Company Category: CMO

NJ Bio

NJ Bio, Inc. is a CRO/CDMO specializing in integrated chemistry and biology services for ADCs and other complex bioconjugates. We offer comprehensive solutions spanning discovery, development, characterization, optimization, and bioanalysis, complemented by robust in vitro and in vivo capabilities to support translational decision-making. We provide toxicology, pharmacology, PK, and immunology services to support safety assessment, efficacy profiling, and translational development of ADC and bioconjugate programs. Our expertise in synthetic chemistry, bioconjugation, linker design, and bioanalytical capabilities, ensure seamless support across the entire drug development process and help accelerate ADC programs to become front-line treatments for cancer patients. | NJ Bio, Inc. is a CRO/CDMO that provides high-quality integrated chemistry and biology services to clients mostly from the biotech and pharma sectors. Main service areas include antibody-drug conjugates, bioconjugation, and multistep organic synthesis. The company is headquartered in Princeton, New Jersey, with additional chemistry facilities in Bristol, Pennsylvania. NJ Bio’s facility in Princeton, NJ, occupies ~ 80,000 sq ft of laboratory and office space, with specialized laboratory suites for highly potent compound synthesis, bioconjugation, bioassays, and analytical studies. The facility is very well equipped with instrumentation required for ADC- and bioconjugation-related work. | NJ Bio, Inc. is a CRO/CDMO specializing in integrated chemistry and biology services for ADCs. We offer comprehensive solutions for ADC development, characterization, optimization, and bioanalysis. Our expertise in synthetic chemistry, bioconjugation, linker design, and bioanalytical capabilities, ensure seamless support across the entire drug development process and help accelerate ADC programs to become front-line treatments for cancer patients. | NJ Bio, Inc., is a CRO that provides high-quality integrated chemistry and biology services for ADCs, bioconjugates and nucleic acid-based therapeutics. We strive to be a beacon of excellence in contract research, development and manufacturing by providing cutting-edge biopharmaceutical and advanced chemistry services. Backed by deep expertise in bioconjugation & chemical synthesis, we add value to targeted therapeutic programs through integrated services in conjugation, process development, characterization, and bioanalysis of complex molecules.

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NewBiologix

NewBiologix SA is a technology innovation company developing a proprietary and breakthrough DNA integration platform for the advanced engineering of human and mammalian cell lines. NewBiologix is committed to improve the generation and production of viral vectors used in gene and cell therapies by combining innovative and proprietary bioinformatics platform with advanced R&D experimentation. Next-generation sequencing (NGS)-based genome characterization will be used to develop an innovative and proprietary bioinformatics platform that will help cell line engineering through a combination of exceptionally in-depth datasets, sophisticated genomic analyses, and advanced R&D experimentation. NewBiologix’ technologies will be applied to human (HEK-293) and mammalian (CHO) cell lines engineered to be readily adaptable to meet the viral vector demands and requirements over a full range of products. With a strong Series A financing and an experienced start-up team established, NewBiologix anticipates cell line prototypes will be ready for beta testing with key collaborators by 2024 with the goal of commercially available viral production cell line lines by 2025. | NewBiologix is a technology innovation company developing proprietary platforms for the improved production of viral vectors used in gene and cell therapies. The company offers best-in-class rAAV variant screening, proprietary engineered HEK293 cell line programs, and next-generation sequencing (NGS) services including PacBio, Illumina, Nanopore, and Bionano. Our suite of technologies aims to help biopharmaceutical companies develop transformative gene therapies faster, safer, and at scale. | NewBiologix SA is a biotechnology company developing Swiss-engineered solutions for gene and cell therapy production. Specializing in cell line engineering, the company offers advanced cell lines and a genomic analytical platform, including the Xcell Engineered HEK293 Cell Line, custom high-quality AAV production, and cellular and viral genomic characterization with integrated bioinformatics. Our expertise enables partners to develop and scale gene therapies faster, while ensuring they are safer and more reliable.

