Formulation and Drug Delivery

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.

With a $5 million grant from DARPA, DNA Script and Moderna will develop a prototype for rapid mobile manufacturing of vaccines and therapeutics as part of the DARPA’s Nucleic Acids On-Demand World-Wide program.

Sanofi will perform the fill/finish of up to 200 million doses of Moderna’s COVID-19 vaccine at its Ridgefield, NJ, facility starting in September 2021.

The decision comes from the US CDC Advisory Committee on Immunization Practices following the evaluation of data showing a rare adverse event involving blood clots in combination with low platelet counts within approximately one to two weeks following vaccination.

EMA's PRAC has concluded that there is a possible link to rare cases of blood clots with low blood platelets with Janssen’s COVID-19 vaccine.

Lipid production at Evonik’s Hanau, Germany, site was set up in eight weeks and met high-quality requirements, accelerating delivery time, which was originally set for mid-2021.

DFE’s new line will offer market purity and low endotoxin excipients for use in formulation, while providing drug developers and manufacturers high-quality excipient technology and services.

Design for a new BMS multi-product cell therapy manufacturing site in Leiden is underway, with construction to start later in 2021.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

The additional doses are a result of the European Commission’s expanded advance purchase agreement, which brings the total number of doses delivered to the EU to 600 million.

Biogen UK has announced that the UK’s MHRA and the EC have granted marketing authorization for the subcutaneous (SC) formulation of Tysabri (natalizumab).

This new technology could eliminate the need for cold chain storage, transport, and distribution of temperature-sensitive molecules.

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

Topical drugs are attractive to patients, but these complex products pose challenges for formulators.

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

In-vitro and in-silico tools can help predict in-vivo outcomes for low-solubility drugs formulated as spray-dried dispersions.

A Phase III trial evaluating the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, in adolescents 12 to 15 years of age showed 100% efficacy and positive antibody responses.

Set to be operational in 2026, the new facility will provide added antigen and filling capacity for Sanofi’s influenza vaccine, increasing its availability in Canada, the United States, and Europe.

GSK will provide filling capacity at its Barnard Castle facility in England.

Celonic will manufacture CvnCoV at its facility in Germany.

The company has entered into an agreement with the African Vaccine Acquisition Trust for the supply of 220 million doses of its single-shot COVID-19 vaccine for the African Union’s 55 member states beginning in the third quarter of 2021.

EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.