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
Groupe PARIMA
Groupe PARIMA is a Contract Development and Manufacturing Organization (CDMO), established in 1994. Over the years, we have developed an expertise in the development and manufacturing of non-sterile liquids, suspensions, and semi-solid drug products. This strategic focus has allowed us to establish a unique expertise to support your product development and manufacturing needs, which, combined to our operational flexibility and commitment to delivering on time, enables us to operate as an extension of your team. Our business is 100% fee-for-service and exclusively focused on contract services. We are here to help you meet your company objectives, not to compete with you. | Groupe PARIMA is a leading Contract Development & Manufacturing Organization (CDMO) that excels in the development and manufacturing of non-sterile pharmaceutical products. Specializing in liquids, semi-solids, and suspensions, we offer an extensive range of services focused on product development, commercial manufacturing, packaging and laboratory testing. Our modern facility is equipped to handle complex pharmaceutical formulations and packaging requirements. At the core of our operation is a deep commitment to research and development. Our expert team collaborates closely with clients to design and optimize formulations that meet specific patient needs, ensuring each product achieves optimal effectiveness and regulatory approval. This focus on development is complemented by our flexibility to scale processes seamlessly from pilot batches to clinical supply and eventually large-scale commercial production. Our team of skilled professionals bring a wealth of industry knowledge and technical expertise, making us a preferred partner for both emerging biotechs and established pharmaceutical companies across 28 countries. Groupe PARIMA’s ability to adapt swiftly to changing market conditions and client requirements sets us apart in the dynamic pharmaceutical landscape. With ample manufacturing capacity and comprehensive on-site services including laboratory testing and regulatory compliance activities, we are equipped to handle diverse project demands with precision. Whether advancing a novel treatment or expanding production capabilities, Groupe PARIMA provides the expertise and infrastructure necessary to bring your pharmaceutical products to global markets. Explore the possibilities with Groupe PARIMA as your dedicated CDMO partner. Discover our full range of development capabilities and services at www.groupeparima.com. | Groupe PARIMA, a CDMO since 1994, specializes in the development and manufacturing of non-sterile liquids, suspensions, and semi-solids. With deep expertise in complex formulations, scale-up, and regulatory compliance, we provide end-to-end support from development to commercial production. Our flexible approach, technical proficiency, and commitment to on-time delivery make us a trusted partner for pharmaceutical companies worldwide. As a dedicated contract service provider, we focus entirely on supporting our clients’ success with tailored solutions and operational agility.
Grand River Aseptic Manufacturing
Grand River Aseptic Manufacturing, Inc. (“GRAM”) is a leading contract development and manufacturing organization with advanced equipment and innovative technology that delivers customized solutions to meet clients’ fill and finish needs for liquid vials, lyophilized vials, syringes, and cartridges. With biologic, small molecule, and vaccine capabilities, Grand River Aseptic Manufacturing supports pharmaceutical development, cGMP manufacturing, analytical testing, and regulatory filing. | Grand River Aseptic Manufacturing, Inc. (“GRAM”), a prominent aseptic fill-finish contract development and manufacturing organization, delivers biologics, small molecules, and vaccine capabilities for liquid and lyophilized vials, syringes, and cartridges. Grand River Aseptic Manufacturing’s 300,000 sq. ft. of sophisticated GMP space supports customers’ drug products with advanced equipment, innovative technology, and a breadth of experienced team members.
