Contract Manufacturing Organization CMO
Contract Manufacturing Organization
Contract Manufacturing Organization
CMO | Contract Manufacturing Organization
Biomanufacturing Technology with Unmatched Flexibility & Technology
Fast and safe original drug production through full single-use system
• Faster production
• Higher flexibility
• Reduced Risk of Cross-contamination
• Reduced water consumption
• Reduced energy consumption
• Improved Process Efficiency
ALITA Smart BioFactory Technology is a technology brand based on patented bioengineering technologies that Prestige Biologics is applying to all plants 1, 2, 3, and 4 at various levels. It is an ‘innovative technology model that is still growing’ that continuously researches and introduces flexible and feasible innovative production technologies to production sites.
ALITA Smart BioFactory™ is a future-oriented engineering model that breathes new imagination into the bio-production process with the goal of innovation that can contribute to the biopharmaceutical industry, innovation that can be realized, and innovation that can be applied in the field.
In order to support the successful production and delivery of our customers’ biopharmaceuticals, we are in the process of predictive modeling of improved engineering technology from the engineering point of view and applying it to the actual production site of Prestige Biologics. By repeating this challenging innovation process, we will be able to respond more quickly and rationally to the changing future needs of the CDMO market.
ALITA Smart BioFactory technology is the ‘DNA of innovation‘ to continue the vocation of ‘Innovation for Life‘ that Prestige Biologics aims for. It is part of innovation that supports the belief that the sustainability of technology companies is unlocked through continuous innovation in technology.
CDEMO service that contains the DNA of innovation in CMO and CDMO
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.
Clinical sample production | CMO
• EU GMP facility supporting clinical phases 1, 2 and 3
• Single use system
• GMP-based DS and DP stability studies
• Pharmaceutical analysis service
• Process characterization analysis service
• Analytical method validation
• Process validation
Clinical DP Filling System | CMO
• Fully automated powerful control system that controls contamination by operator intervention
• Systems that support small-scale deployment and clinical-stage development
• Vial and Pre-Filled Syringe Production
Commercial production | CMO
• Analytical Technology Transfer
• Engineering run
• Process Performance Qualification (PPQ)
• Gap Analysis
Storage depot and robotic system
• Robotic storage system under GMP complied facilites.
• GDP certificated storage management
• Biopharmaceutical Depot for materials, finished products, clinical drugs including CPO services
• 2℃ ~ 8 ℃ Cold Storage
• -15 ℃ ~ -25℃ Freezing Storage
• Temperature control system operation according to GMP regulations
Commercial DP Filling System | CMO
• Self-cleaning filling and sealing system to minimize operator contamination.
• Securing high-quality charging facilities with the RABS control system equipped with an automatic foreign body inspection device.
Hybrid System Biopharmaceutical Manufacturing Facility
Prestige Biologics adopted the Full Single-Use System for the first time in Korea and established a GMP production facility.
In order to respond to the rapid demand for medicines in the market, we adopted single-use technology instead of traditional stainless steel, which controls cross-contamination, shortens the cleaning time between batches, and optimizes batch production efficiency.
Using this flexible production system, we support clinical and commercial production quickly and easily.
Producing ability
| Classification | Manufacturing Capacity | |
|---|---|---|
| Campus 1 | P1 (Pioneer) | 6,000 L (2,000 L) |
| 400L (200L) | ||
| P2 (Frontier) | 28,000 L (2,000 L) | |
| Campus 2 | P3 (Voyager) | 88,000 L (2,000 L) |
| P4 (Adventure) | 32,000 L (2,000 L) | |
Open-door Policy for customer
Prestige Biologics is committed to fostering close collaboration through transparent information sharing in order to provide customer-centric services. We adopt an open-door policy to swiftly address key issues that arise during development and production, and we fulfill the role of a partner to successfully achieve shared goals.
Through our customer service objective of “Growth through Openness,” we believe that we will develop advanced technology and fulfill our mission to contribute to the lives of patients.
From clinical development to commercial production
Prestige Biologics provides various services such as analysis service, clinical development, clinical sample production, clinical secondary packaging (double-blind packaging), process development, and commercial production. We respond flexibly to the needs of customers of various needs, such as CDO, CPO, CMO, and CEO. We are also always open to partnerships that develop potential.
