Manufacturing Plants

Abbott Enters into Consent Decree with U.S. Food and Drug Administration for its Sturgis, Mich., Plant; Agreement Creates Pathway to Reopen Facility

Abbott, Business, FDA, Healthcare Companies, Infant Formulas, Infants, Ireland, Manufacturing Plants, Michigan, U.S. Department of Agriculture.

Abbott agreed to enter into a consent decree with the U.S. Food and Drug Administration related to the company’s Sturgis, Mich., infant formula plant. The decree is an agreement between the FDA and Abbott on the steps necessary to resume production and maintain the facility. This does not affect any other Abbott plant or operation. The decree is subject to court approval.

May 16, 2022/by PR Newswire

GSK, Vir ramping up U.S. output of COVID antibody drug

COVID-19 Antibodies, GlaxoSmithKline, Manufacturing Plants, Omicron (B.1.1.529) (South Africa), Rivalries, Sotrovimab, The Wall Street Journal, U.S. government, Vir Biotechnology

GlaxoSmithKline and U.S. partner Vir Biotechnology will boost production of their antibody-based COVID-19 treatment by adding a second manufacturing plant to help meet soaring demand in the United States.

January 21, 2022/by Reuters Health

Teva halts output at U.S. drug plant after FDA flags concerns

Bloomberg, Business, California, FDA, Manufacturing Plants, Shares, Teva

Teva Pharmaceutical Industries temporarily halted drug production at the company’s Irvine plant in California to address issues raised by the U.S. Food and Drug Administration after a recent inspection, the company said on Oct. 4.

October 4, 2021/by Andrew Humphreys

Novartis aims to bottle more than 50 million doses of BioNTech Covid-19 vaccine in 2021

BioNTech, BNT162b2 (Pfizer and BioNTech), COVID-19 Vaccines, EMA, Manufacturing Plants, Novartis, Switzerland

Novartis aims to help manufacture more than 50 million doses of BioNTech’s Covid-19 vaccine in 2021 at the Swiss drugmaker’s Stein, Switzerland fill-and-finish facility after the European Union’s drug regulator approved the bottling plant.

June 22, 2021/by Andrew Humphreys

Moderna Rapidly Expands Covid-19 Vaccine Plant Production

Coronavirus Disease (COVID-19) Pandemic, Manufacturing Plants, Moderna, mRNA-1273/Moderna COVID-19 Vaccine (Moderna)

Moderna is adding two new production lines at the company’s rebuilt former Polaroid plant in Massachusetts to increase overall production capacity by 50 percent for its Covid-19 vaccine.

June 21, 2021/by BioSpace

J&J finds problem with Covid vaccine batch; NY Times says 15 million doses ruined

AstraZeneca, Baltimore, COVID-19 shots, COVID-19 Vaccines, Janssen COVID-19 Vaccine (J&J), Johnson & Johnson, Manufacturing Plants, The New York Times, United States

Johnson & Johnson said on March 31 the company had found a problem with a batch of the drug substance for its Covid-19 vaccine being produced by Emergent BioSolutions, and said the batch did not advance to the final fill-and-finish stage.

March 31, 2021/by Andrew Humphreys

J&J plant authorization clears way for big boost in U.S. Covid-19 shots

Business, COVID-19 Vaccines, Facilities/Sites/Manufacturing, FDA, Indiana, Janssen, Janssen COVID-19 Vaccine (J&J), Johnson & Johnson, Manufacturing Plants, United States

A large plant being used to manufacture Johnson & Johnson’s Covid-19 vaccine was cleared by U.S. regulators on March 23, setting the stage for the weekly U.S. supply to surge more than 20 percent.

March 23, 2021/by Andrew Humphreys

Biden takes steps to help Merck boost Johnson & Johnson Covid-19 vaccine supply

Business, Collaborations, Defense Production Act, Facilities/Sites/Manufacturing, Janssen COVID-19 Vaccine (J&J), Joe Biden, Johnson & Johnson, Manufacturing, Manufacturing Plants, Merck, Partnerships

Merck & Co. will help make rival Johnson & Johnson’s Covid-19 vaccine in order to boost the slower-than-promised production of the one-dose shot, U.S. President Joe Biden said on March 2.

March 2, 2021/by Andrew Humphreys