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    APIs // Active Pharmaceutical Ingredients

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    Key Products KEY PRODUCTS

    • 1,1-Cyclobutane Dicarboxylic Acid

    • Budesonide

    • Cyclobutane Carboxaldehyde

    • Cyclopropyl Methyl Bromide

    • Cyclopropyl Methyl Chloride

    • Esomeprazole Magnesium

    • Esomeprazole Sodium

    • Fulvestrant

    • Ibrutinib

    • Methyl (1R,2S,5S)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxylate HCl

    • Propyl Gallate

    • Remifentanil

    • Vinblastine Sulfate

    • Vincristine Sulfate

    • Vinorelbine Tartrate

    INTERMEDIATES

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    Key Products KEY SERVICES

    • High Potency API (HPAPI) Manufacturing

    • Continuous Flow Chemistry

    • Development of High Potency APIs (HPAPIs)

    • Custom Synthesis & Development

    • Synthesis of Advanced Intermediates

    • Polymorph, Salt & Cocrystal Study

    EXCIPIENTS

    Key Products KEY EXCIPIENTS

    • Propyl Gallate GMP

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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  

    Impressions: 1108

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    #PressRelease With PharmaCompass
    03 Feb 2022
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    “CDMOs like Minakem are standing by to secure drug supply chains and provide to patient’s needs”

    “CDMOs like Minakem are standing by to secure drug supply chains and provide to patient’s needs”

    In a panel discussion on custom synthesis and contract manufacturing, panelist Stéphanie Roullé, VP Sales & Marketing - Minakem, spoke about the company’s markets in terms of their size, segments, and trends. She further commented on key market success factors, the effects of Covid-19 on the market, forecasts in terms of market demands, and how to be prepared to cope with demands amidst the possibility of a second outbreak. Excerpts: What are your company’s target markets? Can you please describe these markets in terms of their market size, segments, and trends? Minakem is a fully integrated development partner and manufacturer of APIs, HPAPIs, key intermediates, and building blocks supplying the clinical as well as commercial needs of biotech and pharmaceutical companies globally. Technically, we can serve all clients who develop and produce medicine based on small molecules, whether it is in therapeutic areas like respiratory, CNS, or cardiovascular diseases, or even in orphan drug applications.  Given our core competence in manufacturing highly-potent APIs (HPAPI) requiring specialized containment, one central area we focus on is oncology, which represents the primary driver in the growth of HPAPI holding a 20-25% market share in highly-potent drug applications. Oncology is also the area with the highest forecasted expenditure in clinical development, unsurprisingly leading to a soaring forecasted number of FDA approvals of any therapy area. The global oncology market is supposed to reach $ 200 billion in sales by 2022 (av. annual growth of 10-13%). Approximately 60% of the oncology pipeline is HPAPI. Apart from conventional cancer treatments, there is a fast-growing number of novel oncology drugs coming from discovery and being clinically tested, including new therapeutic classes such as antibody-drug conjugates or RNA-targeting small molecule drugs. Due to stringent regulatory requirements and high cost of production, innovators in pharma are looking for HPAPI experts from the early phase onwards (50-70% is being outsourced), and ideally, a company that can provide both, HPAPI development and manufacturing services, such as Minakem. Which are the most relevant key success factors in these markets, and how did the key success factors ange in these markets over the last decade? On top of a proven quality track record, full regulatory compliance, and lean manufacturing, clear communication towards our clients combined with the ability to anticipate and to preventively address quality or process performance issues are certain key success factors. Over the last decade, we have seen more and more pharmaceutical companies that were sourcing their intermediates or APIs from low-cost manufacturers in the Far East now coming back to Western CDMOs. One reason is that the Chinese government, for instance, has raised their environmental, health, and safety standards closer to