Company Category: cGMP Manufacturing (Drug Substance)

Eurogentec

Eurogentec is an international company founded in 1985 and part of Kaneka Corp. since 2010. Headquartered in Liege (Belgium) it provides products and services to scientists involved in the life science research, molecular diagnostics and therapeutic developments. Eurogentec has production sites in Europe and United States of America. The company is recognized as one of the major suppliers in the field of genomics and proteomics as well as a trusted US FDA inspected Contract Development and Manufacturing Organization (CDMO) for the bio-production of pharmaceuticals (vaccines and medicines). | Founded in 1985 and part of Kaneka Corporation since 2010, Eurogentec is a leading biotechnology and CDMO company specializing in GMP-certified manufacturing of starting materials and APIs. With facilities in Europe and the USA, we support plasmid DNA, mRNA, recombinant proteins, peptides, antibody fragments, and therapeutic oligonucleotides from early research to clinical and commercial production. Our expertise in process development and scale-up ensures high-quality solutions at every stage. Detailed Description of Products (Event Specific) max 500 characters in English – Plasmid DNA : Starting material & APIs including Nano-plasmids & Minicircle DNA. FastTrack: 4-month production. – mRNA : IVT mRNA (0.1g–50g), saRNA, gRNA with co-/post-transcriptional modifications. – Proteins : GMP production in E. coli & P. pastoris for biotech & pharma. – Conjugates : Chemically modified recombinant proteins for clinical use. – Therapeutic Oligos : ASOs, siRNA, aptamers, CpG oligos. – Peptides : Linear, cyclic & complex-modified. – Antibody Fragments : scFv, Fab, VHH, bispecifics. | Eurogentec—part of Kaneka Corp. since 2010—is a leading international company founded in 1985 and headquartered in Belgium. Accredited by the Belgian AFMPS, US FDA, and Japanese MHLW, we deliver trusted solutions to the life sciences, molecular diagnostics, and therapeutic development sectors. As a major supplier in genomics (oligonucleotides, qPCR kits, reagents) and proteomics (custom and catalog antibodies, peptides), we also act as a reliable CDMO for process development and GMP manufacturing of vaccines and medicines—including therapeutic oligonucleotides, peptides, plasmids, recombinant proteins, mRNA and VHH antibodies. Our comprehensive services cover process transfer, development and optimization, scale-up, tox and clinical batches, GMP and GMP-like manufacturing, Quality Control, QA release, and ICH stability studies. From early-phase development to commercialization, Eurogentec is your single partner for every step of the journey.

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EuBiologics

EuBiologics is listed biopharmaceutical company located in Korea, developing human vaccines against infectious disease using two proprietary technologies, EcML (Monophosphoryl Lipid A, TLR4 agonist) and recombinant CRM197 (Carrier protein). We have currently 7 vaccines in the pipeline. TCV (Typhoid Conjugate Vaccine, NDA), PCV (Pneumococcal Conjugate Vaccine, Ph I completed), MCV (Meningococcal Conjugate Vaccine, Ph I completed), HZV (Herpes Zoster Virus, Non-Clinical), RSV (Respiratory Syncytial Virus, Non-clinical), OCV (Oral Cholera Vaccine, commercialized) and EuCorVac-19 (COVID-19, Ph III). OCV have been supplied to UNICEF/PAHO and several more countries since 2016 after WHO-PQ and captured more than 90% of the public cholera vaccine market. EuBiologics can also offer advanced cGMP-level facilities providing fully integrated CRMO services for mammalian cell and microbial derived biopharmaceutical, from cell line development to large-scale commercial GMP production. EuBiologics is especially specialized in a variety of protein-based therapeutics and vaccines as we have had plenty of experience working with many innovative biotech in getting the right therapeutics. We possess extensive working knowledge of developing and manufacturing different types of vaccine. | EuBiologics is a publicly traded biopharmaceutical company specializing in human vaccines targeting infectious diseases. We leverage our proprietary adjuvant (TLR4 agonist, E. coli-derived) and recombinant carrier protein (CRM197), both of which have global IP protections, to develop novel vaccines. | x

