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IT Italy
Stand No: 41A23
Capua BioServices is a global provider of high-quality services in the field of custom microbial process development and manufacturing. We offer dedicated solutions for proteins, (high-value) small molecules and microorganisms for applications in pharma, food, feed and bio-industrial markets. We are the largest, independent, beta-lactam free microbial contract manufacturing facility in Europe. Our facility is located near Naples, in the south of Italy and has a total fermentation capacity of about 1400 m3 which is spread over two separate fermentation areas. Our associated downstream processing capabilities are spread between multiple, isolated recovery and purification plants with a large diversity of unit operations capable of handling multiple projects in parallel. Recently, we have significantly expanded our spray-drying capabilities, up to pharma API grade. For more than 50 years, we have built a track record based on our extensive experience in working with a variety of bacterial, yeast and fungal systems. We...
Sub-event: ICSE
GB United Kingdom
Stand No: 41M02
Contract Manufacturing Excellence with Cobra Biologics Cobra Biologics is a leading international contract development and manufacturing organisation (CDMO) providing a comprehensive biologics and pharmaceuticals service offering. Our multi-functional and experienced project teams nurture customers' products through to clinical and commercial manufacture within three GMP approved facilities. Expertise Cobra is a contract development and manufacturing organisation (CDMO) supporting the global life sciences industry in the development and manufacture of monoclonal antibodies (mAb), recombinant proteins, DNA, viruses, phage and cell line derived products and pharmaceuticals for clinical trials and commercial supply. For Gene Therapy products we can produce DNA, Adenovirus, AAV, Lentivirus and other virus material for both clinical and commercial supply. Cobra provides manufacturing technologies, platforms and solutions for gene therapy products. For our AAV and Lentivirus customers we have developed a High Quality DNA platform process to enable the rapid supply of small quantities of DNA material for the production...
FR France
Stand No: 41L50
Eurofins Amatsigroup is a leading international Contract Development and Manufacturing Organization (CDMO), headquartered in France. Within Amatsigroup, we provide high-quality, customized and cost-effective drug development solutions, integrated under one roof, to small biotech and major (bio) pharmaceutical customers. Our innovative and flexible approach enables customers to speed up their drug development process, achieving key milestones in a timely manner. The company has three strategic pillars: Drug substance process development and manufacturing for biologics, Pharmaceutical analysis solutions: fit-for-purpose method developments and validations, stability studies and Quality Control (QC) Formulation development and manufacturing of sterile and non-sterile clinical or small commercial batches. Clients also benefit from complementary services such as in-life studies, bioanalysis and clinical trial supply (packaging & logistics). A broad scientific, technical and regulatory expertise, combined with proactive troubleshooting skills, are the key assets of the company. Our goal is to build a sustainable partnership with our customers to support...
DE Germany
Stand No: 40C35
GBA Pharma is a service provider for pharmaceutical companies and is supporting research & development as well as services in the commercial stage. Our success and opportunities is based on a high qualified staff. The headcount of GBA Pharma represents 200 employees distributed over 5 locations in Europe with +50% academic staff. Our portfolio comprises the following service areas: Contract research in the preclinical arena (in vitro & in vivo) Pharmaceutical testing under GMP incl. stability study services & QP release services Bioanalysis under GLP: in vivo toxicology studies and phase-I/II clinical studies GMP qualification of API and drug manufacturer outside the European Union Distribution and clinical trial supply management for multicentre trials Consultancy & regulatory affairs with regard to GMP, GLP & GCP We would be delighted to develop a tailored solution for you.
BR Brazil
Stand No: 110A41
ICF has been founded in 2002 and it has been the first Brazilian bioequivalence and bioavailability laboratory to get certified by ANVISA (Brazil). It is one of the largest pharmaceutical research centers in Brazil and in Latin America and a notable reference for industries and investors from several countries. ICF's commitment with ethics and innovation assure the credibility and quality of our products. ICF has already conducted over 700 bioequivalence studies and it takes part in the history of generic drugs in Brazil. We offer one of the biggest hospital infrastructures in the country with a high technology, diversified portfolio and certificate, two hundred bioanalytical methods – including high complexity methods such as hormones and sprays.?
Sub-event: CPHI
Zone: API
ES Spain
Stand No: 91B30
Kymos is a reliable CRO, certified in GLP and GMP with laboratories in Spain and Italy. Kymos provides contract research, development and analytical services for pharmaceutical, biotechnology, veterinary, fine chemistry, cosmetics and nutraceuticals industries. The main areas of activity are: i) batch testing, batch release and importing of medicinal drug products for human, veterinary and investigational use in the EU; ii) quality control of raw materials and finished drug products, analytical development and validation, stability studies, microbiological testing and PAT-QbD consultancy; iii) biopharmaceutical testing of proteins an monoclonal antibodies and comparability of biosimilars; iv) immunogenicity testing, cell based assays and bioanalysis of biologics and small molecules, including full management o bioequivalence studies.
AT Austria
Stand No: 41G30
Pichia pastoris Protein Expression / Production Excellence Be competitive with high-quality proteins, high-productivity strains & robust and scalable bioprocesses from world´s broadest Pichia pastoris protein production toolbox VTU Technology is a leading contract research and development company, providing time-saving development of cost-efficient recombinant protein production processes for manufacturing of biologics and other proteins Cutting-edge, exclusive, proprietary technologies and extensive know-how are the basis for the broadest toolbox and most versatile technology platform available for Pichia pastoris recombinant protein expression / production enabling highest productivities of up to 25 g/L of secreted protein (peak productivity of 35 g/L) for e.g. cytokines, growth factors, hormones, serum proteins to fusion proteins (Fc-and albumin fusion), protein scaffolds, antibody fragments and vaccine antigens, enzymes or allergens. VTU guarantees tight development timelines and competitive & safe production processes. Unlock Pichia - VTU Technology´s toolbox: Exclusive AOX1 promoter libraries Diverse set of platform strains Proprietary expression enhancing...