those applied in Western countries, resulting in a less signifi cant difference in COGS. Moreover, many Chinese plants even have been closed down due to environmental or safety issues, leading to a shortage in supply of goods and overall supply chain uncertainties. In India, on the other hand, the concern is more related to quality and compliance (e.g., violating cGMP standards, warning letters) as some pharmaceutical companies have experienced it. When it comes to overall performance and future viability of a CDMO; we believe that companies striving to update their technological expertise routinely, cultivating a clear communication style across cultural barriers and monitoring the dynamics in the development departments of their customers; will stand out from the competition and set themselves up for future success. More than ever, today’s focus is to understand our customer’s development products and future commercial requirements: What are the unmet patient’s needs? What therapeutic areas do our clients target? How do novel drug applications work? What does it mean for a company like Minakem in terms of our client’s future needs? Did the coronavirus outbreak affect your supply chains and target markets, and if so, in what way? Where do you see lasting effects and lessons from the covid-19 lockdown? Covid19 has been a game-changer all over the world, and the biggest reality check for all of us is how vulnerable our supply chain is, and how critical it is to protect it. However, while fi rst and foremost focussing on the protection and safety of our employees working at our sites, we implemented from the beginning of this crisis, measures to ensure the sustainability of our supply chains and to guarantee business continuity for our pharma customers and their patients. It has been a success, thanks to the collective work achieved. For each of our development and manufacturing sites, we have worked out business continuity plans taking into account local specifi cs, and having production facilities all located in Europe is clearly a countless advantage. At the end of this crisis, we will not only need to ask ourselves what can be done to better leverage the collective wisdom within the pharmaceutical industry and academia to accelerate the development of life-saving vaccines safely and in quantities needed for global use. We also need to address the issue of maintaining a resilient supply chain during such outbreaks, to manufacture and to transport pharma goods quickly and safely to patients in need. What is your forecast in terms of market demand to the end of the year and beyond? How are you preparing to cope with the future demand and possible setbacks should a second outbreak occur? Everybody points to pharma when it comes to curing diseases and supplying drugs, especially in times like these, when we run at full steam to fi nd a cure for Covid19. Yet behind the big pharma brands is a complex universe of suppliers, distributors, academic institutions, and technology providers. Pharma simply doesn’t have all the required capacity, so they are heavily dependent on companies like Minakem to supply them with their needs for APIs or key building blocks needed in the assembly of new, promising drugs to fi ght this outbreak. Furthermore, in conjunction with the virus outbreak, we are also dealing with other medical problems when Covid19 patients catch a bacterial infection, for instance, or require pain relievers or even anesthesia. Last but not least, people still suffer from CNS, cardiovascular or metabolic diseases. With a signifi cant portion of the manufacturing capacity in pharma now taken by drugs to treat Covid19 or diseases resulting from it, CDMOs like Minakem are standing by to secure drug supply chains and provide to patient’s needs. I, therefore, do rather see an increase in demand for manufacturing capacity over the coming 12-24 months. Minakem is currently in the process of expanding its technical asset bases to meet those demands. We also optimize capacity utilization by constantly reassessing our product portfolio: what has priority for 2020 and what production can safely be moved to a later point in time to meet more urgent patient’s needs. We are also in the lucky position to have multiple GMP-compliant and audited production sites where capacity can be reallocated to some extent to make room for unplanned, time-critical requests. https://www.teknoscienze.com/Contents/Riviste/Sfogliatore/CO4_2020/30/  

