Company Category: cGMP Manufacturing (Drug Substance)

HitGen

HitGen Inc. (SSE: 688222.SH), founded in 2012, is headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen is committed to building a world-class innovative biopharmaceutical enterprise and contributing to the better life and health of mankind. Engaged in the discovery and optimization of small molecules and nucleic acid drugs, HitGen dedicates itself to cultivating an internationally leading drug discovery and optimization system centered on four key technology platforms, including DNA-encoded library technology (including DEL design, synthesis and screening, and application expansion), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), synthetic therapeutic oligonucleotide technology (STO), and targeted protein degradation technology (TPD). It provides new molecular entities (NMEs) at different stages of research and development for the pharmaceutical industry, through its diversified business models including research and development services, out-licensing of projects at different R&D stages, and new drug launches in the long term, with an aim to address unmet clinical needs with innovative therapeutic solutions. As a leader in the field of DEL technology, HitGen has been committed to the development, application and improvement of DEL technology since its establishment. By June 30, 2022, HitGen’s DELs contains more than 1.2 trillion novel, diverse, drug-like small molecules and macrocyclic compounds. These compounds are members of DELs synthesized from many thousands of distinct chemical scaffolds, designed with tractable chemistry, and have yielded proven results for the discovery of small molecule leads against precedented and unprecedented classes of biological targets. Through systematic DEL compound design, HitGen DELs has involved the use of more than 6000 different types of chemical scaffolds, which includes most of the core scaffolds of currently approved small-molecule drugs and many privileged scaffolds of small-molecules in clinical trials, and the approximately 40,000 different building blocks. HitGen has approximately 20 in-house drug discovery projects at different stages of research and development, among which 4 have obtained IND approvals and entered into clinical trials. HitGen is in collaboration with pharmaceutical, biotech and chemical companies, foundations and research institutes in the Americas, Asia, Europe, Africa, and Oceania. For more information, please call +86-28-85197385, +1-508-840-9646 or visit www.hitgen.com. For business development: bd@hitgen.com | HitGen Inc. (SSE: 688222.SH), is a drug discovery research company with headquarters in Chengdu, China, and subsidiaries in Cambridge, UK and Houston, USA. HitGen has established leading technology platforms to enable the discovery and optimization of small molecules and nucleic acid drugs. Our key technology platforms include world-leading DNA-encoded library technology (DEL), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), as well as the emerging technology platforms for synthetic therapeutic oligonucleotide technology (STO), and targeted protein degradation technology (TPD). Through our diverse and flexible business models, we have built up collaboration partnership with several hundred biopharmaceutical research organizations worldwide. HitGen has multiple programmes from early discovery to clinical trial stage. | About HitGen Inc. HitGen Inc. (SSE: 688222.SH), is a drug discovery research company headquartered in Chengdu, China, with subsidiaries in Cambridge, UK and Houston, USA. HitGen has established leading technology platforms to enable the discovery and optimization of small molecules and nucleic acid-based drugs. Our key technology platforms include world-leading DNA-encoded library technology (DEL), fragment-based drug discovery and structure-based drug design technologies (FBDD/SBDD), as well as the emerging technology platforms for oligonucleotide-based therapeutics (OBT), and targeted protein degradation technology (TPD). Meanwhile, we are developing a DEL+AI+ Automated DMTA (Design-Make-Test-Analyze) molecular optimization platform to accelerate the discovery and optimization process of preclinical candidate compounds. Through our diverse and flexible business models, we have built up collaboration partnerships with several hundred biopharmaceutical research organizations worldwide. HitGen has multiple programmes from early discovery to clinical trial stage.

