Company Category: cGMP Manufacturing (Drug Substance)

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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NIPPON SHOKUBAI

Nippon Shokubai provides contract manufacturing (CDMO) services for oligonucleotide and peptide active pharmaceutical ingredients (APIs), often referred to as middle molecules. With our advanced, GMP-compliant facilities, we support every stage—from discovery through clinical trials to post-marketing. We also offer comprehensive solutions for manufacturing process development and analytical method development. We are also actively advancing drug delivery systems (DDS) that are critical for middle molecules. This includes developing substances for targeted delivery to disease sites and new biocompatible polymers for DDS, helping to optimize therapeutic outcomes. Capabilities ・Contract manufacturing (CDMO) of oligonucleotide APIs ・Contract manufacturing (CDMO) of peptide APIs ・Contract manufacturing (CDMO) of middle molecule APIs ・Process development ・Analytical development ・Technical transfer for manufacturing ・New biocompatible polymers (DDS and others) ・siRNA-delivery peptides ・Heteroduplex oligonucleotides | Using our own technology, we at NIPPON SHOKUBAI manufacture ethylene oxide, acrylic acids, catalysts, superabsorbent polymers and so on. We will continue to launch new products in ICT, Life Science and Energy & Environment fields and perpetuate corporate mission of “TechnoAmenity: Providing prosperity and comfort to people and society, with our unique technology”.

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LOTTE BIOLOGICS

LOTTE BIOLOGICS is a global CDMO company committed to provide good quality biopharmaceutical products that enable a healthier world. Since established in 2022, with unwavering dedication and distinction, LOTTE BIOLOGICS has successfully transformed into a global CDMO company following the acquisition of Bristol Myers Squibb’s Syracuse manufacturing site. Furthermore, with a plan for Mega Plants in Korea with a total capacity exceeding 360,000L, LOTTE BIOLOGICS aims to become a Global Top 10 CDMO company in the biopharmaceutical industry. In terms of capabilities, LOTTE BIOLOGICS can offer a comprehensive range of services, from cell line development to clinical and commercial supply of Biologics Drug Substance manufacturing. The production capacity at the Syracuse site is 35,000L (5,000L x7), along with multiple 1,100 L bioreactors for clinical product production, QC testing laboratories, a warehouse, cell bank and product storage and other related facilities. In addition, the Syracuse site has a proven regulatory track record with more than 62 global approvals including from FDA, EMA, PMDA and MFDS. In addition, ADC conjugation facility is currently being installed to meet the increasing demand in the market. The Mega Plants in South Korea, with a total capacity exceeding 360,000L, are scheduled to be GMP ready starting from the year of 2026. In order to foster growth and innovation in the biopharmaceutical industry, “LOTTE Bio Initiatives” will be established on the Mega Plant Campus to provide a platform for bioecosystem. Together with our partners, LOTTE BIOLOGICS is dedicated to providing reliable solution for development, manufacturing and supply of the biopharmaceutical products. For more information, please visit https://www.lottebiologics.com/en | LOTTE BIOLOGICS is a global CDMO company committed to provide good quality biopharmaceutical products that enable a healthier world. Since established in 2022, with unwavering dedication and distinction, LOTTE BIOLOGICS has successfully transformed into a global CDMO company following the acquisition of Bristol Myers Squibb’s Syracuse manufacturing site. Furthermore, with a plan for Songdo Bio Campus in Korea with a total capacity up to 360,000L, LOTTE BIOLOGICS aims to become a Global Top 10 CDMO company in the biopharmaceutical industry. In terms of capabilities, LOTTE BIOLOGICS can offer a comprehensive range of services, from cell line development to clinical and commercial supply of Biologics Drug Substance manufacturing. The production capacity at the Syracuse Bio Campus is 40,000L (5,000L x8), along with multiple 1,100 L bioreactors for clinical product production, QC testing laboratories, a warehouse, cell bank and product storage and other related facilities. In addition, the Syracuse Bio Campus has a proven regulatory track record with more than 62 global approvals including from FDA, EMA, PMDA and MFDS. In addition, ADC conjugation facility is currently being installed to meet the increasing demand in the market, which is projected to be fully in operation by Q1 2025. The Songdo Bio Campus in South Korea, with a total capacity up to 360,000L, are scheduled to be GMP ready starting from the year of 2026. In order to foster growth and innovation in the biopharmaceutical industry, “LOTTE Bio Initiatives” will be established on the Songdo Bio Plant Campus to provide a platform for bioecosystem. Together with our partners, LOTTE BIOLOGICS is dedicated to providing reliable solution for development, manufacturing and supply of the biopharmaceutical products. For more information, please visit https://www.lottebiologics.com/en | LOTTE BIOLOGICS was established in 2022 and is headquartered in Seoul, South Korea. Utilizing a two-track strategy of acquiring and building, LOTTE BIOLOGICS is solidifying its competitiveness in the CDMO market. At the Syracuse Bio Campus in New York, LOTTE BIOLOGICS provides high-quality GMP manufacturing services for drug substances. The facility offers a total production capacity of 40,000L, supported by eight 5,000L stainless steel bioreactors. Additionally, the campus includes extensive analytical QC testing laboratories and warehouse facilities that have received over 62 regulatory approvals from agencies worldwide. LOTTE BIOLOGICS is also advancing into a new area of expertise with Antibody-Drug Conjugates (ADCs) services. With over $100 million invested in ADC modalities, including both drug substance and conjugation capabilities on-site, we offer a seamless, end-to-end service from drug substance manufacturing to conjugation. Looking ahead, LOTTE BIOLOGICS is constructing three advanced bio plants in Songdo, South Korea. With construction of the first plant already underway and expected to be operational by 2027, each facility will feature eight 15,000L stainless steel bioreactors for large-scale commercial production, along with multiple 3,000L bioreactors to meet clinical production needs. Collectively, these plants will provide a manufacturing volume exceeding 360,000L in bioreactor capacity. Through our commitment to delivering innovative medicines to patients worldwide, LOTTE BIOLOGICS aims to become a top-tier global CDMO company in the biopharmaceutical industry.

