Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards

Emergent reportedly had serious problems at Baltimore vaccine plant

By Chris Newmarker | April 6, 2021

Emergent BiosolutionsEmergent BioSolutions was not prepared to take on the mammoth task of churning out millions of COVID-19 vaccine doses to support U.S. efforts to end the pandemic, according to a report published today in The New York Times.

Emergent was ill-equipped despite a $163 million federal contract to prepare the facility for high-volume production, according to the Times investigation, which relied on previously undisclosed internal documents and interviews with current and former federal officials and former company workers.

The company in a statement provided to Pharmaceutical Processing World said that any allegation that its safety, quality, and compliance systems are not working — or that the company does not take such responsibilities seriously — is false.

Emergent’s statement also said: “Unfortunately, a batch of drug substance can fail to meet rigorous quality standards especially during the early part of the manufacturing process. Importantly, our quality control systems are working as designed to detect and isolate any batch that fails to meet quality standards for any reason. Emergent has rigorous safety, quality, and compliance processes that allow early identification of issues and means to address them when they arise.”

Johnson & Johnson (NYSE:JNJ) this week announced that it will assume full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility — news that came days after the disclosure that a factory error resulted in up to 15 million discarded COVID-19 vaccines.

The New York Times — citing internal logs, a government official and a former company supervisor — claims that contamination or suspected contamination also caused Emergent between October and January to discard five lots of AstraZeneca vaccine — with each lot large enough to provide 2–3 million doses.

Federal officials found the pattern of lapsed quality controls at the plant troubling, according to the newspaper.

Emergent BioSolutions meanwhile announced on April 4 that it remains on track with respect to COVID-19 contractual commitments.

 

 

Tell Us What You Think! Cancel reply

Related Articles Read More >

vaccine
U.S. government makes an additional 442,000 monkeypox vaccine doses available 
A Zipline fixed-wing drone in the air drops a package
Cardinal Health starts Zipline drone deliveries of drugs and medical supplies
Pfizer logo
Pfizer to spend $120M to make COVID-19 oral treatment in U.S.
Image of MedTrace Pharma's P3 automated delivery system for 15-O water in action
MedTrace Pharma moves forward on 15 O-water imaging tech

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Pharmaceutical Processing news in a minute?

We Deliver!
Pharmaceutical Processing Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Pharmaceutical Processing World
  • Subscribe to Our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • R&D 100 Awards