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    Challenging Chemistry In Pharmaceutical Manufacturing pdf for Minakem

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    Minafin Group appoints Olivier Ubrich as CEO of Health Chemistry Division

    05 Sep 2024

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    The EDQM has validated updated CEP of Vinorelbine of Minakem, sole Mfg in Europe

    25 Jun 2024

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    Minakem Canada is manufacturing steroid APIs in a brand-new production unit

    17 May 2024

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    Minakem is a fully integrated development partner and commercial manufacturer for pharma companies. With around 70 years of experience, Minakem is a technology-driven company with expertise in complex multi-step synthesis, pressure chemistry, chiral synthesis, halogenation chemistry, steroid chemistry and prazole chemistry. It offers custom development & manufacturing, API manufacturing and the production of key intermediates. Minakem has 3 USFDA-approved development and manufacturing sites in France and Belgium. Minakem is an affiliate of the Minafin Group and has access to all technologies, resources, and capabilities.

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    INTERVIEW #SpeakPharma

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    "Minafin appoints Sébastien Poncet, Managing Director of Minakem Generics & New Therapies"

    "Minafin appoints Sébastien Poncet, Managing Director of Minakem Generics & New Therapies"

    Sébastien Poncet is charged with enhancing the portfolio of proprietary processes and seizing opportunities in new therapies. Louvain-la-Neuve, January 27, 2022 – The Health Chemistry division of the Minafin Group today welcomes Sébastien Poncet as managing director of the Minakem Generics and New Therapies business unit. He is also an executive member of the division. Sébastien is a graduate of the Montpellier School of Chemistry Engineering (ENSCM) and holds a master's degree in business: B2B strategy and marketing from EM Lyon and participated in several international management programs from IMD Lausanne and from INSEAD. Over the past 20 years, he has held numerous sales positions at Solvay, Clariant (now Curia), Johnson Matthey, and Minafin. Sébastien is returning to the Minafin Group following an eight-year tenure at Fareva, where for the last two years he was a member of the executive committee. Frédéric Gauchet, chairman of the Minafin Group, said: "Sébastien’s appointment reflects our desire to enhance our portfolio of proprietary processes for manufacturing generic active ingredients in support of the efforts authorities are taking to secure a European drug supply. Minafin has the advanced know-how in fine chemistry required to enable the development of innovative therapies. But in order to remain at the cutting-edge of ‘new technologies,’ we may consider potential acquisitions in high value-added chemistry or biotechnology." Sébastien will focus on developing the business of active pharmaceutical ingredients that are within the public domain and seizing commercial opportunities generated by emerging therapies such as Messenger RNAs. “I am very pleased to start working again with the world-class teams at Minakem. They are globally recognized for their capacity to design innovative chemical routes, to scale them up successfully and their proven track record agility in the field of active ingredients. And I look forward to collaborating with them on the generic API product portfolio that I see has significant growth potential,” said Sébastien “As for new therapies, the sanitary crisis we are going through has demonstrated their importance in the therapeutic arsenal against COVID-19, for example, messenger RNA vaccines. These new technologies developed with high value-added chemistry are where Minakem’s Research & Development know-how can really make a difference in the years to come.” About the Minafin Group Health Chemistry Division The Health Chemistry division develops and manufactures active ingredients for the pharmaceutical industry through its two business units: Minakem CDMO and Minakem Generics & New Therapies. Minakem is the leader in Europe. It offers a wide range of cutting-edge technologies and pharmaceutical services to ensure that its customers have a seamless supply of high-quality products. The company provides its expertise for the development of exclusive manufacturing processes and to produce active pharmaceutical ingredients following cGMP conditions. Patients' needs being at the heart of its activities, the Healthcare Chemistry division ensures that the drugs it manufactures meet the strictest health and environmental safety standards. Minakem CDMO focuses on proprietary custom synthesis while Minakem Generics & New Therapies develops proprietary manufacturing processes for generic active ingredients and innovative therapies. The three production sites of the Healthcare Chemistry division, approved by the FDA, are located in Louvain-la-Neuve (BE), Dunkirk (FR) and Beuvry-la-Forêt (FR). Created in 2004, Minafin's Health Chemistry division employs 550 people. www.minakem.com About the Minafin Group The Minafin Group is a leading process developer and manufacturer of fine chemicals with three main areas of expertise: health chemistry, green chemistry, and challenging chemistry. Minafin operates six industrial manufacturing sites across Europe and North America. They provide customers in pharmaceuticals, life-science ingredients and added-value chemicals for high-tech application, with a range of proprietary processes, custom manufacturing, R&D, analytical and regulatory services, as well as formulations. Minafin invests significantly in R&D to create value for customers by specializing in innovations and eco-friendly solutions that bring a competitive edge and sustainability. Its strong industrial capabilities are consolidated through nine business units: Minakem CDMO, Minakem Generics, Blendamix, Pennakem, Minasolve, Minagro, EcoXtract, Minascent and Pressure Chemicals, which generated over €243M (approx. $280M) in revenue in 2020. Founded in 2004 as a privately held industrial company, Minafin is headquartered in Belgium and employs 900+ staff.  www.minafin.com Press contact: Sylvie Boone –Press Relations Minafin Group –Sylvie.boone@minafin.com –32/497.540.945  

