Located in Montreal, Canada, ITR Laboratories is a full service CRO offering nonclinical toxicology testing for developing drugs. ITR’s GLP-compliant safety testing services can support your next product registration effort in any global market. We perform studies in general toxicology, inhalation, infusion, safety pharmacology, immunology and genetic toxicology. Lab support services include analytical, bioanalytical, ligand binding (PK, PD and biomarkers) assays, and flow cytometry. Over 30 years, ITR has grown from a small facility with 50 staff, to a mid-sized CRO with over 400 employees serving the global market. With over 6000 studies successfully completed, ITR continues to expand its facility and the expertise of its scientific staff. ITR is committed to providing the highest quality services to suit the needs of sponsors; our expert staff will continue to stay up-to-date with the latest technological developments to ensure we are always ready for new and challenging projects. | Located in Montreal, Canada, ITR Laboratories is a full service CRO offering nonclinical toxicology testing for developing drugs. ITR’s GLP-compliant safety testing services can support your next product registration effort in any global market. We perform studies in general toxicology, inhalation, infusion, safety pharmacology, immunology and genetic toxicology. We also offer juvenile toxicology services. Lab support services include analytical, bioanalytical, ligand binding (PK, PD and biomarkers) assays, and flow cytometry. Over 30 years, ITR has grown from a small facility with 50 staff, to a mid-sized CRO with nearly 500 employees serving the global market. With over 6000 studies successfully completed, ITR continues to expand its facility and the expertise of its scientific staff. ITR is committed to providing the highest quality services to suit the needs of sponsors; our expert staff will continue to stay up-to-date with the latest technological developments to ensure we are always ready for new and challenging projects. | Located in Montreal, Canada, ITR Laboratories is a full service CRO offering nonclinical toxicology testing for developing drugs. ITR’s GLP-compliant safety testing services can support your next product registration effort in any global market. We perform studies in general toxicology, inhalation, infusion, safety pharmacology, immunology and genetic toxicology. We also offer juvenile toxicology services. Lab support services include analytical, bioanalytical, ligand binding (PK, PD and biomarkers) assays, and flow cytometry. Over 35 years, ITR has grown from a small facility with 50 staff, to a mid-sized CRO with over 500 employees serving the global market. With over 6000 studies successfully completed, ITR continues to expand its facility and the expertise of its scientific staff. Our most recent expansion was completed in February of 2023 and added an additional 8 animal rooms for a total of 80 rooms. Specializing in inhalation toxicology, ITR has 22 exposure rooms with over 750 completed inhalation studies, ITR is ranked as the #1 inhalation CRO in the world. ITR is committed to providing the highest quality services tailored to the needs of sponsors; our expert staff continues to stay up-to-date with the latest technological developments to ensure readiness for new and challenging projects.
iRepertoire
Over the past decade, iRepertoire has developed gold standard technologies for immune repertoire sequencing. Our core technologies provide the ability to amplify expressed V(D)Js in B or T cells, and we offer the only technology that can measure all 7 immune chains simultaneously. We also offer a single cell solution to capture V(D)J rearrangements from rare cell populations. Beyond sequencing, iRepertoire now provides comprehensive data analysis services that accelerate biomarker discovery, advance disease research, and support IO drug development programs. iRepertoire is committed to creating cutting-edge technology and analytical solutions that adapt to the ever-changing immune sequencing landscape. | .
Immunology Consultants Laboratory, Inc.
ICL is a U.S.-based manufacturer of biochemical reagents and life science products, specializing in the production of antibodies and ELISA kits for both IVD and research applications. With over 45 years in the biotech industry, ICL has built a strong presence among the world’s leading research institutions, in vitro diagnostics (IVD) manufacturers, and biopharma companies. Backed by in-house research and development, ICL also offers custom solutions for research teams and IVD companies with needs that go beyond standard offerings. | With over 45 years of expertise, ICL is a U.S.-based manufacturer of high-quality antibodies and immunoassays serving the global life science market, including CDMOs, pharmaceutical companies, and IVD manufacturers. From our laboratory in Portland, Oregon, we produce reliable primary and secondary antibodies, ELISA kits, and host cell protein (HCP) detection assays in both human and animal models. Whether you’re developing a commercial diagnostic, optimizing a bioprocess, or conducting critical research, our reagents are designed to meet your performance standards. Explore our catalog or contact us to learn how our custom antibody and assay development services can support your next project.