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HIPRA Biotech Services

HIPRA Biotech Services is a CDMO supporting pharmaceutical and biotech companies across the full early clinical to commercial lifecycle of biologic and vaccine products. Backed by over 50 years of scientific and technical excellence including our internally commercialized and marketed COVID vaccine, we offer end-to-end development and GMP manufacturing solutions across a wide range of expression platforms, from viral to mammalian to microbial platforms, to make clinical and commercial drug substance and drug product for our clients. With a team of 450+ R&D scientists and over 1,000+ professionals in Manufacturing, QA and QC, state-of-the-art facilities, and a strong regulatory track record, we deliver both clinical and commercial programs with speed, quality, and flexibility. We continuously invest in innovation and capacity expansion, making us a trusted partner that will grow with our clients for their long-term success. https://www.hipra.com/en/cdmo-services

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HANS Scientific

HANS Scientific is your nimble partner for CMO and WFI Generation. Our on-staff engineering and regulatory teams enable us to ramp projects quickly and with flexibility to meet your requirements. We are an agile, US-Based CMO with aseptic Fill/Finish and ALUS Lyophilization chamber. Highly innovative WFI generation equipment designed/built in the US, and bulk WFI in Bioprocess containers are readily available.

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Hanmi Fine Chemical

Hanmi Fine Chemical was established in 1984 and has since grown into a world-class, Active Pharmaceutical Ingredient company through ceaseless technological developments and facility investments based on a foundation of talented people with creativity and challenge-seeking spirits. We are a pharmaceutical company that exports Active Pharmaceutical Ingredients to more than 40 countries through strategic alliances with global companies and by establishing independent technologies and a world-class quality system with excellence. HanmiCap, our proprietary 5′ cap analog for mRNA IVT is a state-of-the-art cap analog series that provides excellent translation efficacies and COGs for the overall success in your mRNA drug. | USFDA approved GMP manufacturer in South Korea. Peptide CDMO PEG CDMO Polymer/Lipid CDMO Small Molecule CDMO mRNA materials – HanmiCap, Pseudo UTP, M1-Pseudo UTP, etc

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GfM Milling and Micronization Services LLC.

GfM, founded in 1985 in Bremen, Germany, is the world’s largest independent, family-owned micronization CMO. We refine APIs, excipients, and other products to the highest cGMP standards for the pharmaceutical, chemical, food, nutraceutical, and cosmetic industries. Expanding to the U.S., we’ll support projects from our new Bethlehem, PA facility in 2026, bringing expertise in particle size reduction and analysis to meet your production needs.

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Forge Biologics

Forge Biologics is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company. Forge’s mission is to enable access to life changing gene therapies and help bring them from idea to reality. Forge’s 200,000 square foot facility utilizes 20 cGMP suites in Columbus, Ohio, the Hearth, to serve as its headquarters. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. Offerings include process and analytical development, plasmid DNA manufacturing, viral vector manufacturing, final fill, as well as regulatory consulting support to accelerate gene therapy programs from preclinical through clinical and commercial stage manufacturing. By taking a patients-first approach, Forge aims to accelerate the timelines of these transformative medicines for those who need them the most. To learn more, visit www.forgebiologics.com. | Forge Biologics, a member of Ajinomoto Biopharma Services, is a hybrid gene therapy contract manufacturing and clinical-stage therapeutics development company, enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and regulatory consulting support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com. | Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases. To learn more, visit www.forgebiologics.com | Forge Biologics, a member of Ajinomoto Bio-Pharma Services, is a gene therapy contract development and manufacturing organization (CDMO) enabling access to life-changing gene therapies by bringing them from concept to reality. Forge’s 200,000 square foot facility, the Hearth, is headquartered in Columbus, Ohio, and houses 20 custom-designed cGMP suites with 20,000L of bioreactor capacity. Forge’s end-to-end, scalable plasmid and AAV manufacturing services include research-grade manufacturing, process and analytical development, cGMP manufacturing, fill and finish, and integrated regulatory support to help accelerate the timelines of transformative medicines for patients with genetic diseases.

