Formulation and Drug Delivery

The companies will collaborate on the manufacturing, clinical development, and regulatory activities for Novavax’s COVID-19 vaccine in Japan.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

Sanofi and GlaxoSmithKline have been selected to supply the US government and the European Union with millions of doses of their COVID-19 vaccine candidate.

The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.

The companies have agreements to supply its mRNA-based COVID-19 vaccine to Japan and Canada, pending regulatory approvals in those countries.

The use of analytical assays is crucial for determining that biosimilar critical quality attributes remain on point.

This article presents the results of a survey conducted to gain insight on the impact of the COVID-19 pandemic on biomanufacturing operations.

This study suggests that using a simple centrifugal method can produce a natural polymer-blend molecule that can successfully be used as an oral delivery mechanism for poorly soluble drugs.

Particle engineering is a useful tool to manipulate API particles into a form that is manufacturable and deliverable to the patient.

Understanding and overcoming excipient variation are crucial for successful continuous processes.

The early success seen on the market for approved cell and gene therapies poses both technical and manufacturing challenges for pipeline candidates on the road to commercialization.

Outsourcing partners provide capacity and tech transfer expertise in the pharmaceutical industry response to the COVID-19 pandemic.

Pharmapack Europe 2021 has been rescheduled after a careful review by the event organizers with key stakeholders.

The companies will combine Intravacc’s OMV delivery platform with S-proteins with Celonic’s CHOvolution mammalian cell expression system to produce B and T-cell responses against SARS-CoV-2.

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

Pending approval of the Pfizer and BioNTech mRNA-based vaccine candidate against SARS-COV-2, the companies will supply the US government with an initial 100 million doses.

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

The project will focus on providing a faster route to clinical studies for AstraZeneca’s potential COVID-19 vaccine, AZD1222.

The UK government has secured early access to 90 million COVID-19 vaccine doses from the BioNTech/Pfizer alliance and Valneva.

Study reports immune and T-cell response from CanSino COVID-19 vaccine candidate.

Preliminary data from a German Phase I/II trial shows Pfizer/BioNTech COVID-19 vaccine candidate produces immune response.

Strong immune response by patients receiving two doses of vaccine suggests a possible treatment strategy.