CMO

Contract Manufacturing Organization

Contract Manufacturing Organization
CMO | Contract Manufacturing Organization

Prestige Biologics operates a full single-use manufacturing system, minimizing the risk of cross-contamination while significantly improving product changeover efficiency. This manufacturing platform is designed to flexibly accommodate a wide range of product characteristics and batch sizes.

In particular, Plant 4 features the ALITA SMART BIOFACTORY™ hybrid system, where the upstream process utilizes single-use technologies and the downstream process is equipped with stainless steel facilities. This configuration enables both operational flexibility and reliable large-scale manufacturing capabilities.

Beyond adopting advanced manufacturing technologies, Prestige Biologics focuses on enhancing manufacturing efficiency, process flexibility, and product quality through engineering-driven improvements and predictive modeling that can be validated and implemented in real production environments.

CDMO Services Driven by a DNA of Innovation

The fast-changing pharmaceutical environment makes it difficult to accurately forecast demand. Prestige Biologics' CDEMO service utilizes ALITA Smart BioFactory™, a proprietary technology for customized engineering solutions, to provide customized manufacturing suites for customers' products.

01

Development

  • Establish manufacturing strategy and comprehensive development roadmap during early-stage development
  • Develop scale-up strategy for transitioning research-scale processes to commercial manufacturing
  • Development and validation of quantitative and qualitative analytical methods for product characterization
  • Formulation design aligned with the target product profile (TPP)
  • Establishment of cell culture-based upstream processes and purification-focused downstream processes
  • Technology transfer for transition of established processes to GMP manufacturing
02

Drug Substance

  • Drug substance manufacturing for clinical and commercial supply
  • Process validation to ensure process consistency and reproducibility
  • GMP-compliant batch production and process operation
03

Drug Product

  • Drug product manufacturing for clinical and commercial use
  • GMP-compliant Fill & Finish process operation and process validation
  • Comparability studies to ensure quality consistency upon process changes
04

Analytical Testing

  • Analytical method validation to ensure accuracy and reliability
  • In-process testing for quality control during manufacturing
  • Batch release testing for lot disposition
  • Stability testing to verify ongoing product quality
05

Clinical Secondary Packaging & Labeling

  • Global regulatory-compliant labeling and relabeling
  • Batch-level clinical packaging designed to support double-blind clinical trials
  • GMP-compliant Master Batch Record and process control
06

Storage

  • Temperature-controlled storage across multiple ranges (15–25℃ / 2–8℃ / −80℃ ~ −15℃)
  • Long-term cell bank (MCB/WCB) storage in liquid nitrogen (LN₂) tanks
  • Comprehensive storage management system with temperature monitoring, access control, and record management
07

Distribution

  • Domestic and global logistics infrastructure
  • Cold chain logistics management tailored to product requirements
  • End-to-end distribution system ensuring product integrity and traceability throughout transit