Aseptic Transfer for Oncolytic Virus Continuous Production

Industry Trends/Regulatory Requirements:

In biopharmaceutical production, especially for live virus formulations, ensuring absolute sterile containment and preventing cross-contamination are core challenges, which directly impacts drug safety and efficacy.

Regulatory agencies (e.g., NMPA, FDA) have extremely stringent regulatory requirements (e.g., GMP, "Good Manufacturing Practice for Drugs" Annex - Biological Products) that explicitly stipulate:

• Sterility Assurance: Production operations must be conducted in a Grade A clean environment to minimize the risk of microbial, particulate, and pyrogen contamination.

• Cross-Contamination Control: For multi-product campaign manufacturing, effective engineering controls (such as containment systems) must be used for physical isolation.

• Process and Validation: Beyond reliable equipment, the entire manufacturing process must undergo complete validation, supported by detailed documentation to demonstrate compliance.

Project Background：

The client is an innovative pharmaceutical company holding an internationally leading position in the field of oncolytic viruses. Their core product, the oncolytic virus M1, is poised to bring a breakthrough to cancer therapy due to its three major advantages: the convenience of intravenous injection, the outstanding efficacy of targeted treatment, and the high stability of its lyophilized preparation. The client urgently needed to implement continuous manufacturing within a filling isolator, specifically requiring aseptic and contained transfer for various materials.

AUSTAR Solution：

AUSTAR delved deeply into the client's process details and custom-designed a complete set of solutions:

• Efficient Transfer: Provided various RDB（Rapid Docking Bag）configurations to ensure efficient and rapid RTP (Rapid Transfer Port) docking and transfer of materials between the isolator and the pass-through chamber.

• One-Stop Compliance Service：From initial scheme design and equipment implementation to final provision of full-cycle validation documentation support (including IQ/OQ/PQ), we ensure that the entire transfer solution not only meets performance requirements but also fully complies with the regulatory requirements of global agencies.

AUSTAR Value & Client Benefits:

Through close cross-departmental collaboration within AUSTAR and multiple rounds of in-depth technical communication with the client's R&D and production teams, we enabled the enterprise to implement China's first sterile, contained transfer solution featuring an isolator paired with a full range of RTP products.

• Overcoming Industrialization Bottlenecks: We completely resolved the critical challenge of material transfer for live virus formulations in continuous production, clearing obstacles for scaled-up manufacturing.

• Ensuring Compliance and Quality: With a validated and reliable technical solution, we ensured sterility assurance in the production process, significantly reducing compliance risks and providing solid support for drug registration.

• Accelerating New Drug Launch: By guaranteeing the smooth and reliable operation of core production stages, AUSTAR effectively advanced the client’s R&D process for this cutting-edge oncolytic virus drug, paving the way for it to benefit patients sooner.