Company Category: Cell Biology Tools

Crystal Pharmatech

Established in 2010, Crystal Pharmatech is a global company with around 250 employees and three R&D centers located in Suzhou (China), New Jersey (USA), and Toronto (Canada). We are distinguished by our comprehensive suite of specialized services, which includes API solid-state research, crystallization, preformulation, formulation development, and manufacturing. Our scientific leadership team, averaging 15 years of experience, has successfully delivered over 100 early-phase and 19 commercialized products for worldwide pharmaceutical companies. We have catered to over 1,000 clients, aiding in the development of more than 2,000 new chemical entities. Utilizing our distinctive expertise, we collaborate with clients to design and develop the most appropriate crystal form and formulation for further development. Our principle of “getting the crystal form and formulation right the first time for Phase I” not only accelerates the progression of your molecule to IND filing and Phase I clinical trials but also minimizes the need for human PK bridging studies. This method saves time and reduces costs as your program progresses to Phase II and beyond. Crystal Pharmatech is a specialized CRO/CDMO focused on Solid State Research, Pre-Formulation, Formulation Development, and Manufacturing. Our strength lies in our concentrated expertise in these areas, and we offer the following Mol2Med™ Integrated Services: the First-Time-Right 3-STEP Approach. This method is designed to quickly advance small molecule lead compounds or preclinical candidates into Phase I and further, with unmatched efficiency and precision. The approach starts at the lead optimization/PCC stage: This innovative method ensures a robust API form and a scalable manufacturing process, leading to a First-Time-Right formulation for Phase I. By streamlining the transition to future clinical studies following Phase I success, our First-Time-Right approach lays the groundwork for optimized drug development and future success. Step 1: Developability Assessment Our method evaluates the physicochemical properties of all lead candidates to identify the most “developable” lead, benchmarking against industry standards and aiming for the highest likelihood of success in GLP Tox and FIH studies. It also aids in deciding whether a free form or salt, and either a crystalline form or an amorphous solid dispersion should be chosen for further development. Step 2: Solid Form Screening/Selection and Pre-Formulation We begin with thorough screening and selection of the optimal crystalline form for the API. We then develop an ideal preclinical formulation to support PK/PD and GLP Tox animal studies. Step 3: Formulation Development and CTM Manufacturing Our API-specific “First-time-right” strategy produces the best formulation for Phase I and subsequent clinical studies. This approach allows late-stage development to concentrate on process optimization and scale-up without significant formulation changes, thereby eliminating the need for human PK bridging studies. Service offerings: 1. Polymorph screening, salt screening, cocrystal screening, solid form screening a. Most solid drugs can exist in different solid forms (polymorph, anhydrate, hydrates, solvates, cocrystals, salts, and amorphous forms), which lead to different physicochemical properties, such as solubility, stability, particle size and others. Therefore, screening and selection of the ideal API solid forms is critical to obtain the highest standard quality, performance and a good manufactured reproducibly. 2. Solid state research a. Solid state characterization, solid state research, single crystal growth 3. Crystallization development a. The aim of a crystallization process development is to find a crystallization process which can stable produce the optimal solid form with all desired properties such as particle size, particle shape, bulk density, purity, yield, residual solvent content, etc. Experienced engineers agree that crystallization is an inherently challenging process, one that involves a blend of art and science. Even small variations in the process can have profound impact on the outcome for both the API producer and its business pharmaceutical partners, which incorporate the API into finished drug formulations. At Crystal Pharmatech, successful crystallization development is based on a fundamental understanding of physicochemical and engineering principles, implementation and development of technologies and expertise in specialized areas. 