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National Health Research Institutes

The National Health Research Institutes (NHRI) is a non-profit organization and a government funded mission-oriented research institution in Taiwan. NHRI dedicates to the medical and health research concerning the general well-being of the people in Taiwan. NHRI tackles important diseases in Taiwan through basic and translational research, and provides evidence based recommendation to the government to help guide timely health policy. NHRI acts as a think tank for vaccine production, biomedical engineering and pharmaceutical industries in Taiwan. | The National Health Research Institutes (NHRI) is a non-profit foundation established by the government with its organization charter created by an Act of Congress (Legislative Yuan) and signed in 1995 by President Teng-hui Lee. Being an autonomous research organization under the supervision of the Department of Health, Executive Yuan, the NHRI is dedicated to the enhancement of medical research and the improvement of health care in this country. Scientists at the NHRI conduct mission-oriented medical research and investigate many aspects of the basic biomedical sciences, as well as specific diseases. These range from the common problems such as aging, cancer, infectious diseases, mental disorders, occupational diseases, to health policy. It is our hope that the knowledge, experience, and facilities at the NHRI will become important resources to the whole nation in understanding, preventing, and curing diseases. The NHRI has been established to serve the following purposes: To plan the overall directions of national science and technology development in health and medical care; To coordinate, integrate, and support research activities undertaken by medical institutions in this country; To further educate and train young scientists and physicians; To establish an objective and fair system for reviewing and assessing research projects and their progress; To facilitate the exchange of information and to promote domestic and international cooperation. It is anticipated that both public and private sector efforts of the NHRI will help achieve excellence in medical research in Taiwan.

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Mycenax Biotech, Inc.

CDMO Expertise: 25+ years of development and manufacturing experience in biologics, including mAbs, recombinant proteins, ADCs, and cell & gene therapies. Regulatory Compliance: Inspected by EMA, PMDA, and Health Canada, and supported by advanced digital systems including eQMS and LIMS. GMP Facilities: 2 plants supporting toxicology studies, clinical trials, and commercial production with integrated Drug Substance & Drug Product service

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Montgomery County Economic Development Corporation

The Montgomery County Economic Development Corporation serves as the official economic development entity for Montgomery County, Maryland to accelerate business development, attraction, retention and expansion in key industry sectors while advancing equitable and inclusive economic growth. We operate as a 501(c)(3) nonprofit public-private partnership, funded by Montgomery County. | The Montgomery County Economic Development Corporation serves as the official economic development entity for Montgomery County, Maryland to accelerate business development, attraction, retention and expansion in key industry sectors while advancing equitable and inclusive economic growth.

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MITRO BIOTECH CO.,LTD.

MITRO, founded in 2012, is the first molecular imaging CRO company in China. By applying Radiolabeling and Molecular Imaging techniques, MITRO provides outstanding services including preclinical and clinical drug screening, bio-distribution, pharmacokinetics and pharmacodynamics. MITRO can provide one-stop service for radiopharmaceuticals including in vitro discovery, radiochemistry, pre-clinical study, clinical study and registration. | Established in 2012, MITRO Biotech Co., Ltd. focuses on providing professional and efficient CRO and CDMO services of radioisotope labelled molecular imaging to the global pharmaceutical and biopharmaceutical industries. Headquartered in Jiangning District, Nanjing City, it currently has offices in China, the United States, and the United Kingdom with over 200 employees worldwide. With complete qualifications and facilities, MITRO currently has a radioactive laboratory certified by AAALAC, which can meet the animal welfare standards at home and abroad. It has 26 kinds of nuclide qualifications that can meet various experimental requirements. It is a CRO company with clinical and animal PET/CT, which can realize continuous dynamic and static scanning of large and small animals. Mitro has dived into the field of nuclear medicine for many years, with a solid business foundation, brand power, and years of rich project experience. | MITRO, established in 2012, currently has offices in USA, UK and China with over 180 staff members. MITRO has over 86,000 sq ft. of radiolabeling and AAALAC accredited animal facility including rodents and NHPs. MITRO focuses on providing professional and efficient CRO and CDMO services of radiolabeling and molecular imaging to the global pharmaceutical and biopharmaceutical industries. MITRO in USA is based in New Haven, CT with over 24,000 sq ft. of research space. MITRO USA is organized into Clinical, Chemistry, and Imaging Sciences Divisions with administrative and project support including regulatory affairs, QA, data, IT, and business operations. Our research staff has leadership roles in numerous clinical imaging trials focused on neuroscience and radiopharmaceuticals aimed at the causes and developing more effective treatments for neurodegenerative disorders.

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Miltenyi Bioindustry

Miltenyi Bioindustry is a global CDMO with 5 sites across the world. We support all efforts for cell therapy developers, from pre-clinical to commercial scale, as a full-service provider for the development and manufacture of cell therapy products and lentiviral vectors. We have been manufacturing clinical cell therapy products since 2017, and we are completely integrated with our cell therapy and analytical platforms. As the leading experts in our technology, we specialize in enabling automated and closed manufacturing of cutting edge autologous and allogeneic cell therapy processes. Maintaining our dedication and integration into cell therapy workflow, we have been manufacturing GMP lentiviral vector since 2014. We leverage a platform process designed to minimize time spent in PD and deliver high quality LVV in shorter timelines. Our VSV-G LVV platform can take you from preclinical through commercial manufacturing. We also recently launched our preclinical BaEV LVV platform designed for typically harder-to-transduce cell types such as NK cells (clinical platform available in 2025). We are a division of Miltenyi Biotec, a pioneering innovator in the cell therapy industry for over 30 years.