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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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Industrial Technology Research Institute (ITRI)

ITRI is committed to driving the development of various industries with its outstanding technology and research abilities in hopes to create economic values and promote social well-being. In addition to playing a role of researcher and developer in the fields of medicine as well as medical devices, it has also established a complete structure of CRO (Contract Research Organizations) and CDMO (Contract Development & Manufacturing Organization) services. The one-stop biomedical services platform of ITRI provides assistance in a wide range of scopes, including research and development, model translation, GXP trial production, pre-clinical/clinical trial, post-marketing consultation, etc. This mechanism makes it possible for domestic manufacturers to lower their initial cost of investment, and accelerate their research and development. ◆ Regulation Consulting: FDA/TFDA/CE application, medical device verification/export, medical device/medicine registration, IRB document organization, clinical trial application, and more. ◆ Licencing: Bio-IT, diagnostics and precision medicine technology, regeneration medicine technology, natural medicine and healthcare technology, targeted drug and delivery technology. ◆ Prototyping: Domestic supply chain linkage, medical device design control, market analysis, strategy analysis of regulation in commercialization, and more. ◆ Preclinical/Clinical Trial: Functional safety assessments, clinical research organization linkage, clinical evaluation and analysis, clinical trial planning, clinical trial analysis and reports. ◆ Other Services: Quality system consulting, commercialization consulting, smart health solutions, software validation, medical device risk management, information security risk evaluation, technical documents preparation, business ecosystem linkage, and more.

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Indiana Pavillion

The Indiana Pavilion is brought to you by BioCrosscrossroads. BioCrossroads is a catalyst for Indiana’s diverse and growing life sciences industry, supporting collaboration, expertise, and investments that fuel innovation and transform global health.

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