CDMO, CMO, Supplier Roundup in Supporting COVID-19 Projects

By Miranda Greenberg -

June 4, 2020

The latest from CDMOs, CMOs, and suppliers in COVID-19 projects featuring AGC Biologics, Almac, and Advent Srl.

Biologics Manufacturing

Advent To Manufacture COVID-19 Vaccine for Oxford University
Advent Srl, a CDMO providing viral vector manufacturing, reports that it has manufactured 13,000 doses of a COVID-19 vaccine candidate, ChAdOx1 nCoV-19, developed by the University of Oxford. The first 4,000 doses have been delivered for use in the Phase II/III clinical trial by the University of Oxford, England.

Advent announced a partnership in February 2020 with the Jenner Institute at Oxford University. Advent manufactured its first batch of vaccine in over one month from receiving the seed stock.

The vaccine comprises a non-replicating adenovirus vector with the addition of the SARS-CoV-2 spike protein of the COVID-19 virus. It is hoped that the vaccine will result in people forming antibodies to the COVID-19 spike proteins, which would prevent infection and generate immunity in the tested population.

In late April (April 2020), the University of Oxford announced a partnership with AstraZeneca for the development and potential large-scale distribution of the COVID-19 vaccine candidate. Last month (May 2020), AstraZeneca announced it had been awarded more than $1 billion from the Biomedical Advanced Research and Development Authority, part of the office of Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, for the development, production and delivery of the University of Oxford’s COVID-19 vaccine, starting in the fall (fall 2020).

Source: Advent Srl


Novavax Selects AGC Biologics to Manufacture Novel COVID-19 Vax
AGC Biologics, a biologics CDMO, has entered into an agreement with Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, for the large-scale GMP production of a component of Novavax’s COVID-19 vaccine candidate, NVX-CoV2373.

NVX-CoV2373 is a stable, prefusion protein made using Novavax’s proprietary nanoparticle technology. Under the agreement, AGC Biologics will manufacture Matrix-M, Novavax’s proprietary saponin-based adjuvant, which is used to enhance the immune response and stimulate high levels of neutralizing antibodies. AGC Biologics will optimize process development for scaled-up production of Matrix-M to increase Novavax’ capacity to deliver doses in 2020 and 2021.

Novavax recently initiated development of NVX-CoV2373 with Phase I clinical trial results expected in July of 2020.

Source: AGC Biologics


General

Almac Receives $288,000 Grant for COVID-19 Clinical Efforts
Almac Group, a Craigavon, UK-based CDMO, has received a $288,000 grant from the COVID-19 Therapeutics Accelerator, an initiative by the Bill & Melinda Gates Foundation, Wellcome and Mastercard, to support a clinical study in Sub-Saharan Africa for a potential COVID-19 treatment.

Almac Clinical Services is providing various clinical services from protocol through to patient delivery while Almac Sciences is providing analytical support. In an effort to expedite the drug-development process, Almac Clinical Services has received the active drug and is providing over-encapsulation services, manufacturing a placebo match, and packaging and labelling supplies to support the blinded clinical trial. Almac Sciences is conducting analytical and stability testing for the investigational drug.

Almac Clinical Services will ship all supplies to the clinical site with onward management of logistics and distribution of the drug. The study is being led by an African principal investigator. In addition, Almac is supporting a second open-label clinical study through the distribution of commercial packs to a pharmacy in South Africa.

The COVID-19 Therapeutics Accelerator is an initiative launched by the Bill & Melinda Gates Foundation, Wellcome and Mastercard, with funding from public and philanthropic donors to speed up the response to the COVID-19 pandemic by funding the identification, assessment, development and scale-up of treatments.

Source: Almac Group