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    03 Feb 2022
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    CORPORATE CONTENT #SupplierSpotlight

    Product List 2024

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    Corporate Presentation

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    GMP Certificate 2023

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    Building Blocks & GMP Excipients 2021

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    CDMO for Custom APIs & HPAPIs

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    Analytical Services

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    A Word With Minakem Teknoscienze

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    Minakem Interview

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    Challenging Chemistry in Pharmaceutical Manufacturing

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    DATA COMPILATION #PharmaFlow

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    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    CDMO Activity Tracker: Novo’s parent buys Catalent for US$ 16.5 bn; Fujifilm, Merck KGaA, Axplora expand capabilities

    During the first half (H1) of 2024, the global contract development and manufacturing organization (CDMO) landscape was driven by the escalating demand for complex drug development and manufacturing.With the industry grappling with constantly evolving therapeutic modalities, CDMOs are racing to invest in cutting-edge technologies and infrastructure to meet the growing needs of pharmaceutical and biotech companies.Some of the key players in the CDMO space are Catalent, EUROAPI, Lonza, Axplora, Thermo Fisher, SEQENS, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Famar, LGM Pharma, Veranova, and Evonik.View CDMO Activity Tracker for H1 2024 (Free Excel Available) Novo’s parent buys Catalent for US$ 16.5 bn; Bora, Lonza, Siegfried expand US footprintDuring H1 2024, several European and Asian drugmakers expanded their footprints in the US. In February, Novo Nordisk’s parent company, the Novo Nordisk Foundation, announced the acquisition of Catalent through its investment arm Novo Holdings for US$ 16.5 billion. Novo Holdings plans to sell three of Catalent’s “fill-finish” sites to Novo Nordisk for US$ 11 billion. The deal is expected to allow the Danish drugmaker “to serve significantly more people living with diabetes and obesity,” a company statement said.Taiwan-headquartered Bora Pharmaceuticals forged ahead with its expansion plans in the US market by acquiring Minnesota-based generics manufacturer Upsher-Smith Laboratories. Emergent BioSolutions said it is selling its Maryland facility to an affiliate of Bora. This site in Camden is part of its CDMO, Emergent Bioservices, and offers clinical and commercial non-viral aseptic fill/finish services on four fill lines, including lyophilization, formulation development, and support services.Swiss drugmaker Lonza has agreed to acquire Genentech’s manufacturing facility in California, US, from Roche for US$ 1.2 billion in cash. The site, located in the city of Vacaville, is one of the largest biologics manufacturing facilities in the world by volume.Lonza also launched an artificial intelligence-driven route design technology for choosing the optimal synthetic pathway to manufacture novel APIs.Switzerland’s Siegfried is acquiring a Wisconsin (US)-based CDMO that specializes in early-phase development and manufacturing services from Curia Global to strengthen its capabilities in North America. Siegfried will further develop the site into its North American Siegfried Acceleration Hub for early-phase CDMO services.