DP Sterile Manufacturing / Fill & Finish
Introduction to Fill&finish
Fill & Finish is a critical phase in pharmaceutical manufacturing, where drug products are filled into their final packaging and finished for distribution. This process is especially crucial in aseptic manufacturing, where maintaining sterility and product integrity is paramount. It involves accurately dispensing the product into vials, syringes, or other containers, followed by sealing and labeling. The process must occur in highly controlled environments to prevent contamination, ensuring that the product remains safe and effective for patient use. Eurofins CDMO’s expertise in advanced aseptic services encompasses state-of-the-art fill & finish capabilities, assuring the highest quality standards in every aspect of pharmaceutical production.
A comprehensive range of Fill&finish services for small batches
We offer a diverse array of aseptic processing services, adapting to various drug product configurations. We accommodate a broad spectrum of compounds, primary packaging systems, batch sizes, and fill volumes, making us an ideal partner for converting Active Pharmaceutical Ingredients or bulk products into Finished Dosage Forms for clinical and commercial purposes. Our proficiency in sterile aseptic filling activities spans across small molecules and biologics, including peptides, proteins, mAbs, and more.
Aseptic manufacturing facility in Europe
We are thrilled to announce a 75% increase in production capacity for our European fill& finish site, achieving full compliance with Annex 1 standards. Our facility now features 2 autonomous production areas tailored for lyophilized and liquid products, equipped to handle up to 5000 vials and 6000 vials or syringes respectively. This enhancement includes new equipment installations such as a boiler, steam generator, autoclave (allowing terminal sterilization for small batches) and an advanced environmental monitoring system. The lyophilizer and depyrogenation oven have been revamped, ensuring top-notch quality and performance.
Tailored solutions for parenteral formulation and sterile manufacturing
Our optimized aseptic processes and expertise in parenteral formulation and sterile manufacturing set us apart. Our advanced production lines are designed for both liquid and lyophilized forms (Lyophilisation), catering to various fill volumes and minimizing dead volume. We employ disposable product contact parts and materials to expedite the development process. With batch sizes ranging from less than 0.5L to 50L and various options for vials, prefilled syringes, and more, we are equipped to meet your unique manufacturing needs.
Our capabilities
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Bulk |
From < 0,5L and up to 50L per batch |
|
Vials |
Up to 5,000 units (e.g. 2R vials) per batch |
|
Prefilled syringes |
Up to 5,000 units (e.g. syringes 1mL long) per batch |
|
Others |
Upon feasibility assessment and gap analysis per batch |
Contact us today to explore how our optimized aseptic services, efficient fill & finish capabilities, and unmatched manufacturing expertise can benefit your project!
