Syngene, a global contract research, development, and manufacturing organization (CRDMO), recently announced the acquisition of its first biologics site in the USA – fitted with multiple monoclonal antibody (mAbs) manufacturing lines.
Bora Pharmaceuticals, a Taiwan-headquartered contract development and manufacturing organization (CDMO), has completed the acquisition of Emergent BioSolutions' sterile manufacturing facility in Baltimore-Camden, Maryland, USA. The facility adds drug product fill/finish to Bora’s extensive biologics drug substance capabilities.
In the aftermath of a far-reaching mix-up of Astra Zeneca’s Covid vaccine ingredients with those of Johnson & Johnson’s shot, US CDMO Emergent BioSolutions not only has lost half of its stock market value but is also facing shareholder lawsuits related to other offenses, including securities fraud.
Eastman Chemical has agreed to sell several rubber additives lines and related technology assets of its tire additives business to an affiliate of One Rock Capital Partners for $800 million. The deal does not include the Impera and other performance resins product lines of the tire additives business, which accounted for 14% of the company’s 2020 sales of $8.47 billion.
The (almost) worst-case scenario in the mix-up of Johnson & Johnson and AstraZeneca’s Covid-19 vaccine at the Baltimore, Maryland, plant of CDMO Emergent BioSolutions apparently has occurred. After an extensive FDA probe at the site, it was determined that around 60 million J&J doses will have to be discarded, the newspaper New York Times reported.
The US Food and Drug Administration will allow the restart of CDMO Emergent BioSolutions’ still shuttered Bayview plant in Baltimore, Maryland, within the next few days, the newspaper Wall Street Journal (WSJ) has reported. The paper said it understands that contamination problems at the plant have been resolved.
Problems at CDMO Emergent BioSolutions in the US state of Maryland and the resulting Food and Drug Administration shutdown of its Baltimore vaccine production facility continue to cloud the rollout of Johnson & Johnson’s Covid-19 shot. The newspaper Washington Post said the US federal government will not send any supplies of the healthcare group’s single-dose vaccine to states over the coming week, citing the weekly shipment allocation of the Centers for Disease Control (CDC).
As part of a plan to establish a network of manufacturing partners to help boost capacity ahead of a potential FDA approval of a Covid-19 vaccine, US healthcare giant Johnson & Johnson (J&J) recently signed agreements with two US companies.