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Enzene

Enzene is an end-to-end CDMO with services spanning discovery, development, and commercial supply, operating integrated sites in Pune (India) and New Jersey (USA). As a pioneer in next-generation biologics technologies, Enzene is disrupting the existing biologics manufacturing paradigm with its patented EnzeneX™ technology, which was the first fully-connected continuous manufacturing™ (FCCM™) platform validated for commercial biologics supply. We partner with innovators and biosimilar developers to deliver accelerated time-to-market, increased production yields, and cost reductions across a broad range of biologic modalities. Committed to pushing the boundaries of biologics manufacturing innovation, Enzene is striving to reduce monoclonal antibody production costs to below $40 per gram by 2025. Our microbial and mammalian drug substance plants, as well as our sterile fill & finish plant in India are EU-GMP certified. | Enzene is a leading global continuously innovative development and manufacturing organization (CIDMO). The company was founded on a belief that we have a responsibility to positively impact healthcare around the world by providing the technological expertise, passion for innovation, and dedication to helping clients bring accessible and affordable products to market. Built on a proven history of successful commercial launches and a strong early-stage product pipeline, Enzene continues to disrupt the CDMO industry with novel processes that improve quality and productivity while reducing costs and carbon footprint. Our comprehensive capabilities encompass R&D, analytics, and GMP manufacturing, empowering us to offer innovative, high-quality solutions that meet diverse client needs. By providing end-to-end CDMO services for biologics, from cell line development to fill & finish for complex molecules, we are a versatile CDMO partner for our clients across a wide array of modalities. And with multiple manufacturing lines at our Pune, India and New Jersey, USA facilities, Enzene is strategically positioned to meet the escalating demand for biologics and biosimilars across both hemispheres. Additionally, our proprietary continuous manufacturing technology, EnzeneX™, sets us apart as visionaries in the industry, driving healthcare advancement and setting new standards for biologics development and manufacturing. The EnzeneX™ platform optimizes quality, efficiency, and flexibility while supporting cost-effective, sustainable production of top-tier biologics, thereby improving global patient access. At Enzene, we are leaders who seek to solve today’s biotech challenges as well as tomorrow’s by upholding our core values of innovation, integrity, excellence, entrepreneurship, candor, and respect.

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EMD Serono

EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany, in the US and Canada, is a science-led organization dedicated to making a meaningful difference in the lives of people affected by cancer. Our oncology research aims to leverage our synergistic portfolio to tackle challenging tumor types, as we work to illuminate a path to scientific breakthroughs to transform patient outcomes. Learn more at www.emdseronooncology.com | We are the healthcare business in the U.S.A. & Canada for Merck KGaA, Darmstadt, Germany, a vibrant science and technology company. Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. The passion of our curious minds makes a positive difference to millions of people’s lives every day. In Healthcare, we discover unique ways to treat the most challenging diseases, such as multiple sclerosis and cancer. Our Life Science experts empower scientists by developing tools and solutions that help deliver breakthroughs more quickly. And in Electronics, we develop science that sits inside technologies and changes the way we access, store, process, and display information. Everything we do is fueled by a belief in science and technology as a force for good. A belief that has driven our work since 1668 and will continue to inspire us to find more joyful and sustainable ways to live. We are curious minds dedicated to human progress. | In Healthcare, we are at the forefront of developing pioneering therapies – boldly aiming to meaningfully change the lives of patients, their families, and their caregivers. We are unlocking leaps in highly specialized fields with significant unmet medical needs. We leverage internal discoveries and external partnerships to serve patients who need it most across all continents. As one company, science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. The passion of our curious minds makes a positive difference to millions of people’s lives every day. Life Science experts empower scientists by developing tools and solutions that help deliver breakthroughs more quickly. And in Electronics, we develop science that sits inside technologies and changes the way we access, store, process, and display information. Everything we do is fueled by a belief in science and technology as a force for good. A belief that has driven our work since 1668 and will continue to inspire us to find more joyful and sustainable ways to live. We are sparking discovery, elevating humanity. | We are the healthcare business in the U.S.A. & Canada for Merck KGaA, Darmstadt, Germany, a vibrant science and technology company. EMD Serono Aspires to create, improve and prolong lives — As One for Patients. Science is at the heart of everything we do. It drives the discoveries we make and the technologies we create. The passion of our curious minds makes a positive difference to millions of people’s lives every day. In Healthcare, we discover unique ways to treat the most challenging diseases, such as multiple sclerosis and cancer. Our Life Science experts empower scientists by developing tools and solutions that help deliver breakthroughs more quickly. And in Electronics, we develop science that sits inside technologies and changes the way we access, store, process, and display information. Everything we do is fueled by a belief in science and technology as a force for good. A belief that has driven our work since 1668 and will continue to inspire us to find more joyful and sustainable ways to live. We are curious minds dedicated to human progress.

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EirGenix, Inc.

