CDMO

Research and Development Polaris Pharmaceuticals
DesigneRx Pharmaceuticals - Chengdu

  • Founded in 2013, the company covers an area of about 490,000 sq. ft. in the Chengdu High-Tech Industrial Development Zone, Sichuan Province.

    At present, we are actively building a world-class large-scale cGMP biopharmaceutical manufacturing facility.

    Services and Solutions

    • Research and Development
    • Microbial
    • Mammalian
    • Gene & Cell Therapy
Contract Development and Manufacturing Organization (CDMO)
  • At Polaris we have a complete state of the art biopharmaceutical manufacturing facility, and all manufacturing processes (from cell bank production through to fill and finish) are performed in-house .
  • At Polaris we have broad in-house Quality Control and Quality Assurance capabilities to ensure compliance, consistency, quality, and safety during the manufacturing of drug product.
  • At Polaris we design and implement customer-specific processes, matching the development stages with commercial viability and product lifecycles in mind.
  • At Polaris Development and Preclinical activities are executed as non-GMP studies.
  • At Polaris Early Clinical Manufacturing is supported using qualified methods and processes following cGMP guidelines and practices.
  • At Polaris, our flexible approach to, and utilization of, stage appropriate activities results in early-stage cost savings. This provides assurance of the compliance of all regulatory support necessary in successfully establishing program advancements in both late stage and commercial cGMP manufacturing.

Research and Development

Process Development

  • Cell line development
  • Upstream process optimization
  • Downstream process optimization
  • Process scalability testing

Comparability Study Platform

  • Process performance comparison
  • Lot release data comparison
  • Extended characterization (side-by-side)
  • Stability data comparison (long-term and accelerated)
  • Forced degradation data comparison (side-by-side)

Drug Substance cGMP Manufacturing

Cell Banking Service

  • Cell Bank Generation and Storage

Fermentation

  • Separate Upstream Manufacturing Area
  • Single-Use Bioreactors/Fermentors
  • Batch Centrifuge and Microfluidics Microfluidizer
  • Harvest and Holding Vessels

Purification

  • Separate Downstream Manufacturing Area
  • Chromatography and Tangential Flow Filtration (TFF) Systems
  • Dedicated Column Packing Area
  • Single-Use Buffer Preparation Tanks

Drug Product Formulation, Fill and Lyophilization

Polaris can provide you with exceptional fill-finish operations and all necessary elements required for the delivery of high-quality parental products for clinical needs.

cGMP Formulation, Fill and Lyophilization

  • cGMP Compliant Fill-Finish Suite
  • Aseptic Filling Line with Isolator System
  • Lyophilizer (Freeze Dryer)
  • In-house Visual Inspection and Labeling

Quality

Quality Assurance

  • At Polaris, our drug products are produced following Current Good Manufacturing Practices (cGMP). Our experienced Quality Assurance Team is efficient and experienced in the release of drug product components, intermediates, and final products, and complies with all appropriate regulations.

Quality Control

  • Analytical method development capabilities
  • Process intermediate microbial property testing abilities
  • Able to test microbiological properties of process intermediates
  • Able to perform stability testing
  • Able to perform testing for product strength, potency, identity, purity, and safety
  • Able to effectively monitor the quality of manufacturing areas and utility systems
  • Able to test microbiological properties of process intermediates

Analytical Services

Stability Assay/Method Development and Testing

  • Stability storage at multiple temperatures and time points
  • Continuous chamber monitoring
  • Emergency power system

Raw Material Testing

  • Sterility
  • Bioburden

Developability Study Services

In-process CMC Development Services

Lot Release Method Development and Testing

Process Equipment (DS USP) Installation

Single-Use Bioreactors/Fermentors

Batch Centrifuge and Microfluidics Microfluidizer

Process Equipment (DS DSP) Installation

Chromatography System and Chromatography Column

TFF System (UF/DF)

Process Equipment (DP) Installation

Aseptic Filling Line with Isolator System

Lyophilizer (Freeze Dryer)

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