CDMO, CMO, Supplier Roundup in Supporting COVID-19 ProjectsBy
The latest from CDMOs/CMOs and suppliers in COVID-19 projects featuring Fujifilm Wako Pure Chemical, Chime Biologics, and Vectura Group.
Chemicals/Chemical API Manufacturing
Fujifilm Wako Pure Chemical Launches SARS-CoV-2 Mutation-Detection Kit
Fujifilm Wako Pure Chemical Corporation has launched a mutation detection kit for SARS-CoV-2, the virus that causes COVID-19.
The L452R mutation detection kit is a research reagent to detect SARS-CoV-2 mutation. This research reagent is capable of detecting L452R mutation at a high sensitivity from SARS-CoV-2 positive specimen.
In addition, the combination with the detection kits for N501Y and E484K mutations, that were launched in this March (March 2021), makes it possible to identify the UK variant, South African/Brazilian variants, and Indian/California variants. The Indian and California variants don’t have N501Y or E484K mutations, but have L452R mutation. In addition, some Indian variants have mutation of E484Q as well as L452R.
Fujifilm Wako Pure Chemical is also currently developing the detection kit for E484Q mutation found on the Indian variant. The combination of this kit with L452R mutation detection kit enables it to identify Indian variants with E484Q mutation.
This kit is used in the Japanese government’s COVID-19 testing programs. Additionally, the company is engaged in research and development for new variants says it will expand the lineup of mutation detection kits with early introduction to the market.
Humanigen, Chime Biologics in Mfg Pact for COVID-19 Drug
Humanigen, a Burlingame, California-based biopharmaceutical company, and Chime Biologics, a Wuhan, China-based CDMO, have entered into a manufacturing services agreement to produce the bulk drug substance and drug product of lenzilumab, Humanigen’s therapeutic candidate in development for COVID-19.
The production of the bulk drug substance and drug product of lenzilumab is for commercial sale following receipt of the requisite regulatory authorizations or approvals in regions outside of the US, including Europe, the UK, India, and Brazil.
Under the agreement, Chime will use its modular manufacturing facility in China that uses KUBio, Cytiva’s cGMP modular manufacturing platform. The cell-culture capacity at the facility is 24,000 L with planned expansion to 140,000 L with Chime willing to commit at least 56,000 L for Humanigen manufacture annually. Technical transfer work has already begun, and commercial product is planned to be available in 2022.
Source: Humanigen and Chime Biologics
Formulation Development/Drug-Product Manufacturing
Vectura, Inspira Enter Pact To Develop Inhaled COVID-19 Treatment
Vectura Group, a Chippenham, UK-based CDMO of drug products, and Inspira Pharmaceuticals, a London-based company focused on developing therapies for respiratory and infectious diseases, have entered into an agreement to develop an inhaled formulation of Inspira’s lead drug candidate for the treatment of COVID-19.
Inspira’s research focuses on proprietary IPX formulations, which are based on processed and purified extracts from a plant source. These extracts contain proteolytic enzymes that have been shown to inactivate the SARS-CoV-2 virus in vitro, according to the company. The IPX technology platform has additional potential applications in other lung infections and treatment of biofilms associated with respiratory disease.
The agreement allows Vectura to perform further testing and development work to prepare initially for Phase I clinical studies using its vibrating mesh nebulizer to deliver the IPX formulations directly to the lungs. All studies will be undertaken at Vectura’s Chippenham, UK facility.
Source: Vectura and Inspira Pharmaceuticals