Country: Netherlands

BioConnection is a GMP contract manufacturer for the production of sterile drug products in vials or syringes. Our state-of-the art GMP manufacturing facility in Oss, The Netherlands is EMA and US-FDA certified and we have more than 15 years of experience. We can handle liquid products (including suspensions) and freeze dried products in batch sizes ranging from a few hundred vials per batch for personalized medicine purposes up to 150,000 vials per batch for commercial productions. We offer complete drug product service packages including drug product development, filling and freeze drying, technology transfers, scale-up, validation programs, analytical support, stability studies, regulatory dossier support, label & pack (incl. serialization) and final GMP release. | BioConnection is a CDMO for the development and manufacturing of injectable (bio)pharmaceutical products (aseptic). Our state-of-the art GMP manufacturing facility in The Netherlands is EMA and US-FDA certified. We have over 18 years of experience and can handle liquid products (incl. suspensions) and freeze-dried products in batch sizes ranging from a few hundred vials (e.g personalized medicine) up to 150,000 vials per batch for clinical or commercial productions. We offer complete drug product (DP) packages including DP development, freeze-drying, technology transfers, scale-up, validation programs, analytical support, stability studies, regulatory, label & pack (incl. serialization) and final GMP release. | BioConnection fulfills the needs of innovative and generic (bio)pharmaceutical companies by offering flexible state-of-the-art development and GMP-compliant manufacturing services for sterile drug products, both commercial and clinical. We are an experienced and reliable partner for developing and aseptically filling and finishing your (bio)pharmaceutical products. At BioConnection, we support the entire drug life cycle, from producing materials for toxicology studies to clinical material manufacturing (Phase I-III) and final market production (up to 500 L). We excel in smooth project transitions, including internal technical transfers, scale-ups, and efficient preparation for Process Performance Qualification (PPQ) campaigns before market launch. We believe that every client is unique, and every project deserves personalized attention and a tailor-made solution. What sets us apart is our commitment to collaboration and flexibility throughout the process all within the framework of the EMA and FDA rules and regulations. | We are a CDMO focused on filling, finishing, and lyophilizing injectable (bio)pharmaceutical products. We operate from our US-FDA and EMA-approved production site in Oss, the Netherlands. We can support the entire drug life cycle; from producing materials for toxicology studies to clinical material manufacturing (Phase I-III) as well as efficient preparation for PPQ campaigns and final market production using two automated filling lines. We also provide specialized small-scale (hand fill) services for personalized medicines, ensuring precision and flexibility. We have the means, the motivation & expertise and infrastructure to bring your invention from the lab bench to the clinic and to the market. We are an experienced and reliable partner and we believe that every client is unique and important and therefore deserves personalized attention through tailor-made solutions. What sets us apart is our commitment to collaboration and flexibility throughout the process, all within the framework of the EMA and FDA rules and regulations. In addition, we offer a broad range of support services such as process and formulation development, lyo-cycle development and/ or optimization, analytical development & validation, technical transfer, scale-up, process validation, stability studies, label & pack (including serialization), and final batch certification for release to clinic or market.