4. Pre-formulation Development a. Preformulation development, preformulation studies, amorphous solid dispersion screening, vehicle selection to support animal studies 5. Formulation Development, CTM manufacturing, spray drying, hot melt extrusion, oral solid dosage, clinical supply service, clinical trial material a. Crystal Pharmatech has rich experience in the development of new drug products during the whole life cycle. Based on the concepts of Quality by Design (QbD) and Fit-for-Purpose (FFP), a suitable formulation development strategy will be adopted in view of the characteristics and technical requirements of different kinds of products at different stages. We aim to develop a robust formulation and process for your product, to rapidly advance to different stages of clinical research. Product changes will be minimized in the subsequent clinical and marketing process to achieve comprehensive and efficient development goals by scientific bridging study design. As a professional pharma formulation company, we have top-notch equipment and instruments for formulation development and analysis, which can support the development of oral solid dosage forms at all stages from early clinical to commercialization. The first-time success of GMP production of clinical samples can be effectively guaranteed and thus saving the development cost and shortening the development cycle by taking the following strategies: compaction and mathematical simulation technologies, similar critical equipment between GMP and R&D, and the same personnel responsible for R&D and GMP production of clinical samples. 6. Biologics analytical services a. Typical CMC-related analysis of primary and higher order structure, product and process purity, and forced degradation with correlation bioactivity with MS identity for potential critical quality attributes. Additional modalities such as traditional types of ADC & novel conjugated combinations, mRNA & lipid nanoparticles in combination with a strategic partner. Sample pretreatment strategy combined with LC-MS to complement assays used in various bioassays and cell/ gene analysis to support structure/ function elucidation. Analysis of protein expression from cell, tissue, or blood matrix. Bioactivity, effector functional (ADCC& ADCP), and ligand binding analysis for potency and mechanism of action. PK/PD for investigational & preclinical analysis, and extendable to clinical analysis as needed. | x | Established in 2010, Crystal Pharmatech is a global CRO/CDMO with around 300 employees and four R&D centers located in Suzhou, New Jersey, California, and Toronto. We provide integrated development support across small molecules, biologics, and nucleic acid therapeutics. Our core capabilities include API solid-state research, crystallization development, preformulation, formulation development, analytical support, and manufacturing. Through Crystal Bio Solutions, we also offer biologics characterization and CMC analytical services, Bioanalysis and Biomarker (BABM) services, and Quantitative Clinical Pharmacology (QCP). Through Crystal NAX, we extend our platform into nucleic acid therapeutics with DNA synthesis, RNA synthesis, LNP formulation, analytical and characterization services, and early-phase manufacturing. Our scientific leadership team, averaging 15 years of experience, has successfully supported over 100 early-phase and 19 commercialized products for pharmaceutical companies worldwide. We have served more than 1,000 clients and contributed to the development of over 2,000 new chemical entities. Utilizing our specialized expertise, we collaborate with clients to design and develop the most appropriate crystal form, formulation, and development strategy for further advancement. Our Mol2Med™ First-Time-Right approach is designed to establish a robust API form and scalable manufacturing process early, helping accelerate programs toward IND filing and Phase I while reducing later-stage development risk. Service offerings: 1. Polymorph screening, salt screening, cocrystal screening, and solid form screening • Many drug substances can exist in different solid forms, including polymorphs, anhydrates, hydrates, solvates, cocrystals, salts, and amorphous forms. These forms can significantly affect solubility, stability, particle size, manufacturability, and overall performance. Screening and selecting the right solid form is therefore critical for successful development. 