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    #Interview With Chemistry Today
    06 May 2021
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    “Analytics has become a vital element of the development of new products”

    “Analytics has become a vital element of the development of new products”

    Thierry van Nieuwenhove, CEO of the End Market Division at Minafin Group, discusses the challenges faced by the company and the changes performed to meet them. He talks about possible investments in the near future, technologies supporting Minakem’s development, patient-centric strategies, and the importance of analytical management in the pharmaceutical development and manufacturing value chain. Mr Van Nieuwenhove, you joined minafin group as CEO of the End Market Division three years ago. What new challenges did you bring to the group, and what are the changes performed to meet them? In only three years we have worked as a team to : Develop Minakem as a recognized brand on the CMO market; Minakem has a lot of services and technologies ( some very unique) that can help our customers to be fast and efficient to the market. We ensured the service a Customer receives from any of our sites remains identical and in line with the expected standard. Ensure our existing and future customers are placed in the center of our focus. Whatever your position in the company, one must remember that the customer should be in the center of our attention. Eventually, we must all acknowledge that a Customer- centric organization in our industry means that we pay attention to the patient that will ultimately be at the end of the chain! As such words like quality, efficiency, the security of supply, mean a lot to us. Roll out OE (Operational Excellence) to the entire organization. The focus was to ensure that we continuously improve ourselves, we deliver and improve efficiency and involve all our teams in this success. It is a long term journey, but which today has already given successes in our daily life. The pharma business unit represents 70 percent of the group’s revenues, but the cosmetic and agri-food businesses are undoubtedly essential niches markets as well. Are you planning to invest in these businesses in the near future? Yes, in three years, we have transformed Minasolve (Cosmetics) from a mono-product business to a full catalog company. Minasolve, under the “Green Solving Attitude” spirit, is now able to offer the Cosmetic Industry a fully integrated green alternative to cosmetics ingredients and preservatives. The “sustainable beauty” represents, within Minasolve, a definite meaning of giving every customer a green option for their products, with a service on top!. We have recently launched Minagro. Minagro is the green solving option for the agro-industry. Our focus is to ensure that sustainable agro-industry also means using eco-friendly products that ultimately will be used in our fields. Concerning the pharma business division (minakem), are there any new technologies that have supported its development? There are technologies, e.g., flow chemistry, enzyme-catalysis, or RC1 profiling, that simply improve the process economy or safety aspects of pharma manufacturing. Minakem is undoubtedly looking into those and has already taken steps towards implementing such technologies on a routine basis. When it comes to new, enabling technologies, it is crucial not only to analyze the development pipelines of our customers in the pharmaceutical industry but also to analyze what new therapeutic concepts are currently are under investigation. The trends in innovative medicine also pretty much determine what technologies a CMO needs to apply to address those needs. Here, we can see a good part of the early-stage pharmaceutical pipelines changing to what we call “new modalities,” chemical APIs that look more structurally complex or different, in nature, versus their predecessors. There are new, semi-synthetic conjugates, hybrid-molecules, complex heterocycles or multifunctional molecules that are engineered to hijack cellular processes, such as translational regulation or degradation mechanisms. The challenge for a company like Minakem, who is in the small molecule business, is, how can those trends be translated into chemical solutions, and what tool-box do we need to make it happen? For a good part, maybe even for the majority, we do not need a completely different technical set-up. We just need a highly flexible and easy adjustable manufacturing configuration that can handle even more highly diverse chemical processes in parallel, not just high volume blockbuster drugs: new catalytic systems that can also be run in continuous flow and at deep temperatures; a semi-synthetic process involving enzymes an aqueous-organic media; sophisticated monitoring devices that allow us to process sensitive coupling reactions, especially in conjugations smoothly–just to name a few. Minakem is continuously learning how to upgrade its technological basis and how to attract the right talents who can help us to move to the next level of innovation. Pharma business has become patient-centric, and the tagline of the company “chemistry for life” summarises perfectly the core mission of minakem. How can a company (cdmo) like minakem contribute to better human health? How can the safety of the supply chain be improved? How can quality be assured? How can time to market be accelerated without an increase in costs? Companies like Minakem, who are providing custom manufacturing services to the pharmaceutical industry, are essential for patients’ needs and the entire society. Everybody points to pharma when it comes to curing diseases and adequately supplying drugs and medical devices. Yet behind the big pharma brands is a complex universe of suppliers, distributors, academic institutions, think tanks, and technology providers. Facing the current Coronavirus sanitary crisis, the biggest reality check is how vulnerable our supply chains are, and how critical it is to protect them. To re-design and diversify them might be an essential consequence after we have overcome this crisis. And this is were companies like Minakem play a key role. The final pill package is just the tip of the iceberg. We all depend heavily on every step of the way from the original idea in the lab to the final pill going smoothly. Having the right partners with companies like Minakem within this complex and interdependent supply chain is not only essential – it saves lives. Our customers in the pharmaceutical industry rely on the collective wisdom, capacity and commitment of everybody involved in making the transition from the bench to the patients’ bedsides happen. Furthermore, our responsibility doesn’t just stop at providing products and services to our customers under the highest quality standards, where we get routinely audited and certified, we also need to make sure medicine becomes affordable for all patients in need. Here, we do not only optimize our existing supply chains and production facilities to assure smooth and cost-efficient processes, this is also where science and technology comes in. To find the best synthetic pathway to a chemical API using novel technologies in order to reduce cumbersome multi-step processes and to eliminate waste is always in our focus to stay lean and cost-effective, which ultimately translates into affordable prices for medical treatments. For instance, there are examples where the manufacturing cost of an API could be cut in half by employing a specifically designed catalyst system to eliminate costly protection/deprotection steps in chemical processing. It is also the reason why we closely monitor our customer’s product pipelines so we can prepare ourselves for lean manufacturing of their products by employing innovative technical solutions. What are, according to you, the issues impacting the pharmaceutical development and manufacturing value chain? How are you going to face them? ANALYTICS. Today all pharma companies are looking at speed to market and first-time-right quality whether we speak about new or existing products. Analytics has become a vital element of the development of new products, and authorities are getting more and more focus on the quality of the product as impurities are being tracked at levels that were never thought about less than five years ago. Realizing today that Analytical Management is as crucial as operation, R&D,… is a gap that all companies have not yet been able to make and certainly to implement. We have taken that path for three years!A word with Thierry van Nieuwenhove – CEO End Market – Minafin Group 

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    #Interview With Chemistry Today
    28 May 2020
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