Vaccine Development and Manufacturing

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

CGT Catapult has launched the Advanced Therapies Skills Training Network, designed to open career opportunities and upskill staff in advanced therapy and vaccine manufacturing in the UK.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.

Scaling needs for potential COVID-19 vaccines depend not only on capacity, but also on supply chain challenges and technological hurdles.

After a difficult year, biopharma science delivers promising results.

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

An independent data safety monitoring board found that clinical trial data demonstrated that the vaccine candidate met its primary endpoint and demonstrated protection from COVID-19.

Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.

Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.

Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.

Pfizer and BioNTech’s BNT162b2 shows efficacy of 95%; the companies plan to submit a request, within days, to FDA for an EUA.

Moderna’s COVID-19 vaccine candidate can be distributed using widely available vaccine delivery and storage infrastructure.

The new facility, which is expected to be operational by mid-2026, will utilize cell-based technology to produce influenza vaccines for influenza pandemics and seasonal vaccination programs, both in Australia and globally.

The vaccine will enter into a Phase III clinical trial in the United States and Mexico by the end of November, which could potentially support global authorization and approval of the vaccine.

FDA issued emergency use authorization for bamlanivimab for patients at risk for severe COVID-19.

Interim efficacy data suggests the Pfizer/BioNTech mRNA-based vaccine has an efficacy rate above 90%.

Biopharma can apply new manufacturing practices adopted during the COVID-19 pandemic to enhance bioprocessing.

The document provides analytical strategy options for the control of recombinant viral vectored vaccines to support COVID-19 vaccine developers.

In the wake of its efforts to develop a COVID-19 vaccine candidate, the company has secured two additional properties in the Gaithersburg, MD area.

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.