Government of Tamil Nadu – Guidance & TICEL Bio Park Limited
Guidance TamilNadu Guidance Tamil Nadu is the investment promotion agency of the Government of Tamil Nadu, India’s most industrialized state. With a robust and diverse industrial ecosystem, Tamil Nadu is advancing its biotechnology sector with a focused, mission-driven approach. As a single-window facilitation body, Guidance offers end-to-end support to investors through a dedicated team of sector specialists, policy advisors, and international consultants. We streamline the investment journey by coordinating with industry stakeholders, community partners, and government departments—consolidating efforts to ensure a seamless and efficient business experience. In the life sciences sector, Guidance’s primary objective is to position Tamil Nadu as the investment destination of choice. This is achieved by enhancing ease of doing business, reducing operational costs, enabling policy frameworks tailored to the evolving global life sciences landscape, and providing sustained, expert-backed support throughout the investment lifecycle. TICEL Biopark Limited TICEL Biopark Limited, Chennai, Tamil Nadu, India is a state – of – art Biotechnology Park established in 2004 in Tamil Nadu, India. TICEL Biopark is promoted by TIDCO (Tamil Nadu Industrial Development Corporation) in technical collaboration with Cornell University, USA. TICEL Biopark supports Biotech ecosystem from their early stage of research to pilot-scale production by providing laboratory infrastructure and equipment support. Major companies such as Biocon biologics, Teva pharma, Levim biotech, Amway, Johnson & Johnson, Hiyoshi India and Revvity Health sciences are located in Ticel Bio Park. The Biotech Core Instrumentation Facility, housed at TICEL Biopark, provides equipment support to startups and industries. TICEL provides Laboratory infrastructure which supports to create GMP/GLP/ Contract Research (CRO) / Contract Manufacturing (CMO) / testing facility. TICEL infrastructure includes utilities such as RO water plant, Gas Bank, Vacuum air, Compressed air, Fume hood exhaust with scrubber, HVAC system, Bio waste disposal, STP & ETP plant etc. TICEL supports startups/Industries by providing equipment, incubation space, and resources to conduct research and commercialize their products. TICEL also conducts skill development programs and hands-on workshops for students and scientific professionals. Additionally, TICEL undertakes contract research and contract manufacturing work at its Biotech Core Instrumentation Facility.
Genezen
Genezen is a best-in-class gene therapy CDMO with over a decade of experience focused on supporting the demands of the cell and gene therapy manufacturing market worldwide. With capabilities to work across vector-modality, Genezen partners with innovator organizations to deliver life-saving gene and cell therapies – from concept to commercial. With flexible and customer-centric programs, Genezen tailors its partnership-model approach to all sizes and stages of organizations, to make viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen’s state of the art Lexington, MA site holds multiple global regulatory licenses, including with the FDA, EMA, Health Canada, and MFDS Korea, and the company offers the following capabilities: – Process Development – Analytical Development – cGMP Viral Vector Manufacturing – Patient Sample Testing – Cell Therapy Manufacturing – Master Cell Bank Production and Expansion
GBI Biomanufacturing
GBI is a full-service biopharmaceutical CDMO based in Florida that aims to eliminate manufacturing risk for companies developing complex biologic therapeutics. Our responsive teams of experts across development, manufacturing, project management, and quality can leverage our many platforms to move your project forward on time and on budget. With an extensive offering of development services, state-of-the-art manufacturing equipment, and project support, GBI is truly a full-service CDMO biologics partner. Our approach pairs our expert knowledge base with an open mind towards scientific discovery so that together we can develop an optimal way to make our systems work for you and your biologics project, no matter how complex it may be. | GBI is a full-service biopharmaceutical CDMO based in Florida that aims to reduce manufacturing risk for companies developing complex biologic therapeutics. Our responsive teams of experts across process development, manufacturing, project management, and quality can leverage our many platforms to move your project forward on time and on budget. With an extensive offering of process development services, state-of-the-art manufacturing equipment, and project support, GBI is truly a full-service CDMO biologics partner. Our approach combines knowledge and scientific discovery to develop an optimal way to make our systems work for you and your biologics project, no matter how complex it may be.
FyoniBio
With a history in ISO-9001 compliant contract development services in the last 15 years FyoniBio provides solutions for supporting the customers in their biopharma development program. Our offerings include: • Cell line Development using human GlycoExpress® and rodent CHOnamite®: Start with fast and cost-efficient feasibility studies to identify the best cell host for your biopharma project. • USP, DSP , Formulation and analytical development: We establish and deliver the full package to hand over for GMP manufacturing. • Mass Spectrometry based PTM and protein analytics: For in depth protein characterization, we provide MS based protein and PTM analytics to include into clone development to identify the clone providing the best quality, stability studies or full final protein characterization for IND submission. • Bioassay development: Cell based assays like ADCC, CDC, ADCP, cell activation assays, killing assays, cell binding assays as well as biochemical assays like antigen binding (e.g. affinity