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More CDMOs in COVID-19 deals

30th July 2020

Submitted by:

Andrew Warmington

The ongoing race to develop the first effective vaccines for the treatment of COVID-19 continues to generate manufacturing and development agreements between pharmaceutical giants, biotechs and CDMOs.

Most recently, Sterling Pharma Solutions agreed to carry out final purification of drug product for Moleculin Biotech’s WP1122 drug candidate from its site in Cary, North Carolina. Moleculin is about to submit an IND for this to the FDA and wanted a reliable source of supply in the US.

Also within July, late-stage biotech Novavax reached separate agreements with Fujifilm Diosynth Biotechnologies (FDB) and AGC Biologics to manufacture the drug bulk substance and the saponin-based Matrix-M adjuvant respectively for its COVID-19 vaccine candidate, NVX-CoV2373, which it created via recombinant nanoparticle technology. FDB’s site in Morrisville, North Carolina has begun production of the first batch for a Phase III trial due to begin later this year.

Matrix-M was developed in-house at Novaxax and AGC will deliver large-scale production for trials. This is all part of the $1.6 billion award made to Novavax under the federal government’s Operation Warp Speed programme to develop millions of doses of vaccine.

Earlier, Novasep signed a partnership with AstraZeneca to produce the active substance for Oxford University’s COVID-19 vaccine from dedicate specific production areas at its site at Seneffe, Belgium. The project is also supported by the Inclusive Alliance for Vaccines, comprising France, Germany, Italy and the Netherlands.

AMRI has been named as the second US API supplier for ViralClear Pharmaceuticals, which is investigating the potential of merimepodib to fight SARS-CoV-2 either as a stand-alone treatment or in combination with other antiviral agents or immune modulators. Merimepodib was previously developed for chronic hepatitis C and psoriasis by Vertex.

In May, Lonza signed a ten-year strategic collaboration agreement with messenger RNA therapeutics and vaccines firm Moderna, under which they it will carry out large-scale manufacture of Moderna’s mRNA vaccine for SARS-CoV-2, mRNA-1273. Production has begun in the US and they aim to manufacture up to 1 billion doses in time.

The project is partly funded by Moderna’s contract with Biomedical Advanced R&D Authority (BARDA). This is part of the Office of the Assistant Secretary for Preparedness & Response within the Department of Health and Human Services, which was announced on 16 April. Moderna submitted an IND application for Phase II and later stage studies 11 days later.

Separately, CordenPharma has expanded an ongoing strategic manufacturing services agreement with Moderna to include the supply of lipid excipients for mRNA-1273. These will be produced at the company’s site in Switzerland for the Phase II trial.

In Japan, Kaneka has agreed to supply API for the anti-influenza drug, Avigan Tablet (favipiravir) to Fujifilm. This is expected to be effective against COVID-19 and the Japanese government is increasing its stockpiles in order to supply it to up to 2 million people. Fujifilm is therefore ramping up tablet production.

Finally in April, Alcami formed a partnership to supply API for clinical trials of Eagle Pharmaceuticals’ Ryanodex (dantrolene sodium) for injectable suspension, which inhibited the growth of the virus in in vitro tests. Eagle has applied to the FDA for an IND for a Phase II clinical trial and has requested an expedited review. The drug is already approved for the treatment of malignant hyperthermia.

UPL to split out specialities

Indian agrochemicals giant UPL has announced plans to transfer its speciality chemicals business, including agrochemical

Submitted by:

Andrew Warmington

AI for SAPs

Together with Algo Artis, Japan’s Nippon Shokubai has developed an algorithm-based means for the production

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Andrew Warmington

Nippon Shokubai's API Facility in Japan

Nucleic acid API boost

Nippon Shokubai is to expand its GMP capacity for nucleic APIs tenfold It will install

Submitted by:

Andrew Warmington

Flamma's facility in Dalian

Flamma opens in China

Italian CDMO Flamma Group has officially opened its new cGMP plant at Dalian, China, where

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Andrew Warmington

GL Chemtec has opened a new kilo lab

GL Chemtec completes kilo lab

CDMO GL Chemtec has announced the completion of a cGMP kilo lab at Oakville, Ontario

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Andrew Warmington

Sterling's facility at Deeside, UK

CDMOs in ADC investments

Five CDMOs across the world have separately announced investments in antibody-drug conjugates (ADCs). Piramal Pharma is

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Andrew Warmington

Halozyme has dropped its approach to buy Evotec

Halozyme abandons Evotec bid

San Diego-based biopharmaceutical company Halozyme Therapeutics has withdrawn the offer it made for Evotec after

Submitted by:

Andrew Warmington

Afyren Neoxy plant

Milestones for two greentech firms

Afyren has achieved continuous production at its Afyren Neoxy plant at Clermont-Ferrand (pictured)

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Andrew Warmington

Origin by Ocean derives its materials from sargassum

CABB in algae biorefinery deal

CABB has agreed a strategic partnership to establish a first-in-kind algae biorefinery at its site at Kokkola

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Andrew Warmington

First waste-based biosurfactants

Belgian start-up AmphiStar has launched what it claims are the first fully upcycled biobased surfactants

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Aether to supply Seqens

Indian firm Aether Industries has entered into a manufacturing agreement with Chemoxy International, a UK-based

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Andrew Warmington

New model for biocatalysts

BASF, the Austrian Research Centre of Industrial Biotechnology (ACIB) and the University of Graz in

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Andrew Warmington

CBE JU funds 31 more projects

The Circular Bio-based Europe Joint Undertaking (CBE JU), a €2 billion partnership between the EU

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Andrew Warmington

Ribbon cutting ceremony at Lubrizol's new office

Lubrizol opens London office

Lubrizol has opened a new office in Hammersmith, London. This will be home to a

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Andrew Warmington

Sudarshan to buy Heubach

India’s Sudarshan Chemical Industries (SCIL) has entered into a definitive agreement to acquire the Heubach

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Andrew Warmington

Alliance in natural fragrances

Sensegen, a US-based specialist in biotech-enabled fragrances, notably a new class of natural musk raw

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Andrew Warmington

Croda breaks ground in China

Croda International has broken ground for a low-carbon, multi-purpose production facility on a greenfield site

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Andrew Warmington

CCT collaboration for Givaudan

Flavours and fragrances giant Givaudan has agreed a research collaboration for the development of sustainable

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Andrew Warmington

REACH Authorisation

Candidate List ‘reaches’ 250

The European Chemicals Agency (ECHA) has added three more substances to the Candidate List of

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Andrew Warmington

Staff at Brenntag's newly acquired Czech site

CO2-free distribution site first

Brenntag has officially inaugurated what it claims to be the first CO2-emission-free chemical distribution site

Submitted by:

Andrew Warmington