CDO

Contract Development Organization

Contract Development Organization

Prestige Biologics provides Contract Development Organization (CDO) services, supporting the full lifecycle of drug development from early nonclinical development through commercial manufacturing.

CDO services include Master Cell Bank manufacturing, as well as process technology development for upstream and downstream processes. The company also develops a range of analytical methods tailored to each product and process.

1. USP and DSP development

Prestige Biologics supports the seamless transition of partners’ biopharmaceutical candidates from the research stage to commercial manufacturing through upstream process (USP) and downstream process (DSP) development.

Based on its proprietary technologies and extensive experience, the company also provides optimized processes designed to ensure productivity, cost-effectiveness, and quality.

1-1. Upstream process development

Prestige Biologics develops upstream processes designed to achieve cost-effective and highly productive cell culture operations.

Method for Manufacturing Antibodies Through Glycan Content Control

This technology is based on the first identification that glycerol can increase the afucosylated content of antibodies, and enables the regulation of antibody glycan content using manganese and uridine. Through this approach, a high-quality target antibody population can be manufactured consistently. In addition, the cell culture process is simplified, offering improved efficiency in terms of both time and cost.

  • 5
    Design of Experiment (DoE) Studies
  • 5
    Media/Feed Development
  • 5
    Strategy Development

1-2. Downstream process development

Prestige Biologics develops optimized downstream purification processes.

Non-Protein A purification process for antibodies.

  • 5
    Design of Experiment (DoE) Studies
  • 5
    Resin Screening
  • 5
    UF/DF Development
  • 5
    Determination of In-Process Control and In-Process Testing (IPC & IPT) Conditions

Protein A purification process vs Non-Protein A purification process

Protein A Purification Process
Non-Protein A Purification Process

Detailed purification steps may vary depending on the product.
Chon and Zarbis-Papastoitsis, 2011; Pinto et al., 2015; Xenopulos, 2015)

2. Analytical Method Development

Analytical methods tailored to process and product characteristics are established to evaluate the various quality attributes required throughout drug development. Purity and impurity analyses are also performed to ensure product quality consistency and reliability.

3. Non-GMP DS & DP Manufacturing and IND Filing Support

Continuous control is maintained over R&D and manufacturing processes related to DS and DP product quality, supporting systematic management across the drug development process. Development data required for IND filing are also provided, enabling stable drug development through support for regulatory submission documentation.