CDMO, CMO, Supplier COVID-19 Developments: Partnering and Operations

The latest from CDMOs, CMOs, and suppliers on supporting COVID-19 efforts featuring Cobra Biologics, Emergent Biosolutions, WuXi AppTec, Almac and Eurofins.

Biologics manufacturing

Cobra Biologics To Develop COVID-19 Vaccine
Cobra Biologics, a biologics CDMO, is working as part of a consortium led by the Jenner Institute of Oxford University, a research institute focused on vaccine development, to rapidly develop, scale up, and produce a potential adenoviral vaccine candidate, ChAdOx1 nCov-19 (ChAdOx1), for fast-tracked clinical trials for COVID-19.

The ChAdOx1 consortium includes: the University of Oxford’s Jenner Institute; the University of Oxford’s Clinical Biomanufacturing Facility, the Vaccines Manufacturing and Innovation Center; Advent Srl, a vaccine CDMO; Pall Life Sciences; Cobra Biologics; and Halix BV, a CDMO.

The ChAdOx1 consortium is currently (as reported March 31, 2020) recruiting individuals from a range of ages in the UK to trial the vaccine’s efficacy. Cobra is planning for a fast set-up phase to facilitate the production of a GMP working cell bank and then 200-L GMP viral vaccine. The consortium partners expect to develop and manufacture the vaccine candidate in multiple batches to support a 1-million dose scale batch size by the summer of 2020.

Source: Cobra Biologics

Emergent Biosolutions Enters Pacts for Experimental Vaccines
Emergent Biosolutions, a CDMO of biologics and vaccines, has signed manufacturing contracts with two separate companies (Novavax and Vaxart) and has initiated development of two plasma-derived product candidates to support development of their vaccines against the novel coronavirus (COVID-19). 

Novavax. Emergent is partnering with Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, to support bringing into the clinic Novavax’s experimental vaccine candidate against COVID-19. Under the agreement, Emergent will produce the COVID-19 experimental vaccine candidate, which is based on Novavax’s proprietary recombinant protein nanoparticle technology platform and proprietary Matrix-M adjuvant. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase I clinical study within the next four months (as reported on March 10, 2020).

Vaxart. Emergent is also partnering with Vaxart, a South San Francisco, California-headquartered developer of oral recombinant vaccines, to develop and manufacture Vaxart’s experimental oral vaccine candidate for COVID-19. Development services began in March (reported on March 10, 2020) and upon Vaxart’s election, Emergent will produce clinical material to enable Vaxart to initiate a Phase I clinical study that is expected to begin early in the second half of 2020.

Under the agreement, Emergent will provide development services out of its Gaithersburg, Maryland. location and manufacture drug substance at its Bayview facility in Baltimore, Maryland, designated as a Center for Innovation in Advanced Development and Manufacturing (CIADM) by the US Department of Health and Human Services. Emergent’s Bayview CIADM is the same facility used to manufacture drug substance for Emergent’s collaboration with Novavax. The facility has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, according to information from Emergent.

Emergent internal development. Emergent has also initiated development of two product candidates for the treatment and prevention of COVID-19 using Emergent’s hyperimmune platforms. Hyperimmunes are polyclonal antibody therapeutics derived from plasma that use the immune response in humans or animals. Emergent will develop the first product candidate, COVID-HIG, manufactured from human plasma with antibodies to SARS-CoV-2, the virus that causes COVID-19, as a potential treatment for severely hospitalized patients as well as for protection for at-risk individuals. Its second product candidate, COVID-EIG, manufactured from plasma of immunized horses with antibodies to SARS-CoV-2, will be developed as a potential treatment for severely hospitalized patients.

Emergent has initiated plasma collection efforts for both human and equine platforms with a goal of manufacturing clinical material within the next four to five months (as reported on March 10, 2020) in anticipation of beginning a clinical study as early as the third quarter of 2020.

Source: Emergent Biosolutions (Novavax), Emergent Biosolutions (Vaxart) and Emergent Biosolutions (internal product candidates) 

CMAB Biopharma Resumes Operations in China 
CMAB Biopharma, a biologics CDMO headquartered in Suzhou, China, reported on March 19, 2020 it has resumed full operation at its facility in Suzhou, China. Based on CMAB’s assessment and management of the situation at its facility, the company has maintained the operation of research and development and manufacturing services.

The company had initiated pandemic prevention and control measures beginning in January 2020. These measures included the formulation of guidelines and management measures, implementation of personal health registration for all staff and visitors, establishment of health checkpoints for daily temperature monitoring, provision of personal protective equipment (medical masks, protective goggles, protective gloves), and alcohol disinfection every two hours. Additionally, CMAB said it strictly regulated employees, visitors and third-party personnel in accordance with local government requirements to reduce unnecessary business trips and visits. For remote and international customers, the company implemented dedicated video and teleconference channels to avoid the potential risks of in person meetings.

Source: CMAB Biopharma


Almac Expedites Support for COVID-19 Clinical Trials
Almac Clinical Technologies, a member of the Almac Group, has expedited deployment of multiple interactive response technology (IRT) solutions to be used in clinical development in support of COVID-19 treatments.

Almac reports that several clinical trial sponsors are partnering with the company, which is supporting expedited pathways to emergency clinical trials designed to investigate the efficacy of investigational medicinal products and commercially pre-approved medicinal products against COVID-19. The result of these collaborations materialized in the form of fully functioning IRT systems used for patient randomization and clinical-trial-material management which were designed, validated, and deployed in under seven days.

Source: Almac Clinical Technologies

Eurofins Launches Testing to Detect COVID-19 on Surfaces
Eurofins Technologies, a provider of diagnostic technologies for immunoassays and molecular detection methods, has launched GeneScan VIRSeek SARS-CoV-2 RT-PCR, an integrated solution including RNA extraction and test kits based on real-time reverse transcription polymerase chain reaction for the detection of SARS-CoV-2, the virus that causes the novel coronavirus (COVID-19) in swabs of environmental surfaces.

Source: Eurofins Technologies

WuXi AppTec’s Site in Wuhan, China Resumes Operation
WuXi AppTec, a CDMO of small molecules, cell and gene therapies, and testing services, reported on March 11, 2020 that the company’s Wuhan, China site has resumed operations, in compliance with local regulations and global COVID-19 health and safety guidelines. With this site’s re-opening, WuXi AppTec has resumed operations at all facilities in China. Prior to the Wuhan site re-opening, WuXi AppTec temporarily transferred operations to other sites to continue to support customers’ projects.

Source: WuXi AppTec

BGI Launches Inflatable Biosafety Lab for COVID-19 Testing
BGI Genomics, a Shenzen, China-based provider of genomic-sequencing and proteomic services in collaboration with the company Etopia, have launched a mobile, inflatable P2 level biosafety laboratory, named the Huo-Yan Air Lab, as an in-country diagnostic laboratory for COVID-19. The biological nucleic acid laboratory launched by BGI is for the screening and testing of SARS-CoV-2, the virus that causes COVID-19. A P3 level biosafety laboratory was constructed using an inflatable structure during the Ebola outbreak in 2014 in West Africa, where BGI contributed to the response efforts and helped to develop virus detection kits. A patent for the Huo-Yan Air Lab has been filed and registered with the international Patent Cooperation Treaty. The lab covers an area of approximately 400 square-meters and is designed to process from 5,000 to 10,000 samples per day.

Source: BGI Genomics

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