Newsletter | October 12, 2023

10.12.23 -- The Cancer Drug Shortage: When Quality Fails

FEATURED EDITORIAL

Combination Product QMS Requirements For The EU Market

Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

Key Considerations In Selecting A Robotic Solution For Endotoxin Testing

The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system.

The Cancer Drug Shortage: When Quality Fails

Our industry is failing cancer patients with the current cancer drug shortage. Why is this happening and what can we do about it? This expert provides her insights from the perspective of a quality control professional.

INDUSTRY INSIGHTS

A Glass Package Designed Specifically For Pharmaceutical Use

A comprehensive solution for multiple glass quality issues that affect drug products is essential to avoid costly delays and drug product recalls, all while increasing patient safety.

From Myth To Mastery: Unveiling The Secrets Of Virus Bank Manufacturing

It is crucial to start off your product development right. Here, you will learn how to best approach virus bank production. Further, we review best practices, how to overcome common obstacles, and more.

NEWS HEADLINES

Kashiv BioSciences Enrolls First Patient In Phase III Clinical Study For ADL018, A Biosimilar Candidate To XOLAIR (omalizumab)

Adalimumab-adbm, Boehringer Ingelheim's Interchangeable Biosimilar To Humira®, Now Available At Low Wholesale Acquisition Cost

FDA Approves Biogen’s TOFIDENCE™ (tocilizumab-bavi), A Biosimilar Referencing ACTEMRA®

ProciseDx Announces The First FDA-Cleared Therapeutic Drug Monitoring Tests For Biologic Drugs, Humira®, Remicade®, And Their Biosimilars

Alvotech Enters Into Exclusive Licensing Agreement With Kashiv Biosciences For Development And Commercialization Of A Proposed Biosimilar To Xolair® (Omalizumab)

SOLUTIONS

Is Evaporation Important For Optical Biosensors?

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