ADC “Biological Missile” Production Code Series III | Safe Delivery of Highly Potent ADCs: How Silicone Tubing Builds a Robust Contamination Barrier

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As a targeted cancer therapy, antibody-drug conjugates (ADCs) combine the precise targeting capabilities of antibody-based therapeutics with the potent cytotoxic effects of small-molecule drugs. Like a “biological missile,” an ADC can deliver its payload precisely into target cells while minimizing damage to surrounding tissues. As of 2025, more than 20 ADC products have been approved worldwide, making ADCs one of the most active areas of research in the biopharmaceutical industry.

Although the manufacturing processes for antibodies and small-molecule drugs are relatively well established, downstream ADC processing—including conjugation, ultrafiltration, purification, fluid transfer, and fill-finish—often involves the use of organic solvents. This places higher demands on the single-use components used throughout the process. As a common bridging component connecting different process steps, silicone tubing plays an important role in fluid transfer. Ensuring precise and reliable delivery of ADC drug products through silicone tubing is therefore a key consideration.

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Figure 1: BioLink Single-Use ADC Processing Platform

BioLink’s SynaLinX® Platinum Cured Silicone Tubing Series is specifically designed for fluid transfer applications across the entire biopharmaceutical process and strictly complies with GMP requirements and pharmacopoeial standards. As a critical component that comes into direct contact with drug products, the tubing is manufactured and tested in strict accordance with applicable regulatory guidelines and quality requirements throughout the entire product lifecycle, from development and manufacturing controls to final testing.

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A Comprehensive Product Portfolio for Diverse Applications

SynaLinX® Platinum Cured Silicone Tubing Series (TST/MST/HST):

Available in hardness levels ranging from 50A for short-term pumping to 80A for high-pressure transfer at 3–5 bar, the SynaLinX® tubing series offers different performance profiles to cover most fluid transfer applications throughout ADC drug manufacturing.

SynaLinX® Platinum Cured Silicone Pump Tubing (PST):

Specifically designed for peristaltic pumps, PST offers excellent fatigue resistance and can withstand continuous peristaltic pumping for over 100 hours without deformation. Its excellent resilience ensures stable and precise fluid transfer, making it well suited for high-precision filling applications.

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Figure 2: BioLink SynaLinX® Platinum Cured Silicone Tubing Series

Stringent Cleanliness Standards for Enhanced Biopharmaceutical Manufacturing Safety

High-Standard Material Selection: SynaLinX® Platinum Cured Silicone Tubing is manufactured using medical-grade raw material pellets and contains no animal-derived components. It features ultra-low extractables, extremely low adsorption, and excellent biocompatibility. A secondary curing process further minimizes extractables from the tubing, helping ensure the safety of drug manufacturing from the source.

Manufactured in a Cleanroom Environment: SynaLinX® Platinum Cured Silicone Tubing is manufactured in an ISO 14644-1 Class 7 cleanroom and complies with the requirements of the ISO 9001:2015 quality management system and applicable cGMP regulations. Stringent particulate control measures effectively minimize the risk of foreign matter contamination, while bacterial endotoxin levels are strictly controlled at <0.25 EU/mL to minimize the risk of pyrogen contamination.

Multiple Sterilization Options: SynaLinX® Platinum Cured Silicone Tubing supports three commonly used sterilization methods: autoclave sterilization, ethylene oxide (EtO) sterilization, and gamma irradiation, meeting the sterilization requirements of different ADC drug manufacturing processes.

Excellent Compatibility for the Stringent Requirements of ADC Drug Delivery

SynaLinX® Platinum Cured Silicone Tubing is supported by comprehensive validation data. It has successfully passed a full range of biocompatibility tests, including USP Class VI cytotoxicity and ISO 10993 sensitization testing. In addition, detailed BPOG extractables study reports are available to help customers streamline and expedite drug registration and regulatory submissions.

Given the specific characteristics and stringent requirements of ADC manufacturing processes, high concentrations of organic solvents such as DMSO, DMAc, and DMF are commonly used. SynaLinX® Platinum Cured Silicone Tubing has also undergone relevant compatibility validation. The results demonstrate that the tubing can be used reliably for 30 days with organic solvents at concentrations of up to 35%, while it can also meet the requirements for short-term fluid transfer with these solvents at 100% concentration, providing reliable support for the safe and stable manufacturing of ADC drugs.

Conclusion

ADC manufacturing processes are highly demanding. The handling of highly potent drug solutions and organic solvents places stringent requirements on the safety and compatibility of fluid transfer components. As a critical consumable in pharmaceutical manufacturing, BioLink SynaLinX® Platinum Cured Silicone Tubing addresses contamination and stability challenges during ADC drug solution transfer through a comprehensive product portfolio, stringent cleanliness standards, and excellent solvent compatibility.

Meanwhile, its comprehensive compliance and validation framework helps meet the regulatory submission and commercial-scale production requirements of pharmaceutical companies, establishing a robust quality safeguard for fluid transfer and supporting the safe, stable, and scalable manufacturing of ADC drugs.

References

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