ASEPTIC FILL FINISH AND LYOPHILIZATION

ASEPTIC PROCESSING

Liof Pharma is a leading CDMO partner, specialized in providing contract development and small/medium scale or personalized aseptic processing and lyophilization manufacturing services, for clinical batches and commercial supply of high value sterile drugs. We are specialized on aseptic filling, especially in biologics and complex injectable formulations. We hold EU GMP authorization for the manufacture of biological medicines: small volume liquids and lyophilized products.

PROCESS DEVELOPMENT

Liof Pharma offers contract process development and preclinical supply services including flexibility on the manufacturing of small batch size pilot lots for preclinical trials for efficacy and safety, as well as other complementary studies for technology scale up.

We have extensive experience working with complex substances such as biologics, including monoclonal antibodies, peptides, RNA, other proteins, adenovirus, etc.

We also provide feasibility studies, cycle optimization, engineering batches and stability, clinical and validation batches. We can provide all in-house validation support, from protocol design to execution, manufacturing, packaging, and related processes.

VIALS FOR INJECTION

Combining a purpose-built facility and experienced development scientists, we work with disposable equipment and have a flexible set up to handle multiple formats of vials for injection and to ensure fast and flexible technical transfers, without the need for extensive cleaning validations.

Our standard formats are 2R, 6R, 10R, 30H and 50H glass vials, according to standard ISO 8362. For more information or verification of our capabilities with your specific material/format, contact us!

STERILE PLASTIC BOTTLES

We are able to formulate and aseptically fill sterile plastic bottles (eye drop type, otic, nasal…).

Our standard formats are 10 mL and 15 mL plastic bottles. For more information or verification of our capabilities with your specific material/format, contact us!

LYOPHILIZED STERILE VIALS

Our pharmaceutical CDMO service of lyophilized sterile vials of drugs and biologics, is one of our areas of expertise. Knowing how to design an appropriate manufacturing process is critical for both regulatory and efficiency purposes. We are one of the most experienced companies in pharmaceutical lyophilization of immunological products, gene therapy products and biotechnology products.

Lab scale and industrial lyophilization available.

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