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MilliporeSigma

MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, is committed to advancing cancer research. Our extensive portfolio of over 300,000 products supports the development of novel therapies, diagnostics, and prevention strategies. We offer solutions across key areas, including molecular tools, sample preparation, antibodies, cell culture, live cell analysis, biochemicals, and biomarker immunoassays. Cancer research is a multidisciplinary effort, and we provide integrated tools that accelerate progress at every stage—from basic to clinical research. Our molecular tools allow researchers to study cancer’s genetic and molecular foundations, while our high-quality antibodies enable the detection of proteins involved in cancer progression. MilliporeSigma also offers advanced sample preparation technologies for analyzing DNA, RNA, and proteins from tumor samples, and live cell analysis platforms for real-time insights into cellular behaviors and drug responses. Our biomarker immunoassays help identify cancer biomarkers and monitor treatment efficacy, supporting the development of early detection tests and personalized medicine. We are dedicated to empowering researchers with innovative solutions that help advance cancer prevention, detection, and treatment. MilliporeSigma is your trusted partner in tackling cancer biology complexities, accelerating breakthroughs, and realizing a future where cancer is more treatable and preventable. | As a leading science and technology company, we uniquely combine three specialized, innovation-driven businesses: Life Science, Healthcare, and Electronics. We utilize our multi-industry expertise to address a wide spectrum of global challenges. By supplying advanced scientific research and biotechnological manufacturing products, developing therapies for serious diseases, and providing high-performance materials for semiconductors and displays, we contribute to improving health, scientific progress, and technology for people around the world. | MilliporeSigma is the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. We are built to serve you in your drug development journey – as one trusted partner. Whether you need Millipore® CTDMO services, with decades of development, manufacturing, and testing expertise, to deliver a streamlined experience, or standalone industry-leading BioReliance® contract testing services and analytical development, we are built to serve you – to accelerate your milestones and breakthroughs. | MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, leverages over 35 years of CDMO experience and 75 years of contract testing services to redefine the industry CDMO model for today’s dynamic market needs. Our integrated Millipore® CTDMO Services offer expertise in development, manufacturing, contract testing, and technologies from pre-clinical to commercial stages, serving as a single experienced partner to accelerate your milestones and breakthroughs. With extensive experience in mRNA & LNP Formulation, ADC, Small Molecule, Biologics, and Viral Vector, we are dedicated to supporting your drug development journey as a trusted partner. Whether you seek a streamlined experience with a single partner or standalone industry-leading BioReliance® contract testing services and analytical development, we are committed to accelerating your milestones and breakthroughs while forging partnerships aimed at bringing breakthroughs to life to ultimately help patients. 2025 North America Advance Biotech Grant Award Ceremony Join us in the Start-up Stadium at 1:30pm, June 17th, to hear from our finalists and discover who will receive $258,000 in bioprocessing technologies, bioprocessing consulting services, contract testing services, and a full subscription to Emprove® Premium. The next round of applications will open in early 2026. | From the first spark of discovery to full-scale manufacturing, we stand beside you with the products, services, and expertise to help you move with speed and confidence. As a global leader in life science, MilliporeSigma supports innovators across biotech and pharma with 300,000+ products and comprehensive solutions all designed to help you progress from early research through process development, scale-up, and manufacturing. What you can explore with us: • Lab essentials and workflows to keep research moving day to day • Water purification systems for consistent lab performance • Raw and starting materials to support reliable manufacturing • Bioprocessing solutions and customized systems for your unique process needs • Ultrafiltration and downstream technologies to support scalable production • Contract testing and CDMO services to help you advance programs and meet quality requirements Whether you’re advancing a lead candidate, scaling a platform, or strengthening manufacturing readiness, we’ll connect you with experts who can help. | MilliporeSigma, the U.S. life science business of Merck KGaA, Darmstadt, Germany, partners with food safety teams to enable you to improve lab testing efficiencies with reliable products and services that meet ever changing regulations. It is through our collaborations that we can advance the safety and analysis of foods and beverages using trusted brands like Millipore® with microbiology solutions for hygiene, environmental monitoring & pathogen detection, Supelco® analytical solutions for analysis of food contamination and authenticity, Milli-Q® lab water solutions and Sigma Aldrich lab & production materials, including chemicals, inorganics & solvents throughout the supply chain, manufacturing and distribution. | MilliporeSigma is the U.S. life science business of Merck KGaA, Darmstadt, Germany. MilliporeSigma’s portfolio spans more than 300,000 products enabling scientific discovery. MilliporeSigma has customers in life science companies, university and government institutions, hospitals and industry. More than 1 million scientists and technologists use its products. The company is committed to solving the toughest problems in life science by collaborating with the global scientific community. | MilliporeSigma is the U.S. life science business of Merck KGaA, Darmstadt, Germany. With 19,000 employees and 72 manufacturing sites worldwide, MilliporeSigma’s portfolio spans more than 300,000 products enabling scientific discovery. MilliporeSigma has customers in life science companies, university and government institutions, hospitals and industry. More than 1 million scientists and technologists use its products. The company is committed to solving the toughest problems in life science by collaborating with the global scientific community. For more information, www.emdmillipore.com and www.sigma-aldrich.com.

