Steriline designed a robotic filling line for Shilpa Medicare comprising a semiautomatic needle filling and stoppering machine and a vial capping machine that requires minimal human interaction and fits in a 3.9-foot-long lab. The line is used for sterile injectable oncology drugs.
A less mature quality management system looks backward and collects only general or nonspecific data, while a mature QMS is proactive and uses predictive analytics, statistics, process capabilities and other tools to prevent anomalies from recurring. ISPE's Advancing Pharmaceutical Quality program team is developing guidance to help pharmaceutical manufacturers achieve QMS maturity, says APQ team Chair Tami Frederick.
Catalent plans to invest $100 million in a facility in Anagni, Italy, acquired last year from Bristol Myers Squibb, to produce drug substances for monoclonal antibodies and other complex biologics. The upgrade, which Catalent expects to complete by April 2023, will include the installation of two 2,000-liter single-use bioreactors and the infrastructure for six more.
Maintenance schedules based on predictive analytics can generate substantial savings, which can be wiped out by excessive false positives that cause unneeded or too-frequent equipment shutdowns. Condition-based maintenance and advanced troubleshooting rely on the same technologies as predictive maintenance but use data differently and facilitate an analytics-driven maintenance-service strategy, four McKinsey experts write.
The US Justice Department has charged four Chinese nationals with hacking or trying to hack into corporate, university and government computer systems -- including the NIH -- in at least a dozen countries to install malware and steal trade secrets and proprietary data. The indictment identifies three alleged hackers as officers with the Hainan State Security Department, and prosecutors say infectious disease research data was a primary target of the years-long campaign.
RxAll, a startup aiming to reduce drug counterfeiting in Africa, raised $900,000 in pre-seed funding and $2.25 million in a seed funding round for its RxScanner. The handheld molecular spectroscopy device uses machine learning to authenticate a drug sample in 20 seconds and is already in use at hospitals and pharmacies in Nigeria.
The UK's National Institute for Health Research will give the University of Cambridge and the Cambridge University Hospital NHS Foundation Trust about $504,200 to develop a COVID-19 test.
Tick-borne illnesses including Lyme disease, anaplasmosis, babesiosis and spotted fever rickettsiosis have become more prevalent in the US over the last few years, according to data from the CDC. Experts attribute the increases to greater awareness and environmental factors such as climate change and expanding tick populations.
A convertible note financing round has raised $13 million for ProciseDx from major shareholders like Nestlé Health Science and Biosynex SA. The funds will enable the company to proceed with FDA submissions for its point-of-care platform and test menu expansion.
Poseida Therapeutics joined PACT Pharma and the Fred Hutchinson Cancer Research Center as the final partner in Cellares' Cell Shuttle development program. The partners get an early look at Cellares' closed, automated cell therapy production unit that's about the size of a conference room, maintains its own cleanroom environment and is manned by a robot that moves single-use cartridges from one modular bioprocessing instrument to the next, producing 10 or more doses at a time, says Cellares co-founder and CEO Fabian Gerlinghaus.
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