2. Solid-state research • Solid-state characterization, solid-state research, absolute structure determination, crystal identification, and related analytical support for API form understanding and selection. 3. Crystallization development • Crystallization process development is aimed at establishing a robust and reproducible process that consistently delivers the target solid form with desired properties such as particle size, particle shape, bulk density, purity, yield, and residual solvent profile. Crystal Pharmatech approaches crystallization development through a combination of physicochemical understanding, process expertise, and practical engineering considerations. 4. Preformulation development • Preformulation studies, developability evaluation, amorphous solid dispersion screening, vehicle selection, and related work to support PK/PD and GLP tox studies, while clarifying the most suitable path forward for formulation and clinical development. 5. Formulation development, analytical development, CTM manufacturing, spray drying, hot melt extrusion, oral solid dosage, and clinical supply • Crystal Pharmatech provides integrated formulation development and manufacturing support for oral drug products from early clinical stage through commercial readiness. The First-Time-Right strategy is designed to develop robust formulations and scalable processes early, so later development can focus on optimization and scale-up with fewer major formulation changes. Capabilities include analytical research and quality control, clinical and commercial GMP manufacturing, and clinical supply support. 6. Biologics characterization and CMC analytical services • Product quality analysis, including identity, purity, potency, and safety testing using orthogonal biochemical and biophysical methods. • High-resolution mass spectrometry for intact mass analysis, peptide mapping, PTM and glycan profiling, sequence coverage, and charge variant assessment. • Impurity characterization, including host cell proteins, residual DNA, residual Protein A, detergents, endotoxin, and bioburden analysis. • Bioactivity and potency assays, including cell-based potency, reporter, and binding assays. • Developability assessment and preformulation studies, including stress studies, forced degradation, excipient compatibility, and stability risk evaluation. • Advanced analytical support for complex modalities such as ADCs, peptides, ASO, siRNA, mRNA, LNP, and AAV. 7. Bioanalysis and Biomarker (BABM) services • Immunoassays using ELISA, MSD, Gyrolab, Luminex, SPX, and related platforms for proteins, antibodies, oligonucleotides, and biomarker quantification. • LC-MS and LC-MS/MS support for ADCs, oligonucleotides, peptides, small molecules, and endogenous biomarkers. • Cell-based assays for potency, mechanism of action, neutralizing antibody assessment, and functional pharmacology endpoints. • Flow cytometry for immunophenotyping, receptor occupancy, and biomarker strategy support. • ELISpot assays for cell-mediated immune response evaluation. • Molecular biology capabilities including qPCR, ddPCR, RNA-Seq, NanoString, and NGS workflows. • Additional support for immunogenicity strategy, ADA/NAb assessment, PK/PD analysis, exploratory and clinical biomarkers, central lab logistics, and eCTD-ready data packages. 8. Quantitative Clinical Pharmacology (QCP) services • Noncompartmental PK/TK analysis and reporting. • Statistical programming with SAS and CDISC-compliant deliverables, including SEND, SDTM, ADaM, tables, listings, figures, define.xml, and reviewer guides. • Translational modeling and simulation to support first-in-human dose projection, clinical PK/PD understanding, and study design decisions. • Pharmacometrics, including population PK/PD modeling and exposure-response analysis for dose selection and trial optimization. • Quantitative systems pharmacology and model-informed drug development support for indication selection, biomarker strategy, and regulatory decision-making. 9. Nucleic acid therapeutics services • DNA synthesis • RNA synthesis • LNP formulation services • Analytical and characterization services • Early-phase manufacturing

