Wednesday, October 14, 2020 Daily Archives

Predicting Viral Clearance Using a Non-Infectious MVM Surrogate in Downstream Development

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This webcast features: David Cetlin, Senior Director, R&D, Cygnus Technologies As viruses can arise during the manufacture of biopharmaceuticals, regulatory agencies require viral clearance validation studies for each biopharmaceutical prior to approval. These studies are typically conducted in biosafety level (BSL)-2 facilities and require large capital and human resources. Due to these hurdles, process knowledge pertaining to viral clearance is limited during development and characterization. The use of an accurate, economical, and quantifiable non-infectious viral surrogate would enable downstream purification…

October 14, 2020

Vaxart ups production as oral COVID-19 vaccine dosing begins

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Vaxart agrees deal with Kindred Biosciences to expand manufacturing of COVID-19 vaccine candidate. Yesterday, Vaxart announced that the first subject had been dosed in a Phase I study for its oral tablet COVID-19 vaccine candidate. Prior to this, the biotech had agreed with Kindred’s contract development and manufacturing organization (CDMO) subsidiary, Centaur Biopharmaceutical Services, to increase the scale of production. As a result, Centaur will manufacture clinical trial material for the prospective vaccine out of its Elwood, Kansas, plant at…

October 14, 2020

J&J trial pause does not bode well for viral-vector COVID vaccines, analyst

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Johnson & Johnson says the pausing of dosing in trials of its COVID-19 candidate is not unusual, but one analyst believes this could have significant negative impact for viral-vector based vaccines. Johnson & Johnson announced at the beginning of the week it has temporarily paused further dosing in all its COVID-19 vaccine candidate clinical trials due to an unexplained illness in a study participant. This included the Phase III ENSEMBLE trial of JNJ-78436735, also known as Ad26.COV2-S, recombinant, which is…

October 14, 2020

SQZ Biotech lines up $75m IPO for cell therapy R&D

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SQZ Biotechnologies says its technology can produce cell therapies in less than 24 hours compared to a month or more for current products and is looking to use IPO proceeds toward the completion of Phase I development of its lead therapeutic candidate. In paperwork filed with securities regulators late last week, SQZ set a preliminary $75 million goal for its IPO. The Watertown, MA-based biotech has applied for a listing on the New York Stock Exchange under the stock symbol “SQZ.†SQZ…

October 14, 2020