True Flexibility for your Fill & Finish Needs
In our ISO 7 facility with Grade A isolator technology, we provide aseptic fill and finish solutions tailored to diverse molecules and formats. From enzymes, vaccines, and monoclonal antibodies to small molecules, we support clinical trial batches with semi-automatic filling, labeling, packaging, batch release and GMP storage.
Our state-of-the-art isolator technology combined with lyophilization capabilities enables us to handle both liquid and solid formulations with the highest aseptic standards.
Liquid Injectables
Sterile liquid solutions prepared in Grade A environment with full traceability and quality control.
Lyophilized Products
Advanced freeze-drying capabilities for enhanced stability and extended shelf life of your biological products.
Capsule Filling
Expanding capabilities to include capsule filling for solid oral dosage forms and specialized applications.
1
Aseptic Filling
Grade A isolator (ISO 5) in ISO 7 cleanroom
2
Lyophilization
State-of-the-art freeze-drying for stability
3
Visual Inspection
100% inspection for quality assurance
4
Labelling
Compliant labelling systems
5
Secondary Packaging
In-house packaging solutions
6
Batch Release
GMP storage (-80ºC to RT) and QP release
Our Key Capabilities
Grade A Isolator Technology
ISO 5 environment within ISO 7 filling suite, ensuring the highest level of aseptic conditions for your products.
Semi-Automatic Filling & Crimping
Flexible, efficient systems designed for small to medium batch sizes, perfect for clinical trials and orphan drugs.
Wide Molecule Range
Specifically designed for biologics including pDNA, enzymes, vaccines, monoclonal antibodies and small molecules.
In-House Secondary Packaging
Complete packaging services including labelling and secondary packaging. All under one roof for streamlined operations.
Flexible Storage Solutions
GMP storage capabilities from -80°C to room temperature, accommodating diverse product requirements.
Batch Release Services
Complete batch release and documentation support to expedite your product’s path to patients.
Our Fill & Finish facility is operated under 53Biologics’ corporate Quality Management System and has been inspected and approved for GMP operations. The isolator-based filing line has been designed following EU GMP Annex 1 guidelines. All in compliance with GMP regulations, tailoring our services to meet our clients’ specific production requirements.
Vials
Sizes: 2R to 30R
Batch size: Up to 5,000 vials
Ideal for liquid injectables and lyophilized products
Bottles
Volumes: 50mL to 20L
Batch size: Up to 600 bottles
Perfect for bulk solutions and intermediate volumes
Bags
Volumes: 250mL to 200L
Batch size: Up to 500 bags
Suitable for large volume cell culture media and buffers
Our Fill & Finish services are particularly well-suited for orphan drugs, early-phase clinical studies and small commercial batches, where flexibility and reliability are critical.
We would love to hear from you!
Please note that job applications submitted through this form will not be considered. Use the Careers page.
53Biologics is a Spanish CDMO specialized in decoding biologics production, from DNA to proteins. The company provide services from preclinical development to GMP manufacturing, supporting their clients in getting their biological products to market as quickly as possible.
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