Arthrogen, an Amsterdambased clinical stage biopharmaceutical company, is developing local gene therapy for inflammatory diseases, using viral mediated gene transfer. The first target indication is in the field of rheumatic diseases.
The company BIRD-C GmbH (Biotech Innovation Research Development and Consulting) is a privately held R&D company based in Vienna, Austria. Since its inception in 1998 BIRD-C has developed innovative solutions to various commercially relevant problems. Over the past couple of years most of the company’s activities have been focused on the development of a unique, internationally renowned and proprietary technology platform that allows for the generation of empty bacteria shells, so-called Bacterial Ghosts (BGs) and its use for vaccine development and tumor therapy. Another platform is the production of bacteriophages (viruses against bacteria) and their use for control of bacterial pathogens and related infections and as diagnostic detection vehicles for bacteria. BIRD-C strives to significantly contribute to the improvement of human and veterinary products through the development and application of product solutions conducted jointly with commercial partners. The company is open to discussions with parties interested in applying and licensing BIRD-C technologies and to actively support its product development partners and licensees during the product development, evaluation and production process to ensure a successful technology transfer and application of the products.
For more information, please visit: www.bird-c.at.
CARsgen is a clinical-stage immunotherapy company focused on the development of novel chimeric antigen receptor T (CAR-T) cell therapy for solid tumors. Founded in Shanghai in Nov 2014, the company received Series A funding in late 2014, and initiated Phase I clinical trial of EGFR CAR-T therapy in Chinese patients with glioblastoma multiforme (GBM) and Phase I clinical trial of GPC3 CAR-T therapy in Chinese patients with relapsed or refractory hepatocellular carcinoma (HCC) in early 2015. Company further received Series B funding, $30M, in Jan 2016, and completed both Phase I GBM and HCC trials in 2H2016. In early 2017, Company completed the construction of GMP facility in Shanghai and opened US headquarter in San Diego for global clinical development and product launch. With strategically planned pipeline for global clinical development, CARsgen is well-positioned to bring novel cell therapies to cancer patients worldwide.
For more information, please visit: http://www.carsgen.com/.
Cell Medica is committed to improving patients’ lives through the significant therapeutic potential of cellular immunotherapy. Our approach is to apply innovative technologies with the aim of improving the treatment of cancer and immune reconstitution following hematopoietic stem cell transplant.
Global BioTherapeutics Inc (GBT) is a preclinical stage biotechnology company focused on developing a hepatic vector delivery platform for the safe & effective implementation of gene therapy for the treatment of inherited and acquired diseases.
For more information, please visit: http://www.global-biotherapeutics.com/.
Rexgenero is a leading regenerative medicine company and developer of advanced cell-based therapeutics for the treatment of serious diseases that are poorly treated with existing therapies. The company is based in the UK with additional operations in Spain including clinical, regulatory, manufacturing and research and development. The primary focus is on critical limb ischemia (CLI), a major global health issue. The company is developing a portfolio of clinical-stage cell therapies with a lead program, REX-001, an autologous cell therapy, which has recently started two Phase III clinical trials in patients with CLI and diabetes mellitus.
For more information, please visit: http://www.rexgenero.com/.
Synpromics gives researchers, developers and manufacturers unprecedented control of gene expression through proprietary technology that yields highly specific and active synthetic promoters, thus facilitating a competitive IP position for our partners.
TC BioPharm (TCB) is an immunotherapy company developing novel cell-based products for treatment of cancer and severe viral infections. The Company’s mission is to develop and commercialise innovative cell-based products to treat disease, improving patient health and Quality of Life.
Telocyte focuses on curing Alzheimer’s disease. Telocyte plans to run FDA-sponsored human trials to reverse Alzheimer’s pathology at the cellular level. Currently, there are no effective medical or pharmaceutical interventions for those suffering from Alzheimer’s disease. We have the technology, the support, and the clinical experience to begin the first-in-human trials of an effective clinical cure for Alzheimer’s.
apceth is a rapidly growing, clinical stage biopharmaceutical company, based in Munich, developing targeted therapies for cancer, inflammation and tissue regeneration. Our proprietary platform technology is based on next generation genetically modified MSC therapeutics which demonstrate highly efficient homing to tumors and areas of inflammation and injury, where they are able to express any desired therapeutic gene. Furthermore, the cells can be used as an allogeneic, off-the-shelf product.
