Contract Development And Manufacturing Organizations (CDMO)

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Lonza Builds Swiss Fill & Finish Facility

Swiss CDMO Lonza plans to build a large-scale commercial fill & finish facility in Stein. The new facility, to be located on the same campus as Lonza’s existing clinical drug product capabilities, will cost roughly 500 million Swiss francs and should be completed in 2026.

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Expansion at SK Biotek API Plant to Cost $35 Miilion

South Korean CDMO SK Pharmteco (SKTP) said it will spend $35 million on the initial phase of a planned expansion at the Dublin, Ireland, API site the conglomerate acquired from Bristol Myers Squibb in 2017. Prior to that, SK had been a BMS supplier for around a decade.

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Olon Establishes Central R&D Hub near Milan

Major API supplier Olon is establishing a €10 million central R&D hub at its headquarters site in Roadano, near Milan. The Italian company said the facility paves the way for a further major expansion and diversification of its expertise in active pharmaceutical ingredients supplied to the CDMO and generics markets.

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EureKING Poised to Shake up European CDMO Scene

EureKING, a new special purpose acquisition company (SPAC) steered by former European biopharma executives, launched itself on May 9 and in a subsequent listing on the Paris-based Euronext stock exchange raised €150 million to buy up small European CDMOs that make biologics, cell and gene therapies or live biotherapeutics.

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Symeres Boosts US Foothold with Organix Buy

Symeres, a Dutch CDMO and contract research organization, has acquired Organix, a US-based specialized organic chemistry services producer that focuses on lipids. The two firms are highly complementary and the combination unlocks significant strategic value, said Symeres, which generates nearly 50% of its revenues in the US.

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Asahi Kasei Medical Buys Bionova Scientific

Asahi Kasei Medical, through a US subsidiary, has agreed to buy biologics CDMO Bionova Scientific for an undisclosed sum. Located in Fremont, California, Bionova provides process development services to biopharmaceutical companies, especially those developing next-generation antibody-based drugs.

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Germany’s Merck Buys US CDMO Exelead

Germany’s Merck has signed a definitive agreement to acquire Exelead, a US biopharmaceutical CDMO, for around $780 million in cash. The Indianapolis, Indiana-based company specializes in complex injectable formulations, including Lipid Nanoparticle (LNP)-based drug delivery technology, which is key to mRNA therapeutics and vaccines for indications such as Covid-19.

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GTP Bioways Investing €12 Million at Toulouse

French CDMO GTP Bioways, a specialist in biotherapies and nanotherapies, is investing €12 million in two new biopharmaceutical production lines at its site in Toulouse. The first line will be dedicated to production using microbial systems (bacteria and yeast), while the second is designed for the culture of mammalian cells at a scale of 10 l.

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Avid Bioservices Expanding Cell and Gene Therapy

Avid Bioservices, a biologics-oriented CDMO based in the US state of California, is building a new plant in Costa Mesa, California, as part of a plan to expand its cell and gene therapy portfolio. The purpose-built facility, to be located five miles from its current base in Tustin, California, will be dedicated to viral vector development and CGMP manufacturing.

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Germany’s Merck Expands CDMO Footprint

Germany’s Merck has opened its second production facility for viral vectors at Carlsbad, California, a move the company said significantly expands its global CDMO footprint. The new €100 million plant will more than double the company’s existing capacity to support large-scale commercial and industrial manufacturing for viral gene therapy.

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Managing Supply for Complex Biotherapeutics

Successfully managing the drug substance manufacturing of Antibody-Drug Conjugates (ADCs) requires a sophisticated understanding of the technological development process and access to a range of large- and small-molecule manufacturing assets.

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French CDMO Yposkesi Builds Second Bioproduction Site

Yposkesi, a French CDMO specializing in cell and gene therapies, has started building a second commercial bioproduction facility, known as project SKY. The plant is being designed to be cGMP- compliant with both European and US regulations. Operations are expected to start in 2023.

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Covid-19 Driving Manufacturing, CDMOs Driving Growth

The CPhI executive post-pandemic pharma survey, produced by Informa Markets as part of the CPhI Pharma 2021 Report, predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. The findings suggest that over the next 5 years, governments and companies will gradually look to reduce complexity and increase regional self-reliance.

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Vaccine Filling at the Highest Level

Recent studies show that contract manufacturers for the pharmaceutical industry, so-called CDMOs (contract development and manufacturing organizations), have so far been little involved in the production of vaccines. This is changing with the outbreak of the Covid-19 pandemic.

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Regis Technologies Completes Lab Expansion

US-based CDMO Regis Technologies has completed a major expansion of its laboratory facilities for development of active pharmaceutical ingredients (APIs) at its site in Morton Grove, Illinois. The project, kicked off two years ago, doubles the company’s capacity to take on new development projects.

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Lonza to Sell two Capsule Sites to NextPharma

Swiss CDMO Lonza said it intends to unload two of its capsule production sites, at Ploermel, France, and Edinburgh, Scotland, for an undisclosed sum to London-based CDMO NextPharma. The proposed deal is subject to regulatory approval. According to reports, most of the affected employees are expected to transfer to the new owner.

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The Coronavirus Crisis: Challenges and Opportunities for CMOs, CDMOs and CROs

The coronavirus crisis caused by the Covid-19 pandemic has uncovered problems that have been smoldering beneath the surface of the pharmaceutical industry — including CMOs/CDMOs and CROs — and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Andrew Henderson, Sterling Pharma Solutions

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Mark Quick, Recipharm

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Peter Halkjaer-Knudsen, Raybow Pharmaceuticals

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Matthew Moorcroft, Lonza

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Alan Walker, Kaneka

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: David Zimmermann, Kalexsyn

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Andrew Thompson, J-Star

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Jean-Luc Herbeaux, Hovione

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: GianMarco Negrisoli, Flamma

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Peter Pekos, Dalton Pharma Services

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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Expert Interview: Michael Quirmbach, CordenPharma

So far, the pharmaceutical industry — including CMOs/CDMOs and CROs — has responded well to the outbreak of the Covid-19 pandemic. However, the coronavirus crisis has uncovered problems that have been smoldering beneath the surface and need to be addressed. That supply chains are vulnerable to disruption when major development, production and transportation hubs are blocked or shut down has become painfully obvious.

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