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Coherence Biotech Co. Ltd.

Coherence Bio is a lab automation company developing tools to accelerate AI based drug discovery, through end-to-end automation of cell-based testing.

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CNCure Co., Ltd.

CNCure is a pioneering biotech startup dedicated to revolutionizing cancer therapy and diagnostics. We specialize in developing bacteria-based cancer immunotherapeutics and theranostic platforms leveraging microbial theapeutics and nuclear medicine. One of our core technologies is the Salmonella-based Armed Microbe (SAM) platform, which utilizes innovative approaches to target tumors and enhance anticancer immune responses. Our flagship products, CNC-101 and CNC-105, directly target tumors, induce immune responses, and establish long-term antitumor immunological memory to prevent recurrence. In addition, CNCure is advancing diagnostic technologies with radiotracer-based tools for the high-sensitivity detection of fatal diseases such as fungal infections. Our [18F]FDS and [18F]DMPY2 tracers enable high-resolution visualization of gram-negative bacterial and fungal infections and malignant melanoma, respectively. CNCure is dedicated to pioneering innovations in cancer treatment, striving to improve patient outcomes and quality of life on a global scale. By actively participating in numerous national and international R&D projects, we continue to drive groundbreaking research and development. Our extensive patent portfolio is a testament to our technological excellence and commitment to shaping the future of oncology. Founded in 2019 by leading experts in cancer immunotherapy and radiopharmaceuticals, CNCure has developed a robust scientific foundation, a cutting-edge technology platform, and a strong pipeline. In the second half of 2024, we were honored to be one of only 14 companies, out of over 100 applicants, selected for Johnson & Johnson’s JLABS Korea program, which aims to accelerate life-science innovation. As we advance the clinical development and commercialization of our theranostic candidates, we actively seek joint-development partnerships and investments to expand our global presence. Our vision is to revolutionize cancer treatment through groundbreaking bacteria-based immunotherapies and radiopharmaceuticals that address critical unmet medical needs. | CNCure Co., Ltd. is a pioneering biotechnology company based in Hwasun, Republic of Korea, dedicated to revolutionizing cancer therapy and diagnostics. Founded in 2019, CNCure specializes in bacteria‑based cancer immunotherapeutics and integrated theranostic platforms leveraging microbial and nuclear medicine. The company’s lead candidate, CNC‑101, is a next‑generation bacterial immunotherapy built on attenuated Salmonella typhimurium technology, designed to selectively colonize the tumor microenvironment and reprogram it into an immuno‑active state that enhances anti‑tumor immune responses. Preclinical data demonstrate promising efficacy and safety profiles across multiple solid tumor models. Beyond immuno‑oncology, CNCure is advancing radiopharmaceutical and theranostic platforms that combine imaging and therapy for improved tumor targeting, treatment monitoring, and personalized decision‑making. CNCure actively pursues global partnerships and business development to translate its innovative platforms into clinical applications that address unmet medical needs. CNCure continues to present its scientific and clinical progress at major international conferences.

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Changzhou Smart-Lifesciences Biotechnology Co.,Ltd.

Smart Lifesciences develops innovative scientific products and provides professional one-stop solutions. Our technology platform originated in chromatography and has been applied across the broad field of protein science-from protein preparation to purification, detection, and application development services. For large-scale manufacturing, our active DMF filings enable a seamless workflow to accelerate the translation of research.

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Celaid Therapeutics Inc.

Celaid Therapeutics Inc. is developing an allogeneic hematopoietic stem cell (HSC) therapy for hematological diseases in the United States, with both an IND filing and initiation of a Phase 1/2 clinical study planned for 2027. Originating from the University of Tokyo and the University of Tsukuba, Celaid is a biotechnology startup with proprietary technology for the selective ex vivo expansion of HSCs. By enabling safe, efficient, and scalable expansion of human HSCs, Celaid aims to advance next-generation cell and gene therapies, including treatments for hematologic and genetic diseases, ex vivo HSC gene therapies, and angiogenesis-based therapies for ischemic conditions. [Company’s Conference Objectives] Celaid Therapeutics has two primary objectives: (1) to out-license its lead asset, CLD-001, to global pharma and biotech companies, and (2) to license its proprietary HSC expansion technology to CDMOs and pharma partners.______________________ (1) CLD-001 is an HSC therapy for non-malignant diseases (U.S. IND planned in 2027) that addresses key HSCT limitations—such as donor scarcity and HLA mismatch—by leveraging cord blood and proprietary expansion technology to deliver optimally matched, engraftable HSCs. (2) In parallel, Celaid is pursuing technology licensing and strategic collaborations, focusing on applications in iPSC-derived HSC expansion, ex vivo HSC gene therapy, and scalable manufacturing of blood and immune cell therapeutics, supported by joint research with global CDMO and pharma partners. [Lead asset pipeline, CLD-001] CLD-001 is being developed as a hematopoietic stem cell (HSC) therapy for hematological diseases, with an Investigational New Drug (IND) application planned in the United States in 2027. The program targets non-malignant diseases, addressing a significant unmet need in curative treatment options. Rare blood disorders – including aplastic anemia, primary immunodeficiencies, inherited metabolic disorders, and sickle cell disease – typically present in childhood and are associated with severe physical and neurological complications, leading to poor long-term prognosis. At present, the only curative treatment is allogeneic hematopoietic stem cell transplantation (HSCT). However, substantial limitations remain, including donor scarcity, HLA mismatch, transplant-related mortality, and complications such as graft-versus-host disease (GvHD). CLD-001 is designed to overcome these challenges. By utilizing cryopreserved cord blood from established cord blood banks, the therapy addresses donor availability constraints. Furthermore, proprietary HSC expansion technology resolves the inherent limitation of low stem cell counts in cord blood, enabling the generation of sufficient cell doses for transplantation. This approach allows for the selection and provision of optimally HLA-matched HSCs tailored to individual patients. Through these innovations, CLD-001 aims to deliver HLA best-matched, bone marrow–engrafting HSCs, with the potential to significantly improve engraftment outcomes and overall survival in patients undergoing HSC therapy. [Technology License activities] Celaid is also advancing technology license-out activities, positioning its platform for adoption by biotech companies, CDMOs, and pharmaceutical partners. Celaid has also been actively engaged in collaborative research with CDMOs and pharma companies across the U.S., Europe, and Japan, generating early commercial validation and demonstrating the platform’s ability to address partner-specific manufacturing challenges—particularly in iPSC-derived HSC expansion, ex vivo HSC gene therapy manufacturing, and the scalable production of blood and immune cell–based therapeutics.

