Vaccine Development and Manufacturing

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

Packaging and transporting large quantities of COVID-19 vaccines pose challenges for the cold chain.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

Shutting down the COVID-19 pandemic requires a global, selfless effort.

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

The company has formed an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s COVID-19 vaccine candidate, to the people of Singapore.

Freezers, shipping containers, and tracking systems aid distribution of COVID-19 vaccines.

The HERALD trial will involve participants 18 years and older who will receive a two-dose schedule of CVnCoV or placebo at multiple sites is Europe and Latin America.

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.

Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

The company has received $500 million in funding from Sino Biopharmaceutical for further development, capacity expansion, and manufacturing of CoronaVac, its COVID-19 vaccine candidate.

CDMO HALIX will manufacture the drug substance for AstraZeneca’s COVID-19 vaccine candidate, AZD1222, at commercial scale at its cGMP facility in the Netherlands.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.

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.