Services
Aseptic Processing and Lyophilization
Process Development
At Liof Pharma, we offer contract development services and preclinical supply of small pilot batches for pre-clinical studies, as well as complementary studies for technology scale-up.
Our RABS-system equipment ensure flexibility, efficiency, and safety throughout all processes.
Experience with complex substances:
Biologics: monoclonal antibodies, peptides, oligonucleotides, other proteins
Adeno-associated viruses (AAV) and viral vectors
Additional services:
Feasibility studies
Cycle optimization
GMP-like technical and stability batches
Clinical and validation batches
Comprehensive in-house validation support, from protocol design to execution, manufacturing, filling, and related processes
Vials for injection
We have purpose-built facilities and a team of expert scientists in development. Using single-use equipment and flexible setups, we provide aseptic filling for multiple vial formats, ensuring rapid tech transfers without extensive cleaning validations. We have extensive experience filling liquid vials for immunological, gene therapy, and biotech products.
We formulate and aseptically fill sterile plastic bottles for ophthalmic, otic, and nasal applications.
Standard vial filling capabilities (glass vials, ISO 8362) for injectables:
| Vial Size | Drug Product liquid Filling Capacity | |
|---|---|---|
| 2R | Up to 200 L of bulk formulation for vial filling. Batch size based on the fill volume (per unit) | 30.000 vials/batch |
| 6R | 18.000 vials/batch | |
| 10R | 14.600 vials/batch | |
| 30H | 6.600 vials/batch | |
| 50H | 4.300 vials/batch | |
To check compatibility with your specific material or format
Sterile Lyophilized Vials
Our expertise in pharmaceutical lyophilization of biologics is one of our key strengths. Designing the right manufacturing process is critical to meet regulatory requirements and operational efficiency.
We offer lyophilization at both laboratory and industrial scales.
Standard sterile vial lyophilization capacities (glass vials, ISO 8362):
| Vial size | Lyophilization Capacity |
|---|---|
| 2R | 13.800 vials/load |
| 6R | 7.200 vials/load |
| 10R | 6.200 vials/load |
| 30H | 2.700 vials/load |
| 50H | 1.700 vials/load |
Discover how we can support your project with advanced aseptic processes.
Sterile Plastic Bottles
We formulate and aseptically fill sterile plastic bottles for ophthalmic, otic, and nasal applications.
Standard formats:
10 mL
15 mL