In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|April 30, 2020
The Wistar Institute and Batavia Biosciences Collaborate to Manufacture and Distribute Wistar’s Rubella Vaccine Globally
Author(s)BioPharm International Editors
With funding from the Bill & Melinda Gates Foundation, Batavia’s low-cost vaccine manufacturing process will be used to produce Wistar’s drug substance and drug product formulations, to be distributed to vaccine manufacturers.
Advertisement
The Wistar Institute and Batavia Biosciences announced a collaboration to streamline the clinical-grade manufacture and global distribution of Wistar’s rubella vaccine seed stock commonly known as RA 27/3, the companies announced in an April 29, 2020 press release. In December 2019, Wistar was awarded a grant from the Bill & Melinda Gates Foundation to support this global access-focused international collaboration.
“We must continually find creative ways for non-profit and for-profit companies to work together to make life-saving technologies easily accessible to people around the globe,” said Heather Steinman, Wistar’s vice-president for business development and executive director of technology transfer, in the press release. “The generous funding support from the Gates Foundation is the glue that has enabled Wistar and Batavia Biosciences to unite with a single mission of ensuring long-term supplies of RA 27/3.”
“Combining the established know-how and experience at The Wistar Institute with our technology to manufacture vaccines at low cost and the support of the Bill & Melinda Gates Foundation provides us with an exciting opportunity to increase the distribution of a critical vaccine,” said Chris Yallop, Batavia’s CSO and COO, in the press release.
The rubella vaccine was developed at Wistar in 1969 and is safe and effective at providing long-lasting protection. The number of countries using rubella vaccines in their national immunization programs is steadily increasing. Despite this progress, rubella control is lagging behind, and several countries have neither introduced the vaccine nor set elimination or control targets. One major issue is supply shortage, mainly due to insufficient production capability. The number of companies that produce rubella vaccines has been steadily decreasing, causing global shortages of the vaccine. Batavia, headquartered in the Netherlands, shares with Wistar a focus on rapidly accelerating the development of vaccines and other biopharmaceutical product candidates from discovery to market to improve global health.
With the Gates foundation support, Wistar will be able to archive the existing supplies of research-grade rubella virus seed stock and transfer the necessary supplies to Batavia to enable the development of readily accessible good manufacturing practice-grade rubella drug substances and drug product formulations, with the intent to distribute these critical materials to vaccine manufacturers around the world through a universal license agreement construct.
Source:
Advertisement
Related to this article
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.
Beam Therapeutics’ base-edited cell therapy risto-cel meets its primary endpoint in the BEACON sickle cell disease trial, Amgen’s CD40L antagonist dazodalibep reduces systemic disease activity in the phase 3 OASIZ-301 Sjögren’s disease trial, and ImvivaBio’s allogeneic CD19/BCMA CAR-T CTA313 sustains lupus remission through 12 months.
ImvivaBio’s off-the-shelf CD19/BCMA CAR-T cell therapy CTA313 kept 88% of evaluable patients with refractory lupus in DORIS remission at Month 12, according to longer-term phase 1 data presented at ACR Convergence 2026.
Full phase 3 OASIZ-301 results show both dosing regimens of Amgen’s CD40L antagonist fusion protein dazodalibep reduced systemic disease activity in Sjögren’s disease at Week 48. The every-four-weeks dose also improved patient-reported dryness.
FDA grants RMAT and Fast Track designations to AbelZeta’s CD20/CD19 bispecific CAR-T prizlon-cel in relapsed or refractory large B-cell lymphoma, Larimar Therapeutics completes a BLA seeking accelerated approval of nomlabofusp for Friedreich’s ataxia, and Merck’s GLP-1/glucagon receptor agonist efinopegdutide meets its primary endpoint in a phase 2b MASH trial.
Advertisement
Advertisement
Trending on BioPharm International
1
ImvivaBio’s Dual-Target Allogeneic CAR-T Sustains Lupus Remission Through 12 Months
2
Updates on Simtra BioPharma Solutions’ Bloomington Capacity Expansions
3
Blackstone to Provide Pfizer Up to $1.5 Billion for Monthly GLP-1 Berobenatide Development
4
Amgen’s Dazodalibep Reduces Systemic Disease Activity in Phase 3 Sjögren’s Trial
5