Nephron, Rapid Micro Announce First-of-its-Kind Automated Microbial MonitoringJuly 30, 2019
WEST COLUMBIA, S.C. – Nephron Pharmaceuticals Corporation and Rapid Micro Biosystems today announced the Nephron 503(b) Outsourcing division will deliver critical medical supplies to hospitals faster than ever, thanks to a new tool that automates microbial monitoring in the drug manufacturing process.
As the first and only growth-based system of its kind in microbial testing, Growth Direct™ automates the incubation, colony counting, and data entry of microbial environmental testing. Growth Direct, now in use at Nephron, also detects any potential microbial growth 50 percent faster than the human eye. Cutting detection time allows Nephron to ship critical medical supplies to hospitals faster than using traditional microbial testing methods.
“We work hard day in and out to deliver safe, effective and affordable life-saving medications as efficiently as possible,” said Nephron CEO Lou Kennedy. “Automating our microbial monitoring process allows us to produce safer drugs faster and decreases the shortage of opioid-free pain medication currently facing our nation’s hospitals.”
“We’re excited that Nephron Pharmaceuticals Corporation has joined the growing list of global pharmaceutical manufacturers who are upgrading and automating their QC Microbial testing methods with the Growth Direct,” states Rob Spignesi CEO of Rapid Micro Biosystems. “And we are proud to help Nephron Pharmaceuticals reduce the shortage of important drugs that help make surgery safer and less painful for patients across the country.”
About Nephron Pharmaceuticals
Nephron 503B Outsourcing is a division of Nephron Pharmaceuticals Corporation. This division produces pre-filled sterile syringes and IV bags for hospitals across America, in an effort to alleviate their drug shortage needs. In accordance with the DQSA draft guidance, the company follows cGMP, GDP and all quality expectations. The company has been licensed by the Food and Drug Administration as a sterile manufacturer of generic respiratory medications along with an Outsourcing Facility providing equal sterility and quality. Nephron received a 2017 ISPE/FOYA innovation award for the high level of automation present throughout the facility. For more information, please visit www.nephronpharm.com.
About Rapid Micro Biosystems
Rapid Micro Biosystems (RMB) creates, sells, validates and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct™—the first and only growth-based system to automate rapid compendial QC Micro testing—ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation. RMB is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes. For more information, visit www.rapidmicrobio.com. Follow RMB at @rapidmicrobio or LinkedIn.