The National Academy of Sciences has given a boost to an unsettling idea: that the novel coronavirus can spread through the air-not just through the large droplets emitted in a cough or sneeze. Though current studies aren't conclusive, "the results of available studies are consistent with aerosolization of virus from normal breathing," wrote Harvey Fineberg, who heads a standing committee on Emerging Infectious Diseases and 21st Century Health Threats. If the coronavirus can indeed be suspended in the ultrafine mist that we produce when we exhale, protection becomes more difficult, strengthening the argument that all people should wear masks in public to reduce unwitting transmission of the virus from asymptomatic carriers. Learn More
Cellex and Mayo Clinic Launch Tests to Determine COVID-19 Immunity from Previous Exposure
The U.S. FDA has approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19. This is different than assays that test for presence of the virus-those test to determine if a patient has COVID-19. These new antibody tests determine if the person was exposed to the virus, had COVID-19 and recovered. And it suggests, if positive, that the person is now immune to COVID-19 and can't get it again. Cellex has been granted an emergency use authorization (EUA) for its test while the Mayo Clinic is moving forward at this time without FDA approval as it has not been deemed necessary. Learn More
Emergent to Produce Novavax’s Flu Vaccine Under CDMO Deal
Emergent BioSolutions will produce a quadrivalent flu vaccine developed by Novavax, which recently announced positive late-stage study results for the experimental treatment. Emergent plans to make the NanoFlu vaccine at its Baltimore Bayview location. The facility is also working on an experimental Novavax vaccine for the new coronavirus, which causes the disease COVID-19. Emergent will have the flexibility to ramp up coronavirus-related work at Bayview if the vaccine candidate shows promise. The facility, designated by the U.S. government as a Center for Innovation in Advanced Development and Manufacturing, can produce hundreds of millions of doses of vaccine each year, the company said. Learn More
PDUFA, BsUFA Resource Capacity Planning: Report Recommends Refinements
A new report from Booz Allen Hamilton commissioned by the US FDA recommends refinements to the agency's workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs. The 25-page report makes five main recommendations for FDA to improve its capacity planning adjustment methodology but finds that overall FDA's methodology and current implementation of its resource capacity planning "align conceptually" with the agency's objectives. The FDA is now soliciting public comments on the report and says it will develop a "new robust methodology" to use going forward based on the recommendations and the comments it receives. Learn More
Automated Buffer Preparation Using Quaternary Valve in Fast Performance Liquid Chromatography for Protein Purification from a Cell Membrane
There is a great need for high-throughput protein purification to produce protein molecules for research and therapeutics. Although there have been significant advancements made in automated multi-step chromatography and preparative in-process design-of-experiment (DOE) capabilities in commercial fast performance liquid chromatography (FPLC) instruments, almost all commercial FPLCs rely on a binary buffer mixing system, which hinders automated buffer preparation. Nevertheless, current-generation FPLCs are equipped with a quaternary mixer designed for limited in-line buffer preparation and preparative pH scouting DOE experiments. Learn More
Do you know of a single-use manifold for fluid transfer that does not utilize Y connectors, stopcocks and the like?
Yes. There is a single-use manifold for fluid transfer that was introduced to our community in the last couple of years that in itself does not require the use of Y connectors, stopcocks and the like. It fits 3/8" tubing ID's and is capable of a max pressure of 15 psi. No word yet if there are plans to accommodate different tubing ID's or if an automated version is in the works. I have provided a link below to more information.
Virus Contamination in Biomanufacturing
In an interview with Pharmaceutical Technology, Robert Kiss, PhD, gives the inside scoop on PDA's TR 83: Virus Contamination in Biomanufacturing.
Webinar: Reach the Ultimate Level of Data Integrity with Sartocheck®5 Plus
Tuesday, May 5th, 2020
Filter integrity test values are part of the batch protocol and are used to justify the drug release. Long term reliable data is therefore crucial to avoid quality deviations and potential 483 warning letters. Devastating malware incidents and the continuing threat of computer viruses have created an urgent need for data protection and security. Join this webinar to learn more about how the Sartocheck 5 Plus can help you reach the ultimate level of Data Integrity.
Key Objectives:
- Get full understanding of the importance of data integrity and data security related to filter integrity test results
- Get an insight on how the Sartocheck®5 Plus Filter Tester has been designed for inherent resistance against data virus and malware
- See how the Sartocheck®5 Plus Filter Tester fulfills the ALCOA+ principles
Chilling Concussed Cells Shows Promise for Full Recovery
In the future, treating a concussion could be as simple as cooling the brain. That's according to research conducted by University of Wisconsin-Madison engineers, whose findings support the treatment approach at the cellular level. "There are currently no effective medical treatments for concussions and other types of traumatic brain injuries," says Christian Franck, the UW-Madison associate professor of mechanical engineering who led the study. "We're very excited about our findings because they could potentially pave the way for treatments we can offer patients." The researchers published their findings in the journal PLOS ONE. Learn More
Adsorptive Membranes for Trapping Viruses
A U.S. Patent for "Adsorptive Membranes for Trapping Viruses" was awarded to the Wisconsin Alumni Research Foundation on March 31st, 2020. The present invention is a disposable, virus-trapping membrane, and a corresponding method to remove viruses from solution are described. The membrane includes a disposable, micro-porous filter membrane and a ligand immobilized on the membrane. The ligand irreversibly and selectively binds viruses. The ligand also has a pKa sufficiently high to repel antibodies via electrostatic charge repulsion. Learn More
1968 “2001: A Space Odyssey” Released in Theaters
On this day in 1968, Stanley Kubrick's 2001: A Space Odyssey debuts in theaters. Kubrick, whose 1964 Cold War satire Dr. Strangelove had been popular with audiences and critics alike, was intrigued by science fiction but felt the genre rarely produced interesting films. He became determined to make one, using the sci-fi story The Sentinel as source material and enlisting its author, Arthur C. Clarke, as his co-writer. Learn More
Thinking of any food you have bought in the last two weeks, have you sanitized the packaging?
What Almost Dying Taught Me About Living
"The hardest part of my cancer experience began once the cancer was gone," says author Suleika Jaouad. In this fierce, funny, wisdom-packed talk, she challenges us to think beyond the divide between "sick" and "well," asking: How do you begin again and find meaning after life is interrupted? Learn More
Akron Biotech Expands to Second US Manufacturing Facility
Akron Biotech has acquired a state-of-the-art 60,000-square-foot biologics manufacturing site in Sarasota, FL, bolstering the company's U.S. capacity and strengthening its position as an ancillary materials supplier. The site will be operational later this year. The Sarasota site will facilitate rapid growth in each of the company's three main cGMP business verticals: cytokines and growth factors, growth and cryopreservation media, and viral inactivated human-derived media supplements. It also enables the company to add cGMP-compliant plasmid development and production to its custom development and manufacturing services, addressing one of the central bottlenecks in the cell and gene therapy industry. Learn More
Walt Disney World Once Had It’s Own Airport With a Singing Runway
Grooves in the tarmac were spaced so the lines played the opening notes of "When You Wish Upon a Star". The airport closed in 1972. Learn More