LYOMAC, EXPERT ON API LYOPHILIZER PROVIDER

Lyomac, a leader in advanced lyophilization technology, offers next-generation freeze-drying solutions meticulously engineered to meet the unparalleled demands of modern API and sterile intermediate manufacturing. Our freeze dryer is designed not just to remove water, but to preserve the intricate molecular structures and biological activities that define these high-value pharmaceutical assets.

Lyomac able to offer with drying capacity ranging from 4 ~ 2,000 Liters.

The Evolving Landscape of APIs and Sterile Intermediates: Why Freeze Drying is Indispensable

The trend towards sophisticated and often thermolabile pharmaceutical ingredients makes freeze drying an essential processing step. Here are some of the most prevalent and critical API and sterile raw material categories where lyophilization provides an indispensable advantage:

1. Peptide & Oligonucleotide APIs:
   • Products: GLP-1 receptor agonists (e.g., Semaglutide, Tirzepatide precursors), anticoagulant peptides, siRNA, antisense oligonucleotides (ASOs), and various diagnostic oligonucleotides.
   • Challenge: These highly structured molecules are extremely susceptible to thermal degradation and aggregation in liquid form.
   • Lyomac Solution: Our precise temperature control and controlled freezing profiles preserve their delicate secondary and tertiary structures, ensuring high purity, conformational integrity, and extending shelf life.
2. mRNA Vaccine Components & Lipid Nanoparticles (LNPs):
   • Products: mRNA vaccine drug substance precursors, enzymes used in mRNA synthesis (e.g., T7 RNA polymerase), and pre-formed lipid nanoparticle (LNP) components.
   • Challenge: mRNA is notoriously unstable. LNPs, though protective, can also be sensitive to traditional drying. Aseptic conditions are non-negotiable.
   • Lyomac Solution: Our sterile processing capabilities (CIP/SIP, isolator integration) protect against contamination, while gentle lyophilization stabilizes the mRNA and LNP structures, facilitating cold-chain independent storage and transport.
3. Highly Potent APIs (HPAPIs) & Cytotoxic Drugs:
   • Products: Oncology drugs, hormones, and other APIs effective at very low doses.
   • Challenge: Protecting personnel from exposure and preventing cross-contamination, while maintaining product purity and stability.
   • Lyomac Solution: Integrated containment features (closed systems, isolator/RABS interfaces) ensure operator safety and product integrity. The ability to precisely control the amorphous state post-lyophilization can also enhance dissolution and bioavailability.
4. Enzymes, Growth Factors & Cell Culture Media Components:
   • Products: Bioprocessing enzymes (e.g., DNAse, protease), various growth factors (e.g., EGF, FGF), and sterile-filtered cell culture media additives.
   • Challenge: Maintaining biological activity, preventing denaturation, and ensuring sterility for cell culture and bioproduction.
   • Lyomac Solution: Low-temperature, controlled drying cycles preserve enzymatic activity and protein integrity. Sterile filtration prior to lyophilization, combined with aseptic processing, guarantees a contamination-free product essential for cell therapies and biomanufacturing.
5. Blood Derivatives & Plasma Fractions:
   • Products: Albumin, immunoglobulin, coagulation factors (e.g., Factor VIII, Factor IX).
   • Challenge: Preserving the activity of complex protein mixtures and ensuring terminal sterility.
   • Lyomac Solution: Lyomac’s robust and validated systems ensure the stable formulation of these life-saving biologics, supporting long-term storage and global distribution under stringent regulatory requirements.

Lyomac’s Next-Generation Freeze Drying: Engineered for Pharmaceutical Excellence

Lyomac’s advanced freeze dryers are specifically designed with the nuances of API and sterile raw material processing in mind:

1. Unrivaled Process Control for Optimal API Stability:
   • Precision Temperature Uniformity: Our advanced fluid circulation systems maintain shelf temperature uniformity within ±0.5°C, eliminating hot spots and preventing degradation of sensitive APIs during drying.
   • Controlled Freezing & Annealing: Lyomac’s sophisticated control algorithms enable precise management of freezing rates and annealing stages. This is crucial for achieving desired product morphology (e.g., amorphous vs. crystalline states), preventing collapse, and optimizing residual moisture levels, directly impacting API stability and dissolution.
2. Superior Sterility & Containment for Critical Materials:
   • Integrated CIP/SIP Systems: Fully automated Clean-in-Place (CIP) and Sterilization-in-Place (SIP) systems ensure thorough, validated cleaning and sterilization, meeting the highest aseptic processing standards.
   • Aseptic Design & Isolation: Lyomac systems boast smooth internal surfaces, minimal dead legs, and are seamlessly integratable with isolators or Restricted Access Barrier Systems (RABS). This provides robust containment for HPAPIs and maintains aseptic conditions for sterile raw materials and biologics.
   • Hydraulic Vial Stoppering: An in-situ, sterile stoppering mechanism seals vials under vacuum or inert gas, preventing contamination post-drying.
3. Advanced Process Monitoring & Regulatory Compliance:
   • FDA 21 CFR Part 11 Compliant SCADA System: Our Supervisory Control and Data Acquisition (SCADA) system provides comprehensive data logging, audit trails, and user management, ensuring full regulatory compliance and facilitating easy validation.
   • Optional PAT Integration: For high-value APIs, we offer integration with Process Analytical Technology (PAT) tools, such as in-line mass spectrometers and freeze-drying microscopes, allowing for real-time monitoring of critical process parameters and product attributes, optimizing cycle development, and ensuring quality.
4. Customization & Scalability for Diverse Production Needs:
   • Tailored Configurations: Lyomac offers extensive customization options for shelf configurations, chamber sizes, condenser capacities, and temperature ranges, accommodating everything from small-batch R&D to large-scale commercial production of APIs and intermediates.
   • Modular Design: Our modular approach ensures that our solutions can grow with your needs, providing a seamless transition from laboratory development to pilot and full commercial scales.

The Lyomac Advantage: Enabling Pharmaceutical Innovation

By choosing Lyomac, you are partnering with a company dedicated to pushing the boundaries of pharmaceutical freeze drying. We provide:

• Uncompromising Product Quality: Ensuring the integrity, activity, and purity of your APIs and sterile raw materials, all depends on LYOMAC refrigeration, vacuum control precisely.
• Enhanced Operational Efficiency: Optimizing cycle times, reducing energy consumption, and minimizing material loss. which is based on our smart SCADA system
• Regulatory Assurance: Built-in compliance features to navigate complex pharmaceutical guidelines with confidence.
• Expert site support: From initial process development and equipment selection to installation, validation (IQ/OQ/PQ), and ongoing technical support.

Contact Lyomac today to discover how our next-generation freeze-drying solutions can elevate the manufacturing of your advanced APIs and sterile raw materials, ensuring stability, purity, and market readiness.