Aseptic filling

Baccinex is a Swiss based fill&finish CDMO specialized in development and manufacturing of sterile & lyophilized clinical material for pre-clinical, Phase I, II and III as well as commercial supply batches. Our expertise is forged by 15 years of sterile clinical and commercial material manufacturing. We produce 150 GMP batches per year of both clinical and commercial supply. We are a one-stop flexible structure CDMO with a batch size from 500 to 12’000 vials on one production line (generally for clinical batches) and up to 40’000 vials on a second production line (mainly for commercial supply). We also propose in-house sterile ampoules manufacturing. Our services include: -          pre-manufacturing development, -          scale-up from laboratory to GMP or process transfer from former sub-contractor -          pilot batches, GMP-like batches -          sterile dosage forms (liquid and lyophilized in vials or ampoules) GMP manufacturing, -          clinical and commercial packaging, -          serialization -          QC release analytics, -          stability studies programs, -          GMP storage. We have a wide expertise in biological products and molecules as peptides, proteins and small molecules. Our project management team is one of our main assets in any aspect concerning successful project implementation and execution with regards to overall flexibility, timelines, financial balance, responsiveness. We are managing about 50-60 different clinical and commercial projects per year.