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MIAS Pharma Ltd

MIAS Pharma Ltd was set up in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs. Customers are small to medium Pharma / Bio-Pharma companies that look to enter the EU market but do not have required Manufacturing and Importation licence or the Quality/Regulator expertise to comply with complex EU regulations. MIAS Pharma delivers two main solutions: 1. A licensing framework to enable pharmaceutical importation and batch certification (required before each batch of a medicine can be made available in the EU/EEA marketplace) 2. Qualified Person (QP) services to oversee the release of investigational medicinal product for Clinical Trials and commercial product to the market. MIAS Pharma also provide oversight of: – European Qualified Person (QP) services – Regulatory compliance of manufacturing activities – Regulatory compliance of Repackaging / Relabeling services – Regulatory compliance of Shipment and Transportation activities – Compliance with responsibilities as a Market Authorisation Holder (MAH) MIAS operates in a hub and spoke model with a core group of MIAS employee being able to rely on a group of associated to flex up/down capacity depending on clients’ requirements. | MIAS Pharma Ltd was set up in 2016 to enable Pharma / Bio-Pharma companies to manufacture and import products into the EU / EEA in a compliant manner, at optimal cost, with no significant investment in licence application activities or office / personnel costs. Primary customers are small to medium Pharma / Bio-Pharma companies that look to enter the EU market but do not have required Manufacturing and Importation licence or the Quality/Regulator expertise to comply with complex EU / UK regulations. In recent times MIAS also supports CMOs, CROs, Packaging companies and Testing companies QP solutions to take the burden off internal resources. MIAS Pharma delivers two main solutions: 1. A licensing framework to enable pharmaceutical importation and batch certification (required before each batch of a medicine can be made available in the EU/EEA marketplace) 2. Qualified Person (QP) services to oversee the release of investigational medicinal product for Clinical Trials and commercial product to the market. MIAS Pharma also provides: 1. European & UK Qualified Person (QP & QA) services 2. QP Audit programs 3. QMS Design: WDA & MIA 4. Turnkey EU Launch solutions: Packaging, Labelling, Distribution & Testing (Via Alliances) 6. Support for IMPD and Market Authorisation (MA) submissions MIAS operates in a hub and spoke model with a core group of MIAS employees being able to rely on a group of international associates to flex up/down capacity depending on clients requirements. | MIAS Pharma Supports Companies to carry out both Clinical Studies and Commercial Product launches in Europe and the UK. We hold licences known as MIA’s which allow us to import and QP release your products. As part of our service offering we can support you with: – EU / UK set-up – We can support your IMPD / MA submissions – Via our partner companies we can support Market Access, commercialisation and Distribution – QP Release – Product testing and retains – Audit Programs – WDA and RP Services

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Menarini Biotech S.r.l.

Menarini Biotech (“MBH”) is a fast-growing, agile, fully integrated CDMO for biologics located in the greater Rome area, Italy. Established in 2003, Menarini Biotech’s mission is to provide fast and efficient, yet very customer-centric, world-class, high-quality, services for biotech companies from preclinical development to GMP manufacturing (Mammalian and Microbial) up to BSL-2. These include CHO cell line development and analytical development for standard and non-standard mAbs, and new molecular formats, e.g. bispecifics, ADCs, fusion proteins. Our Quality System complies with AIFA/EU GMP requirements.

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