The contract development and manufacturing organization Rentschler Biopharma (Laupheim, Germany) has begun constructing a new facility in Milford, Massachusetts, next to an existing facility. The new 22,000-ft2 facility will boost the company’s cGMP manufacturing capacity and its ability to produce complex molecules for U.S.-based clients. Once completed, the facility will contain space for manufacturing, single-use…
Whistleblower: FDA downplayed safety issues at Merck vaccine plant
A former FDA inspector accused the agency of downplaying safety problems at a Merck plant tapped to manufacture Johnson & Johnson’s COVID-19 vaccine. The whistleblower alleged that a 2018 inspection uncovered evidence that employees in the facility in Durham, N.C. engaged in a host of unsanitary practices. A letter to President Biden from the U.S.…
Digital shift management cures pharma processing communication woes
The increasing complexity of drugs — including vaccines, biologics, sterile injectables and cell therapies — brings pharmaceutical companies significant manufacturing challenges during the pandemic. In turn, this complexity drives supply chain disruptions and changes to business and operational processes to accommodate social distancing, remote working and quarantining. Some pharmaceutical manufacturers have prioritized the manufacture of…