Agenmestencel-T is apceth’s first-in-man, first-in-class, next generation cell therapy product, for the targeted treatment of advanced cancer. The cells are purified from the patient’s bone marrow, expanded in cell culture and genetically modified using apceth´s proprietary technology. A phase I/II clinical trial for the treatment of advanced gastrointestinal tract adenocarcinoma has already entered the Phase II stage in 2015.
Agenmestencel-L is the off-the-shelf version of Agemnestencel-T, produced from the bone marrow of healthy donors and is currently in late-stage preclinical testing and due to enter clinical trials shortly for the same indications.
apceth is also using its state-of-the-art dedicated manufacturing facility and quality management system to offer contract GMP manufacturing, process development and associated services such as GMP and regulatory and logistical support for cell based products. We are able to develop and manufacture any native or gene modified cell type to the highest GMP standards of quality and adherence to local laws and regulations in Europe and other international regulatory territories.
For more information, please visit: http://www.apceth.com/.
ERA has unparalleled level of expertise in the field of strategic regulatory consulting and over the last 24 years has supported over 500 biopharmaceutical products navigate regulations in Europe, USA, UK, Australia and Canada, including the first stem cell product to receive approval in Europe, Holoclar, where ERA’s support was credited with securing the fastest approval the EMA had issued for an ATMP. ERA has extensive experience in working with viral vectors, gene therapy, gene editing and other leading edge technologies. ERA takes pride in not just being experts in the following of regulatory guidelines and legislation but also utilising our skills to lay robust positions before regulators that help shape the standards and practices for first in-class products.
For more information please visit http://www.eraconsulting.com/.
GE Healthcare Life Sciences provides tools and technologies, solutions and expertise which enable the biopharmaceutical industry to develop and manufacture biotherapeutic medicines and vaccines cost-effectively. Our products and platform solutions are designed to meet the key challenges posed at every stage in the biomanufacturing process, delivering the desired product at the required purity and safety: all with fast development and integrated solutions in mind. Across the bioprocessing spectrum, our focus is on supporting you from idea to result.
For more information, please visit: http://www3.gehealthcare.com/en.
Oxford BioMedica plc (LSE: OXB) is a leading gene and cell therapy Group with an unrivalled portfolio of gene therapy products in development and a platform of exclusive and pioneering technologies with which it designs, develops and manufactures unique gene-based medicines for some of world’s largest pharmaceutical companies. Leveraging its proprietary LentiVector® IP and gene delivery system technology platform and unique tumour antigen (5T4), Oxford BioMedica is advancing its pipeline of seven gene therapy products addressing diseases for which there are currently no treatments or that are inadequately treated today, including ocular and central nervous system disorders. OXB Solutions, the Group’s industry-leading manufacturing and development business, provides services to collaborators and partners working in gene and cell therapy, including Novartis and Immune Design corp. In addition, the Group has licenced products and IP to Sanofi, Pfizer, GlaxoSmithKline, MolMed, Sigma-Aldrich, Biogen Idec, Emergent BioSolutionos and ImaginAb. Further information is available at www.oxfordbiomedica.co.uk and www.oxbsolutions.co.uk.
PCT, a Caladrius Company (PCT), a wholly owned subsidiary of Caladrius Biosciences, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry that works with clients to achieve commercial-readiness for their products. For more than 17 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 120 clients, advancing cell therapy and immunotherapy product candidates from the development stage all the way through to commercialization. PCT offers manufacturing of cell therapy products, engineering and innovation services, process and product development, cell and tissue processing, collection and storage, consulting, facility design, validation, and due diligence evaluations. These services enable clients to focus on quality, cost of goods, scalability, and sustainability as key mile markers as they think beyond regulatory approval.
For more information, please visit: www.pctcaladrius.com.
TrakCel documents, integrates and orchestrates every aspect of the cell therapy supply chain in a scalable, compliant and validated technology framework. From donor enrolment, scheduling, sample collection through to shipment of the cellular starting material, manufacturing and final infusion, a successful and scalable cell therapy supply chain demands standardised processes, automated electronic records, real-time visibility and end-to-end traceability to ensure final product quality.
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