GMP-Qualified Manufacturing Technology
TirzPharm's production facilities are equipped with cutting-edge technology for solvent supply, peptide synthesis, purification, and the isolation of active ingredients and intermediates. With GMP-compliant equipment and validated cleaning procedures, you can be confident in receiving consistent excellence in every batch.
Peptide and oligonucleotide synthesis (“Upstream”)
Our diverse capabilities, expert advice, and dedication to quality guarantee smooth scalability, enhanced equipment utilization, and improved efficiency throughout the production process. Collaborating with TirzPharm provides you with:
Diverse production capabilities: This includes solution-phase and solid-phase synthesis reactors, along with innovative methods such as Molecular Modifications.
Smooth scalability: Effortless scalability is achievable with solution-phase reactors reaching up to 8000 litres and solid-phase peptide synthesis (SPPS) reactors up to 500 litres. Larger options are currently under development, with a new facility in Bubendorf offering sizes up to 1000 litres.
Enhanced equipment: Rely on our GMP-qualified equipment, which includes OligoPilot synthesizers and custom-designed cleavage and deprotection equipment trains, ensuring precise control and safety when handling hazardous reagents.
Improved efficiency and quality: Our sophisticated automation and data management systems, featuring a Manufacturing Execution System and a process data historian, enhance efficiency and guarantee superior quality.
Dedication to quality: By adhering to Quality by Design principles and incorporating in-process controls and process analytical technology, we consistently achieve high-quality outcomes.
Purification and Isolation of Peptides and Oligonucleotides
TirzPharm is committed to the ongoing enhancement and modernization of its purification equipment to satisfy the increasing demand for bulk peptide and oligonucleotide pharmaceuticals. In addition, our team will offer you:
Advanced purification methods: Employ a variety of advanced purification techniques, such as preparative high-performance liquid chromatography (HPLC), ion exchange (IEX), size-exclusion chromatography (SEC), and ultra-filtration (UF/TFF). Scalable manufacturing: Our equipment facilitates highly efficient or continuous production of ultra-pure products in multi-kg quantities per batch.
Precise control and scalability: Dynamic axial compression (DAC) stainless steel columns with diameters of up to 60 cm guarantee optimal performance during the separation phase. Stringent microbiological control: ISO 8 and ISO 7 clean rooms equipped with HEPA-filtered air uphold rigorous microbiological control standards.
Safety measures: Down-flow booths reduce microbial contamination, and highly active pharmaceutical ingredients are managed in safety workbenches or isolators rated up to OEB level 4.
Controlled isolation: Meticulously controlled isolation processes, including precipitation, crystallization, and lyophilization of intermediates and final active pharmaceutical ingredients (API), ensure that predefined physicochemical properties are achieved. Multiple lyophilisers for quality assurance: A range of lyophilisers of different sizes ensures product integrity and quality across all batches.