Company Category: Formulation Development (Drug Product)

Midas Pharma

One Partner – many Opportunities. Midas Pharma is a mid-sized pharmaceutical company, founded 1988 and based in Ingelheim, Germany. Midas offers products, services and expertise along the entire pharmaceutical value chain – from Starting Materials and Active Pharmaceutical Ingredients to market-ready Finished Products and Devices. Since over three decades the family-owned company has successfully contributed to the Pharma sector and has step by step expanded its competencies. With more than 270 employees and 10 locations in all major pharmaceutical markets worldwide Midas Pharma has excellent local know-how, local contacts and well-established networks in different pharmaceutical sectors. Visit Midas Pharma at the German Pavilion and www.midas-pharma.com | Accelerate your development of Biologics and Drug Device Combinations and benefit from the experience and comprehensive pharmaceutical support to safeguard your project executions – from pre-clinic to commercial phase. Benefit from our experience and our wide-ranging portfolio, from cell-line development, CDMO, QM, RA, PV, QP, MA holder and supply chain management service, to complete your projects. Resilience your supply chains with our broad portfolio of biopharmaceutical ingredients and drug substances from R&D to commercial supply, as natural & unnatural Amino-acids, building blocks for Nucleic Acids (Nucleotides, Cap-analogues and Phosphoramidites) as well as Linkers & Payloads for drug conjugates. Ask us also about our customized solutions. Multiply your licensing opportunities for innovative developments. | Where innovation meets expertise – Midas Pharma is your all-in-one provider for biopharma Accelerate your development of Biologics and Drug Device Combinations and benefit from our expertise and tailored pharmaceutical support to safeguard your project executions – from drug discovery to commercial phase. Focus on your specific demands, whether it’s optimizing capacity or importing your product into the European Union, by using our pharma infrastructure: EU QP release services (in-house QPs), regulatory support incl. marketing authorization holdership and pharmacovigilance services (in-house EU-QPPV). Exploit our wholesale and supply chain expertise to import, launch and distribute your biopharmaceutical products. Speed up your drug discovery and development with our comprehensive bioanalytical services for mAbs, ADCs, peptides, and nucleic acids. We offer a wide range of cutting-edge analytical methods, e.g., for structural and functional characterization of proteins, lead & clone selection, and biosimilar studies. Resilience your supply chain with our broad portfolio of biopharmaceutical intermediates (Building blocks for TIDES, Linkers & Payloads etc.), produced at GMP-compliant sites. Discover Gx Inbeneo®, our next generation autoinjector, which addresses the challenges of subcutaneous self-administration of biopharmaceuticals with injection volumes of up to 3 ml and ultra-high viscosities. The constantly pre-pressurized system ensures smooth continuous injection with shortened injection times; a needle that is not in contact with the drug product prevents needle clogging. Gx Inbeneo® offers quick customization to different formulations for faster time-to-market. Midas Pharma advantages: – All-in-one provider with modular service offers, tailored to your needs – Collaboration from expert to expert – EU headquartered, with a global operational footprint | With more than 35 years of experience, Midas Pharma brings proven expertise to every stage of the biopharmaceutical product life cycle. As a fully-fledged pharmaceutical company with EU GMP/GDP/WDA and MIA licenses, we offer a complete and reliable infrastructure tailored to your needs, whether you are an innovative start-up or an established biopharmaceutical company. Combining scientific expertise with a robust global network, Midas Pharma delivers integrated end-to-end solutions that accelerate your path from early-stage R&D to market. We provide the insight, infrastructure, and commitment needed to achieve your goals with confidence and to succeed in the competitive biopharmaceutical landscape. Your key benefits: • Process development: Expertise in biotechnological and chemical processes, covering preclinical development to commercial manufacturing. • Analytical services: Comprehensive structural and functional analysis that delivers precise insights into your molecule; tailored solutions, aligning technical accuracy with strategic goals through a holistic approach. • Starting materials, intermediates, drug substance, drug product, fill and finish (non GMP and GMP quality): Robust supply chain, including documentation in compliance with the authority requirements worldwide. • Novel autoinjector platform: Innovative solutions that overcome key challenges in subcutaneous delivery – enabling the injection of small and large volumes, especially but not only for high concentrated biologics. • GMP services: From EU QP release to global import/export: guaranteeing your products meet all regulatory standards. • Market entry strategy: Guidance through the process of entering target markets, including due diligence and clinical trials. • Business Development Advisory Services: With our global network spanning mid‑ and top‑tier biopharma in the US, Europe, and Asia, we deliver expert advisory support to accelerate your partnering success. Our customized services include financial modeling and valuation, deal structuring, due diligence, partner identification, and contract negotiation empowering you to maximize shareholder value. • Commercial operations: Comprehensive wholesale solutions along with marketing authorization holder (MAH) and pharmacovigilance (PV) services. Analytical services powered by Biofidus – A member of the Midas Group

