Advanced Tubing Solutions for Peptide Drug Manufacturing

Optimized for semaglutide processing with low extractables, high durability, and superior material compatibility.

Introducing the rapid growth of peptide therapeutics has brought increased attention to the materials used in pharmaceutical manufacturing systems. Among these therapies, semaglutide has emerged as a leading treatment for type 2 diabetes and obesity. However, its peptide-based structure and formulation complexity require careful handling throughout processing.
While much focus is placed on formulation and active ingredients, fluid transfer systems—especially tubing—play a critical role in maintaining product quality. Inadequate tubing materials can lead to adsorption, contamination, or chemical incompatibility, ultimately affecting drug stability and process efficiency.

Challenges in Semaglutide Processing
Semaglutide presents several challenges during manufacturing due to its physicochemical properties:
• Surface adsorption: Peptide molecules may adhere to polymer surfaces, leading to drug loss
• Aggregation risk: Surface interaction and shear stress can induce aggregation
• Sensitivity to materials: Contact surfaces can influence stability and potency
Additionally, semaglutide formulations typically include approximately 0.55%
Phenol as a preservative.
Phenol introduces further complexity because it can:
• interact with polymer matrices
• extract additives or plasticizers
• affect tubing integrity over time
These factors make material compatibility a key consideration in tubing selection.

Imaliner® Tubing: Engineered for Biopharmaceutical Applications
To address these challenges, Imaliner tubing, developed by Ami Polymer Pvt. Ltd., offers a specialized solution for pharmaceutical fluid transfer.
Imaliner tubing features a bi-layer thermoplastic elastomer (TPE) construction, combining:
• Inner layer: Smooth, inert, low-friction surface
• Outer layer: Mechanically robust, abrasion-resistant elastomer
This dual-layer design allows the tubing to provide both chemical compatibility and mechanical durability, which are essential in modern biopharmaceutical manufacturing.

Minimizing Peptide Adsorption
One of the most critical factors in handling peptide drugs is reducing interaction with contact surfaces.
The ultra-smooth inner lining of Imaliner tubing helps:
• minimize adsorption of semaglutide molecules
• maintain consistent drug concentration
• reduce variability in dosing
By limiting surface interaction, the tubing supports better process control and product consistency.

Compatibility with Phenol-Containing Formulations
The presence of phenol in semaglutide formulations requires tubing materials that are chemically stable.
Thermoplastic elastomers used in Imaliner tubing are designed to:
• Exhibit minimal swelling in dilute phenol concentrations (~0.55%)
• maintain low extractables and leachables profiles
• resist chemical degradation during prolonged exposure
This ensures that both the active drug and preservative remain stable, which is essential for maintaining formulation integrity and meeting regulatory expectations.

Mechanical Performance in Processing Conditions
Biopharmaceutical manufacturing involves dynamic conditions such as pumping, bending, and continuous fluid flow.
Imaliner tubing is engineered to withstand these demands, offering:
• high flex-crack resistance for repeated bending cycles
• durability under peristaltic pump operation
• low spallation, reducing the risk of particle contamination
• consistent internal diameter for accurate and reliable fluid transfer
These features make it suitable for both batch and continuous processing systems.

Applications in Semaglutide Manufacturing
Imaliner tubing can be effectively used across multiple stages of semaglutide production:
1. Bulk drug substance transfer
2. Buffer preparation and formulation mixing
3. Sterile filtration processes
4. Aseptic filling operations
5. Sampling and analytical workflows
Its compatibility with single-use systems also supports modern manufacturing approaches focused on flexibility and contamination control.

Advantages Over Conventional Tubing
Compared to traditional materials such as PVC and silicone, Imaliner tubing offers:
• lower peptide adsorption
• improved chemical resistance
• reduced extractables and leachables
• enhanced mechanical durability
• better performance under continuous pumping
These advantages contribute to higher process reliability and improved product quality.

Conclusion
As the demand for peptide therapeutics continues to grow, the importance of material selection in fluid transfer systems becomes increasingly evident.
For sensitive formulations like semaglutide, tubing is not just a passive component—it is a critical factor influencing stability, efficiency, and compliance.
Imaliner® tubing from Ami Polymer Pvt. Ltd. provides a well-engineered solution by combining:
• reduced drug–surface interaction
• compatibility with phenol-containing formulations
• robust mechanical performance
These characteristics position it as a valuable option for biopharmaceutical manufacturers seeking reliable and high-performance tubing solutions.

Final Insight
In advanced pharmaceutical manufacturing, even the smallest components can have a significant impact.
And when it comes to semaglutide processing, the right tubing can make all the difference.