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FAREVA

Farera as a CDMO is providing a large service offer as sterile injectable and high potent, biological drug, conventionnal product, medial devices, foods supllements and probiotics as well as Drug substance manufacturing of recombinant protein, Andibody Dug Conjugason (ADC) with the associated Fill& Finish | FAREVA is a leading global pharmaceutical CDMO with industry leading capabilities in the development and manufacturing of a large range of Drug Products and Active Pharmaceutical Ingredients (APIs). FAREVA employs 13,000 people distributed in 41 production sites located in 13 countries in EMEA and the Americas. 16 of the FAREVA sites are dedicated to pharmaceutical activities. FAREVA’s API division has operations in 3 European sites located in France and Germany. | Fareva is a leading global pharmaceutical CDMO with a network of 16 manufacturing sites and 3 development sites throughout EMEA and the Americans. We offer comprehensive drug product and API services, including formulation development, clinical manufacturing, scale-up, and commercial manufacturing of small and large molecules. Our capabilities cover a wide range of dosage forms, such as OTC products, oral solid doses, non-sterile liquids and solids, ophthalmics, as well as sterile fill/finish and lyophilized presentations. In addition, our facilities have extensive expertise in secondary packaging, enabling us to serve as a fully integrated partner for our clients’ end-to-end pharmaceutical needs.

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eXmoor Pharma

eXmoor is a full service Cell & Gene Therapy CDMO with a difference. We are backed by 20 years CMC consultancy experience, supporting over 150 organisations to accelerate novel therapies from discovery to patients. We provide expert solutions at all stages of the development journey from early process development and scale-up through to GMP manufacture, fill and finish and QP release. We are open, transparent and will work with you at every step to de-risk and streamline your project and maximise the chances of product success. | eXmoor Pharma is a full-service Cell & Gene Therapy CDMO with a difference. Backed by over 20 years of consultancy experience, we’ve helped more than 170 organisations accelerate therapies from discovery to delivery. We deliver more than manufacturing. Our integrated consultancy and technical development services span the full journey from early-phase strategy to GMP manufacturing and commercialisation. Our in-house experts work as an extension of your team, helping you plan, scale, and deliver therapies that are clinically and commercially viable. We bring deep domain knowledge across process development, analytical science, facility design, GMP production, and regulatory strategy. With a purpose-built facility and a commitment to full IP freedom, we give innovators the space and flexibility to focus on what matters most: getting life-changing treatments to patients faster.