EirGenix is the leading company in biologics development and GMP manufacturing and has solid experience in various biologics (mAb, bi-specific mAbs, r-proteins, COVID-19 Spike protein, fusion proteins, RNA, ADC, Viral Vector, etc.). As of now, we have successfully completed more than 70 biologics projects for clients all over the world. Moreover, we have signed global licensing collaborations with Sandoz for our Trastuzumab biosimilar (EG12014), which BLA has been submitted to the US FDA in December 2021. Among others, our services include: – Up to 12×2,000L SUB mammalian cGMP production capacity – Dual cell Line development & banking for mammalian and microbial systems – Upstream/Downstream process development – Analytical and QC – One-stop full service from DS to DP – US FDA inspected and the EIR report received – Japan PMDA and Taiwan FDA certified – Biosimilars pipeline available for licensing and or collaboration | EirGenix is a leading CDMO in biologics development and GMP manufacturing that has solid experience in various biologics (mAb, BsAbs, r-proteins, COVID-19 Spike protein, fusion proteins, ADC, pDNA, Viral Vector, etc.). We have completed > 70 biologics projects for clients all over the world. Moreover, we have signed global licensing collaborations with Sandoz for our Trastuzumab biosimilar (EG12014), which BLA was approved in the EU and waiting for US FDA approval. Among others, our services include: – One-stop full service from DS to DP CGMP Clinical and Commercial manufacturing of Microbial and Mammalian strains – Up to 12 x 2,000L mammalian capacity – Dual Cell Line Development & banking for mammalian and microbial systems – Upstream/Downstream process development – Analytical and QC – US FDA, Japan PMDA, Australia TGA, EU EMA, and Taiwan FDA inspected – Biosimilars pipeline available for licensing and or collaboration | EirGenix is Taiwan’s leading biologics CDMO, providing end-to-end development and manufacturing solutions that meet FDA, PMDA, EMA, and TGA standards. Since 2012, we have successfully delivered 100+ projects across mammalian and microbial platforms, supporting global clients from early-stage development to commercialization. Our comprehensive services include cell line development, process and analytical development, and cGMP manufacturing for both clinical and commercial supply. With a robust 12 × 2,000L single-use bioreactor capacity and expanding microbial fermentation capabilities, we are equipped to handle large-scale production needs. Award-Winning Excellence Since 2017, EirGenix has been consistently recognized for excellence in biologics development and manufacturing, earning multiple prestigious industry awards that demonstrate our commitment to innovation and quality. Recent Awards (2023-2025): – Best ADC CDMO in Taiwan – Asia Pacific Biopharma Excellence Awards 2025 – Most Promising Monoclonal Antibodies Pipeline – Taiwan Biopharma Excellence Awards (TBEA) 2024 – National Science and Technology Drug R&D Award – Gold Medal (2023, Taiwan) (for EirGasun® 150mg) – BioProcessing Excellence Award – Greater China Region (2022) (IMAPAC Asia Biologics – Manufacturing Conference) Accelerate your biologics development with EirGenix. Visit us at BIO 2025 or contact us to explore tailored solutions for your next project.

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Ecolab Life Sciences

Ecolab’s Purolite™ Resins receive continued investment from Ecolab to support development, production, and customer support. We have one of the industry’s largest technically trained sales teams in ion exchange and specialty resin technology, backed by five Research and Development centers, nine application labs and five production facilities. With our ability to quickly respond, supply, and develop, we can solve your application challenges and optimize your system. Ecolab’s Life Sciences division is dedicated to developing the best possible products and services to support our customers in the pharmaceutical industry. Our comprehensive solutions and technical expertise are focused on cleaning, sanitization and contamination control, all while ensuring safety, compliance and operational efficiency. Our strategy is to stay focused on two core areas: Global Trends and Regulatory Changes that impact your operations, and develop solutions to keep you on the cutting edge. | Ecolab Life Sciences is a segment of Ecolab and a global leader in technologies and services designed to enhance productivity, reduce costs, and accelerate the development of critical medicines. Leveraging over a century of innovation, Ecolab Life Sciences provides comprehensive solutions and expert guidance across bio-decontamination, drug purification, active pharmaceutical ingredients (APIs) and excipients. With a strong commitment to ensuring safety, compliance, and operational efficiency, Ecolab Life Sciences partners with organizations to support their mission of advancing health and wellbeing worldwide.