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CancerFree Biotech

CancerFree Biotech has a patented system to create patient-derived organoids (PDO) using a bionic tumor culture system, which can be used as an avatar to help physicians and patients develop the optimal cancer treatment strategy. The technology uses blood specimens, making it easy and non-intrusive, and has been successful in deriving 130+ different types of solid tumors from real-world cancer patients. CancerFree Biotech is also collaborating with pharmaceutical companies, using their PDO model to predict clinical trial outcomes during the drug development process, potentially helping to validate compounds during the preclinical and clinical trial phases. | CancerFree Biotech has developed a proprietary cancer cell culture system called E.V.A. (Ex Vivo Avatar). E.V.A. combines 3D cell culture scaffolding with AI image recognition to facilitate tumor cell proliferation. Using just 20mL of patient blood, the platform grows tumor cells to generate heterogeneous organoid models that closely mimic the patient’s internal tumor. These models allow pharmaceutical companies to identify the best candidates for clinical trials by validating the efficacy of their drugs in suppressing tumor cells from real patients. | CancerFree Biotech has developed Prometheus Lab AI, a smart-glasses platform that automates R&D lab documentation. With hands-free, real-time workflow capture, Prometheus converts visual input into structured experiment records, reducing manual errors and significantly cutting down on documentation time.

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BloodScan Biotech Inc.

BloodScan Biotech Inc. is a biotechnology company dedicated to precision oncology. Founded through technology transfer from a research team at the University of Michigan, BloodScan focuses on advancing innovations in liquid biopsy with the goal of becoming a key global driver in early cancer detection and disease monitoring. Our flagship product, Labyrinth One, is the world’s only liquid biopsy system capable of achieving tissue-biopsy-comparable performance. The system enables stable, fully automated enrichment of circulating tumor cells (CTCs) and delivers ultra-sensitive capabilities for early cancer screening and monitoring. Three Core Advantages: 1. Reliable CTC Isolation and Monitoring in Advanced Cancer – Enables disease monitoring and treatment response assessment in late-stage patients. 2. Tissue-Biopsy-Comparable Performance – Provides accuracy and biological integrity comparable to conventional histopathology. 3. Ultra-Sensitive Early Cancer Screening – Enhances early cancer detection rates to support more precise and timely treatment decisions. Our vision is to establish CTCs as a central pillar of next-generation cancer diagnostics, empowering healthcare systems worldwide to deliver earlier, more precise, and more personalized cancer care. | BloodScan Biotech Inc. Pioneering Liquid Biopsy for Precision Oncology BloodScan Biotech Inc. is a biotechnology company at the forefront of next-generation liquid biopsy technologies, committed to transforming cancer diagnostics through precision medicine. Established in 2023 as a spin-off from the University of Michigan, BloodScan focuses on advancing circulating tumor cell (CTC) isolation to improve early cancer detection, real-time treatment monitoring, and personalized therapeutic decision-making. The heart of BloodScan’s innovation is the Labyrinth One – Automated CTC Enrichment System, a compact, benchtop platform designed for high-throughput, label-free isolation of viable CTCs directly from blood samples. Unlike traditional antibody-based capture technologies, Labyrinth One utilizes microfluidic separation to deliver exceptional purity, recovery, and reproducibility—all within a 15-minute workflow. This allows for seamless integration into both clinical and research laboratory settings, enabling routine use of CTCs for diagnostics and translational oncology research. BloodScan’s mission is to bridge the gap between academic innovation and clinical implementation. Through strategic partnerships with research institutes, oncology centers, and clinical laboratories, the company aims to accelerate the adoption of liquid biopsy technologies and expand access to non-invasive cancer diagnostics that can meaningfully improve patient outcomes.

