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Grand River Aseptic Manufacturing Selected As 2021 Facility Of The Year Awards Winner For Special Recognition For Operational Agility COVID-19 Impact


News
| April 28, 2021
Grand River Aseptic Manufacturing Selected As 2021 Facility Of The Year Awards Winner For Special Recognition For Operational Agility: COVID-19 Impact
Grand Rapids, Mich., April 28, 2021 /PRNewswire/  Grand River Aseptic Manufacturing ( GRAM ), a leading injectable contract development and manufacturing organization ( CDMO ), was awarded the 2021 Facility of the Year Award for Special Recognition of Operational Agility: COVID-19 by the International Society for Pharmaceutical Engineering (ISPE). GRAM received the distinction for the design and efficacy of its 60,000 sq. ft., world-class, large-scale fill/finish facility in downtown Grand Rapids, Michigan.
GRAM designed the fill/finish facility from the ground up with a focus on safety, capacity, and flexibility. Employee safety, exceeding regulatory requirements, and client needs stayed at the forefront by choosing best-in-class technology and facility design sol ....

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Emergent Plummets as FDA Inspects J&J Vaccine Production Site


Emergent Plummets as FDA Inspects J&J Vaccine Production Site
Riley Griffin, Bloomberg News
The exterior view of the Emergent BioSolutions plant on April 01, 2021 in Baltimore, Maryland.
, Photographer: Tasos Katopodis/Getty Images
(Bloomberg) Emergent BioSolutions Inc. shares plunged after U.S. regulators told the company to stop making Johnson & Johnson’s Covid-19 vaccine at a company facility where 15 million doses of an ingredient used in the vaccine had to be discarded.
The U.S. Food and Drug Administration on April 12 initiated an inspection of a Baltimore-based Emergent facility responsible for making the underlying drug substance in the vaccine. Four days later, the FDA asked Emergent to stop making new materials there and to quarantine existing materials until the inspection and any remediation are concluded, according to a company filing on Monday. ....

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