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Dr. Reddy’s Biologics

Dr. Reddy’s Biologics is a global player in biosimilars, driven by our purpose of accelerating access to innovative medicines. Over the last 25 years, we’ve developed robust capabilities in development, manufacturing, and commercialization, focusing on oncology and immunology. With teams in Hyderabad, Basel, and New Jersey, our cGMP manufacturing facility in Hyderabad is WHO-approved and integrates drug substance and drug product manufacturing. Our R&D team has diverse capabilities, from cell line development to clinical trials, allowing us to develop high-quality biosimilars for global markets. We’ve launched several biosimilar products, with more in the pipeline. Our recent partnerships and successful studies demonstrate our commitment to expanding our portfolio and making a difference in patients’ lives worldwide. | We at Dr. Reddy’s Biologics enable access to high-quality, cost-competitive biosimilars. The future we imagine is one where patients worldwide find ease in illness, every day. Our state-of-the-art manufacturing facilities and end-to-end capabilities bring this future within reach making us a leading biosimilars manufacturer. | We are dedicated to providing access to affordable and innovative medicines, driven by our purpose of ‘Good Health Can’t Wait’. Our products and services span across Active Pharmaceutical Ingredients (API), generics, branded generics, biosimilars, and over-the-counter pharmaceutical products globally.

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Cytovance Biologics

Cytovance Biologics, Inc. (Cytovance Biologics) is a leading biopharmaceutical contract development and manufacturing organization (CDMO) that excels in the rapid and cost-effective development and manufacture of large molecule active pharmaceutical ingredients (APIs). Cytovance Biologics utilizes both mammalian cell culture and microbial fermentation to express monoclonal antibodies, fragment antibodies, bispecifics, enzymes, fusion proteins, vaccines, and other biological products, including plasmid DNA and cell-based therapeutics. In addition to its clinical and commercial CGMP API manufacturing services, Cytovance Biologics offers well-integrated development services supporting the entire product lifecycle, including cell line development, cell banking, microbial strain development, process and analytical development, and process characterization. Our state-of-the-art facilities in Oklahoma City are designed to meet United States, European Union, and other global regulatory standards. Cytovance Biologics offers deep industry expertise and unique customized services for the scale-up and CGMP manufacture of protein-based therapeutics; from early-stage pre-clinical development to commercial production, for both mammalian and microbial. Further information can be found at www.cytovance.com. | Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) offering ingenuity and integrated development services to support large molecule biologics throughout the journey from R&D to regulatory approval. These services include mammalian cell line development, cell banking, microbial strain development, process and analytical development, process characterization, and cGMP manufacturing. The company’s 140,000+ sq. ft. state-of-the-art facilities in America’s Heartland are designed to meet US, EU, and global regulatory requirements. Find out more at https://cytovance.com/ | Streamline your biomanufacturing with a US-based partner that is large enough to support you at every stage but small enough to stay agile and provide your program with the care it deserves. Cytovance® Biologics is a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO) offering ingenuity and integrated development services to support large molecule biologics throughout the journey from R&D to regulatory approval and commercial supply. These services include mammalian cell line development, cell banking, microbial strain development, process and analytical development, process characterization, and cGMP manufacturing. The company’s 140,000+ sq. ft. state-of-the-art facilities in America’s Heartland are designed to meet US, EU, and global regulatory requirements.

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Cincinnati Children’s Hospital Medical Center

Cincinnati Children’s Innovation Ventures as well as staff from Cincinnati Children’s Applied Gene and Cell Therapy Center will be onsite.

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Cfm Oskar Tropitzsch GmbH

Cfm Oskar Tropitzsch GmbH assists the chemical, pharmaceutical and biotechnological industry in sourcing and producing chemical specialties. The core of our work is to supply the product which our customer is looking for – with the right documentation, the correct quantity from mg to mt and proper quality and this not only for a one shot business but to support projects from RnD state up to commercial production. To achieve these challenging goals Cfm Oskar Tropitzsch GmbH uses its excellent knowhow and worldwide network of qualified suppliers. Finding the best solution! …it’s not just a sentence – it’s our mission! | Cfm Oskar Tropitzsch GmbH assists the chemical, pharmaceutical and biotechnological industry in sourcing and producing chemical specialties. The core of our work is to supply the product which our customer is looking for – with the right documentation, the correct quantity from mg to mt and proper quality and this not only for a one shot business but to support projects from RnD state up to commercial production. To achieve these challenging goals Cfm Oskar Tropitzsch GmbH uses its excellent knowhow and worldwide network of qualified suppliers. Finding the best solution! …it’s not just a sentence – it’s our mission! Our product categories are: -ADC-Payloads -API`s -Contract Manufacturing / Contract Fermentation within Europe/US -Diagnostic Reagents like e.g. DTT -Excipients – Contract Manufacturing of Excipients (g-kg) -Metals & Metal Compounds -Peptide Synthesis -Pytochemicals -Small Molecules (Fermentation Products)

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