Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Feds put J&J in charge of vaccine production at Emergent plant

By Sean Whooley | April 5, 2021

Johnson & JohnsonJohnson & Johnson (NYSE:JNJ) announced that it assumed full responsibility for the production of its COVID-19 vaccine at the Emergent BioSolutions Bayview (Baltimore) facility.

The company’s announcement comes days after news broke that a factory error made at that facility resulted in 15 million discarded COVID-19 vaccines.

New Brunswick, N.J.–based J&J’s single-dose vaccine was authorized by the FDA  for emergency use in March. A handful of days later, the Biden administration announced a contract for 100 million doses of the vaccine.

However, news came to light that workers at an Emergent BioSolutions (NYSE:EBS) facility in Baltimore made a mistake several weeks ago when formulating the ingredients for Johnson & Johnson’s COVID-19 vaccine, requiring 15 million doses of it to be discarded.

A quality control process revealed that one batch of a drug substance for the J&J COVID-19 vaccine “did not meet quality standards,” according to a statement from Johnson & Johnson. The batch did not reach the fill-and-finish stage of manufacturing.

In response to the error, J&J issued a news release over the weekend stating that it assumes full responsibility for the manufacturing of drug substance for the vaccine at the Emergent Bayview facility. It is adding dedicated leaders for operations and quality while significantly increasing the number of manufacturing, quality and technical operations personnel to work alongside specialists already at Emergent.

The company made a point to note that all doses of its COVID-19 vaccine distributed to date have met both company and regulatory quality standards. At the same time, it continues to work with the FDA toward the emergency use authorization (EUA) of the Emergent Bayview Facility.

Johnson & Johnson still expects to deliver the 100 million doses it is contracted to produce to the U.S. government by the end of May.

About The Author

Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Tell Us What You Think! Cancel reply

Related Articles Read More >

Antheia_Logo (1)
Pharma ingredient manufacturer Antheia raises $56M Series C
Prolific Machines logo.
Prolific Machines enters FDA program to enhance therapeutics manufacturing platform
Genentech roche
Roche, Genentech to build $700M drug manufacturing plant in North Carolina
Amgen
Amgen to spend $900M to expand U.S. biopharma manufacturing
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

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.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 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
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE