In this week’s news, FDA issues disruption guidelines, Ology and Inovio to make Covid-19 vax and more…
US FDA advises on disruption reporting during Covid-19 pandemic
The US FDA has issued guidance to help CDMOs and drug firms notify it of manufacturing interruptions during the Covid-19 pandemic.
The regulator issued the document last week, explaining the aim is to try and prevent shortages of vital medicines.
It wrote, “Due to the COVID-19 pandemic, FDA has been closely monitoring the medical product supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products.”
The EMA issued similar guidance at the start of the month.
US CDMO Ology will make Inovio Covid-19 vax for DOD trials
Ology Bioservices will develop and make a DNA vaccine against SARS-Cov2, the virus that causes COVID-19.
Under the deal Ology will manufacture Inovio’s DNA vaccine (INO-4800), with the aim being to deliver it to the US Department of Defense (DoD) for upcoming clinical trials.
A day earlier the DOD contracted Ology to develop and manufacture a monoclonal antibody for treatment and prevention of infection with SAR-CoV2.
The CDMO will work with Vanderbilt University Medical Center (VUMC) in Nashville, Tennessee to develop and manufacture the monoclonal antibody.
Bright Path joins FDA’s emerging tech programme
Bright Path Laboratories has been accepted into the US FDA’s Emerging Technology Program.
The North Carolina CDMO said joining the programme paves the way for it use its low-cost and scalable API production technology to boost US drug ingredient manufacture.
Bright Path’s business is based on a scalable continuous manufacturing technology designed to send starting materials through an uninterrupted process until the final API product is complete.
CDMOs are benefitting from evolving pharma licensing deals
The contract manufacturing sector is benefiting from the pharmaceutical industry’s vogue for later stage licensing deals according to an industry expert.
iona Barry, associate editor, GlobalData PharmSource told Bioprocess Insider “The timing of in-licensing deals for recently approved NMEs is moving later in the drugs’ life cycles.
“This benefits late-phase clinical and commercial dose CDMOs over preclinical and early-phase clinical CDMOs, since for three-quarters of approved licensed NMEs, outsourcing deals are struck after licensing,” she continued.