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Evonik Corp

“Evonik is active in more than 100 countries around the world and goes far beyond chemistry to create innovative, profitable, and sustainable solutions for our customers. Evonik’s Health Care business line is a global innovation hub for the world’s leading life science companies from the pharmaceutical, nutraceutical and medical device industries. We support customers along the entire product cycle from early development to commercial manufacturing. Our system solutions are backed by the scientific excellence of our interdisciplinary and diverse teams.” | Evonik Health Care offers a broad portfolio of cell culture ingredients and related services as a technology platform which contributes to highly effective drug development. Our cell culture solutions can be used in the manufacturing of therapeutic proteins like monoclonal antibodies, as well as in the production of viral vectors for gene therapy and specific cells for cell therapy. Our portfolio helps you to ensure optimal growth and viability of cells, enabling the efficient production of biopharmaceutical drugs. The Evonik production network relies on decades-long manufacturing experience and an excellent degree of backward integration to ensure the highest level of quality control and the reliable supply of critical cell culture ingredients. Are you faced with upstream challenges in cell culture? Our Global Competence Network for Cell Culture Solutions is your primary resource when you are looking for system solutions to enhance your media and processes. Whether you would like to intensify a process or scale it up, our multidisciplinary team is ready to help. Our network includes experts in business, application technology, and research and development covering chemistry, cell biology, bioprocessing and media optimization. Our commitment to innovation extends beyond our products. As a solutions provider, we are dedicated to helping biopharma companies and media manufacturers navigate the complex regulatory environment and market access challenges. Building up on our strong expertise in biotechnology and biosolutions, we provide application support and media formulation guidance to help you boost the cell culture performance while reducing complexity and cost of biopharma production. | The Health Care business at Evonik is a global innovation hub for the world’s leading life science companies. We support customers across the entire product lifecycle – from early development to commercial manufacturing – with a broad portfolio of advanced drug delivery technologies, CDMO services for APIs and HPAPIs, and high-performance biopharma solutions. Backed by scientific excellence, sustainability, and a trusted network of western-based facilities, we help the world’s leading life science companies accelerate innovation and improve patient outcomes – today and tomorrow. Evonik is a leading global specialty chemicals company headquartered in Essen, Germany, operating in over 100 countries. Focused on high-growth megatrends like health, nutrition, and sustainability, Evonik develops innovative, tailor-made products for industries ranging from pharmaceuticals and automotive to agriculture. | Evonik is a leading specialty chemical manufacturer of additives, bismaleimide resins, thermoplastic resins and semi-finished products used in composite products and markets worldwide. | Discover Smart Effects, where innovation meets sustainability. Our advanced solutions, leveraging the synergy of silica and silanes, cater to diverse industries including green mobility, agriculture, and food. By utilizing cutting-edge technologies and efficient processes, Smart Effects delivers exceptional value and performance. We are committed to driving positive change with eco-friendly products that benefit both our customers and the planet. Join us in shaping a smarter, greener future with Smart Effects. | For more than 50 years Evonik has served customers worldwide with innovative products and services for medical devices. With our global team of experts we support you at every stage of your product development. We offer a comprehensive portfolio of customized biomaterials and services that open up new possibilities for patient-specific treatment, empowering our customers to bring their ideas to life. | Evonik’s performance additives and dispersing agents for the plastics industry improve the production process and final quality of products. With ongoing challenges around upcoming regulations, the cost and availability of raw materials, and reducing energy use, the plastics industry continues to come under increasing pressure to improve sustainability through better recycling, waste reduction and resource efficiency. The only way to achieve all of this is through continuous innovation. | Evonik Care Solutions is a leading sustainable specialties partner for companies in the beauty and personal care industries. Evonik offers a broad portfolio of innovative ingredients, technologies, and services that enable customers to achieve superior sustainability and functionality in their formulations. Recognized as a powerhouse and global leader, Evonik operates across a diverse range of markets and applications, including active ingredients, active delivery systems, skin care, sun care, color cosmetics, hair care, skin cleansing, alternative preservation, and product stability. | Evonik provides market-relevant and technologically differentiated products for the personal care and oral care industries. Evonik’s Care Solutions portfolio includes solutions for formulation design, innovative emulsifiers, emollients, product protection, natural alternative preservatives, and active ingredients, including clinically-tested ceramide, peptide, delivery system, and botanicals. Evonik Silica’s broad and diverse portfolio is designed to fit consumer’s needs in silica shape, size, distribution, flexibility, compatibility, and application skin-feel and appearance, providing personal care solutions for skincare, decorative cosmetics, rinse-off formulations, and oral care solutions for whitening and sensitive toothpastes. | Evonik Industries, a global chemical company, develops and manufactures specialty chemicals for various products and markets worldwide.Providing solutions to the packaging industry, Evonik’s Coating & Adhesive Resins Business Line offers DEGACRYL® HS, a range of methacrylic polymers for applications like dairy or pharmaceutical packaging.DEGACRYL® HS binders are THE major ingredient for high-quality coatings and are known for their secure seal and smooth peel capabilities. DEGACRYL® HS not only offers direct adhesion to aluminum, PET and paper, but also seals to all common substrates, like polystyrene, polypropylene, polyethylene and many more – all while being free of styrene and PVC.In order to reduce plastic waste, Evonik offers sustainable DEGACRYL® HS grades that enable NIR sorting of plastics and improve recycling efficiency by enabling mono material packaging. Furthermore, recyclability of paper packaging coated with DEGACRYL® HS is possible without having to compromise seal strength or barrier properties. | Evonik is a world leader in the manufacture of high performance products supporting lightweight design, 3D printing and efficient production of fiber-reinforced composites. It supplies foam core materials for sandwich construction, plus thermoplastic & thermosetting resin matrices and their components, including crosslinkers, catalysts, methacrylates, impact strength modifiers and process additives. | Evonik’s High Performance Polymers takes you on the move with its solutions for electric and hybrid vehicles. When developing today’s high-voltage automotive electrical systems, manufacturers rely on VESTAMID® polyamide 12 for the most crucial electric vehicle battery components including busbars and cooling lines for battery packs, and VESTAKEEP® for wire windings in electric motors. | Evonik Protectosil(R) portfolio of water repellents, corrosion inhibitors, ANTIGRAFFITI(R) and easy to clean products are designed to protect and preserve precast and masonry.

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