Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
News|Articles|June 4, 2020
Netherlands Partnership to Develop an Intranasal COVID-19 Vaccine
Author(s)Pharmaceutical Technology Editors
The new vaccine would be made with a Newcastle disease virus vector that expresses the immunogenic spike protein of SARS-CoV-2
Advertisement
In the Netherlands, Intravacc, a research and development vaccine institute, is partnering with Wageningen Bioveterinary Research (WBVR) and Dutch Utrecht University to develop an intranasal vaccine against COVID-19.
The target vaccine will be made up of a Newcastle disease virus (NDV) vector that expresses the immunogenic spike protein of SARS-CoV-2, which is a target for neutralizing antibodies. Its developers decided upon a nasal vaccination, which will provoke both mucosal and systemic immunity, while offering protection against additional infections at other mucosal sites (e.g., , in the lungs, intestines, and genital tract).
Intravacc will use its FDA-approved Vero cell platform to develop the vaccine and ready it for cGMP production, according to a company press release.
“Intravacc’s strength is its ability to bridge the gap between academia and research centers towards pharma,” said Intravacc’s CEO Dr. Jan Groen, in the press release. The Vero cell platform is already widely used to produce polio vaccines, Groen says, which should enable the partners to fast-track production of pilot lots of the vaccine, and then transfer the technology to large vaccine manufactures.
Source:
Advertisement
Related to this article
The FDA approves oral pritelivir for drug-resistant herpes sores in immunocompromised patients; what it means for antiviral development and manufacturing.
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Advertisement
Advertisement