Our Medication Product Range

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Our laboratory in India provides world-class expertise in lyophilization product and process development. We take pride in the consistent delivery of parenteral products as economical and rapid as possible. At Area Life Sciences, we have experts in lyophilization rigorously trained to achieve excellence. 

LYOPHILIZATION (Cake Forms Parenterals) 

Lyophilization – Freeze -Drying -is a crucial enabling process technology for many important parenteral drugs. Close to 60 percent of biopharmaceuticals, including enzymes, proteins, hormones, and monoclonal antibodies, must be lyophilized as these therapeutic agents are insufficiently stable for ready-to-use solution dosage forms. In solution, many drugs substances are susceptible to even modest changes in temperature and chemical environment. These complex molecules undergo hydrolytic, oxidative, and aggregation reactions, compromising both potency and safety. Consequently, parenterals must often be distributed "Cold-Chained"-refrigerated or maintained frozen from manufacturing line to patient. Even then, freezing and/or thawing may cause some proteins to aggregate. Lyophilization overcomes poor stability by rendering labile drugs and proteins in a solid form more tolerant of long-term product storage. 

Lyophilization extends the shelf life of drugs and biologicals, preserving their chemical and biological properties. It involved less cumbersome storage and handling. Lyophilization reduces the temperature requirement for shipping and protects the biologicals’ vitality. Compared with other methods, lyophilization dries biological at lower temperature, reducing the damage to the product and retaining the molecular integrity. Our manufacture provides world-class expertise in lyophilization product and process development, and prides itself on consistent delivery of parenteral products as economical and rapid as possible.  Lyophilization is a costly, complex, and facility-intensive operation that many companies do, but few do well. We employ scientists rigorously trained in lyophilization science, making us ideally equipped to achieve excellence. Lyophilization process validation at our manufacture not only includes assurance of the meeting of all physical and chemical requirements of the lyophilized dosage form, but also includes the maintenance of sterility in transferring product and during the free-drying cycle itself. With so many competencies for developing, manufacturing, and validating robust lyophilized products. Our manufacture Contract Manufacturing Services (CMS) have become the avenue of choice for many marketers, both large and small, with developmental, clinical and commercial stage lyophilization products. 

ADVANTAGES OF LYOPHILIZATION 

Product is stored in dry Product is dried without elevated temperatures It is good for oxygen and air sensitive drugs Rapid reconstitution Constituents of dried drugs are homogeneously dispersed Sterility of the product can be achieved and maintained 

LYOPHILIZER FEATURES 

• 9.5 Sq. Mtr Lyophilizer with capacity of 50000 vials in single batch 
• 1.5 Sq. Mtr Lyophilizer with capacity of 5000 vials in one cycle
• Validated and standardized cycles as per product Eutectic temperatures 
• Fully automatic process control Hydraulic stoppering device Clean In Place (CIP) cleaning system 
• Steam In Place (SIP) 
• Steam sterilization system (D Version) 
• Vaporized Hydrogen Peroxide (VHP) sterilization system 
• Batch loader / un-loader for bulk products in trays 
• Systems applying isolator and containment technology 
• Products and documentation to meet FDA regulations and in compliance with GLP, cGMP, and GAMP guidelines