determination, FcgR binding, in-vitro activity assays) • Clinical bioanalysis/immunomonitoring: Evaluation of pharmacokinetic and pharmacodynamic characteristics of biotherapeutics as well as their immunogenic and neutralizing potential in patients like analysis for anti-drug-antibodies (ADAs) using screening/confirmatory/titration assays, Analysis of ADA for neutralizing activity, PK analysis, biomarker serum levels. | FyoniBio is a CDO and clinical laboratory offering custom-tailored services at different drug development stages to pharmaceutical and biotechnology companies. At FyoniBio, we leverage 15 years of specialized expertise in biopharmaceutical CMC development to deliver cutting-edge scientific solutions as a Contract Development Organization (CDO). Our integrated ISO-9001:2015 services encompass the entire spectrum of biopharmaceutical development, from crafting stable high-titre cell lines in mammalian expression systems to meticulous process development and rigorous quality control. With comprehensive bioanalytical capabilities tailored for preclinical and clinical studies, we empower biopharmaceutical companies to accelerate their CMC projects with confidence, precision, and reliability. At FyoniBio, our commitment to excellence extends beyond our expertise in biopharmaceutical CMC. A special focus lies on our versatile and robust cell line portfolio, which includes our highly productive CHO platform technology CHOnamite® (for high-yield production of up to 10 g/L), our proprietary CHOFlow® cell line (a FUT-8 KO cell for ADCC enhanced afucosylated mAbs), as well as the human GlycoExpress® platform (for complex glycoproteins). Coupled with upstream and downstream process optimization, state-of-the-art equipment, and in-house developed software for glycan analytics, our comprehensive services ensure unparalleled efficiency and quality throughout the development process. Moreover, our service portfolio is complemented by GCLP-compliant bioanalysis of clinical samples, including pharmacokinetics, genotyping, biomarker, and immunogenicity assessment, providing a seamless integration of scientific capabilities from development to clinical trials. Our powerful cell line portfolio is strengthened with: • Customized feasibility studies to select the best suitable host cell line meeting the requirements for each individual complex recombinant protein. • State-of-the-art cell line development using the CellCelector technology to select highest expressing clones meeting the monoclonality requirements • Integrated robust upstream (USP) and downstream (DSP) development, as well as analytical development, to competitive accelerate timelines. • Extensive protein characterization (e.g., PTMs; N-glycans; O-glycans) ensured by our in-depth expertise in mass spectrometry. • Bioassay development (e.g., ADCC, CDC; ELISA, FACS). • Clinical bioanalysis (PK, ADA) for proteins and oligonucleotides under GCLP regulations. | At FyoniBio, we leverage 15 years of specialized expertise in biopharmaceutical CMC development to deliver cutting-edge scientific solutions as a Contract Development Organization (CDO). Our integrated ISO-9001:2015 compliant services encompass the entire spectrum of biopharmaceutical development, from crafting stable high-titre cell lines in mammalian expression systems to meticulous process development and rigorous quality control. With comprehensive bioanalytical capabilities tailored for preclinical and clinical studies, we empower biopharmaceutical companies to accelerate their CMC projects with confidence, precision, and reliability. At FyoniBio, our commitment to excellence extends beyond our expertise in biopharmaceutical CMC. A special focus lies on our versatile and robust cell line portfolio, which includes our highly productive CHO platform technology CHOnamite® (for high-yield production of up to 12 g/L), our proprietary CHOFlow® cell line (a FUT-8 KO cell for ADCC enhanced afucosylated mAbs), as well as the human GlycoExpress® platform (for complex glycoproteins). Coupled with upstream and downstream process optimization, state-of-the-art equipment, and in-house developed software for glycan analytics, our comprehensive services ensure unparalleled efficiency and quality throughout the development process. Moreover, our service portfolio is complemented by GCLP-compliant bioanalysis of clinical samples, including pharmacokinetics, genotyping, biomarker, and immunogenicity assessment, providing a seamless integration of scientific capabilities from development to clinical trials. Our powerful cell line portfolio is strengthened with: • Customized feasibility studies to select the best suitable host cell line meeting the requirements for each individual complex recombinant protein. • State-of-the-art cell line development using the CellCelector technology to select highest expressing clones meeting the monoclonality requirements • Integrated robust upstream (USP) and downstream (DSP) development, as well as analytical development, to competitive accelerate timelines. • Extensive protein characterization (e.g., PTMs; N-glycans; O-glycans) ensured by our in-depth expertise in mass spectrometry. • Bioassay development (e.g., ADCC, CDC; ELISA, FACS). • Clinical bioanalysis (PK, ADA) for proteins and oligonucleotides under GCLP regulations.
FUJIFILM Biotechnologies
FUJIFILM Biotechnologies, a subsidiary of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With over 4,800 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoXTM global network with major facilities in the United States, the United Kingdom, and Denmark, with a planned new site in Holly Springs, North Carolina, USA. The Company’s kojoXTM manufacturing network ensures supply chain agility for its customers through modular facilities and standardized processes for seamless scaling and technology transfers. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing.
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.