Harvest Integrated Research Organization (HiRO)
HiRO is a modern global CRO delivering full-service clinical trial support across ANZ (for over 25 years), APAC, US, and Europe. We combine global infrastructure with genuine local expertise, offering sponsors the agility and personalization that larger organizations can’t match, without sacrificing rigor or reach. From regulatory strategy, clinical operation support and management, site identification and management, biometrics, pharmacovigilance and medical monitoring, HiRO accelerates the path from discovery to patients. Highlights ⦁ Modern local CRO operating across ANZ, APAC, US, and Europe ⦁ Full-service: clinical design, regulatory, biometrics, safety, and monitoring ⦁ Global expertise paired with hands-on regional insight ⦁ Agile operations built for faster, cleaner clinical data ⦁ True partnership model, embedded in your team from day one | Harvest Integrated Research Organization (HiRO) is a globally oriented, innovative clinical research organization (CRO). With global operations and integrated capabilities, HiRO provides a full range of cross-border solutions and services to its clients, including early pre-clinical strategic planning, clinical trial design, regulatory affairs, pharmacovigilance, statistics, data management, end-to-end project management, and clinical and medical monitoring services. As an emerging global CRO, HiRO strives to become a market-leading, integrated global clinical research organization that works collaboratively with biotech and pharmaceutical companies to bring new products from the laboratory to the market, providing more effective solutions for patients worldwide.
GCCL
Accelerate your global trials with GCCL – All-in-One Clinical Lab Solution (Central Lab + BA Lab + R&D) GCCL, a Lab CRO based in South Korea, specializing in clinical sample analysis services for all phases of trials. With an exclusive lab service available for clinical trials and a logistics system that meets global quality standards, GCCL is building trust with over 200 partners globally by providing a sample analysis and bioanalytical service spanning the entire cycle of clinical trials to meet customer demands. Based in Korea as a strategic hub for the Asia-Pacific region, GCCL is South Korea’s only provider of a fully integrated “all-in-one lab solution,” combining a Central Lab, Bioanalytical Lab, and Biosafety Level 3/2 (BL3) facilities. This unified approach delivers consistent analytical quality, reliable data, and reduced time and costs by minimizing sample handling. Leveraging its proprietary G-HUB IT platform, cutting-edge analytical technologies, and global LIMS, GCCL provides end-to-end, high-quality clinical sample analysis services—from collection to storage—positioning itself as a trusted partner in drug development. Its dedicated R&D lab drives method development, biomarker discovery, and the evaluation of innovative analytical technologies, continuously enhancing capabilities to meet evolving clinical trial needs. -Supporting clinical trials with comprehensive laboratory services across all therapeutic areas and pipelines (from sample collection and kit production to analysis and storage) -Collaborating on R&D for pipelines, including biosimilars, bioanalysis, assays, and more -Offering clinical trial consulting, including study design and regulatory/approval support
Divamics Inc
Divamics Inc. is a cross-disciplinary company with the core technology of AI and physics force field, helping collaborators to hunt new hits and PCCs in a more efficient and accurate way, especially for undrugable targets. Also, we offer clinical insights, such as resistance analyses and expansion of drug indications. Our signature capacities include drug design for GPCR, allosteric sites, and PPI, transcription factors. Our targeting modalities cover small molecules, peptides, PROTAC, XDC, synthetic biology, and more. We have already collaborated with 25+ MNCs/bioteches to advance over 35 new drug development pipelines and achieved multiple breakthrough results. Our records include: *FIC Project: Pioneering Drug Development* 1. Proposed binding site hypotheses, enabling the creation of drugs from scratch 2. Identified hits within 30 syntheses in a FIC pipeline with no pre-existing clinical drugs *BIC Project: Revolutionizing Structural Optimization* 1. Combined SAR computational analysis with expert medicinal chemistry insights to innovate structural optimization 2. Achieved patent breakthrough and better potency within just 