最新的帖子

五月 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

Manager, Particle Tech, Lab

以前的博客

十二月 28, 2020

Particles in Injectable Drugs

Lynn Yao

Lynn Yao

Manager, Scientific Affairs, CN

Particle Analysis

六月 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

四月 03, 2019

The Challenges of Combination Products

Fran DeGrazio

Fran DeGrazio

VP, Technical Services and Scientific Affairs

Compatibility Issues Chart

三月 07, 2019

Simplify the Journey™ - Integrated Solutions for Particles

Doug Hostetler

Doug Hostetler

Sr Manager, Integrated Solutions, Lab

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