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Medicilon USA Corp

Medicilon is a leading CRO company that provides comprehensive drug R&D services on a global scale. From drug discovery, pharmaceutical research to preclinical research, Medicilon has supported more than 2000 client R&D programs worldwide resulting in 520 IND filings. With proven scientific excellence and FDA-aligned methodologies, we help biotech and pharmaceutical innovators fast-track their path from discovery to IND success. | Medicilon is a leading CRO company that provides comprehensive drug R&D services on a global scale. Medicilon has 21 years experience in the industry and has supported more than 2000 client R&D programs worldwide resulting in 580 IND filings. The company has over 441,320 ft2 of chemistry labs with > 1300 chemists located at three different sites. With operations in the USA, China, and Europe, Medicilon is a leading CRO offering integrated pharmaceutical R&D services, including DMPK/PD, toxicology (GLP and non-GLP), chemistry, discovery biology, and CMC research. In addition, Medicilon offers attractive large animal models (non-human primates, dogs, rabbits, and miniature pigs), tumor & non-tumor animal models (including Xenograft models, PDX / PDXO models), and support for simultaneous U.S. IND filing to streamline global drug development and approval.

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LTS Lohmann Therapy Systems

LTS LOHMANN Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches (TTS) and Oral Thin Films (OTF) for the pharmaceutical industry. LTS is also advancing emerging drug delivery technologies like Micro Array Patches (MAP) for the transdermal delivery of large molecules, biological actives and vaccines. LTS´s commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 30 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. Founded in 1984, LTS operates today from three sites: Andernach, Germany, West Caldwell, NJ, USA and St. Paul, MN, USA. LTS has also a representative office in Shanghai, China. | We CARE. We CREATE. We DELIVER. The driving philosophy behind LTS. As a trusted technology partner for the pharmaceutical industry, we develop and manufacture innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) as well as wearable drug delivery devices (“OBDS”). LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 40 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Microneedle Array Patches (“MAP”) for the transdermal delivery of small and large molecules, biological actives and vaccines. With its Sorrel(TM) wearable drug delivery platform LTS offers patient friendly solutions for complex drugs delivery at home. Founded in 1984, LTS operates today from four sites: in Andernach, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA and Netanya, Israel. LTS has also a representative office in Shanghai, China. | LTS is a trusted technology partner for the pharmaceutical industry. We develop and manufacture innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) as well as wearable drug delivery devices (“OBDS”). We are also advancing emerging drug delivery technologies, including Microneedle Array Patches (“MAP”) for the transdermal delivery of small and large molecules, biological actives and vaccines. LTS´ commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 40 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. Founded in 1984, LTS operates today from four sites: in Andernach, Germany, West Caldwell, NJ, USA, St. Paul, MN, USA and Netanya, Israel. LTS has also a representative office in Shanghai, China.

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Kemwell Biopharma Private Ltd.

Kemwell is a biologics focused Contract Development and Manufacturing (CDMO) company providing services to global biopharmaceutical organisations. Kemwell’s facilities, located in Bangalore, India, are designed with technological support from a leading German biopharma company.The team is experienced to undertake end-to-end activities right from cell line development till cGMP clinical and commercial manufacturing. Kemwell also undertakes standalone projects such as process optimisation, analytical method development or validation, formulation development and optimization, stability studies, resin reuse study, tech transfer and cGMP manufacturing, process characterization, etc. We are currently supplying commercial mAb in 35 plus countries and have worked with US innovator/biotech companies to accelerate development for their pipeline drugs since 2012. | As a trusted biologics CDMO partner we provide end-to-end service from clinical development to commercial-scale manufacturing, we have an extensive process characterization infrastructure and experience in process development including complex mAbs – (Bispecific, Trispecific, ADC and Complex fusion proteins), Analytical Development (Bioassays, Mass Spec, and SPR), and formulation development (in-house stability studies, Liquid, Lyo, and high concentration protein formulation). To enhance our drug product fill-finish capabilities, we have introduced the OPTIMA Pre-Filled Syringe line, in addition to our existing liquid and lyophilized vial offerings. | Kemwell has 40+ years of experience being a CDMO based out of Bangalore, India and provides services to global biopharmaceutical organisations. Our FDA-approved site supports end-to-end biologics programs from development to commercial supply and features: • 5000L+ upstream capacity with single-use and stainless-steel bioreactors • Commercial fill-finish lines for liquid vials, lyo vials and pre-filled syringes with isolator technology • Capabilities across monoclonals, bispecifics/tri-specifics, fusion proteins, biosimilars

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IPCA LABORATORIES PVT. LTD.

