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Manufacturing Process

The overall manufacturing process of Ropeginterferon alfa-2b (P1101) Drug Substance (DS) is divided into the upstream process and the downstream process. In addition, the process control strategy was established to ensure the consistency in production. This well-developed process was also validated in 2014. Moreover, the specifications of Ropeginterferon alfa-2b were set and validated in term of the product quality control.

Critical Equipment

Fermentor

The 40-L stainless steel fermenter is equipped in the PEC Taichung site. The fermenter is both a compact bioprocess system available in microbial fermentation and a versatile sterilizable-in-place (SIP) multi-use system. The manufacturing process can be controlled by the built-in software and optional supervisory software. This fermentation system is used to produce protein drug Active Pharmaceutical Ingredient (API).

Protein Purification System

The Protein Purification System equipped in the PEC Taichung plant is an automated liquid chromatography system built for process scale-up and large-scale biopharmaceutical manufacturing. This purification system can be configured to develop gradients at any flow rate with feedback loop technology. The built-in computer with UNICORN software allows standalone operation or integration into any plant-wide control system.

HVAC system

The overall function of the HVAC system is to provide an adequate and controllable environment and ultimately protect the quality of the products in the GMP facility. The air is supplied into the office area, the CNC area (Controlled-Non-Classified zone), and the Grade C and Grade D areas. Air supply, temperature, humidity, pressure drop, air change rate and recirculation rate for the HVAC system are designed according to the process needs and the regulation requirements.

Water system

Water-For-Injection (WFI) is used to produce Ropeginterferon alfa-2b. The regular monitoring program is executed and the specification for WFI has to meet USP/EP requirements.

Other relevant utilities

Other utilities in the Taichung GMP Plant are power supply systems, pure steam, compressed dry air, and gas systems. These utilities are also qualified and validated.