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BIOTECHNOLOGY VALLEY

The Biotechnology Industrialists’ Association (BİYOSAD) aims to drive human development via innovative, high value-added products and services and is establishing the Biotechnology Valley within the Biotechnology Specialized Industrial Zone (BİOSB) in Istanbul. This project aspires to situate Turkey among the world’s leading biotechnology hubs. Biotechnology Valley, positioned in strategically located Tuzla, Istanbul, is a comprehensive initiative designed to create a specialized biotechnology ecosystem. The project aims to boost Turkey’s global presence in the biotechnology market through strong collaborations between business, academia, and the government. It spans 2.7 million square meters and will feature technology development zones, R&D centers, testing and calibration labs, patent offices, and specialized biotechnology schools. Our goal is to enhance global export potential by fostering domestic production of high value-added biotechnology products. We prioritize guiding industry and academia toward innovative collaboration, exploring nature’s possibilities in light of science. Our mission extends beyond meeting current demands to making a positive impact for future generations through sustainable and collaborative efforts. Biotechnology Valley is dedicated to enabling breakthrough technologies in the sector and hosting research that benefits society, adding value to both science and business. We are committed to providing a safe, innovative, and supportive business environment for all sector stakeholders. Join us as a partner in transforming Türkiye and the world into a leading biotechnology center. | Biotechnology Valley is a strategic technology and innovation ecosystem established under the leadership of the Biotechnology Industrialists Association (BIYOSAD) to lead Türkiye’s vision in biotechnology across science, technology, and production. Bringing together the public sector, industry, academia, and investors, the Valley aims to build a high–value-added, sustainable, and globally competitive biotechnology infrastructure. Located in Tepeören, Istanbul, and spanning approximately 2.7 million square meters, Biotechnology Valley is one of Türkiye’s most comprehensive biotechnology initiatives. With its advanced R&D centers, technology development zones, modern manufacturing facilities, and shared infrastructure, the Valley is designed as an integrated hub for local and international companies operating in pharmaceuticals, biotechnology products, medical technologies, and advanced life sciences. Biotechnology Valley is not only a center for production and R&D, but also a living and innovation ecosystem with sustainability at its core. The project prioritizes energy-efficient infrastructure, renewable energy solutions, water efficiency practices, integrated waste management systems, and comprehensive strategies to reduce carbon footprint. This approach positions biotechnology production in harmony with nature and with a strong sense of responsibility toward future generations. The Valley offers a collaborative, innovative, and scalable ecosystem for a wide range of stakeholders, from start-ups and research institutions to global players and investment funds. Through its open innovation approach, Biotechnology Valley promotes knowledge sharing and co-creation, aiming to integrate Türkiye’s biotechnology potential into the global value chain. With its robust infrastructure, sustainability-driven framework, and international vision, Biotechnology Valley continues to advance with determination toward becoming a regional and global center for biotechnology.

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