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

By Miranda Greenberg -

August 6, 2020

The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Thermo Fisher Scientific, Wockhardt, and Vigene Biosciences.

Biologics Manufacturing

Altimmune, Vigene Biosciences in Mfg Pact for COVID-19 Vaccine 
Altimmune, a Gaithersburg, Maryland-based clinical-stage biopharmaceutical company, and Vigene Biosciences, a Rockville, Maryland-based CDMO specializing in viral vectors, have entered into an agreement to manufacture AdCOVID, Altimmune’s single-dose intranasal vaccine candidate for COVID-19.

Vigene will deploy its capabilities to manufacture AdCOVID. Following recent positive preclinical data, Altimmune plans to start a Phase I clinical trial of AdCOVID in the fourth quarter of 2020.

Altimmune says it is also initiating scale-up of manufacturing of its AdCOVID vaccine for advanced clinical trials and commercial production and is engaged in discussions with additional strategic manufacturing partners with the goal of producing at least 100 million doses of AdCOVID in 2021.

AdCOVID is an intranasal vaccine candidate designed to block viral infection and to provide protection against viral spread through the stimulation of both mucosal and systemic neutralizing antibodies (IgA and IgG) as well as cell-mediated immunity. By stimulating mucosal immunity in the nasal cavity, a point of entry and replication for SARS-CoV-2, the virus that causes COVID-19, the company says AdCOVID has the potential to defend against both infection in the recipient as well as spread of the virus to others.

Source: Altimmune and Vigene Biosciences


Formulation Development/Drug-Product Manufacturing

Wockhardt in COVID-19 Supply Pact with UK Government
Wockhardt, a Mumbai, India-based pharmaceutical company and CDMO, has entered into an agreement with the UK government to fill–finish COVID-19 vaccines. The manufacturing will be undertaken at CP Pharmaceuticals, a subsidiary of Wockhardt based in Wrexham, North Wales, UK.

As per the agreement, the company has reserved manufacturing capacity to allow for the supply of multiple vaccines to the UK government in addressing COVID19, including AZD1222, the vaccine co-invented by the University of Oxford and its spinout company, Vaccitech, and licensed by AstraZeneca.

The government has reserved one fill–finish production line for its exclusive use for the next 18 months (as reported on August 3, 2020) in order to guarantee the supply of vaccines required to address COVID-19 in the UK.

In the UK, Wockhardt employs over 400 people at its 612,000-square-foot manufacturing facility in Wrexham.

Source: Wockhardt


General

Thermo Fisher Launches Automated Testing System for COVID-19
Thermo Fisher Scientific has introduced a new automated polymerize chain reaction (PCR) testing system for COVID-19 that is designed to analyze up to 6,000 samples in a single day.

The Thermo Fisher Scientific Amplitude Solution is a molecular diagnostic testing system that uses the company's Applied Biosystems QuantStudio 7 Flex Real-time PCR instruments, along with liquid-handling products from Tecan Group, a Männedorf, Switzerland-based company specializing in laboratory automation and liquid handling. The modular solution delivers test results in a four-step process.

The amplitude solution uses Thermo Fisher's Applied Biosystems TaqPath COVID-19 combo kit, a multiplex diagnostic test that contains the assays and controls needed for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19. The company says it plans to apply for emergency use authorization to the US Food and Drug Administration and to secure additional authorizations globally.

As part of this offering, Thermo Fisher will enter into supply agreements with customers to supply reagents and consumables and test kits.

Source: Thermo Fisher Scientific