to particulate contamination<sup>1</sup>.
John Rech

John Rech

Manager, Particle Tech, Lab

Previous Posts
CZ Syringe and Vial with patient and nurse

December 28, 2020

Particles in Injectable Drugs

Lynn Yao

Lynn Yao

Manager, Scientific Affairs, CN

Particle Analysis

June 11, 2019

Particulate Challenges

Fran DeGrazio

Fran DeGrazio

V.P. Technical Customer Service & Scientific Affairs

Leo Posner of Johnson & Johnson presenting at the PDA Combo Workshop

April 03, 2019

The Challenges of Combination Products

Fran DeGrazio

Fran DeGrazio

VP, Technical Services and Scientific Affairs

Compatibility issues Chart

March 07, 2019

Simplify the Journey™ - Integrated Solutions for Particles

Doug Hostetler

Doug Hostetler

Sr Manager, Integrated Solutions, Lab

Particle Testing

March 01, 2019

Achieving ″Zero″ Defects for Visible Particles in Injectables

Olga Laskina

Olga Laskina

Sr Tech Acct Spec, TCS, NA

Leur Lock Syringes

February 25, 2019

Particles in Intravitreal Injections - Part II

Susan Dounce

Susan Dounce

Principal SME, PFS CZ, TCS

February 22, 2019

West Analytical Services Introduces New Particle Testing Capabilities

Deirdre Swinden

Deirdre Swinden

Director, Marketing Communications

February 20, 2019

Particles in Intravitreal Injections - Part I

Susan Dounce

Susan Dounce, PhD

Principal SME, Pre-filled Syringes

Particle Analysis

February 15, 2019

Particle Size Analysis – To Trust or Not?

SokTiang Koh

Sok-Tiang Koh

Vice President, Scientific Affairs & Technical Services, Asia-Pacific

Survey Responses

January 25, 2019

Industry Insight – Particles and Sterile Drug Products

Verun Gupta

Varun Gupta

Supervisor, Particles, Analytical Labs NA

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