Ipca Laboratories Ltd. is a global, consumer-led pharmaceutical company committed to improving lives since 1949. For over 60 years, Ipca has been a trusted healthcare partner across more than 120 countries spanning six continents. We are a fully integrated pharmaceutical company with capabilities in the manufacture of over 350 formulations and 80 APIs across multiple therapeutic segments, supported by 35 manufacturing facilities and 8 R&D centers. Our state-of-the-art R&D center in Mumbai, along with our advanced manufacturing facility in Pithampur, Madhya Pradesh, specializes in the development and biomanufacturing of monoclonal antibody (mAb) biosimilars. The facility adheres to global GMP standards and produces high-potency biosimilars for both domestic and regulated international markets, including the USA and Europe. It is equipped with single-use Drug Substance (DS) and Drug Product (DP) systems, automated processes, a zero liquid discharge effluent treatment plant, and environmentally sustainable practices. Ipca is also among the fastest-growing companies within the top 20 pharmaceutical companies in India. We believe there is strong potential for collaboration between our organizations in the biosimilars space. Possible areas of partnership include: Drug Substance and Drug Product development and manufacturing In-licensing and out-licensing of monoclonal antibody (mAb) molecules Technology transfer and know-how sharing Peer-to-peer biosimilar business development across global markets We have developed a robust biosimilar pipeline (mAb and non-mAb) targeting key markets including the EU, UK, USA, Canada, Japan, India, and Rest of the World (ROW).

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INTRAVACC

Intravacc is an established independent CDMO with years of experience in developing and optimizing vaccines for infectious diseases and therapeutic vaccines, which has transferred its technology worldwide for vaccines against polio, measles, diphtheria, Hib, and influenza. Around 30% of childhood disease vaccines are based on Intravacc’s technology and knowhow. Intravacc offers a wide range of expertise for independent vaccine development, from concept to Phase I/II clinical studies, for customers around the world. Intravacc continues to capitalize on the critical global trends in healthcare: the ever-growing need for prevention and intervention for infectious diseases and cancer. Our innovative vaccine platforms and vaccine contract development and manufacturing capabilities are well positioned to address the unmet needs in the vaccine and immune therapy market which is currently estimated at $37 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 6.6% to $55 billion by 2027. The company’s head office is located on the Utrecht Science Park location Bilthoven, The Netherlands, and has state-of-the-art laboratories and GMP production facilities. Intravacc B.V. is a limited liability company incorporated under Dutch law. Intravacc is a state holding company since 1 January 2021, under the Ministry of Health, Welfare and Sports (VWS). | . | Your specialized CDMO to accelerate the development of your viral, bacterial, therapeutic, and conjugate vaccines. From discovery to phase II clinical trial. Based in the Netherlands within the Utrecht Science Park in Bilthoven, Intravacc is a globally recognized pioneer and leader in translational vaccinology. With decades of experience, we stand as an independent Contract Development and Manufacturing Organization (CDMO) within the vaccine industry. Our purpose is to serve as the vital link between your discoveries and early-stage clinical trials of new vaccines. We understand that this journey from concept to GMP production is often riddled with challenges, and we specialize in mitigating risks and reducing costs. | Your specialized CDMO for viral, bacterial, therapeutic, and conjugate vaccines Based in the Netherlands and nestled within the Utrecht Science Park in Bilthoven, Intravacc is a globally recognized leader in translational vaccinology. With decades of experience, we stand as an independent Contract Development and Manufacturing Organization (CDMO) within the vaccine industry. Our purpose is to serve as the vital link between your discoveries and early-stage clinical trials. We understand that this journey from concept to GMP production is often riddled with challenges, and we specialize in mitigating risks and reducing costs. The entire team at Intravacc is committed to blazing new paths in vaccine development. We have an exceptional track record imagining and realizing technologies that enable tomorrow’s vaccines. That expertise in vaccine development is at the core of our CDMO services and candidate vaccines out-licensing.

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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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