BioPharm International Editors

Catalent and Johnson & Johnson announce joint investment and tech transfer to prepare for rapid scale-up and segregated cGMP commercial manufacturing capacity.

AstraZeneca and the University of Oxford have announced that they will collaborate on the global development and distribution of the university’s potential recombinant adenovirus vaccine aimed at preventing COVID-19 infection.

ILC Therapeutics, a biotech company based in the United Kingdom, has discovered two separate novel treatments for patients suffering with COVID-19 prior to needing ventilators.

Solentim and ATUM will bundle together the Leap-In Transposase platform with the VIPS single cell cloning instrument for cell line development.

MilliporeSigma’s Bio4C Software Suite combines process control, analytics, and plant-level automation.

The event will be rescheduled for April 20–22, 2021 at the Javits Center in New York City.

With funding from the Bill & Melinda Gates Foundation, Batavia’s low-cost vaccine manufacturing process will be used to produce Wistar’s drug substance and drug product formulations, to be distributed to vaccine manufacturers.

The platform provides access to case studies, new technologies, expert insight, published and peer-reviewed articles, webinars, news updates, videos, and interviews.

A comprehensive turnkey system based on LabVantage’s laboratory information management system platform allows laboratories to implement COVID-19 biobanking, testing, and research.

The statement, published by the International Coalition of Medicines Regulatory Authorities, outlined its commitment to a strengthening of global collaboration in the fight against COVID-19.

The approval was based on pharmacokinetic data, the relationship of exposure to efficacy, and the relationship of exposure to safety.

The company has expanded capabilities for aggregate analytics to include dynamic light scattering.

NIH trial shows remdesivir accelerates recovery; Gilead study shows similar efficacy for 5- and 10-day dosing.

Merck will provide funding and will work with researchers at the Institute for Systems Biology to identify targets for therapeutic intervention and vaccine development.

A report into the Swiss biotech sector has shown that there is continued growth in the sector, which has received investments from public and private companies worth CHF 1.2 billion (US$1.2 billion).

MicrofluidX has raised £1.4 million (US$1.7 million) in seed funding, which it will use to develop its novel cell bioprocessing technology for cell and gene therapy.

A UK BioIndustry Association industry-led vaccine manufacturing group has welcomed a recent announcement by the government of the UK, that it will receive £14 million (US$17.3 million) in investment to rapidly scale up the development of vaccines for COVID-19.

The vaccine will be based on a ReiThera-proprietary simian adenoviral vector with strong immunological potency and low pre-existing immunity in humans.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

Emergent will offer up its drug substance manufacturing services with support by investments from Johnson & Johnson starting in 2020.

The approval was based off of positive results from a Phase III study that showed patients 70 years or younger treated with the BTK inhibitor lived longer without disease progression.

Bayer will provide CAD $1.5 million (USD$1 million) toward two studies to evaluate its chloroquine and interferon beta-1b combination therapies.

Catalent Biologics increased capacity at its Bloomington, IN Facility.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.

The companies will collaborate on the discovery and development of next-generation drug and engineered cell therapies focused on natural killer cells.

The phase-II, randomized, double-blind, placebo-controlled trial will study the efficacy and safety of the live biotherapeutic in 90 individuals with COVID-19 symptoms.

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

The report outlines the company’s approaches to product quality, safety, environmental sustainability, and diversity and inclusion.

Through the agreement, BARDA will support the advancement of the vaccine candidate to FDA licensure and will handle all late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacture in 2020.

This milestone achievement will allow the companies to move forward with developing a GMP-compliant manufacturing process for clinical testing.