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  Merck Millipore, SK Bioscience lead CGT boom; Fujifilm, Axplora, expand CDMO capabilitiesThe burgeoning field of cell and gene therapies (CGTs) is driving significant investments in CDMOs. CGTs saw considerable deal-making too. Merck KGaA agreed to buy Wisconsin-based Mirus Bio for US$ 600 million. Mirus Bio is a specialist in the development and commercialization of transfection reagents that are used to help introduce genetic material into cells. These reagents play a key role in the production of viral vectors for CGTs.Similarly, South Korea’s SK Bioscience acquired a 60 percent stake in IDT Biologika GmbH for KRW 339 billion (US$ 244 million). IDT Biologika is a 104-year-old German company that ranks among the top 10 vaccine producers in the world.CDMOs are also expanding their capabilities in order to lead innovation for their pharmaceutical partners. Fujifilm Diosynth Biotechnologies is investing US$ 1.2 billion in its large-scale cell culture CDMO business to further expand its end-to-end bio-manufacturing facility in North Carolina, bringing the total investment in the facility to over US$ 3.2 billion. Similarly, Merck KGaA owned MilliporeSigma made its biggest investment in the Asia-Pacific region in March when it invested € 300 million (US$ 327 million) in a new bioprocessing production center in Daejeon, South Korea.German CDMO giant Axplora is investing € 8 million (US$ 8.73 million) to expand capacity for antibody drug conjugate (ADC) payload manufacturing at its Le Mans site in France. Catalent completed upgrades to its capsule filling capabilities of dry powders for inhalation to handle potent drugs at its Boston facility. This now positions Catalent as the CDMO with the largest GMP capacity for capsule spray-dried and carrier-based inhaled powders.LGM Pharma increased its Analytical Testing Services (ATS) by 50 percent with a US$ 2 million investment and introduced new suppository manufacturing capabilities to its CDMO portfolio. Minakem has invested in a new production unit in Montreal, Canada, for steroid APIs.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  EUROAPI kicks off four-year sweeping plan; LegoChem partners Samsung Biologics for ADC programSanofi’s spinoff EUROAPI marked 2024 as a “transition year”, setting in motion its Focus-27 plan for profitable growth in the future. The sweeping four-year plan includes a streamlined value-added portfolio focused on highly differentiated and profitable APIs, and a CDMO focused on late-stage and high-value complex small molecules and tides supported by unique technological platforms. The leading French small molecules player signed a five-year collaboration with Ireland’s Priothera wherein EUROAPI will develop and industrialize the manufacturing process of an innovative, complex molecule for blood cancers – mocravimod. The project will be carried out at EUROAPI’s site in Budapest, which is its center of excellence for complex chemistry.South Korea’s CDMO powerhouse Samsung Biologics has partnered LegoChem Biosciences and will provide antibody development and drug substance manufacturing services as a part of LegoChem’s ADC program designed to treat solid tumors. LegoChem aims to submit an investigational new drug application to the US Food and Drug Administration (FDA) in the first half of 2025. Aurigene and Vipergen have joined forces to offer DNA-encoded library (DEL) screening for drug discovery. By combining Aurigene’s drug discovery capabilities with Vipergen’s DEL screening technologies, they seek to create a powerful tool that can quickly test over a billion small-molecule compounds against different disease targets. Dr. Reddy’s Laboratories’ company Aurigene also inaugurated its biologics facility spread across 70,000 square feet.Chinese biotech startup Pleryon is collaborating with France’s SEQENS, a leader in specialty ingredients, to develop and manufacture the former’s lead candidate, an innovative polymer to treat osteoarthritis. Famar is collaborating with Lavipharm and will serve as the contract manufacturer for the latter’s recently added analgesic pharmaceutical products — Lonarid N and Lonalgal.View CDMO Activity Tracker for H1 2024 (Free Excel Available)  Our view Key trends observed in H1 2024 include a surge in investments for fill-finish facilities, a growing emphasis on cell and gene therapies, and advancements in ADC manufacturing. With the proliferation of these new classes of drugs, the CDMO space has been rapidly changing in recent years. In the future, the integration of digital technologies, such as AI and automation, will be a key differentiator for CDMOs looking to optimize their operations and accelerate drug development timelines. 
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    08 Aug 2024
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