CPO

Contract Packaging Organization

Contract Packaging Organization | CPO

Prestige Biologics provides secondary packaging services for investigational medicinal products. Integrated support is available throughout clinical trial operations, encompassing labeling, packaging, storage, and transportation.

Through flexible operations tailored to customer requirements, investigational medicinal products are carefully managed to ensure reliable supply to clinical trial sites.

In addition, operations conducted within GMP- and GDP-certified facilities, together with a systematic quality management system, ensure the safety and reliability of investigational medicinal products.

Receipt of IP and Packaging Materials

QC Testing of Packaging Materials

Secondary Packaging
De-labeling & Re-labeling

IP Storage

IP Transportation

Refrigerated Pharmaceutical Storage Facility

IPs received from customers are systematically stored and managed under appropriate temperature-controlled conditions in accordance with GMP requirements.

Secondary packaging operations are performed in accordance with SOPs and quality control procedures established in consideration of the characteristics and storage conditions of each IP.

Secondary Packaging

Packaging processes are thoroughly established, documented, and operated in accordance with customer-specific requirements and project characteristics. Reliable services are provided through pre-operation training, work record management, and systematic quality control procedures.

A range of secondary packaging operations for clinical trials is also supported, including de-labeling and re-labeling of comparator medicinal products.

Clinical Supply and Cold Chain Services

Supply and transportation services are provided in accordance with the storage conditions required for each IP.

Reliable supply to domestic and international clinical trial sites is supported through qualified vendor management, with appropriate temperature conditions maintained throughout transportation.

Temperature monitoring is performed throughout the transportation process, and the relevant data are provided upon completion of delivery.

CPO Service

Packaging of IP requires flexible operations tailored to the specific requirements and supply plan of each clinical trial.

Prestige Biologics provides customer-tailored secondary packaging services for a wide range of IP used in clinical trials.

Secondary Packaging

  • N
    Customer-Tailored Packaging
  • N
    De-labeling & Re-labeling
  • N
    Production of Labels in Various Formats and Languages

Storage

  • N
    Controlled Storage under Appropriate Temperature Conditions
  • N
    Operation of Validated Storage Facilities
  • N
    EMS-Based Temperature Monitoring
  • N
    Temperature Data Recording and Management

Distribution

  • N
    Cold Chain Transportation Support
  • N
    Supply to Domestic and International Clinical Trial Sites
  • N
    Temperature Monitoring and Management
  • N
    Securing Qualified Vendors

GMP Compliance

  • N
    GMP System Management Framework
  • N
    SOP-Based Operational Management
  • N
    Work Record Management and Documentation
  • N
    Implementation of Quality Control Procedures

Expertise

  • N
    Customer-Tailored Services
  • N
    Real-Time Project Response Capabilities
  • N
    Packaging Solutions Compliant with GMP Requirements

Facility

  • N
    GMP- and GDP-Certified Facilities
  • N
    Packaging Operations Infrastructure
  • N
    Temperature Management System
  • N
    Quality Management System

Global-Standard Storage Services
GDP Depot within GMP-Certified Facilities

Prestige Biologics provides storage services in compliance with GMP and GDP requirements.

Storage systems are operated under controlled ambient (15–25°C), refrigerated (2–8°C), and frozen (-25 to -15°C) conditions according to the characteristics of pharmaceutical products and raw materials. A systematic management process has also been established in accordance with quality management requirements.

Ultra-low temperature storage services utilizing liquid nitrogen tanks are also available for Cell Bank storage, enabling management tailored to the specific characteristics and requirements of each sample.

Storage conditions are continuously monitored through temperature monitoring systems and quality management procedures, while operational services are provided in accordance with customer requirements and supply schedules.

Supported by a logistics infrastructure strategically located within Korea’s major distribution network, efficient supply operations are provided for both domestic and international customers. Transportation and logistics services are also supported through a network of qualified vendors.