Vaccine Development and Manufacturing

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically.

The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.

The new excipients manufacturing facility is expected to be completed in 2025.

Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on percent transduction for AAV measured.

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.

invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.

Vaccine nationalism strengthens viruses and poses deadly risks for all involved.

The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.

Nicole Lewis, PVP Program Manager at Boston Children's Hospital, discusses the science behind precision vaccines, a form of personalized vaccines.

Thanks to Jane M. True VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, for an absorbing conversation around the topic: Addressing the Next Pandemic Must be Diverse, Reliable, and Sustainable.

Pharmaceutical companies have shifted their approach to development of vaccines as a result of the COVID-19 pandemic.

Process and plasmid design optimization, disposable equipment, and flexible platform processes all play important roles.

Advances in vaccine development are creating partnerships and stimulating clinical trials to develop new mRNA applications.

Moderna and Merck’s investigational personalized mRNA cancer vaccine has been granted Breakthrough Therapy Designation by FDA.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

FDA plans to authorize a common bivalent shot that targets both the original COVID-19 strain and Omicron subvariants.

Messenger RNA is inherently unstable and thus requires unique solutions to protect its cohesion.

She also mentioned the Clinical Trials Regulation and the Clinical Trials Information System (CTIS) launching at the same time to help energize the clinical research area of the EU.

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

The approval is based on results from the pivotal EFFISAYIL 1 Phase II clinical trial.

mRNA-1273.222 has also received FDA EUA for children and adolescents between six and 17 years of age and for adults over the age of 18 years of age.

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Increasing molecular diversity is creating a need for the reinvention of process development and control strategies.

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.