Liof Pharma
European CDMO specializing in aseptic fill-finish and lyophilization of sterile biologic medicinal products. Services cover formulation, small-to-medium clinical and commercial GMP manufacturing, analytical quality control, process development and cold-chain distribution. The company reports >15 years of experience and compliance with international regulators (EMA, FDA, ANVISA, AEMPS, among others).
Industries
Nr. of Employees
small (1-50)
Liof Pharma
Products
Quality Control
Comprehensive quality control services ensuring the quality of manufactured drug products, raw materials, packaging materials, and bulk solutions through rigorous testing and compliance with international standards.
GMP analytical quality control
Quality assurance and regulatory compliance services covering the entire product lifecycle with a strong focus on patient safety.
Formulación y Fabricación Avanzada
Servicios de llenado aséptico y liofilización con cumplimiento cGMP para fabricación clínica y comercial de lotes pequeños y medianos, especializados en biológicos complejos y terapia génica.
Aseptic Filling of Biological Medicinal Products
Comprehensive CDMO solutions for the aseptic manufacturing of high-value sterile medicinal products including vials for injection, plastic eye-dropper bottles, and vial lyophilization.
Viales para Inyección
Servicio de llenado aséptico de múltiples formatos de viales de vidrio para inyección con equipos desechables y configuración flexible.
Clinical and Commercial Manufacturing
Comprehensive aseptic fill-finish and lyophilization manufacturing services for clinical (Preclinical, Phase I-III) and commercial supply, specializing in complex substances such as biologics, monoclonal antibodies, peptides, and proteins.
Quality Control
Comprehensive quality control services ensuring the quality of manufactured drug products, raw materials, packaging materials, and bulk solutions through rigorous testing and compliance with international standards.
GMP analytical quality control
Quality assurance and regulatory compliance services covering the entire product lifecycle with a strong focus on patient safety.
Formulación y Fabricación Avanzada
Servicios de llenado aséptico y liofilización con cumplimiento cGMP para fabricación clínica y comercial de lotes pequeños y medianos, especializados en biológicos complejos y terapia génica.
Aseptic Filling of Biological Medicinal Products
Comprehensive CDMO solutions for the aseptic manufacturing of high-value sterile medicinal products including vials for injection, plastic eye-dropper bottles, and vial lyophilization.
Viales para Inyección
Servicio de llenado aséptico de múltiples formatos de viales de vidrio para inyección con equipos desechables y configuración flexible.
Clinical and Commercial Manufacturing
Comprehensive aseptic fill-finish and lyophilization manufacturing services for clinical (Preclinical, Phase I-III) and commercial supply, specializing in complex substances such as biologics, monoclonal antibodies, peptides, and proteins.
Services
Contract formulation and aseptic manufacturing services for clinical and commercial batches under cGMP, including sterile filtration, filling and lyophilization where required.
Aseptic fill–finish for liquid and lyophilized products, process development, pilot- and validation-batch production and lyophilization at laboratory and industrial scales.
Microbiology, biochemistry, bioassays and physicochemical analyses; stability study design/execution per ICH; analytical method development, transfer and validation to meet ICH/FDA/EMA guidelines.
Validated cold-chain storage and distribution of final drug product to clinical sites or commercial distributors, integrated with manufacturing services.
Tailored regulatory CMC recommendations and project-specific advisory services to support development and regulatory submissions.
Qualified Person service to confirm and certify batches and to oversee compliance with clinical trial and commercialization authorizations.
Contract formulation and aseptic manufacturing services for clinical and commercial batches under cGMP, including sterile filtration, filling and lyophilization where required.
Aseptic fill–finish for liquid and lyophilized products, process development, pilot- and validation-batch production and lyophilization at laboratory and industrial scales.
Microbiology, biochemistry, bioassays and physicochemical analyses; stability study design/execution per ICH; analytical method development, transfer and validation to meet ICH/FDA/EMA guidelines.
Validated cold-chain storage and distribution of final drug product to clinical sites or commercial distributors, integrated with manufacturing services.
Tailored regulatory CMC recommendations and project-specific advisory services to support development and regulatory submissions.
Qualified Person service to confirm and certify batches and to oversee compliance with clinical trial and commercialization authorizations.
Expertise Areas
- Aseptic fill–finish
- Lyophilization (freeze-drying)
- Clinical and commercial GMP manufacturing
- Process development and scale-up
Key Technologies
- Aseptic filling
- Lyophilization (freeze-drying)
- Single-use systems
- Restricted access barrier systems (RABS)