6 syntheses of peptides, currently in Phase II clinical trials; Phase II clinical trial data to be presented at the ADA Conference, June 2024 We want to find collaborators such as the early discovery departments of MNCs, biopharmaceuticals and biotechs, with flexible cooperation modes including strategic joint research and others. | Divamics Inc. is a cross-disciplinary company with the core technology of AI and physics force field, helping collaborators to HUNT NEW LEADs and PCCs in a more efficient and accurate way, especially for UNDRUGGABLE targets. Also, we offer clinical insights, such as resistance analyses and expansion of drug indications. Currently, we have 40+ partners (10 listed companies/MNCs, 2 USA biotechs) for 60 pipeline projects, while 2 of them have reached end of Phase Ⅲ. We work on strategic collaboration mode, or offer AI+DBDD services, based on our partners’ needs. | Divamics: Redefining the Speed of Precision Medicine Divamics is an AI-driven biotech leader accelerating the journey from hit identification to preclinical candidate (Hits-to-PCC). By integrating advanced AI with molecular dynamics, we provide biopharma partners with the clarity and confidence to make critical discovery decisions faster. With a proven track record of supporting 80+ pipelines for over 50 global partners, we have successfully reduced PCC discovery timelines to just 0.5 – 1.5 years. Our platform delivers unmatched precision across four key modalities: small molecules, peptides, antibodies, and nucleic acids.
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
Coriolis Pharma Research GmbH
Coriolis Pharma is a global contract research organization and one of the world leaders in formulation research and development of (bio)pharmaceutical drugs, including cell and gene therapy products and vaccines. The company’s offerings include liquid and lyophilized freeze-dried drug formulation development from early stage to market approval and beyond, lyophilization freeze-drying process development, and analytical development under R&D and GMP. Non-GMP manufacturing services for a wide range of products complete the service offering. More than 725 clients – from start-ups to big pharma – already rely on Coriolis’s scientific expertise. For each project, our highly skilled scientists develop customized study designs that align with our customers’ drug development strategies. | Coriolis Pharma is a globally operating contract research and development organization (CRDO) and a leader in formulation research and development of biopharmaceutical drugs, including cell and gene therapy products and vaccines. We provide high-quality services for liquid and lyophilized drug products from early stage to commercialization and beyond. Manufacturing support and contract analytical services under R&D and GMP complete our service portfolio. Coriolis was founded in 2008 and currently employs more than 200 employees from over 36 nations around the world. | Coriolis Pharma is a globally operating, science‑driven contract research and development organization (CRDO) specializing in drug product development, formulation, lyophilization technologies, and advanced analytics for biopharmaceuticals. Founded in 2008 and with laboraties in Europe and the U.S., the company supports clients from early development to commercialization, offering both R&D and GMP-compliant analytical services across a broad range of biological modalities. As a premier partner for biopharmaceutical innovation, Coriolis Pharma provides expertise in developing liquid and lyophilized drug products, optimizing stability for proteins, peptides, nucleic acids, vaccines, gene and cell therapy products, and virus(-like) particles up to biosafety level S2. Its interdisciplinary team, supported by an expert scientific advisory board, delivers cutting‑edge, tailor-made solutions designed to accelerate and de-risk drug development programs throughout the entire product lifecycle. Coriolis Pharma’s service portfolio includes comprehensive analytical method development, qualification, and validation, ensuring robust regulatory support for biopharmaceutical pipelines. Its commitment to scientific excellence, innovation, and independent operation makes the company a trusted partner for biotechnology firms and pharmaceutical developers worldwide. Meet Coriolis Pharma at the BIO Convention to learn how their integrated development, analytical, and manufacturing services can help advance your biotherapeutic programs faster, safer, and more efficiently.